A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus

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ClinicalTrials.gov Identifier: NCT02804763

Recruitment Status : Completed

First Posted : June 17, 2016

Results First Posted : June 30, 2021

Last Update Posted : June 30, 2021

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Sponsor:

Information provided by (Responsible Party):

UCB Pharma ( UCB Biopharma S.P.R.L. )

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition	Systemic Lupus Erythematosus (SLE)
Interventions	Drug: Placebo Drug: Dapirolizumab pegol (DZP)
Enrollment	182

Participant Flow

Recruitment Details

The study started to enroll patients in June 2016 and concluded in November 2018.

Pre-assignment Details

The study included a 4-week Screening Period, a 24-week Double-Blind Treatment Period and a 24-week Observational Period.

Participant Flow refers to the Randomized Set.


Arm/Group Title	SOC + Placebo iv Q4W	SOC + DZP 6mg/kg iv Q4W	SOC + DZP 24mg/kg iv Q4W	SOC + DZP 45mg/kg iv Q4W
Arm/Group Description	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6 milligrams (mg)/kilogram (kg) intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
Period Title: Double-Blind Period (Week 1 to Week 24)
Started	45	45	45	47
Completed Week 24	44	45	44	45
Finished Wk24 Began Observational Period	44	44	44	45
Completed	44	44	44	45
Not Completed	1	1	1	2
Reason Not Completed
Adverse Event	1	0	0	0
Withdrawal by Subject	0	0	1	2
Consent withdrawal after Week 24	0	1	0	0
Period Title: Observational Period (Wk 24 to Wk 48)
Started	44	44	44	45
Completed	38	43	41	42
Not Completed	6	1	3	3
Reason Not Completed
Lost to Follow-up	2	0	1	1
Withdrawal by Subject	4	0	2	2
Patient moved out of state	0	1	0	0

Baseline Characteristics

Arm/Group Title		SOC + Placebo iv Q4W	SOC + DZP 6mg/kg iv Q4W	SOC + DZP 24mg/kg iv Q4W	SOC + DZP 45mg/kg iv Q4W	Total Title
Arm/Group Description		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	[Not Specified]
Arm/Group Description		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6 milligrams (mg)/kilogram (kg) intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.	[Not Specified]
Overall Number of Baseline Participants		45	45	45	47	182
Baseline Analysis Population Description		...
Baseline Analysis Population Description		Baseline Characteristics refer to the Safety Set which consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug.
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	45 participants	45 participants	45 participants	47 participants	182 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	44 97.8%	44 97.8%	44 97.8%	46 97.9%	178 97.8%
	>=65 years	1 2.2%	1 2.2%	1 2.2%	1 2.1%	4 2.2%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	45 participants	45 participants	45 participants	47 participants	182 participants
		43.50 (12.79)	40.81 (11.55)	42.77 (10.42)	38.94 (12.92)	41.48 (12.01)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	45 participants	45 participants	45 participants	47 participants	182 participants
	Female	41 91.1%	42 93.3%	40 88.9%	43 91.5%	166 91.2%
	Male	4 8.9%	3 6.7%	5 11.1%	4 8.5%	16 8.8%
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	45 participants	45 participants	45 participants	47 participants	182 participants
	American Indian or Alaska Native	2 4.4%	1 2.2%	1 2.2%	1 2.1%	5 2.7%
	Asian	1 2.2%	0 0.0%	1 2.2%	0 0.0%	2 1.1%
	Black	1 2.2%	4 8.9%	1 2.2%	6 12.8%	12 6.6%
	White	27 60.0%	26 57.8%	33 73.3%	27 57.4%	113 62.1%
	Other/Mixed	14 31.1%	14 31.1%	9 20.0%	13 27.7%	50 27.5%

Outcome Measures

1.Primary Outcome


Title	Percentage of Participants With British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-Based Composite Lupus Assessment (BICLA) (mNRI) Response Across 3 Doses of Dapirolizumab Pegol (DZP) and Placebo (PBO) at Week 24
Description	The primary efficacy variable was assessed by establishing if there wa...
Description	The primary efficacy variable was assessed by establishing if there was a dose response relationship between BICLA response at Week 24 and dose, using Multiple Comparison Procedure - Modelling (MCP-Mod). Four candidate dose-response models were evaluated: a linear model, a logistic model, and 2 Emax models, and the MCP-Mod methodology controlled for multiplicity. BICLA response was defined as meeting all of the following criteria: BILAG 2004 improvement: A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤ 1 new B. No worsening in Systemic Lupus Erythematosus Activity Index 2000 (SLEDAI-2K), defined as no increase in SLEDAI-2K total score. No worsening in Physician's Global Assessment of Disease Activity (PGA), defined as < 10 millimeter (mm) increase on a 100 mm visual analog scale (VAS). No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants, and antimalarials.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of all participants in the Randomized Set with the exception of 1 study participant who received less than 1 full dose during the study and 5 study participants who were randomized at Site 321.

Missing values were imputed using a modified non-responder imputation (mNRI).


Arm/Group Title	SOC + Placebo iv Q4W (FAS)	SOC + DZP 6mg/kg iv Q4W (FAS)	SOC + DZP 24mg/kg iv Q4W (FAS)	SOC + DZP 45mg/kg iv Q4W (FAS)
Arm/Group Description:	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
Overall Number of Participants Analyzed	43	43	44	46
Measure Type: Number Unit of Measure: percentage of participants
	0	0	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOC + Placebo iv Q4W (FAS), SOC + DZP 6mg/kg iv Q4W (FAS), SOC + DZP 24mg/kg iv Q4W (FAS), SOC + DZP 45mg/kg iv Q4W (FAS)
	Comments	Multiple contrast testing (MCP-mod methodology) was used to test for a statistically significant dose-response relationship between the primary endpoint (BICLA at Week 24) and dose, which would indicate a drug effect of DZP over Placebo. The best fitting statistically significant model could be used to estimate the dose needed to achieve desired treatment effect.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	=0.0727
	Comments	The lowest p-value (z-statistic with the highest value) was used to establish proof of dose response.
	Method	MCP-Mod
	Comments	[Not Specified]

2.Secondary Outcome


Title	The Percentage of Participants With BICLA (mNRI) Response in the Individual Dose Groups at Week 24
Description	BICLA response was defined as meeting all of the following criteria: ...
Description	BICLA response was defined as meeting all of the following criteria: BILAG 2004 improvement: A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤ 1 new B. No worsening in Systemic Lupus Erythematosus Activity Index 2000 (SLEDAI-2K), defined as no increase in SLEDAI-2K total score. No worsening in Physician's Global Assessment of Disease Activity (PGA), defined as < 10 millimeter (mm) increase on a 100 mm visual analog scale (VAS). No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants, and antimalarials.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

Missing values were imputed using a modified non-responder imputation (mNRI).


Arm/Group Title	SOC + Placebo iv Q4W (FAS)	SOC + DZP 6mg/kg iv Q4W (FAS)	SOC + DZP 24mg/kg iv Q4W (FAS)	SOC + DZP 45mg/kg iv Q4W (FAS)
Arm/Group Description:	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
Overall Number of Participants Analyzed	43	43	44	46
Measure Type: Number Unit of Measure: percentage of participants
	37.2	48.8	54.5	52.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOC + Placebo iv Q4W (FAS), SOC + DZP 6mg/kg iv Q4W (FAS)
	Comments	Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	=0.2699
	Comments	Generalized linear models with factors for treatment and corticosteroid strata were fit using a logit link function for the odds ratios and p-values.
	Method	Chi-squared
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.6
	Confidence Interval	(2-Sided) 95% 0.7 to 3.8
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	SOC + Placebo iv Q4W (FAS), SOC + DZP 24mg/kg iv Q4W (FAS)
	Comments	Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	=0.1036
	Comments	Generalized linear models with factors for treatment and corticosteroid strata were fit using a logit link function for the odds ratios and p-values.
	Method	Chi-squared
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.0
	Confidence Interval	(2-Sided) 95% 0.9 to 4.8
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	SOC + Placebo iv Q4W (FAS), SOC + DZP 45mg/kg iv Q4W (FAS)
	Comments	Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	=0.1518
	Comments	Generalized linear models with factors for treatment and corticosteroid strata were fit using a logit link function for the odds ratios and p-values.
	Method	Chi-squared
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.9
	Confidence Interval	(2-Sided) 95% 0.8 to 4.3
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	SOC + Placebo iv Q4W (FAS), SOC + DZP 6mg/kg iv Q4W (FAS)
	Comments	Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	Crude difference in proportion responding and standard Wald asymptotic 95 % CI based on the normal approximation to the binomial distribution.
	Method	Chi-squared
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Difference vs PBO
	Estimated Value	11.6
	Confidence Interval	(2-Sided) 95% -9.2 to 32.4
	Estimation Comments	Difference and 95 % Wald CI in proportion of responders for SOC + DZP dose 1 iv Q4W (FAS) versus SOC + Placebo iv Q4W (FAS).

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	SOC + Placebo iv Q4W (FAS), SOC + DZP 24mg/kg iv Q4W (FAS)
	Comments	Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	Crude difference in proportion responding and standard Wald asymptotic 95 % CI based on the normal approximation to the binomial distribution.
	Method	Chi-squared
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Difference vs PBO
	Estimated Value	17.3
	Confidence Interval	(2-Sided) 95% -3.3 to 38.0
	Estimation Comments	Difference and 95 % Wald CI in proportion of responders for SOC + DZP dose 2 iv Q4W (FAS) versus SOC + Placebo iv Q4W (FAS).

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	SOC + Placebo iv Q4W (FAS), SOC + DZP 45mg/kg iv Q4W (FAS)
	Comments	Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	Crude difference in proportion responding and standard Wald asymptotic 95 % CI based on the normal approximation to the binomial distribution.
	Method	Chi-squared
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Difference vs PBO
	Estimated Value	15.0
	Confidence Interval	(2-Sided) 95% -5.5 to 35.4
	Estimation Comments	Difference and 95 % Wald CI in proportion of responders for SOC + DZP dose 3 iv Q4W (FAS) versus SOC + Placebo iv Q4W (FAS).

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	SOC + Placebo iv Q4W (FAS), SOC + DZP 6mg/kg iv Q4W (FAS)
	Comments	Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	Generalized linear models with factors for treatment and corticosteroid strata were fit using an identity link function for the LS mean differences.
	Method	Chi-squared
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	LS Mean Difference vs PBO
	Estimated Value	11.9
	Confidence Interval	(2-Sided) 95% -8.7 to 32.5
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	SOC + Placebo iv Q4W (FAS), SOC + DZP 24mg/kg iv Q4W (FAS)
	Comments	Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	Generalized linear models with factors for treatment and corticosteroid strata were fit using an identity link function for the LS mean differences.
	Method	Chi-squared
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	LS Mean Difference vs PBO
	Estimated Value	17.6
	Confidence Interval	(2-Sided) 95% -3.2 to 38.3
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	SOC + Placebo iv Q4W (FAS), SOC + DZP 45mg/kg iv Q4W (FAS)
	Comments	Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	Generalized linear models with factors for treatment and corticosteroid strata were fit using an identity link function for the LS mean differences.
	Method	Chi-squared
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	LS Mean Difference vs PBO
	Estimated Value	15.2
	Confidence Interval	(2-Sided) 95% -5.2 to 35.6
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Percentage of Participants With at Least One Adverse Events (AEs)
Description	An AE was any untoward medical occurrence in a patient or clinical inv...
Description	An AE was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An adverse event (AE) was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AEs that occurred during the study were considered related unless clearly unrelated.
Time Frame	From Baseline (Week 1) until end of the study (Week 48)

Outcome Measure Data

Analysis Population Description

The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug.


Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed	45	45	45	47
Measure Type: Number Unit of Measure: percentage of participants
	66.7	66.7	82.2	74.5

4.Secondary Outcome


Title	Percentage of Participants With a Serious Adverse Event (SAE)
Description	A Serious Adverse Event (SAE) must have met 1 or more of the following...
Description	A Serious Adverse Event (SAE) must have met 1 or more of the following criteria: Death Life threatening Significant or persistent disability/incapacity Congenital anomaly/birth defect (including that occurring in a fetus) Important medical event that, based upon appropriate medical judgment, may have jeopardized the study participant, and may have required medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious Initial inpatient hospitalization or prolongation of hospitalization.
Time Frame	From Baseline (Week 1) until end of the study (Week 48)

Outcome Measure Data

Analysis Population Description

The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug.


Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed	45	45	45	47
Measure Type: Number Unit of Measure: percentage of participants
	13.3	11.1	13.3	10.6

5.Secondary Outcome


Title	Percentage of Participants With at Least One Adverse Events (AEs) of Interest
Description	Adverse events of interest (AEOI) were identified by the Investigator ...
Description	Adverse events of interest (AEOI) were identified by the Investigator based on definitions per protocol, documented on the electronic Case Report Form (eCRF), adequately monitored, and source controlled. AEOI (regardless of seriousness): Moderate to severe infections, including opportunistic infections and tuberculosis (TB) Infusion reactions (including hypersensitivity and anaphylaxis) Thromboembolic events (including but not limited to cardiovascular events, stroke, myocardial infarction, pulmonary embolism, and deep vein thrombosis) Prespecified neurological events: severe and/or serious headache, positional headache, cranial nerve dysfunction, or signs and symptoms of meningitis (photophobia, neck stiffness) Malignancies.
Time Frame	From Baseline (Week 1) until end of the study (Week 48)

Outcome Measure Data

Analysis Population Description

The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug.


Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed	45	45	45	47
Measure Type: Number Unit of Measure: percentage of participants
	24.4	26.7	28.9	25.5

6.Secondary Outcome


Title	Percentage of Participants Who Permanently Withdrew of Study Drug Due to an Adverse Event (AE)
Description	An AE was any untoward medical occurrence in a patient or clinical inv...
Description	An AE was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An adverse event (AE) was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AEs that occurred during the study were considered related unless clearly unrelated.
Time Frame	From Baseline (Week 1) until end of the study (Week 48)

Outcome Measure Data

Analysis Population Description

The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug.


Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed	45	45	45	47
Measure Type: Number Unit of Measure: percentage of participants
	8.9	0	4.4	4.3

7.Secondary Outcome


Title	Mean Change From Baseline in Systolic Blood Pressure
Description	Blood pressure was measured in millimetre of mercury (mmHg).
Description	Blood pressure was measured in millimetre of mercury (mmHg).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description

The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: mmHg
Week 2	Number Analyzed	45 participants	45 participants	45 participants	44 participants
Week 2		3.3 (12.9)	5.1 (10.5)	0.7 (10.7)	3.2 (9.9)
Week 4	Number Analyzed	43 participants	44 participants	43 participants	46 participants
Week 4		0.6 (10.8)	1.0 (7.9)	-2.0 (8.9)	0.6 (12.4)
Week 6	Number Analyzed	43 participants	45 participants	44 participants	45 participants
Week 6		0.3 (11.5)	4.0 (9.9)	2.3 (11.0)	2.4 (10.6)
Week 8	Number Analyzed	44 participants	44 participants	44 participants	43 participants
Week 8		0.5 (12.4)	3.3 (12.6)	-2.4 (9.9)	-0.7 (11.9)
Week 12	Number Analyzed	44 participants	45 participants	45 participants	44 participants
Week 12		-0.7 (10.1)	3.2 (10.5)	-3.0 (11.8)	0.8 (9.2)
Week 16	Number Analyzed	43 participants	44 participants	43 participants	44 participants
Week 16		2.1 (12.3)	2.1 (11.6)	-2.8 (10.6)	0.9 (11.1)
Week 20	Number Analyzed	42 participants	45 participants	42 participants	44 participants
Week 20		1.6 (9.9)	2.6 (9.8)	-1.7 (12.3)	1.5 (11.3)
Week 24	Number Analyzed	43 participants	44 participants	44 participants	44 participants
Week 24		-0.7 (14.3)	1.1 (13.1)	0.3 (11.0)	3.6 (9.3)
Week 28	Number Analyzed	44 participants	43 participants	42 participants	44 participants
Week 28		1.8 (12.3)	3.7 (13.1)	0.9 (10.5)	2.5 (11.8)
Week 32	Number Analyzed	44 participants	44 participants	43 participants	45 participants
Week 32		2.2 (11.1)	3.0 (13.2)	0.4 (11.3)	4.3 (13.7)
Week 36	Number Analyzed	42 participants	42 participants	41 participants	41 participants
Week 36		2.1 (11.0)	3.1 (12.6)	0.2 (10.5)	2.4 (12.9)
Week 40	Number Analyzed	42 participants	43 participants	41 participants	44 participants
Week 40		-1.0 (14.1)	6.2 (12.9)	-2.0 (11.7)	2.5 (11.3)
Week 44	Number Analyzed	39 participants	41 participants	41 participants	42 participants
Week 44		0.1 (12.6)	3.3 (14.1)	1.3 (10.4)	4.2 (11.8)
Week 48	Number Analyzed	38 participants	42 participants	40 participants	42 participants
Week 48		-1.5 (11.5)	4.9 (14.3)	0.1 (10.2)	4.4 (12.0)

8.Secondary Outcome


Title	Mean Change From Baseline in Diastolic Blood Pressure
Description	Blood pressure was measured in millimetre of mercury (mmHg).
Description	Blood pressure was measured in millimetre of mercury (mmHg).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: mmHg
Week 2	Number Analyzed	45 participants	45 participants	45 participants	44 participants
Week 2		2.1 (10.5)	1.4 (8.6)	1.5 (9.3)	2.4 (8.2)
Week 4	Number Analyzed	43 participants	44 participants	43 participants	46 participants
Week 4		-0.7 (7.8)	-1.5 (6.3)	-1.7 (8.2)	-0.1 (8.3)
Week 6	Number Analyzed	43 participants	45 participants	44 participants	45 participants
Week 6		1.0 (10.0)	1.5 (8.6)	1.8 (10.0)	1.9 (7.9)
Week 8	Number Analyzed	44 participants	44 participants	44 participants	43 participants
Week 8		1.1 (9.2)	0.4 (9.1)	0.1 (8.6)	1.0 (8.0)
Week 12	Number Analyzed	44 participants	45 participants	45 participants	44 participants
Week 12		-0.9 (8.4)	-0.3 (6.9)	-2.2 (9.6)	-0.3 (6.9)
Week 16	Number Analyzed	43 participants	44 participants	43 participants	44 participants
Week 16		-0.3 (8.9)	-1.3 (7.6)	-0.7 (9.5)	-0.1 (7.0)
Week 20	Number Analyzed	42 participants	45 participants	42 participants	44 participants
Week 20		1.5 (8.1)	-1.1 (8.7)	-0.7 (9.6)	0.9 (8.8)
Week 24	Number Analyzed	43 participants	44 participants	44 participants	44 participants
Week 24		1.9 (11.2)	1.6 (8.7)	2.3 (10.7)	0.6 (8.7)
Week 28	Number Analyzed	44 participants	43 participants	42 participants	44 participants
Week 28		1.5 (9.1)	-0.2 (8.8)	1.4 (8.4)	2.5 (8.4)
Week 32	Number Analyzed	44 participants	44 participants	43 participants	45 participants
Week 32		2.3 (10.1)	2.8 (9.3)	0.7 (10.2)	2.3 (8.1)
Week 36	Number Analyzed	42 participants	42 participants	41 participants	41 participants
Week 36		3.4 (9.8)	1.4 (10.2)	1.4 (8.4)	2.2 (8.0)
Week 40	Number Analyzed	42 participants	43 participants	41 participants	44 participants
Week 40		1.0 (9.2)	2.6 (7.6)	0.5 (9.9)	3.6 (8.8)
Week 44	Number Analyzed	39 participants	41 participants	41 participants	42 participants
Week 44		0.8 (10.2)	1.5 (8.1)	0.4 (9.4)	2.2 (10.3)
Week 48	Number Analyzed	38 participants	42 participants	40 participants	42 participants
Week 48		1.4 (9.0)	2.3 (8.8)	1.1 (9.4)	2.4 (8.6)

9.Secondary Outcome


Title	Mean Change From Baseline in Pulse Rate
Description	Pulse Rate was measured in beats per minute (beats/min).
Description	Pulse Rate was measured in beats per minute (beats/min).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: beats/min
Week 2	Number Analyzed	45 participants	45 participants	45 participants	44 participants
Week 2		-0.2 (8.3)	0.2 (10.4)	2.3 (9.7)	-0.9 (10.4)
Week 4	Number Analyzed	43 participants	44 participants	43 participants	46 participants
Week 4		1.7 (9.6)	1.5 (8.0)	0.4 (8.4)	-3.3 (9.7)
Week 6	Number Analyzed	43 participants	45 participants	44 participants	45 participants
Week 6		-0.7 (10.2)	0.1 (8.5)	0.8 (8.9)	-0.6 (8.8)
Week 8	Number Analyzed	44 participants	44 participants	44 participants	43 participants
Week 8		1.3 (9.0)	0.3 (9.2)	1.4 (10.2)	-2.6 (10.2)
Week 12	Number Analyzed	44 participants	45 participants	45 participants	44 participants
Week 12		0.6 (10.3)	1.1 (9.8)	-0.3 (10.4)	-1.5 (9.7)
Week 16	Number Analyzed	43 participants	44 participants	43 participants	44 participants
Week 16		-0.8 (9.2)	0.3 (8.9)	0.9 (10.7)	-1.6 (10.6)
Week 20	Number Analyzed	42 participants	45 participants	45 participants	44 participants
Week 20		0.3 (10.6)	1.1 (9.9)	0.8 (9.5)	0.4 (6.6)
Week 24	Number Analyzed	43 participants	44 participants	44 participants	44 participants
Week 24		-1.5 (10.7)	0.8 (10.9)	-0.3 (10.2)	-1.0 (8.7)
Week 28	Number Analyzed	44 participants	43 participants	42 participants	44 participants
Week 28		0.6 (11.8)	1.3 (10.9)	0.0 (9.2)	0.6 (8.8)
Week 32	Number Analyzed	44 participants	44 participants	43 participants	45 participants
Week 32		0.4 (9.8)	1.3 (10.9)	0.8 (11.4)	-2.1 (11.0)
Week 36	Number Analyzed	42 participants	42 participants	41 participants	41 participants
Week 36		-0.7 (10.9)	0.2 (8.3)	0.7 (10.4)	-0.2 (9.8)
Week 40	Number Analyzed	42 participants	43 participants	41 participants	44 participants
Week 40		-0.1 (10.9)	-0.1 (9.8)	0.6 (10.2)	-1.3 (9.6)
Week 44	Number Analyzed	39 participants	41 participants	41 participants	42 participants
Week 44		-0.2 (10.2)	-0.1 (9.8)	0.3 (11.7)	-0.6 (8.9)
Week 48	Number Analyzed	38 participants	42 participants	40 participants	42 participants
Week 48		-0.2 (11.1)	-0.7 (10.6)	-0.9 (11.9)	-2.0 (7.7)

10.Secondary Outcome


Title	Mean Change From Baseline in Temperature
Description	Temperature was measured in Grad Celsius (°C).
Description	Temperature was measured in Grad Celsius (°C).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: Temperature (C)
Week 2	Number Analyzed	45 participants	45 participants	45 participants	44 participants
Week 2		-0.1 (0.4)	0.0 (0.3)	0.1 (0.5)	0.0 (0.4)
Week 4	Number Analyzed	43 participants	44 participants	43 participants	46 participants
Week 4		-0.1 (0.4)	0.0 (0.4)	0.0 (0.4)	0.0 (0.3)
Week 6	Number Analyzed	43 participants	45 participants	44 participants	45 participants
Week 6		-0.2 (0.5)	0.0 (0.4)	0.1 (0.5)	0.0 (0.5)
Week 8	Number Analyzed	44 participants	44 participants	44 participants	43 participants
Week 8		-0.1 (0.4)	-0.1 (0.3)	0.0 (0.4)	0.0 (0.4)
Week 12	Number Analyzed	44 participants	45 participants	45 participants	44 participants
Week 12		-0.1 (0.4)	-0.1 (0.4)	0.0 (0.3)	0.0 (0.4)
Week 16	Number Analyzed	43 participants	44 participants	43 participants	44 participants
Week 16		-0.1 (0.4)	0.0 (0.4)	0.0 (0.4)	0.0 (0.3)
Week 20	Number Analyzed	42 participants	45 participants	42 participants	44 participants
Week 20		-0.1 (0.4)	0.0 (0.4)	0.0 (0.4)	0.0 (0.5)
Week 24	Number Analyzed	43 participants	44 participants	44 participants	44 participants
Week 24		-0.1 (0.5)	0.0 (0.4)	0.1 (0.5)	0.0 (0.4)
Week 28	Number Analyzed	44 participants	43 participants	42 participants	44 participants
Week 28		0.0 (0.4)	0.0 (0.4)	0.1 (0.5)	0.1 (0.5)
Week 32	Number Analyzed	44 participants	44 participants	43 participants	45 participants
Week 32		0.0 (0.4)	0.0 (0.4)	0.1 (0.5)	0.0 (0.4)
Week 36	Number Analyzed	42 participants	42 participants	41 participants	41 participants
Week 36		-0.1 (0.3)	0.0 (0.6)	0.0 (0.4)	0.1 (0.4)
Week 40	Number Analyzed	42 participants	43 participants	41 participants	44 participants
Week 40		0.0 (0.4)	0.0 (0.4)	0.0 (0.5)	0.1 (0.3)
Week 44	Number Analyzed	39 participants	41 participants	41 participants	42 participants
Week 44		0.0 (0.6)	0.0 (0.5)	0.1 (0.4)	0.0 (0.4)
Week 48	Number Analyzed	38 participants	42 participants	40 participants	42 participants
Week 48		-0.1 (0.4)	0.0 (0.4)	0.0 (0.5)	0.0 (0.4)

11.Secondary Outcome


Title	Mean Change From Baseline in Weight
Description	Weight was measured in kilograms (kg).
Description	Weight was measured in kilograms (kg).
Time Frame	Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, and Week 20

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: kg
Week 4	Number Analyzed	43 participants	44 participants	43 participants	46 participants
Week 4		0.0 (1.0)	0.2 (1.0)	0.4 (0.9)	0.3 (1.2)
Week 8	Number Analyzed	44 participants	44 participants	43 participants	43 participants
Week 8		0.3 (1.9)	0.6 (1.4)	0.6 (1.8)	0.4 (1.8)
Week 12	Number Analyzed	43 participants	45 participants	44 participants	44 participants
Week 12		0.4 (2.3)	0.5 (1.6)	0.5 (2.0)	0.6 (2.3)
Week 16	Number Analyzed	43 participants	44 participants	43 participants	44 participants
Week 16		0.3 (2.3)	0.7 (2.3)	0.8 (2.3)	0.5 (2.4)
Week 20	Number Analyzed	42 participants	45 participants	42 participants	44 participants
Week 20		0.3 (2.4)	0.7 (2.6)	1.0 (2.6)	0.5 (2.8)

12.Secondary Outcome


Title	Mean Change From Baseline in Height
Description	Height was measured in centimeters (cm).
Description	Height was measured in centimeters (cm).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description

The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug.


Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed	45	45	45	47
Mean (Standard Deviation) Unit of Measure: cm
	NA ^[1] (NA)	NA ^[1] (NA)	NA ^[1] (NA)	NA ^[1] (NA)

[1]

Here, 'NA' signifies that height was only measured at Screening as per planned analysis. Therefore, data was not collected for this outcome measure.

13.Secondary Outcome


Title	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings
Description	Twelve-lead ECG assessments should have been performed prior to dosing...
Description	Twelve-lead ECG assessments should have been performed prior to dosing (if applicable) and prior to obtaining pharmacokinetic (PK) or other laboratory samples. Electrocardiograms were recorded digitally and read by the Investigator for recording in the electronic Case Report Form (eCRF).
Time Frame	Screening, Week 4, Week 24, Week 28 and Week 48

Outcome Measure Data

Analysis Population Description

The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug.


Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed	45	45	45	47
Measure Type: Count of Participants Unit of Measure: Participants
Screening	8 17.8%	11 24.4%	6 13.3%	6 12.8%
Week 4	11 24.4%	12 26.7%	7 15.6%	10 21.3%
Week 24	9 20.0%	7 15.6%	6 13.3%	10 21.3%
Week 28	1 2.2%	0 0.0%	0 0.0%	0 0.0%
Week 48	8 17.8%	7 15.6%	11 24.4%	9 19.1%

14.Secondary Outcome


Title	Mean Change From Baseline in Hemoglobin
Description	Hemoglobin was measured in grams per liter (g/L).
Description	Hemoglobin was measured in grams per liter (g/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: g/L
Week 2	Number Analyzed	44 participants	42 participants	45 participants	42 participants
Week 2		0.4 (6.4)	-1.8 (5.8)	-0.7 (6.9)	-0.7 (6.8)
Week 4	Number Analyzed	44 participants	44 participants	43 participants	46 participants
Week 4		-1.0 (7.2)	-0.7 (7.7)	-1.4 (8.6)	-0.8 (5.8)
Week 8	Number Analyzed	43 participants	44 participants	44 participants	44 participants
Week 8		-0.3 (7.3)	-1.9 (7.9)	-1.9 (8.6)	-1.3 (7.4)
Week 12	Number Analyzed	44 participants	44 participants	44 participants	44 participants
Week 12		-0.5 (9.5)	-0.5 (8.5)	-0.5 (10.1)	0.2 (8.3)
Week 16	Number Analyzed	44 participants	43 participants	43 participants	45 participants
Week 16		0.3 (10.4)	-0.3 (10.0)	-0.8 (10.6)	-2.7 (8.3)
Week 20	Number Analyzed	43 participants	43 participants	41 participants	43 participants
Week 20		-0.7 (11.5)	0.3 (9.9)	-0.5 (10.1)	-2.4 (7.2)
Week 24	Number Analyzed	42 participants	43 participants	44 participants	44 participants
Week 24		-0.4 (9.7)	-0.7 (11.2)	-0.7 (10.5)	-2.9 (8.1)
Week 28	Number Analyzed	44 participants	41 participants	41 participants	44 participants
Week 28		0.7 (10.6)	-3.4 (11.0)	0.0 (14.1)	-3.1 (9.5)
Week 32	Number Analyzed	43 participants	43 participants	43 participants	42 participants
Week 32		1.6 (12.5)	-1.3 (9.8)	1.0 (12.5)	-1.3 (9.6)
Week 40	Number Analyzed	42 participants	43 participants	41 participants	44 participants
Week 40		0.7 (13.5)	-0.3 (13.5)	1.9 (14.9)	1.1 (11.0)
Week 48	Number Analyzed	38 participants	42 participants	39 participants	42 participants
Week 48		-0.5 (14.3)	-1.5 (11.6)	0.9 (12.5)	-0.7 (10.0)

15.Secondary Outcome


Title	Mean Change From Baseline in Hematocrit
Description	Hematocrit was measured in volume percentage (%) of red blood cells in...
Description	Hematocrit was measured in volume percentage (%) of red blood cells in blood.
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: volume % of red blood cells
Week 2	Number Analyzed	44 participants	42 participants	45 participants	42 participants
Week 2		0.42 (2.52)	-0.25 (2.26)	-0.32 (2.37)	0.00 (2.71)
Week 4	Number Analyzed	44 participants	44 participants	43 participants	46 participants
Week 4		-0.46 (2.29)	-0.17 (2.75)	-0.79 (2.92)	-0.11 (2.31)
Week 8	Number Analyzed	43 participants	44 participants	44 participants	44 participants
Week 8		-0.27 (2.23)	-0.12 (2.94)	-0.86 (2.72)	-0.42 (2.31)
Week 12	Number Analyzed	44 participants	44 participants	44 participants	44 participants
Week 12		-0.23 (2.67)	-0.13 (2.72)	-0.32 (3.39)	-0.02 (2.54)
Week 16	Number Analyzed	44 participants	43 participants	43 participants	45 participants
Week 16		-0.12 (2.86)	0.05 (3.25)	-0.57 (3.32)	-0.84 (2.95)
Week 20	Number Analyzed	43 participants	43 participants	41 participants	43 participants
Week 20		-0.41 (3.20)	0.13 (2.99)	-0.42 (3.32)	-0.80 (2.83)
Week 24	Number Analyzed	42 participants	43 participants	44 participants	44 participants
Week 24		-0.09 (2.61)	-0.40 (3.19)	-0.29 (3.14)	-0.76 (2.33)
Week 28	Number Analyzed	44 participants	41 participants	41 participants	44 participants
Week 28		0.03 (2.98)	-1.02 (3.23)	-0.22 (3.99)	-0.89 (2.47)
Week 32	Number Analyzed	43 participants	43 participants	43 participants	42 participants
Week 32		0.29 (2.89)	-0.62 (2.86)	0.17 (3.43)	-0.21 (2.82)
Week 40	Number Analyzed	42 participants	43 participants	41 participants	44 participants
Week 40		-0.20 (3.32)	-0.24 (4.37)	0.58 (4.11)	0.37 (2.72)
Week 48	Number Analyzed	38 participants	42 participants	39 participants	42 participants
Week 48		-0.59 (3.51)	-0.37 (3.58)	-0.08 (3.21)	-0.11 (2.54)

16.Secondary Outcome


Title	Mean Change From Baseline in Erythrocytes
Description	Erythrocytes was measured in number of erythrocytes per liter (10^12/L...
Description	Erythrocytes was measured in number of erythrocytes per liter (10^12/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: 10^12 erythrocytes per liter
Week 2	Number Analyzed	44 participants	42 participants	45 participants	42 participants
Week 2		-0.004 (0.246)	-0.035 (0.237)	-0.032 (0.223)	-0.028 (0.237)
Week 4	Number Analyzed	44 participants	44 participants	43 participants	46 participants
Week 4		-0.080 (0.243)	-0.018 (0.293)	-0.052 (0.273)	-0.033 (0.210)
Week 8	Number Analyzed	43 participants	44 participants	44 participants	44 participants
Week 8		-0.039 (0.224)	-0.039 (0.280)	-0.069 (0.262)	-0.044 (0.242)
Week 12	Number Analyzed	44 participants	44 participants	44 participants	44 participants
Week 12		-0.024 (0.271)	0.014 (0.292)	-0.010 (0.267)	0.019 (0.226)
Week 16	Number Analyzed	44 participants	43 participants	43 participants	45 participants
Week 16		-0.002 (0.312)	0.041 (0.360)	0.000 (0.302)	-0.051 (0.265)
Week 20	Number Analyzed	43 participants	43 participants	41 participants	43 participants
Week 20		-0.029 (0.333)	0.062 (0.309)	-0.001 (0.325)	-0.047 (0.302)
Week 24	Number Analyzed	42 participants	43 participants	44 participants	44 participants
Week 24		0.005 (0.308)	0.036 (0.312)	0.013 (0.319)	-0.038 (0.240)
Week 28	Number Analyzed	44 participants	41 participants	41 participants	44 participants
Week 28		0.018 (0.340)	-0.040 (0.304)	0.019 (0.346)	-0.050 (0.270)
Week 32	Number Analyzed	43 participants	43 participants	43 participants	42 participants
Week 32		0.048 (0.320)	0.001 (0.284)	0.032 (0.289)	0.027 (0.277)
Week 40	Number Analyzed	42 participants	43 participants	41 participants	44 participants
Week 40		-0.005 (0.343)	0.042 (0.382)	0.054 (0.368)	0.060 (0.256)
Week 48	Number Analyzed	38 participants	42 participants	39 participants	42 participants
Week 48		-0.024 (0.332)	-0.018 (0.295)	0.017 (0.299)	-0.028 (0.245)

17.Secondary Outcome


Title	Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume
Description	Erythrocytes Mean Corpuscular Volume was measured in femtolitres (fL).
Description	Erythrocytes Mean Corpuscular Volume was measured in femtolitres (fL).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: Femtolitres (fL)
Week 2	Number Analyzed	44 participants	42 participants	45 participants	42 participants
Week 2		1.01 (2.28)	0.24 (2.40)	-0.09 (2.66)	0.45 (2.96)
Week 4	Number Analyzed	44 participants	44 participants	43 participants	46 participants
Week 4		0.60 (2.35)	0.08 (2.66)	-0.68 (2.10)	0.40 (3.02)
Week 8	Number Analyzed	43 participants	44 participants	44 participants	44 participants
Week 8		0.23 (3.48)	-0.30 (5.36)	-0.54 (2.85)	-0.16 (2.79)
Week 12	Number Analyzed	44 participants	44 participants	44 participants	44 participants
Week 12		0.06 (3.57)	-0.52 (3.44)	-0.55 (4.67)	-0.57 (3.09)
Week 16	Number Analyzed	44 participants	43 participants	43 participants	45 participants
Week 16		-0.25 (3.41)	-0.65 (4.38)	-1.38 (4.87)	-0.97 (3.62)
Week 20	Number Analyzed	43 participants	43 participants	41 participants	43 participants
Week 20		-0.37 (3.73)	-0.92 (4.58)	-1.00 (5.01)	-0.97 (3.54)
Week 24	Number Analyzed	42 participants	43 participants	44 participants	44 participants
Week 24		-0.23 (3.83)	-1.63 (4.07)	-0.92 (6.51)	-1.05 (4.00)
Week 28	Number Analyzed	44 participants	41 participants	41 participants	44 participants
Week 28		-0.33 (3.61)	-1.40 (4.61)	-0.96 (6.46)	-1.21 (4.91)
Week 32	Number Analyzed	43 participants	43 participants	43 participants	42 participants
Week 32		-0.27 (4.45)	-1.33 (4.32)	-0.45 (6.81)	-1.06 (4.69)
Week 40	Number Analyzed	42 participants	43 participants	41 participants	44 participants
Week 40		-0.36 (5.34)	-1.46 (4.72)	0.07 (6.27)	-0.24 (4.85)
Week 48	Number Analyzed	38 participants	42 participants	39 participants	42 participants
Week 48		-0.98 (5.34)	-0.50 (4.97)	-0.63 (6.92)	0.34 (4.31)

18.Secondary Outcome


Title	Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration
Description	Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration was measu...
Description	Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration was measured in grams per liter (g/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: g/L
Week 2	Number Analyzed	44 participants	42 participants	45 participants	42 participants
Week 2		-2.3 (9.8)	-2.6 (10.9)	0.7 (9.8)	-1.9 (10.1)
Week 4	Number Analyzed	44 participants	44 participants	43 participants	46 participants
Week 4		1.4 (8.7)	-0.9 (10.1)	2.7 (8.6)	-1.2 (12.5)
Week 8	Number Analyzed	43 participants	44 participants	44 participants	44 participants
Week 8		1.7 (11.5)	-3.8 (13.4)	2.1 (8.2)	-0.1 (11.5)
Week 12	Number Analyzed	44 participants	44 participants	44 participants	44 participants
Week 12		0.5 (11.1)	-0.6 (10.7)	0.6 (12.3)	0.5 (12.7)
Week 16	Number Analyzed	44 participants	43 participants	43 participants	45 participants
Week 16		1.6 (13.8)	-1.5 (10.1)	2.3 (11.3)	-0.2 (14.1)
Week 20	Number Analyzed	43 participants	43 participants	41 participants	43 participants
Week 20		1.6 (12.9)	-0.9 (11.3)	2.4 (11.2)	0.4 (12.6)
Week 24	Number Analyzed	42 participants	43 participants	44 participants	44 participants
Week 24		0.0 (13.7)	1.0 (13.2)	0.4 (12.8)	-1.2 (13.1)
Week 28	Number Analyzed	44 participants	41 participants	41 participants	44 participants
Week 28		1.6 (13.4)	-1.3 (14.4)	1.7 (13.8)	-0.6 (16.5)
Week 32	Number Analyzed	43 participants	43 participants	43 participants	42 participants
Week 32		1.7 (18.9)	1.1 (13.8)	1.2 (15.0)	-1.4 (16.0)
Week 40	Number Analyzed	42 participants	43 participants	41 participants	44 participants
Week 40		3.4 (17.6)	0.8 (16.5)	0.1 (15.8)	0.1 (15.4)
Week 48	Number Analyzed	38 participants	42 participants	39 participants	42 participants
Week 48		3.6 (17.1)	-0.6 (16.2)	2.9 (14.5)	0.0 (13.5)

19.Secondary Outcome


Title	Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin
Description	Erythrocytes Mean Corpuscular Hemoglobin was measured in picograms (pg...
Description	Erythrocytes Mean Corpuscular Hemoglobin was measured in picograms (pg).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: Picograms (pg)
Week 2	Number Analyzed	44 participants	42 participants	45 participants	42 participants
Week 2		0.12 (0.71)	-0.18 (0.65)	0.04 (0.43)	0.00 (0.47)
Week 4	Number Analyzed	44 participants	44 participants	43 participants	46 participants
Week 4		0.31 (0.63)	-0.06 (0.79)	0.04 (0.64)	0.02 (0.65)
Week 8	Number Analyzed	43 participants	44 participants	44 participants	44 participants
Week 8		0.20 (0.87)	-0.25 (0.87)	0.04 (0.81)	-0.04 (0.74)
Week 12	Number Analyzed	44 participants	44 participants	44 participants	44 participants
Week 12		0.04 (1.08)	-0.25 (1.03)	-0.09 (1.25)	-0.12 (0.90)
Week 16	Number Analyzed	44 participants	43 participants	43 participants	45 participants
Week 16		0.03 (1.43)	-0.36 (1.31)	-0.20 (1.52)	-0.31 (1.19)
Week 20	Number Analyzed	43 participants	43 participants	41 participants	43 participants
Week 20		0.00 (1.49)	-0.39 (1.40)	-0.10 (1.63)	-0.26 (1.24)
Week 24	Number Analyzed	42 participants	43 participants	44 participants	44 participants
Week 24		-0.13 (1.57)	-0.43 (1.39)	-0.25 (1.96)	-0.44 (1.42)
Week 28	Number Analyzed	44 participants	41 participants	41 participants	44 participants
Week 28		0.01 (1.68)	-0.55 (1.45)	-0.15 (2.09)	-0.44 (1.68)
Week 32	Number Analyzed	43 participants	43 participants	43 participants	42 participants
Week 32		0.01 (2.12)	-0.33 (1.28)	-0.06 (2.39)	-0.48 (1.63)
Week 40	Number Analyzed	42 participants	43 participants	41 participants	44 participants
Week 40		0.17 (2.50)	-0.40 (1.30)	0.03 (2.32)	-0.09 (2.00)
Week 48	Number Analyzed	38 participants	42 participants	39 participants	42 participants
Week 48		0.02 (2.58)	-0.21 (1.48)	0.06 (2.55)	0.10 (1.90)

20.Secondary Outcome


Title	Mean Change From Baseline in Leukocytes
Description	Leukocytes was measured in number of leukocytes per liter (10^9/L).
Description	Leukocytes was measured in number of leukocytes per liter (10^9/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: 10^9 leukocytes per liter
Week 2	Number Analyzed	44 participants	42 participants	45 participants	42 participants
Week 2		0.34 (2.45)	0.27 (1.23)	0.49 (1.46)	0.20 (1.62)
Week 4	Number Analyzed	44 participants	44 participants	43 participants	46 participants
Week 4		0.10 (1.88)	0.27 (1.63)	0.25 (1.47)	0.52 (2.11)
Week 8	Number Analyzed	43 participants	44 participants	44 participants	44 participants
Week 8		-0.25 (2.12)	0.46 (1.41)	-0.05 (1.50)	-0.10 (1.65)
Week 12	Number Analyzed	44 participants	44 participants	44 participants	43 participants
Week 12		-0.27 (1.80)	0.18 (1.73)	0.17 (2.00)	0.23 (2.01)
Week 16	Number Analyzed	44 participants	43 participants	43 participants	45 participants
Week 16		-0.31 (2.18)	0.13 (1.55)	0.21 (1.69)	-0.20 (2.12)
Week 20	Number Analyzed	43 participants	43 participants	41 participants	43 participants
Week 20		-0.24 (2.27)	-0.06 (1.59)	-0.22 (1.74)	0.30 (2.61)
Week 24	Number Analyzed	42 participants	43 participants	44 participants	44 participants
Week 24		-0.22 (2.41)	-0.12 (1.83)	-0.14 (1.75)	-0.34 (1.97)
Week 28	Number Analyzed	44 participants	41 participants	41 participants	44 participants
Week 28		0.05 (2.04)	0.06 (1.93)	0.26 (2.04)	-0.58 (1.70)
Week 32	Number Analyzed	43 participants	43 participants	43 participants	42 participants
Week 32		-0.14 (2.20)	0.08 (1.64)	0.19 (1.67)	-0.44 (1.68)
Week 40	Number Analyzed	42 participants	43 participants	41 participants	44 participants
Week 40		0.17 (2.54)	0.04 (1.60)	-0.35 (1.49)	-0.49 (1.96)
Week 48	Number Analyzed	38 participants	42 participants	39 participants	42 participants
Week 48		-0.49 (1.83)	0.30 (1.53)	-0.14 (2.06)	-0.62 (1.87)

21.Secondary Outcome


Title	Mean Change From Baseline in Basophils
Description	Basophils was measured in number of basophils per liter (10^9/L).
Description	Basophils was measured in number of basophils per liter (10^9/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: 10^9 basophils per liter
Week 2	Number Analyzed	42 participants	39 participants	44 participants	41 participants
Week 2		0.01 (0.03)	0.02 (0.04)	0.00 (0.03)	0.00 (0.02)
Week 4	Number Analyzed	43 participants	43 participants	41 participants	46 participants
Week 4		0.01 (0.03)	0.00 (0.03)	0.01 (0.04)	0.00 (0.02)
Week 8	Number Analyzed	42 participants	41 participants	43 participants	43 participants
Week 8		0.01 (0.04)	0.01 (0.04)	0.01 (0.03)	0.00 (0.02)
Week 12	Number Analyzed	44 participants	40 participants	44 participants	42 participants
Week 12		0.01 (0.03)	0.01 (0.04)	0.00 (0.03)	0.00 (0.03)
Week 16	Number Analyzed	43 participants	42 participants	43 participants	44 participants
Week 16		0.01 (0.04)	0.00 (0.03)	0.01 (0.03)	0.00 (0.03)
Week 20	Number Analyzed	42 participants	40 participants	40 participants	42 participants
Week 20		0.00 (0.03)	0.01 (0.03)	0.00 (0.03)	0.00 (0.03)
Week 24	Number Analyzed	41 participants	40 participants	44 participants	44 participants
Week 24		0.00 (0.03)	0.02 (0.04)	0.00 (0.03)	0.00 (0.03)
Week 28	Number Analyzed	44 participants	39 participants	40 participants	44 participants
Week 28		0.02 (0.05)	0.01 (0.04)	0.00 (0.02)	0.00 (0.03)
Week 32	Number Analyzed	41 participants	40 participants	43 participants	42 participants
Week 32		0.00 (0.03)	0.00 (0.02)	0.01 (0.03)	0.00 (0.03)
Week 40	Number Analyzed	41 participants	42 participants	40 participants	43 participants
Week 40		0.00 (0.02)	0.00 (0.02)	0.01 (0.03)	0.00 (0.03)
Week 48	Number Analyzed	37 participants	41 participants	39 participants	41 participants
Week 48		0.00 (0.03)	0.00 (0.02)	0.00 (0.03)	0.01 (0.03)

22.Secondary Outcome


Title	Mean Change From Baseline in Basophils/Leukocytes
Description	Basophils/Leukocytes was measured in percentages (%).
Description	Basophils/Leukocytes was measured in percentages (%).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: % of Basophils per Leukocytes
Week 2	Number Analyzed	42 participants	39 participants	44 participants	41 participants
Week 2		-0.05 (0.23)	0.02 (0.20)	-0.05 (0.31)	-0.03 (0.27)
Week 4	Number Analyzed	43 participants	43 participants	41 participants	46 participants
Week 4		0.03 (0.27)	-0.06 (0.26)	-0.01 (0.43)	-0.07 (0.26)
Week 8	Number Analyzed	42 participants	41 participants	43 participants	43 participants
Week 8		0.08 (0.42)	0.03 (0.32)	0.00 (0.33)	-0.06 (0.23)
Week 12	Number Analyzed	44 participants	40 participants	44 participants	42 participants
Week 12		0.04 (0.30)	0.09 (0.48)	0.00 (0.25)	-0.07 (0.28)
Week 16	Number Analyzed	43 participants	42 participants	43 participants	44 participants
Week 16		0.01 (0.25)	0.00 (0.28)	-0.02 (0.31)	-0.05 (0.30)
Week 20	Number Analyzed	42 participants	40 participants	40 participants	42 participants
Week 20		-0.02 (0.26)	0.00 (0.27)	-0.07 (0.29)	-0.04 (0.32)
Week 24	Number Analyzed	41 participants	40 participants	44 participants	44 participants
Week 24		-0.04 (0.31)	0.15 (0.44)	-0.03 (0.24)	-0.03 (0.21)
Week 28	Number Analyzed	44 participants	39 participants	40 participants	44 participants
Week 28		0.08 (0.54)	0.03 (0.29)	0.00 (0.24)	0.07 (0.32)
Week 32	Number Analyzed	41 participants	40 participants	43 participants	42 participants
Week 32		-0.03 (0.29)	0.00 (0.23)	0.01 (0.25)	0.01 (0.25)
Week 40	Number Analyzed	41 participants	42 participants	40 participants	43 participants
Week 40		-0.08 (0.24)	-0.03 (0.25)	0.07 (0.29)	0.01 (0.29)
Week 48	Number Analyzed	37 participants	41 participants	39 participants	41 participants
Week 48		-0.01 (0.29)	-0.08 (0.21)	0.02 (0.25)	0.06 (0.28)

23.Secondary Outcome


Title	Mean Change From Baseline in Eosinophils
Description	Eosinophils was measured in number of eosinophils per liter (10^9/L).
Description	Eosinophils was measured in number of eosinophils per liter (10^9/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: 10^9 eosinophils per liter
Week 2	Number Analyzed	42 participants	39 participants	44 participants	41 participants
Week 2		-0.01 (0.04)	0.01 (0.06)	0.00 (0.09)	-0.01 (0.05)
Week 4	Number Analyzed	43 participants	43 participants	41 participants	46 participants
Week 4		-0.01 (0.04)	-0.01 (0.06)	0.00 (0.04)	-0.01 (0.04)
Week 8	Number Analyzed	42 participants	41 participants	43 participants	43 participants
Week 8		-0.01 (0.04)	0.03 (0.16)	0.00 (0.04)	0.01 (0.07)
Week 12	Number Analyzed	44 participants	40 participants	44 participants	42 participants
Week 12		0.00 (0.04)	0.04 (0.20)	0.02 (0.10)	0.02 (0.17)
Week 16	Number Analyzed	43 participants	42 participants	43 participants	44 participants
Week 16		0.00 (0.05)	0.02 (0.11)	0.01 (0.05)	0.00 (0.06)
Week 20	Number Analyzed	42 participants	40 participants	40 participants	42 participants
Week 20		0.00 (0.05)	0.04 (0.24)	0.01 (0.05)	-0.01 (0.05)
Week 24	Number Analyzed	41 participants	40 participants	44 participants	44 participants
Week 24		-0.01 (0.05)	0.04 (0.15)	0.02 (0.07)	-0.02 (0.06)
Week 28	Number Analyzed	44 participants	39 participants	40 participants	44 participants
Week 28		-0.01 (0.04)	0.01 (0.07)	0.01 (0.05)	0.00 (0.06)
Week 32	Number Analyzed	41 participants	40 participants	43 participants	42 participants
Week 32		-0.01 (0.06)	0.01 (0.10)	0.01 (0.05)	-0.02 (0.04)
Week 40	Number Analyzed	41 participants	42 participants	40 participants	43 participants
Week 40		0.00 (0.05)	0.01 (0.06)	0.02 (0.06)	0.00 (0.07)
Week 48	Number Analyzed	37 participants	41 participants	39 participants	41 participants
Week 48		0.00 (0.04)	-0.01 (0.05)	0.00 (0.06)	0.00 (0.06)

24.Secondary Outcome


Title	Mean Change From Baseline in Eosinophils/Leukocytes
Description	Eosinophils/Leukocytes was measured in percentages (%).
Description	Eosinophils/Leukocytes was measured in percentages (%).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: % of Eosinophils per Leukocytes
Week 2	Number Analyzed	42 participants	39 participants	44 participants	41 participants
Week 2		-0.19 (1.07)	0.07 (0.86)	-0.18 (1.13)	-0.29 (1.22)
Week 4	Number Analyzed	43 participants	43 participants	41 participants	46 participants
Week 4		-0.32 (0.96)	-0.05 (1.26)	-0.12 (1.01)	-0.26 (0.94)
Week 8	Number Analyzed	42 participants	41 participants	43 participants	43 participants
Week 8		-0.05 (1.09)	0.54 (2.13)	0.10 (1.11)	0.22 (1.89)
Week 12	Number Analyzed	44 participants	40 participants	44 participants	42 participants
Week 12		0.18 (1.03)	0.70 (3.12)	0.33 (1.68)	0.05 (1.83)
Week 16	Number Analyzed	43 participants	42 participants	43 participants	44 participants
Week 16		0.06 (1.05)	0.36 (1.24)	0.20 (1.40)	-0.11 (1.33)
Week 20	Number Analyzed	42 participants	40 participants	40 participants	42 participants
Week 20		0.04 (1.11)	0.83 (3.58)	0.11 (1.24)	-0.39 (1.29)
Week 24	Number Analyzed	41 participants	40 participants	44 participants	44 participants
Week 24		0.11 (1.16)	0.82 (2.89)	-0.01 (1.22)	0.06 (1.63)
Week 28	Number Analyzed	44 participants	39 participants	40 participants	44 participants
Week 28		0.06 (1.00)	0.21 (1.33)	0.18 (1.02)	-0.03 (1.35)
Week 32	Number Analyzed	41 participants	40 participants	43 participants	42 participants
Week 32		0.02 (1.09)	0.28 (1.60)	0.16 (1.13)	-0.20 (1.03)
Week 40	Number Analyzed	41 participants	42 participants	40 participants	43 participants
Week 40		-0.10 (0.85)	0.05 (1.09)	0.40 (1.23)	-0.09 (1.47)
Week 48	Number Analyzed	37 participants	41 participants	39 participants	41 participants
Week 48		0.09 (1.02)	-0.17 (1.08)	0.06 (0.90)	0.24 (1.03)

25.Secondary Outcome


Title	Mean Change From Baseline in Lymphocytes
Description	Lymphocytes was measured in number of lymphocytes per liter (10^9/L).
Description	Lymphocytes was measured in number of lymphocytes per liter (10^9/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: 10^9 lymphocytes per liter
Week 2	Number Analyzed	42 participants	39 participants	44 participants	41 participants
Week 2		-0.03 (0.39)	0.05 (0.36)	0.16 (0.29)	0.24 (0.37)
Week 4	Number Analyzed	43 participants	43 participants	41 participants	46 participants
Week 4		-0.04 (0.36)	-0.01 (0.47)	-0.01 (0.41)	0.23 (0.42)
Week 8	Number Analyzed	42 participants	41 participants	43 participants	43 participants
Week 8		-0.15 (0.48)	-0.03 (0.39)	0.06 (0.46)	0.14 (0.50)
Week 12	Number Analyzed	44 participants	40 participants	44 participants	42 participants
Week 12		-0.06 (0.43)	0.02 (0.59)	0.01 (0.42)	0.21 (0.51)
Week 16	Number Analyzed	43 participants	42 participants	43 participants	44 participants
Week 16		-0.09 (0.52)	-0.11 (0.51)	-0.02 (0.47)	0.04 (0.40)
Week 20	Number Analyzed	42 participants	40 participants	40 participants	42 participants
Week 20		-0.14 (0.56)	-0.13 (0.54)	0.02 (0.39)	0.13 (0.55)
Week 24	Number Analyzed	41 participants	40 participants	44 participants	44 participants
Week 24		-0.11 (0.51)	-0.08 (0.60)	-0.03 (0.45)	0.05 (0.52)
Week 28	Number Analyzed	44 participants	39 participants	40 participants	44 participants
Week 28		-0.04 (0.57)	-0.02 (0.59)	0.01 (0.53)	0.03 (0.56)
Week 32	Number Analyzed	41 participants	40 participants	43 participants	42 participants
Week 32		-0.11 (0.57)	-0.16 (0.59)	0.05 (0.45)	-0.02 (0.44)
Week 40	Number Analyzed	41 participants	42 participants	40 participants	43 participants
Week 40		-0.11 (0.54)	-0.11 (0.52)	-0.11 (0.43)	-0.03 (0.48)
Week 48	Number Analyzed	37 participants	41 participants	39 participants	41 participants
Week 48		-0.19 (0.68)	-0.19 (0.60)	-0.10 (0.44)	-0.02 (0.49)

26.Secondary Outcome


Title	Mean Change From Baseline in Lymphocytes/Leukocytes
Description	Lymphocytes/Leukocytes was measured in percentages (%).
Description	Lymphocytes/Leukocytes was measured in percentages (%).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: % of Lymphocytes per Leukocytes
Week 2	Number Analyzed	42 participants	39 participants	44 participants	41 participants
Week 2		-1.88 (9.01)	0.19 (6.55)	1.18 (6.09)	2.61 (6.11)
Week 4	Number Analyzed	43 participants	43 participants	41 participants	46 participants
Week 4		-0.88 (7.09)	-1.02 (6.34)	-1.18 (9.93)	0.97 (8.00)
Week 8	Number Analyzed	42 participants	41 participants	43 participants	43 participants
Week 8		-1.98 (10.59)	-1.40 (7.13)	0.56 (10.20)	1.97 (8.51)
Week 12	Number Analyzed	44 participants	40 participants	44 participants	42 participants
Week 12		0.21 (7.87)	0.56 (10.58)	-0.44 (9.90)	2.46 (10.18)
Week 16	Number Analyzed	43 participants	42 participants	43 participants	44 participants
Week 16		-0.91 (8.33)	-1.49 (7.50)	-1.18 (9.65)	0.12 (9.34)
Week 20	Number Analyzed	42 participants	40 participants	40 participants	42 participants
Week 20		-1.97 (10.37)	-0.66 (6.58)	0.88 (10.69)	0.71 (10.32)
Week 24	Number Analyzed	41 participants	40 participants	44 participants	44 participants
Week 24		-0.75 (8.69)	-0.56 (7.35)	-0.52 (10.55)	1.85 (9.67)
Week 28	Number Analyzed	44 participants	39 participants	40 participants	44 participants
Week 28		-1.18 (8.27)	-0.05 (8.51)	-0.05 (9.97)	1.61 (10.55)
Week 32	Number Analyzed	41 participants	40 participants	43 participants	42 participants
Week 32		-1.59 (7.69)	-2.56 (6.51)	-0.16 (7.70)	0.70 (8.74)
Week 40	Number Analyzed	41 participants	42 participants	40 participants	43 participants
Week 40		-2.60 (9.18)	-2.02 (5.99)	-1.36 (10.12)	0.33 (8.41)
Week 48	Number Analyzed	37 participants	41 participants	39 participants	41 participants
Week 48		-1.46 (11.29)	-3.71 (7.41)	-0.84 (9.42)	1.69 (10.05)

27.Secondary Outcome


Title	Mean Change From Baseline in Monocytes
Description	Monocytes was measured in number of monocytes per liter (10^9/L).
Description	Monocytes was measured in number of monocytes per liter (10^9/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: 10^9 monocytes per liter
Week 2	Number Analyzed	42 participants	39 participants	44 participants	41 participants
Week 2		-0.01 (0.17)	0.01 (0.18)	0.05 (0.14)	0.01 (0.13)
Week 4	Number Analyzed	43 participants	43 participants	41 participants	46 participants
Week 4		0.01 (0.18)	0.04 (0.18)	0.01 (0.14)	0.06 (0.19)
Week 8	Number Analyzed	42 participants	41 participants	43 participants	43 participants
Week 8		-0.03 (0.18)	0.04 (0.18)	0.03 (0.16)	0.02 (0.17)
Week 12	Number Analyzed	44 participants	40 participants	44 participants	42 participants
Week 12		-0.01 (0.19)	0.00 (0.14)	0.04 (0.18)	0.06 (0.15)
Week 16	Number Analyzed	43 participants	42 participants	43 participants	44 participants
Week 16		-0.01 (0.17)	0.01 (0.17)	0.05 (0.18)	0.03 (0.14)
Week 20	Number Analyzed	42 participants	40 participants	40 participants	42 participants
Week 20		-0.03 (0.19)	0.00 (0.16)	0.00 (0.13)	0.05 (0.19)
Week 24	Number Analyzed	41 participants	40 participants	44 participants	44 participants
Week 24		0.00 (0.19)	0.04 (0.19)	0.03 (0.17)	0.00 (0.17)
Week 28	Number Analyzed	44 participants	39 participants	40 participants	44 participants
Week 28		0.00 (0.20)	0.04 (0.21)	0.08 (0.19)	0.02 (0.17)
Week 32	Number Analyzed	41 participants	40 participants	43 participants	42 participants
Week 32		-0.01 (0.18)	0.02 (0.19)	0.05 (0.23)	-0.01 (0.19)
Week 40	Number Analyzed	41 participants	42 participants	40 participants	43 participants
Week 40		0.03 (0.17)	0.05 (0.16)	0.04 (0.16)	-0.01 (0.18)
Week 48	Number Analyzed	37 participants	41 participants	39 participants	41 participants
Week 48		-0.02 (0.20)	-0.01 (0.13)	0.03 (0.15)	-0.02 (0.18)

28.Secondary Outcome


Title	Mean Change From Baseline in Monocytes/Leukocytes
Description	Monocytes/Leukocytes was measured in percentages (%).
Description	Monocytes/Leukocytes was measured in percentages (%).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: % of Monocytes per Leukocytes
Week 2	Number Analyzed	42 participants	39 participants	44 participants	41 participants
Week 2		-0.87 (2.50)	-0.07 (2.46)	0.23 (3.03)	-0.37 (2.25)
Week 4	Number Analyzed	43 participants	43 participants	41 participants	46 participants
Week 4		0.26 (3.30)	0.27 (2.41)	-0.16 (3.11)	-0.24 (2.82)
Week 8	Number Analyzed	42 participants	41 participants	43 participants	43 participants
Week 8		-0.21 (3.47)	0.07 (3.61)	0.51 (3.83)	0.08 (3.12)
Week 12	Number Analyzed	44 participants	40 participants	44 participants	42 participants
Week 12		0.07 (2.79)	-0.11 (2.38)	0.22 (3.37)	0.45 (2.74)
Week 16	Number Analyzed	43 participants	42 participants	43 participants	44 participants
Week 16		0.06 (3.30)	0.59 (2.85)	0.43 (3.31)	0.28 (3.13)
Week 20	Number Analyzed	42 participants	40 participants	40 participants	42 participants
Week 20		-0.27 (3.84)	0.56 (3.08)	0.33 (3.81)	0.43 (3.39)
Week 24	Number Analyzed	41 participants	40 participants	44 participants	44 participants
Week 24		0.06 (3.45)	0.84 (2.97)	0.46 (3.00)	0.41 (3.24)
Week 28	Number Analyzed	44 participants	39 participants	40 participants	44 participants
Week 28		-0.24 (3.54)	0.69 (3.24)	0.64 (3.67)	0.94 (3.78)
Week 32	Number Analyzed	41 participants	40 participants	43 participants	42 participants
Week 32		-0.08 (3.11)	0.13 (2.62)	0.46 (3.91)	-0.03 (3.76)
Week 40	Number Analyzed	41 participants	42 participants	40 participants	43 participants
Week 40		0.49 (3.55)	0.64 (2.92)	0.83 (3.69)	0.59 (3.07)
Week 48	Number Analyzed	37 participants	41 participants	39 participants	41 participants
Week 48		-0.04 (3.79)	-0.13 (2.41)	0.47 (3.82)	0.29 (3.30)

29.Secondary Outcome


Title	Mean Change From Baseline in Neutrophils
Description	Neutrophils was measured in number of neutrophils per liter (10^9/L).
Description	Neutrophils was measured in number of neutrophils per liter (10^9/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: 10^9 neutrophils per liter
Week 2	Number Analyzed	43 participants	39 participants	44 participants	41 participants
Week 2		0.28 (2.43)	0.26 (1.17)	0.17 (1.33)	-0.01 (1.46)
Week 4	Number Analyzed	43 participants	43 participants	41 participants	46 participants
Week 4		0.07 (1.82)	0.27 (1.40)	0.21 (1.64)	0.23 (1.96)
Week 8	Number Analyzed	42 participants	41 participants	43 participants	43 participants
Week 8		-0.13 (2.20)	0.41 (1.32)	-0.07 (1.53)	-0.20 (1.49)
Week 12	Number Analyzed	44 participants	41 participants	44 participants	42 participants
Week 12		-0.24 (1.56)	0.20 (1.65)	0.10 (1.94)	-0.01 (2.03)
Week 16	Number Analyzed	43 participants	42 participants	43 participants	44 participants
Week 16		-0.22 (2.13)	0.20 (1.41)	0.15 (1.61)	-0.20 (2.14)
Week 20	Number Analyzed	42 participants	41 participants	40 participants	42 participants
Week 20		-0.07 (2.21)	0.01 (1.22)	-0.39 (1.69)	0.09 (2.51)
Week 24	Number Analyzed	41 participants	40 participants	44 participants	44 participants
Week 24		-0.12 (2.24)	-0.06 (1.54)	-0.16 (1.77)	-0.38 (1.92)
Week 28	Number Analyzed	44 participants	39 participants	40 participants	44 participants
Week 28		0.04 (1.81)	0.13 (1.64)	0.10 (1.91)	-0.62 (1.78)
Week 32	Number Analyzed	41 participants	40 participants	43 participants	42 participants
Week 32		-0.07 (1.87)	0.33 (1.27)	0.07 (1.54)	-0.40 (1.67)
Week 40	Number Analyzed	41 participants	42 participants	40 participants	43 participants
Week 40		0.16 (2.37)	0.16 (1.31)	-0.32 (1.57)	-0.41 (1.88)
Week 48	Number Analyzed	37 participants	41 participants	39 participants	41 participants
Week 48		-0.29 (1.58)	0.55 (1.15)	-0.09 (2.02)	-0.54 (1.78)

30.Secondary Outcome


Title	Mean Change From Baseline in Neutrophils/Leukocytes
Description	Neutrophils/Leukocytes was measured in percentages (%).
Description	Neutrophils/Leukocytes was measured in percentages (%).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: % of Neutrophils per Leukocytes
Week 2	Number Analyzed	42 participants	39 participants	44 participants	41 participants
Week 2		2.99 (10.73)	-0.21 (7.94)	-1.20 (8.40)	-1.93 (8.18)
Week 4	Number Analyzed	43 participants	43 participants	41 participants	46 participants
Week 4		0.91 (9.37)	0.89 (7.82)	1.47 (12.70)	-0.37 (10.27)
Week 8	Number Analyzed	42 participants	41 participants	43 participants	43 participants
Week 8		2.15 (12.95)	0.79 (8.80)	-1.17 (13.28)	-2.23 (10.92)
Week 12	Number Analyzed	44 participants	40 participants	44 participants	42 participants
Week 12		-0.52 (9.44)	-1.25 (11.78)	-0.12 (13.18)	-2.90 (12.85)
Week 16	Number Analyzed	43 participants	42 participants	43 participants	44 participants
Week 16		0.77 (11.02)	0.54 (8.50)	0.56 (12.48)	-0.24 (12.23)
Week 20	Number Analyzed	42 participants	40 participants	40 participants	42 participants
Week 20		2.22 (13.21)	-0.73 (8.42)	-1.25 (14.29)	-0.71 (13.91)
Week 24	Number Analyzed	41 participants	40 participants	44 participants	44 participants
Week 24		0.65 (11.48)	-1.25 (8.74)	0.10 (13.20)	-2.30 (12.41)
Week 28	Number Analyzed	44 participants	39 participants	40 participants	44 participants
Week 28		1.28 (10.38)	-0.88 (10.56)	-0.77 (13.27)	-2.60 (13.79)
Week 32	Number Analyzed	41 participants	40 participants	43 participants	42 participants
Week 32		1.67 (9.93)	2.15 (7.42)	-0.47 (9.80)	-0.48 (12.08)
Week 40	Number Analyzed	41 participants	42 participants	40 participants	43 participants
Week 40		2.29 (11.66)	1.36 (6.95)	0.07 (13.23)	-0.93 (11.50)
Week 48	Number Analyzed	37 participants	41 participants	39 participants	41 participants
Week 48		1.41 (13.58)	4.09 (8.40)	0.30 (12.47)	-2.28 (12.38)

31.Secondary Outcome


Title	Mean Change From Baseline in Platelets
Description	Platelets was measured in number of platelets per liter (10^9/L).
Description	Platelets was measured in number of platelets per liter (10^9/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: 10^9 platelets per liter
Week 2	Number Analyzed	41 participants	42 participants	45 participants	42 participants
Week 2		5.9 (33.2)	10.0 (40.0)	1.4 (47.5)	-1.0 (52.0)
Week 4	Number Analyzed	43 participants	44 participants	43 participants	46 participants
Week 4		-5.2 (51.3)	0.0 (32.4)	4.9 (43.8)	8.1 (42.6)
Week 8	Number Analyzed	42 participants	44 participants	44 participants	44 participants
Week 8		0.2 (45.3)	-0.3 (40.3)	3.9 (52.0)	-6.4 (40.5)
Week 12	Number Analyzed	43 participants	43 participants	43 participants	44 participants
Week 12		-4.3 (50.6)	-1.7 (38.8)	-2.7 (49.0)	1.8 (49.4)
Week 16	Number Analyzed	44 participants	43 participants	43 participants	45 participants
Week 16		0.7 (57.7)	-0.7 (40.5)	-1.5 (66.7)	-2.3 (68.1)
Week 20	Number Analyzed	42 participants	43 participants	41 participants	42 participants
Week 20		9.2 (57.1)	-3.3 (43.0)	0.5 (44.6)	0.8 (64.4)
Week 24	Number Analyzed	42 participants	41 participants	44 participants	43 participants
Week 24		0.2 (60.2)	-5.2 (43.8)	2.4 (68.6)	1.7 (67.0)
Week 28	Number Analyzed	42 participants	41 participants	41 participants	44 participants
Week 28		3.6 (64.6)	1.8 (52.6)	-5.8 (71.9)	1.5 (64.4)
Week 32	Number Analyzed	42 participants	42 participants	42 participants	40 participants
Week 32		4.0 (71.8)	-1.9 (55.4)	-4.6 (57.5)	9.9 (93.8)
Week 40	Number Analyzed	42 participants	43 participants	41 participants	43 participants
Week 40		10.3 (74.9)	14.2 (52.7)	-8.8 (63.2)	-1.5 (67.4)
Week 48	Number Analyzed	37 participants	42 participants	39 participants	42 participants
Week 48		7.1 (67.4)	3.5 (58.2)	-9.5 (70.9)	-8.8 (66.5)

32.Secondary Outcome


Title	Mean Change From Baseline in Cluster of Differentiation 3 (CD3)
Description	Cluster of differentiation 3 (CD3) was measured in cells per microlite...
Description	Cluster of differentiation 3 (CD3) was measured in cells per microliter (cells/µL).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: cells/µL
Week 2	Number Analyzed	38 participants	40 participants	42 participants	40 participants
Week 2		33.0 (313.6)	77.7 (383.6)	106.6 (283.1)	126.9 (338.9)
Week 4	Number Analyzed	39 participants	40 participants	40 participants	39 participants
Week 4		-30.6 (293.5)	-47.7 (504.3)	24.0 (394.9)	227.2 (412.1)
Week 8	Number Analyzed	38 participants	40 participants	39 participants	40 participants
Week 8		-64.7 (405.7)	-58.6 (422.8)	-20.5 (403.2)	78.3 (560.0)
Week 12	Number Analyzed	41 participants	41 participants	40 participants	40 participants
Week 12		-44.2 (283.2)	-48.8 (452.1)	-57.8 (385.1)	43.7 (599.3)
Week 16	Number Analyzed	38 participants	42 participants	38 participants	42 participants
Week 16		-81.9 (479.4)	-141.2 (516.1)	-4.5 (383.2)	-45.4 (520.8)
Week 20	Number Analyzed	40 participants	40 participants	39 participants	42 participants
Week 20		-92.7 (391.1)	-173.4 (490.9)	5.9 (352.9)	-89.9 (577.7)
Week 24	Number Analyzed	39 participants	39 participants	42 participants	43 participants
Week 24		-85.8 (472.5)	-128.9 (569.4)	-88.5 (462.1)	-78.3 (570.7)
Week 28	Number Analyzed	41 participants	40 participants	39 participants	38 participants
Week 28		-27.6 (507.3)	-81.2 (652.7)	46.1 (482.2)	7.4 (561.2)
Week 32	Number Analyzed	41 participants	41 participants	41 participants	41 participants
Week 32		-70.9 (428.4)	-173.6 (565.8)	18.0 (415.0)	-90.5 (504.0)
Week 40	Number Analyzed	40 participants	41 participants	39 participants	43 participants
Week 40		-110.5 (526.4)	-166.9 (542.2)	-1.8 (410.7)	31.7 (528.8)
Week 48	Number Analyzed	35 participants	40 participants	35 participants	41 participants
Week 48		-115.6 (581.1)	-253.1 (637.0)	36.1 (492.3)	22.3 (558.0)

33.Secondary Outcome


Title	Mean Change From Baseline in CD3/Lymphocytes
Description	CD3/Lymphocytes was measured in percentages (%).
Description	CD3/Lymphocytes was measured in percentages (%).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: % of CD3 per Leukocytes
Week 2	Number Analyzed	38 participants	40 participants	42 participants	40 participants
Week 2		-0.7 (6.1)	-0.9 (4.6)	-2.0 (5.7)	-0.2 (7.8)
Week 4	Number Analyzed	39 participants	40 participants	40 participants	39 participants
Week 4		-2.1 (7.3)	-0.5 (6.0)	-1.9 (5.0)	-0.5 (6.8)
Week 8	Number Analyzed	38 participants	40 participants	39 participants	40 participants
Week 8		-0.9 (6.1)	-1.2 (4.8)	-2.6 (5.9)	0.6 (9.5)
Week 12	Number Analyzed	41 participants	41 participants	40 participants	40 participants
Week 12		-0.4 (5.6)	-1.1 (8.2)	-2.4 (6.0)	-0.1 (9.2)
Week 16	Number Analyzed	38 participants	42 participants	38 participants	42 participants
Week 16		-1.9 (5.8)	-1.6 (7.8)	-1.9 (7.6)	-1.4 (7.9)
Week 20	Number Analyzed	40 participants	40 participants	39 participants	42 participants
Week 20		-0.8 (5.0)	0.0 (8.6)	-2.3 (6.9)	0.6 (9.2)
Week 24	Number Analyzed	39 participants	39 participants	42 participants	43 participants
Week 24		0.0 (6.5)	-0.1 (8.8)	-1.8 (6.6)	18.7 (114.3)
Week 28	Number Analyzed	41 participants	40 participants	39 participants	38 participants
Week 28		-0.2 (6.9)	0.2 (8.3)	-2.9 (7.2)	0.9 (10.2)
Week 32	Number Analyzed	41 participants	41 participants	41 participants	41 participants
Week 32		-1.3 (7.0)	0.2 (7.9)	-1.8 (6.8)	1.4 (8.5)
Week 40	Number Analyzed	40 participants	41 participants	39 participants	43 participants
Week 40		0.2 (6.7)	1.4 (6.9)	0.5 (6.5)	3.3 (7.9)
Week 48	Number Analyzed	35 participants	40 participants	35 participants	41 participants
Week 48		1.3 (8.0)	0.3 (7.6)	0.1 (6.2)	4.5 (7.3)

34.Secondary Outcome


Title	Mean Change From Baseline in Cluster of Differentiation 19 (CD19)
Description	Cluster of differentiation 19 (CD19) was measured in cells per microli...
Description	Cluster of differentiation 19 (CD19) was measured in cells per microliter (cells/µL).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: cells/µL
Week 2	Number Analyzed	38 participants	40 participants	42 participants	40 participants
Week 2		9.6 (56.7)	12.3 (76.2)	24.8 (71.0)	63.4 (133.5)
Week 4	Number Analyzed	39 participants	40 participants	40 participants	39 participants
Week 4		-2.8 (46.3)	-31.2 (177.0)	9.2 (60.5)	82.8 (154.5)
Week 8	Number Analyzed	38 participants	40 participants	39 participants	40 participants
Week 8		-13.3 (72.9)	-29.4 (183.5)	8.7 (70.8)	19.4 (146.4)
Week 12	Number Analyzed	41 participants	41 participants	40 participants	40 participants
Week 12		-2.6 (83.4)	-48.1 (207.1)	-17.9 (77.8)	53.2 (203.6)
Week 16	Number Analyzed	38 participants	42 participants	38 participants	42 participants
Week 16		-12.5 (84.3)	-50.1 (201.5)	-10.0 (92.4)	13.2 (147.8)
Week 20	Number Analyzed	40 participants	40 participants	39 participants	42 participants
Week 20		-15.1 (86.0)	-75.4 (216.6)	-2.5 (57.1)	2.7 (132.6)
Week 24	Number Analyzed	39 participants	39 participants	42 participants	43 participants
Week 24		-15.0 (89.3)	-77.2 (231.9)	-20.3 (72.0)	-1.1 (135.0)
Week 28	Number Analyzed	41 participants	40 participants	39 participants	38 participants
Week 28		-20.6 (106.7)	-69.6 (206.7)	-13.1 (84.5)	-13.0 (123.2)
Week 32	Number Analyzed	41 participants	41 participants	41 participants	41 participants
Week 32		-14.3 (106.3)	-75.8 (225.7)	-10.4 (93.0)	-20.9 (168.1)
Week 40	Number Analyzed	40 participants	41 participants	39 participants	43 participants
Week 40		-24.8 (103.3)	-68.6 (211.0)	-26.9 (83.0)	-46.9 (138.0)
Week 48	Number Analyzed	35 participants	40 participants	35 participants	41 participants
Week 48		-37.0 (132.7)	-82.4 (243.7)	-15.5 (83.2)	-41.2 (120.0)

35.Secondary Outcome


Title	Mean Change From Baseline in CD19/Lymphocytes
Description	CD19/Lymphocytes was measured in percentages (%).
Description	CD19/Lymphocytes was measured in percentages (%).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: % of CD19 per Leukocytes
Week 2	Number Analyzed	38 participants	40 participants	42 participants	40 participants
Week 2		-0.3 (2.1)	-0.1 (3.0)	1.0 (3.5)	1.5 (5.9)
Week 4	Number Analyzed	39 participants	40 participants	40 participants	39 participants
Week 4		0.0 (2.9)	-0.5 (3.7)	0.7 (3.3)	2.8 (5.7)
Week 8	Number Analyzed	38 participants	40 participants	39 participants	40 participants
Week 8		0.1 (2.8)	-0.5 (4.2)	0.7 (2.5)	0.4 (6.4)
Week 12	Number Analyzed	41 participants	41 participants	40 participants	40 participants
Week 12		-0.2 (3.2)	-1.0 (3.9)	-0.4 (3.1)	1.7 (7.9)
Week 16	Number Analyzed	38 participants	42 participants	38 participants	42 participants
Week 16		0.0 (4.7)	-1.2 (5.0)	-0.4 (3.3)	0.7 (5.9)
Week 20	Number Analyzed	40 participants	40 participants	39 participants	42 participants
Week 20		-0.4 (3.8)	-2.1 (6.2)	-0.3 (3.0)	-0.2 (6.9)
Week 24	Number Analyzed	39 participants	39 participants	42 participants	43 participants
Week 24		-0.9 (4.5)	-2.0 (6.5)	-0.6 (3.3)	-0.3 (7.3)
Week 28	Number Analyzed	41 participants	40 participants	39 participants	38 participants
Week 28		-1.2 (5.4)	-2.5 (5.9)	-1.1 (3.3)	-1.0 (6.6)
Week 32	Number Analyzed	41 participants	41 participants	41 participants	41 participants
Week 32		-0.4 (4.7)	-2.4 (5.5)	-0.6 (4.4)	-1.6 (6.3)
Week 40	Number Analyzed	40 participants	41 participants	39 participants	43 participants
Week 40		-1.2 (4.7)	-2.6 (5.4)	-1.9 (4.2)	-3.4 (6.7)
Week 48	Number Analyzed	35 participants	40 participants	35 participants	41 participants
Week 48		-1.2 (6.8)	-2.6 (7.2)	-1.6 (4.9)	-3.3 (6.2)

36.Secondary Outcome


Title	Mean Change From Baseline in Aspartate Aminotransferase
Description	Aspartate Aminotransferase was measured in units per liter (U/L).
Description	Aspartate Aminotransferase was measured in units per liter (U/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: U/L
Week 2	Number Analyzed	42 participants	45 participants	45 participants	43 participants
Week 2		-0.5 (8.8)	0.2 (8.0)	4.3 (43.1)	0.0 (7.2)
Week 4	Number Analyzed	44 participants	44 participants	43 participants	46 participants
Week 4		-0.1 (11.2)	0.2 (7.4)	-1.1 (7.6)	-1.9 (8.0)
Week 8	Number Analyzed	44 participants	43 participants	44 participants	44 participants
Week 8		-0.1 (8.7)	-1.5 (6.2)	0.5 (13.0)	-1.1 (8.1)
Week 12	Number Analyzed	44 participants	44 participants	45 participants	44 participants
Week 12		5.1 (27.0)	0.9 (6.2)	-1.8 (10.0)	-2.9 (7.1)
Week 16	Number Analyzed	44 participants	44 participants	43 participants	45 participants
Week 16		0.4 (7.7)	0.0 (6.3)	-2.3 (11.6)	-2.8 (8.4)
Week 20	Number Analyzed	43 participants	43 participants	41 participants	44 participants
Week 20		4.1 (24.1)	1.0 (11.5)	-0.7 (13.8)	-3.8 (8.1)
Week 24	Number Analyzed	42 participants	43 participants	44 participants	44 participants
Week 24		0.6 (11.8)	1.6 (10.4)	-1.8 (11.5)	-3.8 (8.4)
Week 28	Number Analyzed	43 participants	42 participants	40 participants	42 participants
Week 28		0.0 (12.3)	0.0 (10.2)	-1.5 (11.1)	-3.4 (9.1)
Week 32	Number Analyzed	44 participants	44 participants	43 participants	44 participants
Week 32		-0.3 (11.0)	0.3 (6.8)	-0.7 (12.9)	-3.4 (9.2)
Week 40	Number Analyzed	42 participants	42 participants	41 participants	44 participants
Week 40		-0.6 (10.2)	0.1 (9.1)	-0.3 (11.5)	-1.5 (9.8)
Week 48	Number Analyzed	38 participants	42 participants	40 participants	43 participants
Week 48		1.1 (10.8)	0.1 (13.1)	1.4 (13.4)	-2.1 (8.6)

37.Secondary Outcome


Title	Mean Change From Baseline in Alanine Aminotransferase
Description	Alanine Aminotransferase was measured in units per liter (U/L).
Description	Alanine Aminotransferase was measured in units per liter (U/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: U/L
Week 2	Number Analyzed	42 participants	45 participants	45 participants	43 participants
Week 2		2.4 (14.1)	2.6 (10.6)	0.5 (11.1)	-0.1 (8.6)
Week 4	Number Analyzed	44 participants	44 participants	43 participants	46 participants
Week 4		0.8 (9.9)	-0.5 (8.5)	0.9 (7.4)	0.3 (8.2)
Week 8	Number Analyzed	44 participants	43 participants	44 participants	44 participants
Week 8		0.2 (10.2)	-0.8 (8.3)	5.3 (28.8)	-0.6 (9.6)
Week 12	Number Analyzed	44 participants	44 participants	45 participants	44 participants
Week 12		7.0 (21.3)	0.8 (14.3)	-0.8 (8.1)	-0.1 (7.6)
Week 16	Number Analyzed	44 participants	44 participants	43 participants	45 participants
Week 16		1.5 (13.3)	-0.4 (9.3)	0.0 (10.3)	-1.1 (7.8)
Week 20	Number Analyzed	43 participants	43 participants	42 participants	44 participants
Week 20		5.3 (23.6)	-0.2 (10.2)	1.4 (10.8)	-3.7 (6.3)
Week 24	Number Analyzed	42 participants	43 participants	44 participants	44 participants
Week 24		3.1 (20.9)	0.5 (14.1)	2.0 (12.0)	-2.8 (7.7)
Week 28	Number Analyzed	43 participants	42 participants	40 participants	42 participants
Week 28		1.0 (13.9)	0.7 (10.5)	-0.4 (9.3)	-2.7 (7.2)
Week 32	Number Analyzed	44 participants	44 participants	43 participants	44 participants
Week 32		1.2 (13.4)	-0.5 (10.3)	1.3 (10.8)	-3.2 (6.1)
Week 40	Number Analyzed	42 participants	42 participants	41 participants	44 participants
Week 40		-0.5 (13.4)	2.6 (12.8)	3.0 (12.9)	-0.7 (8.3)
Week 48	Number Analyzed	38 participants	42 participants	40 participants	43 participants
Week 48		0.4 (11.5)	-1.2 (10.4)	3.5 (17.0)	-1.1 (7.8)

38.Secondary Outcome


Title	Mean Change From Baseline in Alkaline Phosphatase
Description	Alkaline Phosphatase was measured in units per liter (U/L).
Description	Alkaline Phosphatase was measured in units per liter (U/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: U/L
Week 2	Number Analyzed	42 participants	45 participants	45 participants	44 participants
Week 2		1.8 (10.7)	2.4 (10.6)	1.5 (8.0)	-3.6 (10.1)
Week 4	Number Analyzed	44 participants	44 participants	43 participants	46 participants
Week 4		-1.7 (9.7)	0.7 (9.2)	-0.7 (8.4)	-4.7 (9.4)
Week 8	Number Analyzed	44 participants	43 participants	44 participants	44 participants
Week 8		1.7 (12.9)	2.4 (12.7)	1.8 (15.6)	-6.1 (11.0)
Week 12	Number Analyzed	44 participants	44 participants	45 participants	44 participants
Week 12		2.2 (11.6)	4.2 (16.4)	1.9 (12.9)	-4.4 (11.8)
Week 16	Number Analyzed	44 participants	45 participants	43 participants	45 participants
Week 16		3.1 (10.7)	2.7 (13.0)	0.0 (10.4)	-6.7 (12.8)
Week 20	Number Analyzed	43 participants	45 participants	42 participants	44 participants
Week 20		3.9 (14.0)	1.4 (11.8)	1.4 (11.8)	-7.4 (11.2)
Week 24	Number Analyzed	42 participants	43 participants	44 participants	44 participants
Week 24		4.7 (15.0)	3.7 (14.0)	2.8 (11.6)	-2.7 (14.0)
Week 28	Number Analyzed	43 participants	43 participants	40 participants	43 participants
Week 28		2.8 (14.0)	3.1 (14.2)	1.9 (9.5)	-2.1 (13.5)
Week 32	Number Analyzed	44 participants	44 participants	43 participants	45 participants
Week 32		3.8 (14.6)	2.7 (16.0)	3.2 (12.1)	1.0 (15.9)
Week 40	Number Analyzed	42 participants	42 participants	41 participants	44 participants
Week 40		2.4 (17.1)	1.3 (13.1)	2.7 (13.0)	-3.0 (18.0)
Week 48	Number Analyzed	38 participants	42 participants	40 participants	43 participants
Week 48		2.6 (13.3)	4.0 (16.8)	5.5 (12.8)	-4.5 (18.8)

39.Secondary Outcome


Title	Mean Change From Baseline in Gamma Glutamyl Transferase
Description	Gamma Glutamyl Transferase was measured in units per liter (U/L).
Description	Gamma Glutamyl Transferase was measured in units per liter (U/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: U/L
Week 2	Number Analyzed	42 participants	45 participants	45 participants	43 participants
Week 2		0.3 (7.6)	2.0 (11.5)	8.8 (68.9)	-3.4 (24.3)
Week 4	Number Analyzed	44 participants	44 participants	43 participants	46 participants
Week 4		2.1 (8.7)	-1.3 (8.8)	2.7 (28.5)	-6.5 (35.5)
Week 8	Number Analyzed	44 participants	43 participants	44 participants	44 participants
Week 8		3.5 (23.0)	0.3 (10.5)	-2.8 (49.3)	-9.2 (43.3)
Week 12	Number Analyzed	44 participants	44 participants	45 participants	44 participants
Week 12		4.1 (21.0)	0.5 (13.4)	-5.1 (29.3)	-8.3 (46.1)
Week 16	Number Analyzed	44 participants	45 participants	43 participants	45 participants
Week 16		6.5 (20.2)	2.1 (12.5)	-6.1 (45.0)	-10.6 (47.7)
Week 20	Number Analyzed	43 participants	44 participants	42 participants	44 participants
Week 20		3.5 (14.1)	0.2 (13.4)	-3.7 (50.3)	-8.5 (50.5)
Week 24	Number Analyzed	42 participants	43 participants	44 participants	44 participants
Week 24		7.1 (22.0)	4.0 (18.7)	-0.4 (53.1)	-9.5 (47.2)
Week 28	Number Analyzed	43 participants	43 participants	40 participants	43 participants
Week 28		4.6 (25.7)	2.2 (18.3)	-7.0 (46.8)	0.0 (23.1)
Week 32	Number Analyzed	44 participants	44 participants	43 participants	45 participants
Week 32		4.4 (28.6)	1.5 (16.7)	-5.9 (44.5)	-8.2 (37.4)
Week 40	Number Analyzed	42 participants	42 participants	41 participants	44 participants
Week 40		3.4 (41.3)	5.7 (32.4)	0.4 (10.1)	-9.1 (45.3)
Week 48	Number Analyzed	38 participants	42 participants	40 participants	43 participants
Week 48		1.8 (11.4)	5.3 (23.9)	4.7 (21.6)	-9.8 (44.5)

40.Secondary Outcome


Title	Mean Change From Baseline in Bilirubin
Description	Bilirubin was measured in micromols per liter (µmol/L).
Description	Bilirubin was measured in micromols per liter (µmol/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: μmol/L
Week 2	Number Analyzed	42 participants	45 participants	45 participants	43 participants
Week 2		0.35 (2.72)	-0.48 (2.71)	0.28 (2.38)	-0.78 (3.13)
Week 4	Number Analyzed	44 participants	44 participants	43 participants	46 participants
Week 4		0.07 (2.50)	-0.18 (2.09)	-0.05 (2.14)	-0.79 (2.80)
Week 8	Number Analyzed	44 participants	43 participants	44 participants	44 participants
Week 8		-0.09 (2.66)	-0.69 (2.22)	-0.19 (2.13)	-0.23 (2.80)
Week 12	Number Analyzed	44 participants	44 participants	45 participants	44 participants
Week 12		-0.04 (2.60)	-0.70 (2.74)	0.37 (2.17)	-0.33 (3.28)
Week 16	Number Analyzed	44 participants	45 participants	43 participants	45 participants
Week 16		0.06 (2.41)	-0.45 (2.43)	-0.20 (2.71)	-0.51 (3.64)
Week 20	Number Analyzed	43 participants	43 participants	42 participants	44 participants
Week 20		-0.54 (2.89)	-0.38 (2.51)	0.51 (2.81)	-0.30 (3.03)
Week 24	Number Analyzed	42 participants	43 participants	44 participants	44 participants
Week 24		0.08 (2.75)	-0.14 (2.86)	0.54 (2.18)	-0.38 (3.57)
Week 28	Number Analyzed	43 participants	42 participants	40 participants	42 participants
Week 28		-0.10 (2.98)	-0.26 (3.23)	0.79 (2.71)	-0.82 (2.61)
Week 32	Number Analyzed	44 participants	44 participants	43 participants	44 participants
Week 32		0.09 (2.75)	-0.38 (2.61)	0.93 (3.18)	-0.38 (3.61)
Week 40	Number Analyzed	42 participants	42 participants	41 participants	44 participants
Week 40		-0.26 (3.70)	0.07 (3.18)	1.03 (2.35)	-0.15 (2.64)
Week 48	Number Analyzed	38 participants	42 participants	40 participants	43 participants
Week 48		0.69 (3.57)	-0.50 (3.12)	0.79 (3.04)	-0.20 (2.52)

41.Secondary Outcome


Title	Mean Change From Baseline in Direct Bilirubin
Description	Direct Bilirubin was measured in micromols per liter (µmol/L).
Description	Direct Bilirubin was measured in micromols per liter (µmol/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: μmol/L
Week 2	Number Analyzed	42 participants	45 participants	45 participants	43 participants
Week 2		0.03 (0.92)	-0.06 (0.92)	0.09 (1.12)	-0.24 (1.10)
Week 4	Number Analyzed	44 participants	44 participants	43 participants	46 participants
Week 4		0.10 (1.03)	0.03 (0.75)	-0.04 (0.82)	-0.10 (0.93)
Week 8	Number Analyzed	44 participants	43 participants	44 participants	44 participants
Week 8		0.03 (0.91)	-0.18 (0.55)	-0.17 (0.86)	0.03 (1.10)
Week 12	Number Analyzed	44 participants	44 participants	45 participants	44 participants
Week 12		0.15 (0.99)	-0.07 (0.95)	-0.01 (1.06)	-0.05 (1.30)
Week 16	Number Analyzed	44 participants	45 participants	43 participants	45 participants
Week 16		0.18 (0.81)	-0.01 (0.66)	-0.07 (1.04)	-0.01 (1.40)
Week 20	Number Analyzed	43 participants	43 participants	42 participants	44 participants
Week 20		-0.04 (0.95)	0.07 (0.91)	0.02 (0.94)	0.00 (1.19)
Week 24	Number Analyzed	42 participants	43 participants	44 participants	44 participants
Week 24		0.05 (1.10)	0.14 (0.95)	0.08 (1.02)	-0.08 (1.25)
Week 28	Number Analyzed	43 participants	42 participants	40 participants	42 participants
Week 28		0.06 (1.06)	-0.06 (1.00)	0.11 (0.80)	-0.06 (1.15)
Week 32	Number Analyzed	44 participants	44 participants	43 participants	44 participants
Week 32		0.12 (1.16)	0.05 (0.90)	0.21 (1.21)	-0.04 (1.36)
Week 40	Number Analyzed	42 participants	42 participants	41 participants	44 participants
Week 40		0.07 (1.31)	0.03 (0.76)	0.23 (1.00)	0.07 (1.05)
Week 48	Number Analyzed	38 participants	42 participants	40 participants	43 participants
Week 48		0.31 (1.34)	-0.05 (1.01)	0.20 (1.25)	0.08 (0.98)

42.Secondary Outcome


Title	Mean Change From Baseline in Lactate Dehydrogenase
Description	Lactate Dehydrogenase was measured in units per liter (U/L).
Description	Lactate Dehydrogenase was measured in units per liter (U/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: U/L
Week 2	Number Analyzed	42 participants	45 participants	45 participants	44 participants
Week 2		-3.3 (27.8)	-7.8 (21.2)	-5.9 (35.2)	-12.8 (24.8)
Week 4	Number Analyzed	44 participants	44 participants	43 participants	46 participants
Week 4		-3.0 (23.4)	-3.7 (37.0)	-5.6 (35.6)	-18.5 (34.1)
Week 8	Number Analyzed	44 participants	43 participants	44 participants	44 participants
Week 8		-5.7 (27.4)	-11.8 (31.5)	-9.2 (39.0)	-20.4 (37.4)
Week 12	Number Analyzed	44 participants	44 participants	45 participants	44 participants
Week 12		3.0 (28.7)	-7.4 (34.6)	-11.1 (45.1)	-24.4 (39.0)
Week 16	Number Analyzed	44 participants	44 participants	43 participants	45 participants
Week 16		-2.2 (25.5)	-11.1 (29.9)	-10.6 (48.6)	-22.4 (43.3)
Week 20	Number Analyzed	43 participants	45 participants	41 participants	44 participants
Week 20		-0.7 (33.9)	-10.8 (37.0)	-9.9 (47.8)	-28.5 (32.1)
Week 24	Number Analyzed	42 participants	43 participants	44 participants	44 participants
Week 24		-4.5 (31.3)	-14.3 (31.5)	-14.6 (34.4)	-29.3 (32.2)
Week 28	Number Analyzed	43 participants	43 participants	40 participants	43 participants
Week 28		0.0 (40.8)	-16.0 (40.9)	-13.2 (35.0)	-34.8 (36.9)
Week 32	Number Analyzed	44 participants	44 participants	43 participants	45 participants
Week 32		5.0 (55.0)	-9.9 (43.4)	-8.1 (33.5)	-22.9 (40.6)
Week 40	Number Analyzed	42 participants	42 participants	41 participants	44 participants
Week 40		-1.6 (38.1)	-2.9 (41.1)	-8.0 (28.4)	-20.5 (40.1)
Week 48	Number Analyzed	38 participants	42 participants	40 participants	43 participants
Week 48		-8.8 (35.2)	-4.2 (54.3)	-1.5 (32.7)	-16.0 (36.3)

43.Secondary Outcome


Title	Mean Change From Baseline in Creatinine
Description	Creatinine was measured in micromols per liter (µmol/L).
Description	Creatinine was measured in micromols per liter (µmol/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: μmol/L
Week 2	Number Analyzed	42 participants	45 participants	45 participants	44 participants
Week 2		0.9 (9.1)	-0.1 (8.0)	1.5 (5.8)	0.6 (7.2)
Week 4	Number Analyzed	44 participants	44 participants	43 participants	46 participants
Week 4		-0.8 (8.9)	-0.2 (9.3)	-0.6 (7.3)	-1.4 (8.2)
Week 8	Number Analyzed	44 participants	43 participants	44 participants	44 participants
Week 8		0.5 (7.0)	0.3 (7.6)	-0.5 (6.9)	0.1 (8.4)
Week 12	Number Analyzed	44 participants	44 participants	45 participants	44 participants
Week 12		-0.3 (7.0)	1.4 (7.5)	-0.4 (6.4)	-0.7 (8.2)
Week 16	Number Analyzed	44 participants	45 participants	43 participants	45 participants
Week 16		-0.1 (9.8)	1.0 (8.2)	0.7 (6.8)	-1.1 (9.4)
Week 20	Number Analyzed	43 participants	45 participants	42 participants	44 participants
Week 20		0.7 (8.6)	1.4 (10.2)	0.8 (6.9)	-0.3 (7.7)
Week 24	Number Analyzed	42 participants	43 participants	44 participants	44 participants
Week 24		0.0 (8.8)	0.8 (8.8)	0.3 (6.6)	0.9 (9.7)
Week 28	Number Analyzed	43 participants	43 participants	40 participants	43 participants
Week 28		2.5 (10.0)	2.7 (10.0)	1.0 (7.8)	-0.9 (7.8)
Week 32	Number Analyzed	44 participants	44 participants	43 participants	45 participants
Week 32		5.5 (35.7)	0.5 (8.1)	3.6 (7.8)	1.6 (11.2)
Week 40	Number Analyzed	42 participants	42 participants	41 participants	44 participants
Week 40		2.3 (9.5)	2.2 (8.5)	3.9 (6.0)	3.0 (8.4)
Week 48	Number Analyzed	38 participants	42 participants	40 participants	43 participants
Week 48		1.9 (10.6)	0.7 (7.6)	2.5 (5.2)	2.9 (9.8)

44.Secondary Outcome


Title	Mean Change From Baseline in Urea Nitrogen
Description	Urea Nitrogen was measured in millimoles per liter (mmol/L).
Description	Urea Nitrogen was measured in millimoles per liter (mmol/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: mmol/L
Week 2	Number Analyzed	42 participants	45 participants	45 participants	43 participants
Week 2		0.28 (1.55)	-0.09 (1.23)	-0.05 (1.32)	-0.02 (1.31)
Week 4	Number Analyzed	44 participants	44 participants	43 participants	46 participants
Week 4		-0.07 (1.21)	-0.33 (1.52)	-0.14 (1.20)	0.04 (1.19)
Week 8	Number Analyzed	44 participants	43 participants	44 participants	44 participants
Week 8		0.06 (1.25)	-0.26 (1.22)	-0.19 (1.07)	0.17 (1.59)
Week 12	Number Analyzed	44 participants	44 participants	45 participants	44 participants
Week 12		0.03 (1.13)	-0.39 (1.31)	-0.29 (1.17)	-0.22 (1.15)
Week 16	Number Analyzed	44 participants	45 participants	43 participants	45 participants
Week 16		0.19 (1.35)	-0.18 (1.40)	0.19 (1.49)	-0.03 (1.41)
Week 20	Number Analyzed	43 participants	44 participants	42 participants	44 participants
Week 20		-0.18 (1.29)	-0.20 (1.33)	-0.25 (1.22)	-0.16 (1.08)
Week 24	Number Analyzed	42 participants	43 participants	44 participants	44 participants
Week 24		0.08 (1.69)	-0.44 (1.38)	-0.13 (1.18)	-0.09 (1.50)
Week 28	Number Analyzed	43 participants	43 participants	40 participants	43 participants
Week 28		0.13 (1.38)	0.03 (1.61)	-0.23 (1.26)	-0.22 (1.14)
Week 32	Number Analyzed	44 participants	44 participants	43 participants	45 participants
Week 32		0.40 (2.37)	-0.30 (1.65)	0.21 (1.17)	0.10 (1.43)
Week 40	Number Analyzed	42 participants	42 participants	41 participants	44 participants
Week 40		0.29 (1.54)	0.10 (1.73)	0.21 (1.20)	0.14 (1.43)
Week 48	Number Analyzed	38 participants	42 participants	40 participants	43 participants
Week 48		0.05 (1.22)	-0.31 (1.54)	0.23 (1.38)	-0.02 (1.56)

45.Secondary Outcome


Title	Mean Change From Baseline in Sodium
Description	Sodium was measured in millimoles per liter (mmol/L).
Description	Sodium was measured in millimoles per liter (mmol/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: mmol/L
Week 2	Number Analyzed	42 participants	45 participants	45 participants	44 participants
Week 2		-0.1 (1.9)	-0.4 (2.4)	0.1 (1.6)	0.0 (2.2)
Week 4	Number Analyzed	44 participants	44 participants	43 participants	46 participants
Week 4		-0.3 (2.0)	-0.6 (2.1)	0.3 (2.1)	-0.1 (2.4)
Week 8	Number Analyzed	44 participants	43 participants	44 participants	44 participants
Week 8		0.1 (2.2)	-0.4 (2.4)	0.3 (2.2)	0.1 (2.3)
Week 12	Number Analyzed	44 participants	44 participants	45 participants	44 participants
Week 12		-0.3 (2.0)	-0.5 (2.0)	0.2 (2.0)	0.1 (2.3)
Week 16	Number Analyzed	44 participants	45 participants	43 participants	45 participants
Week 16		-0.4 (2.3)	-0.2 (1.9)	0.0 (2.0)	-0.2 (2.3)
Week 20	Number Analyzed	43 participants	45 participants	42 participants	44 participants
Week 20		0.3 (2.2)	-0.8 (2.2)	-0.1 (2.0)	-0.5 (2.4)
Week 24	Number Analyzed	42 participants	43 participants	44 participants	44 participants
Week 24		-0.1 (2.5)	-0.4 (2.2)	0.0 (2.2)	-0.3 (2.1)
Week 28	Number Analyzed	43 participants	43 participants	40 participants	43 participants
Week 28		0.0 (1.9)	-0.4 (2.4)	0.2 (1.9)	0.1 (2.3)
Week 32	Number Analyzed	44 participants	44 participants	43 participants	45 participants
Week 32		0.0 (2.3)	-0.8 (3.2)	0.1 (2.1)	0.2 (2.2)
Week 40	Number Analyzed	42 participants	42 participants	41 participants	44 participants
Week 40		-0.1 (2.2)	-1.2 (2.2)	-0.1 (1.6)	-0.3 (2.4)
Week 48	Number Analyzed	38 participants	42 participants	40 participants	43 participants
Week 48		-0.4 (2.0)	-1.1 (2.6)	-0.5 (1.7)	0.2 (2.3)

46.Secondary Outcome


Title	Mean Change From Baseline in Potassium
Description	Potassium was measured in millimoles per liter (mmol/L).
Description	Potassium was measured in millimoles per liter (mmol/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: mmol/L
Week 2	Number Analyzed	42 participants	45 participants	44 participants	44 participants
Week 2		0.04 (0.45)	0.15 (0.40)	0.00 (0.36)	-0.03 (0.37)
Week 4	Number Analyzed	44 participants	44 participants	43 participants	46 participants
Week 4		0.06 (0.44)	0.08 (0.35)	-0.07 (0.41)	-0.12 (0.40)
Week 8	Number Analyzed	44 participants	43 participants	44 participants	44 participants
Week 8		-0.04 (0.40)	0.11 (0.38)	0.00 (0.35)	-0.07 (0.40)
Week 12	Number Analyzed	44 participants	44 participants	44 participants	44 participants
Week 12		-0.01 (0.33)	0.02 (0.31)	-0.07 (0.41)	-0.12 (0.34)
Week 16	Number Analyzed	44 participants	44 participants	43 participants	45 participants
Week 16		-0.01 (0.34)	0.16 (0.33)	-0.09 (0.42)	-0.05 (0.33)
Week 20	Number Analyzed	43 participants	45 participants	40 participants	43 participants
Week 20		0.04 (0.38)	0.14 (0.33)	-0.04 (0.46)	-0.08 (0.37)
Week 24	Number Analyzed	42 participants	43 participants	43 participants	43 participants
Week 24		0.06 (0.43)	0.07 (0.39)	0.03 (0.33)	-0.11 (0.37)
Week 28	Number Analyzed	41 participants	43 participants	40 participants	43 participants
Week 28		0.09 (0.43)	0.12 (0.47)	0.06 (0.42)	0.03 (0.45)
Week 32	Number Analyzed	44 participants	44 participants	43 participants	45 participants
Week 32		0.03 (0.44)	0.07 (0.44)	0.10 (0.46)	-0.05 (0.38)
Week 40	Number Analyzed	42 participants	41 participants	41 participants	44 participants
Week 40		0.06 (0.33)	0.16 (0.51)	0.16 (0.39)	-0.06 (0.37)
Week 48	Number Analyzed	38 participants	42 participants	40 participants	43 participants
Week 48		-0.01 (0.30)	0.00 (0.30)	-0.02 (0.39)	-0.07 (0.40)

47.Secondary Outcome


Title	Mean Change From Baseline in Calcium
Description	Calcium was measured in millimoles per liter (mmol/L).
Description	Calcium was measured in millimoles per liter (mmol/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: mmol/L
Week 2	Number Analyzed	42 participants	45 participants	45 participants	44 participants
Week 2		0.008 (0.104)	-0.001 (0.103)	0.004 (0.088)	-0.008 (0.092)
Week 4	Number Analyzed	44 participants	44 participants	43 participants	46 participants
Week 4		0.007 (0.108)	-0.018 (0.099)	-0.018 (0.090)	-0.001 (0.086)
Week 8	Number Analyzed	44 participants	43 participants	44 participants	44 participants
Week 8		-0.006 (0.093)	-0.033 (0.117)	-0.014 (0.106)	-0.003 (0.089)
Week 12	Number Analyzed	44 participants	44 participants	45 participants	44 participants
Week 12		0.006 (0.108)	-0.011 (0.121)	-0.013 (0.097)	-0.004 (0.111)
Week 16	Number Analyzed	44 participants	45 participants	43 participants	45 participants
Week 16		-0.025 (0.106)	-0.004 (0.088)	-0.013 (0.095)	-0.024 (0.119)
Week 20	Number Analyzed	43 participants	45 participants	42 participants	44 participants
Week 20		-0.036 (0.116)	-0.020 (0.084)	-0.015 (0.108)	0.005 (0.080)
Week 24	Number Analyzed	42 participants	43 participants	44 participants	44 participants
Week 24		-0.027 (0.106)	-0.026 (0.094)	-0.012 (0.095)	0.007 (0.100)
Week 28	Number Analyzed	43 participants	43 participants	40 participants	43 participants
Week 28		-0.031 (0.121)	-0.039 (0.091)	-0.016 (0.113)	-0.014 (0.092)
Week 32	Number Analyzed	44 participants	44 participants	43 participants	45 participants
Week 32		0.003 (0.098)	-0.043 (0.099)	0.019 (0.107)	-0.001 (0.105)
Week 40	Number Analyzed	42 participants	42 participants	41 participants	44 participants
Week 40		-0.027 (0.114)	-0.022 (0.115)	0.006 (0.115)	-0.012 (0.105)
Week 48	Number Analyzed	38 participants	42 participants	40 participants	43 participants
Week 48		-0.013 (0.096)	-0.037 (0.119)	-0.004 (0.104)	-0.017 (0.110)

48.Secondary Outcome


Title	Mean Change From Baseline in Phosphate
Description	Phosphate was measured in millimoles per liter (mmol/L).
Description	Phosphate was measured in millimoles per liter (mmol/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: mmol/L
Week 2	Number Analyzed	42 participants	45 participants	44 participants	43 participants
Week 2		0.044 (0.163)	0.032 (0.192)	-0.047 (0.230)	0.033 (0.168)
Week 4	Number Analyzed	44 participants	44 participants	43 participants	46 participants
Week 4		-0.004 (0.162)	-0.029 (0.185)	-0.070 (0.187)	0.020 (0.163)
Week 8	Number Analyzed	44 participants	43 participants	44 participants	44 participants
Week 8		0.006 (0.178)	-0.063 (0.225)	-0.028 (0.207)	0.051 (0.187)
Week 12	Number Analyzed	44 participants	44 participants	44 participants	44 participants
Week 12		0.029 (0.159)	-0.004 (0.149)	-0.015 (0.236)	0.045 (0.183)
Week 16	Number Analyzed	44 participants	44 participants	43 participants	45 participants
Week 16		-0.010 (0.186)	0.012 (0.182)	-0.025 (0.195)	0.005 (0.178)
Week 20	Number Analyzed	43 participants	43 participants	41 participants	43 participants
Week 20		-0.030 (0.208)	-0.037 (0.244)	-0.031 (0.177)	0.013 (0.187)
Week 24	Number Analyzed	42 participants	43 participants	43 participants	43 participants
Week 24		-0.013 (0.181)	-0.042 (0.160)	-0.040 (0.229)	0.035 (0.200)
Week 28	Number Analyzed	41 participants	42 participants	40 participants	42 participants
Week 28		-0.024 (0.189)	0.008 (0.238)	-0.031 (0.232)	0.037 (0.184)
Week 32	Number Analyzed	44 participants	44 participants	43 participants	44 participants
Week 32		-0.002 (0.217)	-0.056 (0.223)	0.015 (0.220)	0.030 (0.190)
Week 40	Number Analyzed	42 participants	41 participants	41 participants	44 participants
Week 40		0.018 (0.207)	0.009 (0.196)	-0.022 (0.208)	0.034 (0.224)
Week 48	Number Analyzed	38 participants	41 participants	40 participants	43 participants
Week 48		0.032 (0.183)	-0.012 (0.167)	-0.044 (0.214)	0.035 (0.190)

49.Secondary Outcome


Title	Mean Change From Baseline in Cholesterol
Description	Cholesterol was measured in millimoles per liter (mmol/L).
Description	Cholesterol was measured in millimoles per liter (mmol/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: mmol/L
Week 2	Number Analyzed	42 participants	45 participants	45 participants	43 participants
Week 2		0.00 (0.49)	-0.07 (0.46)	-0.06 (0.51)	-0.19 (0.47)
Week 4	Number Analyzed	44 participants	44 participants	43 participants	46 participants
Week 4		-0.08 (0.49)	-0.03 (0.46)	-0.07 (0.68)	-0.07 (0.57)
Week 8	Number Analyzed	44 participants	43 participants	44 participants	44 participants
Week 8		-0.09 (0.57)	-0.07 (0.46)	-0.15 (0.81)	-0.17 (0.59)
Week 12	Number Analyzed	44 participants	44 participants	45 participants	44 participants
Week 12		-0.14 (0.72)	-0.16 (0.61)	-0.23 (0.68)	-0.10 (0.75)
Week 16	Number Analyzed	44 participants	45 participants	43 participants	45 participants
Week 16		-0.16 (0.80)	-0.16 (0.66)	-0.35 (0.80)	-0.27 (0.72)
Week 20	Number Analyzed	43 participants	44 participants	42 participants	44 participants
Week 20		-0.27 (0.77)	-0.22 (0.60)	-0.42 (0.81)	-0.23 (0.85)
Week 24	Number Analyzed	42 participants	43 participants	44 participants	44 participants
Week 24		-0.12 (0.87)	-0.17 (0.66)	-0.28 (0.96)	-0.16 (0.78)
Week 28	Number Analyzed	43 participants	43 participants	40 participants	43 participants
Week 28		-0.17 (0.89)	-0.37 (0.63)	-0.35 (0.97)	-0.29 (0.80)
Week 32	Number Analyzed	44 participants	44 participants	43 participants	45 participants
Week 32		-0.13 (0.86)	-0.22 (0.63)	-0.16 (0.83)	-0.15 (0.81)
Week 40	Number Analyzed	42 participants	42 participants	41 participants	44 participants
Week 40		-0.34 (0.87)	-0.25 (0.80)	-0.19 (0.77)	-0.13 (1.15)
Week 48	Number Analyzed	38 participants	42 participants	40 participants	43 participants
Week 48		-0.40 (0.80)	-0.36 (0.74)	-0.23 (0.97)	-0.18 (1.09)

50.Secondary Outcome


Title	Mean Change From Baseline in Triglycerides
Description	Triglycerides was measured in millimoles per liter (mmol/L).
Description	Triglycerides was measured in millimoles per liter (mmol/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: mmol/L
Week 2	Number Analyzed	42 participants	45 participants	45 participants	44 participants
Week 2		-0.176 (1.593)	0.046 (0.683)	0.110 (0.855)	0.183 (0.751)
Week 4	Number Analyzed	44 participants	44 participants	43 participants	46 participants
Week 4		-0.189 (1.212)	-0.004 (0.510)	-0.030 (0.471)	0.084 (0.529)
Week 8	Number Analyzed	44 participants	43 participants	44 participants	44 participants
Week 8		-0.182 (1.554)	0.076 (0.582)	-0.084 (0.498)	0.046 (0.585)
Week 12	Number Analyzed	44 participants	44 participants	45 participants	44 participants
Week 12		-0.265 (1.445)	0.088 (0.713)	0.063 (0.578)	0.009 (0.514)
Week 16	Number Analyzed	44 participants	45 participants	43 participants	45 participants
Week 16		-0.164 (1.345)	0.099 (1.488)	0.142 (0.580)	0.112 (1.035)
Week 20	Number Analyzed	43 participants	45 participants	42 participants	44 participants
Week 20		-0.233 (1.391)	-0.104 (0.837)	0.008 (0.622)	-0.060 (0.707)
Week 24	Number Analyzed	42 participants	43 participants	44 participants	44 participants
Week 24		-0.263 (1.515)	-0.045 (0.774)	-0.013 (0.608)	-0.030 (0.707)
Week 28	Number Analyzed	43 participants	43 participants	40 participants	43 participants
Week 28		-0.013 (1.559)	-0.125 (0.782)	-0.043 (0.423)	-0.036 (0.663)
Week 32	Number Analyzed	44 participants	44 participants	43 participants	45 participants
Week 32		-0.260 (1.418)	0.045 (0.717)	0.057 (0.532)	0.112 (0.718)
Week 40	Number Analyzed	42 participants	42 participants	41 participants	44 participants
Week 40		-0.134 (1.175)	-0.159 (0.765)	0.177 (0.821)	0.022 (0.644)
Week 48	Number Analyzed	38 participants	42 participants	40 participants	43 participants
Week 48		-0.242 (1.516)	-0.149 (0.758)	0.114 (0.507)	0.054 (0.752)

51.Secondary Outcome


Title	Mean Change From Baseline in Protein
Description	Protein was measured in grams per liter (g/L).
Description	Protein was measured in grams per liter (g/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: g/L
Week 2	Number Analyzed	42 participants	45 participants	45 participants	44 participants
Week 2		-0.2 (3.7)	-1.2 (4.0)	-1.0 (4.2)	-1.1 (3.8)
Week 4	Number Analyzed	44 participants	44 participants	43 participants	46 participants
Week 4		-1.5 (4.4)	-1.6 (4.2)	-1.5 (4.7)	-1.7 (4.4)
Week 8	Number Analyzed	44 participants	43 participants	44 participants	44 participants
Week 8		-1.1 (4.4)	-2.1 (4.1)	-1.8 (5.7)	-2.0 (3.9)
Week 12	Number Analyzed	44 participants	44 participants	45 participants	44 participants
Week 12		-0.8 (3.8)	-1.3 (4.7)	-1.4 (5.2)	-1.2 (5.8)
Week 16	Number Analyzed	44 participants	45 participants	43 participants	45 participants
Week 16		-1.2 (5.2)	-0.3 (4.1)	-2.3 (5.6)	-3.8 (5.0)
Week 20	Number Analyzed	43 participants	45 participants	42 participants	44 participants
Week 20		-2.7 (6.0)	-1.6 (4.6)	-2.6 (4.7)	-3.1 (5.4)
Week 24	Number Analyzed	42 participants	43 participants	44 participants	44 participants
Week 24		-2.2 (7.5)	-1.8 (4.6)	-1.8 (5.5)	-2.0 (4.7)
Week 28	Number Analyzed	43 participants	43 participants	40 participants	43 participants
Week 28		-3.1 (7.4)	-2.4 (4.6)	-2.5 (5.7)	-3.6 (6.4)
Week 32	Number Analyzed	44 participants	44 participants	43 participants	45 participants
Week 32		-1.4 (6.9)	-1.5 (5.7)	-0.8 (5.0)	-1.9 (6.4)
Week 40	Number Analyzed	42 participants	42 participants	41 participants	44 participants
Week 40		-2.2 (6.5)	-0.9 (5.0)	-1.8 (5.3)	-2.6 (6.1)
Week 48	Number Analyzed	38 participants	42 participants	40 participants	43 participants
Week 48		-2.3 (6.2)	-2.4 (5.9)	-0.9 (5.1)	-3.4 (6.4)

52.Secondary Outcome


Title	Mean Change From Baseline in Albumin
Description	Albumin was measured in grams per liter (g/L).
Description	Albumin was measured in grams per liter (g/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: g/L
Week 2	Number Analyzed	42 participants	45 participants	45 participants	44 participants
Week 2		0.1 (2.1)	-0.4 (2.4)	-0.5 (2.4)	-0.5 (1.9)
Week 4	Number Analyzed	44 participants	44 participants	43 participants	46 participants
Week 4		-0.5 (2.4)	-0.4 (2.3)	-0.2 (2.4)	-0.3 (1.9)
Week 8	Number Analyzed	44 participants	43 participants	44 participants	44 participants
Week 8		-0.3 (2.3)	-0.3 (2.5)	-0.3 (3.0)	0.1 (2.2)
Week 12	Number Analyzed	44 participants	44 participants	45 participants	44 participants
Week 12		-0.1 (2.2)	0.2 (2.7)	0.2 (2.7)	0.7 (3.0)
Week 16	Number Analyzed	44 participants	45 participants	43 participants	45 participants
Week 16		0.0 (2.5)	1.0 (2.5)	0.1 (2.9)	-0.2 (2.9)
Week 20	Number Analyzed	43 participants	45 participants	42 participants	44 participants
Week 20		-0.7 (2.7)	0.1 (2.7)	0.4 (2.4)	0.4 (2.2)
Week 24	Number Analyzed	42 participants	43 participants	44 participants	44 participants
Week 24		-0.1 (2.9)	0.0 (2.1)	0.4 (2.4)	1.2 (2.7)
Week 28	Number Analyzed	43 participants	43 participants	40 participants	43 participants
Week 28		-0.7 (3.0)	-0.4 (2.3)	0.1 (2.9)	0.1 (2.6)
Week 32	Number Analyzed	44 participants	44 participants	43 participants	45 participants
Week 32		0.6 (2.8)	-0.1 (3.0)	0.9 (3.2)	0.7 (2.8)
Week 40	Number Analyzed	42 participants	42 participants	41 participants	44 participants
Week 40		0.1 (2.8)	-0.1 (2.9)	0.2 (2.6)	0.3 (3.0)
Week 48	Number Analyzed	38 participants	42 participants	40 participants	43 participants
Week 48		0.1 (2.8)	-0.7 (3.0)	0.2 (3.0)	-0.8 (3.5)

53.Secondary Outcome


Title	Mean Change From Baseline in Glucose
Description	Glucose was measured in millimoles per liter (mmol/L).
Description	Glucose was measured in millimoles per liter (mmol/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: mmol/L
Week 2	Number Analyzed	42 participants	45 participants	44 participants	43 participants
Week 2		0.18 (0.75)	0.26 (0.70)	0.09 (0.78)	0.13 (1.28)
Week 4	Number Analyzed	44 participants	44 participants	43 participants	46 participants
Week 4		0.04 (0.71)	0.03 (0.70)	-0.04 (0.90)	0.11 (1.10)
Week 8	Number Analyzed	44 participants	43 participants	44 participants	44 participants
Week 8		0.17 (0.66)	0.12 (0.90)	0.23 (0.95)	0.12 (1.16)
Week 12	Number Analyzed	44 participants	44 participants	43 participants	44 participants
Week 12		-0.08 (0.69)	0.08 (0.66)	-0.13 (0.79)	-0.15 (0.99)
Week 16	Number Analyzed	44 participants	45 participants	43 participants	45 participants
Week 16		0.11 (0.77)	0.06 (0.63)	0.16 (0.92)	-0.18 (1.47)
Week 20	Number Analyzed	43 participants	44 participants	42 participants	43 participants
Week 20		0.16 (0.85)	0.20 (0.84)	0.13 (0.83)	-0.08 (1.01)
Week 24	Number Analyzed	42 participants	43 participants	43 participants	43 participants
Week 24		-0.07 (0.85)	0.05 (0.49)	-0.09 (0.73)	-0.22 (1.06)
Week 28	Number Analyzed	39 participants	43 participants	40 participants	43 participants
Week 28		0.22 (1.01)	0.09 (0.76)	-0.01 (0.74)	0.07 (1.22)
Week 32	Number Analyzed	44 participants	44 participants	42 participants	45 participants
Week 32		-0.04 (0.72)	-0.07 (0.63)	-0.08 (0.65)	0.06 (1.10)
Week 40	Number Analyzed	41 participants	41 participants	41 participants	44 participants
Week 40		-0.05 (0.62)	0.08 (0.71)	-0.09 (0.68)	-0.08 (1.07)
Week 48	Number Analyzed	38 participants	42 participants	40 participants	43 participants
Week 48		-0.14 (0.78)	-0.11 (0.61)	-0.06 (0.64)	-0.14 (1.25)

54.Secondary Outcome


Title	Mean Change From Baseline in Lipase, Pancreatic
Description	Lipase, Pancreatic was measured in units per liter (U/L).
Description	Lipase, Pancreatic was measured in units per liter (U/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: U/L
Week 2	Number Analyzed	42 participants	45 participants	45 participants	44 participants
Week 2		-1.1 (10.5)	2.2 (11.9)	0.1 (9.2)	-0.2 (7.5)
Week 4	Number Analyzed	44 participants	44 participants	43 participants	46 participants
Week 4		-2.1 (9.8)	0.9 (9.1)	0.1 (10.6)	-1.2 (10.0)
Week 8	Number Analyzed	44 participants	43 participants	44 participants	44 participants
Week 8		-3.1 (9.2)	3.7 (11.8)	2.0 (20.0)	-1.8 (10.3)
Week 12	Number Analyzed	44 participants	44 participants	45 participants	44 participants
Week 12		-0.5 (8.7)	1.0 (11.1)	-0.7 (13.4)	-0.6 (9.6)
Week 16	Number Analyzed	44 participants	45 participants	43 participants	45 participants
Week 16		0.4 (7.4)	2.7 (8.4)	0.5 (11.3)	-0.2 (11.8)
Week 20	Number Analyzed	43 participants	45 participants	42 participants	44 participants
Week 20		-0.6 (10.4)	2.1 (8.0)	-0.9 (9.0)	-1.7 (9.3)
Week 24	Number Analyzed	42 participants	43 participants	44 participants	44 participants
Week 24		-0.5 (11.0)	-0.1 (9.1)	-0.1 (8.1)	1.2 (11.8)
Week 28	Number Analyzed	43 participants	43 participants	40 participants	43 participants
Week 28		1.6 (13.1)	1.7 (10.5)	0.5 (11.9)	1.7 (14.1)
Week 32	Number Analyzed	44 participants	44 participants	43 participants	45 participants
Week 32		1.1 (15.1)	1.0 (11.0)	1.2 (10.6)	3.8 (21.6)
Week 40	Number Analyzed	42 participants	42 participants	41 participants	44 participants
Week 40		1.2 (11.0)	1.3 (7.0)	-0.3 (8.9)	2.5 (8.9)
Week 48	Number Analyzed	38 participants	42 participants	40 participants	43 participants
Week 48		1.4 (10.1)	2.2 (10.0)	0.3 (10.7)	3.7 (10.2)

55.Secondary Outcome


Title	Mean Change From Baseline in Creatine Kinase
Description	Creatine Kinase was measured in units per liter (U/L).
Description	Creatine Kinase was measured in units per liter (U/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: U/L
Week 2	Number Analyzed	42 participants	45 participants	45 participants	43 participants
Week 2		-3.0 (67.1)	-2.2 (55.6)	-2.2 (18.2)	0.1 (46.5)
Week 4	Number Analyzed	44 participants	44 participants	43 participants	46 participants
Week 4		29.6 (218.4)	-6.2 (54.8)	3.2 (22.0)	-16.9 (56.5)
Week 8	Number Analyzed	44 participants	43 participants	44 participants	44 participants
Week 8		-4.9 (56.9)	-8.5 (52.7)	-1.5 (23.6)	-4.6 (122.1)
Week 12	Number Analyzed	44 participants	44 participants	45 participants	44 participants
Week 12		-6.3 (57.5)	-8.4 (85.8)	-3.0 (22.4)	-29.4 (80.7)
Week 16	Number Analyzed	44 participants	45 participants	43 participants	45 participants
Week 16		0.9 (59.4)	-11.5 (105.1)	-7.5 (22.2)	-23.2 (106.3)
Week 20	Number Analyzed	43 participants	43 participants	42 participants	44 participants
Week 20		-8.2 (60.0)	5.9 (149.1)	-3.5 (22.2)	-33.4 (95.3)
Week 24	Number Analyzed	42 participants	43 participants	44 participants	44 participants
Week 24		-6.4 (48.6)	-5.4 (123.7)	-2.6 (27.4)	-27.7 (98.9)
Week 28	Number Analyzed	43 participants	42 participants	40 participants	43 participants
Week 28		-1.5 (67.3)	-19.1 (131.5)	-0.7 (25.4)	-36.7 (103.8)
Week 32	Number Analyzed	44 participants	44 participants	43 participants	45 participants
Week 32		2.0 (67.0)	-10.0 (167.0)	34.0 (222.1)	-24.2 (91.2)
Week 40	Number Analyzed	42 participants	42 participants	41 participants	44 participants
Week 40		9.9 (109.1)	-20.4 (131.4)	-2.7 (25.4)	-16.3 (106.4)
Week 48	Number Analyzed	38 participants	42 participants	40 participants	43 participants
Week 48		7.8 (67.3)	-20.4 (138.3)	-3.6 (25.5)	-33.4 (106.5)

56.Secondary Outcome


Title	Mean Change From Baseline in pH
Description	[Not Specified]
Description	[Not Specified]
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: pH
Week 2	Number Analyzed	43 participants	43 participants	44 participants	43 participants
Week 2		-0.01 (0.66)	0.03 (0.62)	-0.07 (0.67)	0.15 (0.78)
Week 4	Number Analyzed	43 participants	43 participants	43 participants	43 participants
Week 4		0.10 (0.77)	0.15 (0.52)	0.06 (0.72)	0.16 (0.74)
Week 8	Number Analyzed	42 participants	44 participants	44 participants	42 participants
Week 8		-0.12 (0.79)	0.00 (0.62)	-0.08 (0.56)	-0.04 (0.65)
Week 12	Number Analyzed	44 participants	43 participants	43 participants	42 participants
Week 12		0.00 (0.81)	0.15 (0.69)	0.03 (0.79)	0.20 (0.83)
Week 16	Number Analyzed	44 participants	45 participants	39 participants	45 participants
Week 16		-0.02 (0.61)	0.00 (0.51)	-0.09 (0.81)	0.11 (0.69)
Week 20	Number Analyzed	42 participants	43 participants	41 participants	43 participants
Week 20		-0.11 (0.75)	-0.01 (0.59)	0.06 (0.58)	0.07 (0.88)
Week 24	Number Analyzed	43 participants	42 participants	44 participants	42 participants
Week 24		0.03 (0.85)	-0.01 (0.46)	-0.11 (0.81)	0.02 (0.81)
Week 28	Number Analyzed	44 participants	42 participants	42 participants	41 participants
Week 28		-0.13 (0.84)	-0.06 (0.57)	-0.05 (0.73)	-0.01 (0.69)
Week 32	Number Analyzed	44 participants	44 participants	42 participants	43 participants
Week 32		-0.02 (0.75)	-0.03 (0.55)	-0.18 (0.66)	0.09 (0.86)
Week 40	Number Analyzed	42 participants	43 participants	41 participants	44 participants
Week 40		-0.14 (0.81)	0.19 (0.66)	-0.21 (0.81)	-0.07 (0.62)
Week 48	Number Analyzed	38 participants	42 participants	40 participants	43 participants
Week 48		-0.11 (0.66)	0.06 (0.73)	-0.11 (0.74)	-0.08 (0.72)

57.Secondary Outcome


Title	Mean Change From Baseline in Erythrocytes (/HPF)
Description	[Not Specified]
Description	[Not Specified]
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: % of Erythrocytes per HPF
Week 2	Number Analyzed	43 participants	43 participants	44 participants	43 participants
Week 2		-6.8 (53.7)	0.1 (8.4)	0.2 (2.4)	0.9 (7.9)
Week 4	Number Analyzed	43 participants	43 participants	43 participants	43 participants
Week 4		-8.7 (52.6)	-0.8 (4.1)	1.4 (10.5)	-0.6 (3.2)
Week 8	Number Analyzed	42 participants	44 participants	44 participants	42 participants
Week 8		-8.7 (53.5)	-0.3 (6.9)	0.4 (6.1)	0.0 (6.8)
Week 12	Number Analyzed	44 participants	43 participants	43 participants	42 participants
Week 12		-8.6 (52.6)	1.3 (17.4)	-0.4 (2.4)	17.4 (118.5)
Week 16	Number Analyzed	43 participants	45 participants	39 participants	45 participants
Week 16		-5.7 (48.0)	-1.3 (4.1)	-0.6 (2.6)	-0.5 (5.5)
Week 20	Number Analyzed	42 participants	43 participants	41 participants	43 participants
Week 20		-7.7 (53.7)	-1.0 (3.5)	-0.1 (3.9)	-0.6 (4.4)
Week 24	Number Analyzed	43 participants	42 participants	44 participants	42 participants
Week 24		-7.2 (53.5)	-1.2 (3.9)	-0.3 (2.3)	-0.9 (4.6)
Week 28	Number Analyzed	44 participants	42 participants	42 participants	41 participants
Week 28		-7.6 (51.3)	-1.3 (4.2)	-0.7 (2.9)	3.0 (16.9)
Week 32	Number Analyzed	44 participants	44 participants	42 participants	43 participants
Week 32		-8.5 (52.5)	4.9 (41.8)	0.0 (3.9)	0.1 (4.5)
Week 40	Number Analyzed	42 participants	43 participants	41 participants	44 participants
Week 40		-9.1 (53.2)	3.5 (18.8)	-0.5 (3.5)	0.4 (5.4)
Week 48	Number Analyzed	38 participants	42 participants	40 participants	43 participants
Week 48		-9.7 (56.3)	-0.4 (5.4)	1.9 (15.5)	0.1 (4.0)

58.Secondary Outcome


Title	Mean Change From Baseline in Leukocytes (/HPF)
Description	[Not Specified]
Description	[Not Specified]
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title		SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description:		This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...	This arm consisted of participants ...
Arm/Group Description:		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Overall Number of Participants Analyzed		45	45	45	47
Mean (Standard Deviation) Unit of Measure: % of Leukocytes per HPF
Week 2	Number Analyzed	43 participants	43 participants	44 participants	43 participants
Week 2		-0.1 (11.4)	-1.4 (8.1)	-0.8 (2.9)	2.9 (13.7)
Week 4	Number Analyzed	43 participants	43 participants	43 participants	43 participants
Week 4		-0.2 (9.0)	-0.6 (8.5)	-0.7 (4.5)	3.0 (12.6)
Week 8	Number Analyzed	42 participants	44 participants	44 participants	42 participants
Week 8		-1.2 (10.4)	4.8 (29.3)	-0.3 (6.8)	3.0 (14.4)
Week 12	Number Analyzed	44 participants	43 participants	43 participants	42 participants
Week 12		-1.1 (11.3)	4.4 (42.2)	-1.3 (4.2)	2.7 (13.9)
Week 16	Number Analyzed	43 participants	45 participants	39 participants	45 participants
Week 16		0.1 (9.6)	-1.6 (12.5)	-0.2 (9.6)	1.8 (12.9)
Week 20	Number Analyzed	42 participants	43 participants	41 participants	43 participants
Week 20		-0.1 (10.1)	3.7 (13.3)	0.4 (9.8)	1.7 (4.0)
Week 24	Number Analyzed	43 participants	42 participants	44 participants	42 participants
Week 24		-1.0 (10.9)	10.7 (52.1)	-0.7 (4.5)	0.4 (4.5)
Week 28	Number Analyzed	44 participants	42 participants	42 participants	41 participants
Week 28		-0.2 (9.6)	2.4 (9.7)	-1.1 (4.4)	2.0 (10.1)
Week 32	Number Analyzed	44 participants	44 participants	42 participants	43 participants
Week 32		-0.6 (10.8)	-0.5 (13.5)	-1.0 (5.4)	4.1 (15.7)
Week 40	Number Analyzed	42 participants	43 participants	41 participants	44 participants
Week 40		-1.6 (10.4)	2.2 (19.8)	1.4 (7.7)	6.8 (30.9)
Week 48	Number Analyzed	38 participants	42 participants	40 participants	43 participants
Week 48		-0.3 (8.9)	10.8 (71.9)	-1.0 (4.0)	0.8 (5.3)

Adverse Events

Time Frame	Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	SOC + Placebo iv Q4W (SS)		SOC + DZP 6mg/kg iv Q4W (SS)		SOC + DZP 24mg/kg iv Q4W (SS)		SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants ...		This arm consisted of participants ...		This arm consisted of participants ...		This arm consisted of participants ...
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
All-Cause Mortality
	SOC + Placebo iv Q4W (SS)		SOC + DZP 6mg/kg iv Q4W (SS)		SOC + DZP 24mg/kg iv Q4W (SS)		SOC + DZP 45mg/kg iv Q4W (SS)
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/45 (0.00%)		0/45 (0.00%)		0/45 (0.00%)		0/47 (0.00%)
Serious Adverse Events Serious Adverse Events
	SOC + Placebo iv Q4W (SS)		SOC + DZP 6mg/kg iv Q4W (SS)		SOC + DZP 24mg/kg iv Q4W (SS)		SOC + DZP 45mg/kg iv Q4W (SS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/45 (13.33%)		5/45 (11.11%)		6/45 (13.33%)		5/47 (10.64%)
Blood and lymphatic system disorders
Anaemia ^* 1	0/45 (0.00%)	0	0/45 (0.00%)	0	1/45 (2.22%)	1	0/47 (0.00%)	0
Autoimmune haemolytic anaemia ^* 1	0/45 (0.00%)	0	1/45 (2.22%)	1	0/45 (0.00%)	0	0/47 (0.00%)	0
Haemorrhagic disorder ^* 1	1/45 (2.22%)	1	0/45 (0.00%)	0	0/45 (0.00%)	0	0/47 (0.00%)	0
Antiphospholipid syndrome ^* 1	1/45 (2.22%)	1	0/45 (0.00%)	0	0/45 (0.00%)	0	0/47 (0.00%)	0
Cardiac disorders
Coronary artery disease ^* 1	0/45 (0.00%)	0	0/45 (0.00%)	0	1/45 (2.22%)	1	0/47 (0.00%)	0
Gastrointestinal disorders
Anastomotic ulcer perforation ^* 1	0/45 (0.00%)	0	0/45 (0.00%)	0	0/45 (0.00%)	0	1/47 (2.13%)	1
Infections and infestations
Cellulitis ^* 1	1/45 (2.22%)	2	0/45 (0.00%)	0	1/45 (2.22%)	2	0/47 (0.00%)	0
Herpes zoster ^* 1	1/45 (2.22%)	1	1/45 (2.22%)	1	0/45 (0.00%)	0	0/47 (0.00%)	0
Influenza ^* 1	1/45 (2.22%)	1	0/45 (0.00%)	0	0/45 (0.00%)	0	0/47 (0.00%)	0
Pseudomonal bacteraemia ^* 1	0/45 (0.00%)	0	0/45 (0.00%)	0	1/45 (2.22%)	1	0/47 (0.00%)	0
Urinary tract infection ^* 1	0/45 (0.00%)	0	0/45 (0.00%)	0	0/45 (0.00%)	0	1/47 (2.13%)	1
Appendicitis ^* 1	0/45 (0.00%)	0	0/45 (0.00%)	0	1/45 (2.22%)	1	0/47 (0.00%)	0
Pyelonephritis ^* 1	0/45 (0.00%)	0	0/45 (0.00%)	0	0/45 (0.00%)	0	1/47 (2.13%)	1
Injury, poisoning and procedural complications
Thoracic vertebral fracture ^* 1	0/45 (0.00%)	0	1/45 (2.22%)	1	0/45 (0.00%)	0	0/47 (0.00%)	0
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus ^* 1	2/45 (4.44%)	3	0/45 (0.00%)	0	0/45 (0.00%)	0	1/47 (2.13%)	2
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous ^* 1	0/45 (0.00%)	0	1/45 (2.22%)	1	0/45 (0.00%)	0	0/47 (0.00%)	0
Renal and urinary disorders
Lupus nephritis ^* 1	0/45 (0.00%)	0	1/45 (2.22%)	1	0/45 (0.00%)	0	1/47 (2.13%)	1
Nephrosclerosis ^* 1	0/45 (0.00%)	0	1/45 (2.22%)	1	0/45 (0.00%)	0	0/47 (0.00%)	0
Renal tubular necrosis ^* 1	0/45 (0.00%)	0	1/45 (2.22%)	1	0/45 (0.00%)	0	0/47 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Pneumothorax ^* 1	0/45 (0.00%)	0	0/45 (0.00%)	0	1/45 (2.22%)	1	0/47 (0.00%)	0
Pulmonary embolism ^* 1	1/45 (2.22%)	1	0/45 (0.00%)	0	0/45 (0.00%)	0	0/47 (0.00%)	0
Vascular disorders
Deep vein thrombosis ^* 1	1/45 (2.22%)	1	0/45 (0.00%)	0	0/45 (0.00%)	0	0/47 (0.00%)	0
1 Term from vocabulary, MedDRA19.1 * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	SOC + Placebo iv Q4W (SS)		SOC + DZP 6mg/kg iv Q4W (SS)		SOC + DZP 24mg/kg iv Q4W (SS)		SOC + DZP 45mg/kg iv Q4W (SS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/45 (42.22%)		23/45 (51.11%)		22/45 (48.89%)		21/47 (44.68%)
Gastrointestinal disorders
Diarrhoea ^* 1	2/45 (4.44%)	2	4/45 (8.89%)	4	3/45 (6.67%)	3	3/47 (6.38%)	3
Nausea ^* 1	2/45 (4.44%)	2	1/45 (2.22%)	1	3/45 (6.67%)	3	1/47 (2.13%)	1
Dyspepsia ^* 1	5/45 (11.11%)	5	1/45 (2.22%)	2	0/45 (0.00%)	0	0/47 (0.00%)	0
Infections and infestations
Nasopharyngitis ^* 1	2/45 (4.44%)	2	5/45 (11.11%)	5	5/45 (11.11%)	6	4/47 (8.51%)	4
Upper respiratory tract infection ^* 1	4/45 (8.89%)	5	4/45 (8.89%)	4	3/45 (6.67%)	3	5/47 (10.64%)	6
Pharyngitis ^* 1	1/45 (2.22%)	1	4/45 (8.89%)	4	4/45 (8.89%)	6	3/47 (6.38%)	4
Urinary tract infection ^* 1	2/45 (4.44%)	3	4/45 (8.89%)	4	2/45 (4.44%)	2	2/47 (4.26%)	2
Bronchitis ^* 1	0/45 (0.00%)	0	3/45 (6.67%)	5	1/45 (2.22%)	1	2/47 (4.26%)	2
Investigations
Hepatic enzyme increased ^* 1	3/45 (6.67%)	3	0/45 (0.00%)	0	0/45 (0.00%)	0	0/47 (0.00%)	0
Musculoskeletal and connective tissue disorders
Back pain ^* 1	2/45 (4.44%)	2	4/45 (8.89%)	4	0/45 (0.00%)	0	2/47 (4.26%)	2
Nervous system disorders
Headache ^* 1	5/45 (11.11%)	5	5/45 (11.11%)	13	4/45 (8.89%)	4	2/47 (4.26%)	2
Migraine ^* 1	0/45 (0.00%)	0	0/45 (0.00%)	0	0/45 (0.00%)	0	3/47 (6.38%)	3
Psychiatric disorders
Anxiety ^* 1	1/45 (2.22%)	1	1/45 (2.22%)	1	3/45 (6.67%)	3	0/47 (0.00%)	0
Vascular disorders
Hypertension ^* 1	1/45 (2.22%)	1	3/45 (6.67%)	3	3/45 (6.67%)	4	2/47 (4.26%)	2
1 Term from vocabulary, MedDRA19.1 * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

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Name/Title:	UCB
Organization:	Cares
Phone:	+1844 599 ext 2273
EMail:	UCBCares@ucb.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Morel T, Cano S, Bartlett SJ, Gordon C, Haier B, Regnault A, Schneider M, Stach C, Cleanthous S. The FATIGUE-PRO: a new patient-reported outcome instrument to quantify fatigue in patients affected by systemic lupus erythematosus. Rheumatology (Oxford). 2022 Aug 3;61(8):3329-3340. doi: 10.1093/rheumatology/keab920.

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Responsible Party:	UCB Pharma ( UCB Biopharma S.P.R.L. )
ClinicalTrials.gov Identifier:	NCT02804763
Other Study ID Numbers:	SL0023 2015-004457-40 ( EudraCT Number )
First Submitted:	June 14, 2016
First Posted:	June 17, 2016
Results First Submitted:	April 19, 2021
Results First Posted:	June 30, 2021
Last Update Posted:	June 30, 2021

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