A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Korean Study Participants With Moderate to Severe Plaque Psoriasis

• ClinicalTrials.gov Identifier: NCT05020249
• Recruitment Status: Completed
• First Posted: August 25, 2021
• Results First Posted: March 22, 2024
• Last Update Posted: March 22, 2024
• Sponsor: UCB Biopharma SRL
• Information provided by (Responsible Party): UCB Pharma ( UCB Biopharma SRL )

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Moderate to Severe Plaque Psoriasis
• Interventions: Drug: bimekizumab; Other: Placebo
• Enrollment: 47

Participant Flow

Recruitment Details	The study started to enroll study participants in September 2021 and concluded in September 2022.
Pre-assignment Details	The Participant Flow refers to the Randomized Set.

Arm/Group Title	Placebo	Bimekizumab 320 mg Q4W
Arm/Group Description	Participants received placebo matched to bimekizumab subcutaneous (sc) injection every 4 weeks (Q4W) until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Participants received bimekizumab 320 milligrams (mg) sc injection Q4W until Week 16.
Period Title: Overall Study
Started	15	32
Completed	14	32
Not Completed	1	0
Reason Not Completed
Protocol Violation	1	0

Baseline Characteristics

Arm/Group Title		Placebo	Bimekizumab 320 mg Q4W	Total
Arm/Group Description		Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Participants received bimekizumab 320 mg sc injection Q4W until Week 16.	Total of all reporting groups
Overall Number of Baseline Participants		15	32	47
Baseline Analysis Population Description		Baseline Characteristics refer to the Randomized Set which consisted of all randomized study participants.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	32 participants	47 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	15 100.0%	32 100.0%	47 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	15 participants	32 participants	47 participants
		40.2 (11.3)	39.7 (9.0)	39.9 (9.7)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	32 participants	47 participants
	Female	3 20.0%	6 18.8%	9 19.1%
	Male	12 80.0%	26 81.3%	38 80.9%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	32 participants	47 participants
	Asian	15 100.0%	32 100.0%	47 100.0%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	32 participants	47 participants
	Not Hispanic or Latino	15 100.0%	32 100.0%	47 100.0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16
Description	The PASI90 response assessments are based on a 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

Randomized Set consisted of all randomized study participants. Study participants with an intercurrent event (discontinuation of IMP prior to Week 16) or who had missing data at Week 16 are counted as non-responders (Non responder imputation (NRI)).

Arm/Group Title	Placebo	Bimekizumab 320 mg Q4W
Arm/Group Description:	Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Overall Number of Participants Analyzed	15	32
Measure Type: Number; Unit of Measure: percentage of participants
	0	81.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bimekizumab 320 mg Q4W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-values for the comparison of treatment groups are based on the Fisher's exact test.
	Method	Fisher Exact
	Comments	[Not Specified]

2. Primary Outcome

Title	Percentage of Participants With an Investigator's Global Assessment (IGA) 0/1 (Clear or Almost Clear With at Least 2-category Improvement From Baseline) Response at Week 16
Description	The Investigator's Global Assessment measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= Clear, no signs of psoriasis; post-inflammatory hyperpigmentation may be present, scale 1= Almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= Mild, just detectable to mild thickening, pink to light red coloration and predominately fine scaling, scale 3= Moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and scale 4= Severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA 0/1 response was defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

Randomized Set consisted of all randomized study participants. Study participants with an intercurrent event (discontinuation of IMP prior to Week 16) or who had missing data at Week 16 are counted as non-responders (NRI).

Arm/Group Title	Placebo	Bimekizumab 320 mg Q4W
Arm/Group Description:	Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Overall Number of Participants Analyzed	15	32
Measure Type: Number; Unit of Measure: percentage of participants
	0	87.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bimekizumab 320 mg Q4W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-values for the comparison of treatment groups are based on the Fisher's exact test.
	Method	Fisher Exact
	Comments	[Not Specified]

3. Secondary Outcome

Title	Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16
Description	The PASI100 response assessments are based on a 100% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

Randomized Set consisted of all randomized study participants. Study participants with an intercurrent event (discontinuation of IMP prior to Week 16) or who had missing data at Week 16 are counted as non-responders (NRI).

Arm/Group Title	Placebo	Bimekizumab 320 mg Q4W
Arm/Group Description:	Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Overall Number of Participants Analyzed	15	32
Measure Type: Number; Unit of Measure: percentage of participants
	0	21.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bimekizumab 320 mg Q4W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.080
	Comments	P-values for the comparison of treatment groups are based on the Fisher's exact test.
	Method	Fisher Exact
	Comments	[Not Specified]

4. Secondary Outcome

Title	Percentage of Participants With an Investigator's Global Assessment (IGA) 0 (Clear With at Least 2-category Improvement From Baseline) Response at Week 16
Description	The Investigator's Global Assessment measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= Clear, no signs of psoriasis; post-inflammatory hyperpigmentation may be present, scale 1= Almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= Mild, just detectable to mild thickening, pink to light red coloration and predominately fine scaling, scale 3= Moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and scale 4= Severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA 0 response (Clear) is defined as clear [0] with at least a two-category improvement from Baseline.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

Randomized Set consisted of all randomized study participants. Study participants with an intercurrent event (discontinuation of IMP prior to Week 16) or who had missing data at Week 16 are counted as non-responders (NRI).

Arm/Group Title	Placebo	Bimekizumab 320 mg Q4W
Arm/Group Description:	Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Overall Number of Participants Analyzed	15	32
Measure Type: Number; Unit of Measure: percentage of participants
	0	21.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bimekizumab 320 mg Q4W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.080
	Comments	P-values for the comparison of treatment groups are based on the Fisher's exact test.
	Method	Fisher Exact
	Comments	[Not Specified]

5. Secondary Outcome

Title	Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 4
Description	The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

Randomized Set consisted of all randomized study participants. Study participants with an intercurrent event (discontinuation of IMP) prior to their Week 4 PASI assessment or who had missing data at Week 4 are counted as non-responders (NRI).

Arm/Group Title	Placebo	Bimekizumab 320 mg Q4W
Arm/Group Description:	Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Overall Number of Participants Analyzed	15	32
Measure Type: Number; Unit of Measure: percentage of participants
	0	75

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bimekizumab 320 mg Q4W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-values for the comparison of treatment groups are based on the Fisher's exact test.
	Method	Fisher Exact
	Comments	[Not Specified]

6. Secondary Outcome

Title	Percentage of Participants With a Patient Symptom Diary (PSD) (P-SIM) Response for Itch at Week 16
Description	The PSD (P-SIM) was designed for use as a daily diary to collect data about the experience of participants with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours, on a 0-10 point numeric rating scale (NRS) where 0 (no symptoms/impact) and 10 (very severe symptoms/worst impact). It consists of 14 items measuring: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment and choice of clothing. A weekly score for each item (including itch) is obtained as an average of daily values for the considered item over the 7 days preceding the visit (weekly score range: 0 (no itch)-10 (very severe itch)). Itch response was defined as a reduction from baseline to Week 16 of at least 4 points on the PSD itch weekly score.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

Randomized Set consisted of all randomized study participants. The denominator when calculating the percentage of participants with a response to the PSD itch item is the number of participants with a baseline itch score >=4 and the numerator is the number of participants with a PSD response for itch at Week 16. Study participants with an intercurrent event (discontinuation of IMP prior to Week 16) or who had missing data at Week 16 are counted as non-responders (NRI).

Arm/Group Title	Placebo	Bimekizumab 320 mg Q4W
Arm/Group Description:	Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Overall Number of Participants Analyzed	12	26
Measure Type: Number; Unit of Measure: percentage of participants
	0	57.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bimekizumab 320 mg Q4W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-values for the comparison of treatment groups are based on the Fisher's exact test.
	Method	Fisher Exact
	Comments	[Not Specified]

7. Secondary Outcome

Title	Percentage of Participants With a Patient Symptom Diary (PSD) (P-SIM) Response for Pain at Week 16
Description	The PSD (P-SIM) was designed for use as a daily diary to collect data about the experience of participants with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours, on a 0-10 point NRS where 0 (no symptoms/impact) and 10 (very severe symptoms/worst impact). It consists of 14 items measuring: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment and choice of clothing. A weekly score for each item (including pain) is obtained as an average of daily values for the considered item over the 7 days preceding the visit (weekly score range: 0 (no pain)-10 (very severe pain)). Pain response was defined as a reduction from baseline to Week 16 of at least 4 points on the PSD pain weekly score.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

Randomized Set consisted of all randomized study participants. The denominator when calculating the percentage of participants with a response to the PSD pain item is the number of participants with a baseline pain score >=4 and the numerator is the number of participants with a PSD response for pain at Week 16. Study participants with an intercurrent event (discontinuation of IMP prior to Week 16) or who had missing data at Week 16 are counted as non-responders (NRI).

Arm/Group Title	Placebo	Bimekizumab 320 mg Q4W
Arm/Group Description:	Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Overall Number of Participants Analyzed	10	24
Measure Type: Number; Unit of Measure: percentage of participants
	0	62.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bimekizumab 320 mg Q4W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-values for the comparison of treatment groups are based on the Fisher's exact test.
	Method	Fisher Exact
	Comments	[Not Specified]

8. Secondary Outcome

Title	Percentage of Participants With a Patient Symptom Diary (PSD) (P-SIM) Response for Scaling at Week 16
Description	The PSD (P-SIM) was designed for use as a daily diary to collect data about the experience of participants with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours, on a 0-10 point numeric rating scale (NRS) where 0 (no symptoms/impact) and 10 (very severe symptoms/worst impact). It consists of 14 items measuring: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment and choice of clothing. A weekly score for each item (including scaling) is obtained as an average of daily values for the considered item over the 7 days preceding the visit (weekly score range: 0 (no scaling)-10 (very severe scaling)). Scaling response was defined as a reduction from baseline to Week 16 of at least 4 points on the PSD scaling weekly score.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

Randomized Set consisted of all randomized study participants. The denominator when calculating the percentage of participants with a response to the PSD scaling item is the number of participants with a baseline scaling score >=4 and the numerator is the number of participants with a PSD response for scaling at Week 16. Study participants with an intercurrent event (discontinuation of IMP prior to Week 16) or who had missing data at Week 16 are counted as non-responders (NRI).

Arm/Group Title	Placebo	Bimekizumab 320 mg Q4W
Arm/Group Description:	Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Overall Number of Participants Analyzed	13	28
Measure Type: Number; Unit of Measure: percentage of participants
	0	64.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bimekizumab 320 mg Q4W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-values for the comparison of treatment groups are based on the Fisher's exact test.
	Method	Fisher Exact
	Comments	[Not Specified]

9. Secondary Outcome

Title	Percentage of Participants With Scalp IGA Response 0/1 (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) at Week 16 for Study Participants With Scalp Psoriasis (PSO) at Baseline
Description	Participants with scalp involvement at Baseline were defined as those with a scalp IGA score >0 at Baseline. Scalp lesions were assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe). Scalp IGA response 0/1 at Week 16 was defined as clear (0) or almost clear (1) with at least a 2-category improvement from Baseline to Week 16.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

Randomized Set consisted of all randomized study participants. Here, Number of Participants analyzed reflect those with a scalp IGA Baseline score >=2. Study participants with an intercurrent event (discontinuation of IMP prior to Week 16) or who had missing data at Week 16 are counted as non-responders (NRI).

Arm/Group Title	Placebo	Bimekizumab 320 mg Q4W
Arm/Group Description:	Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Overall Number of Participants Analyzed	14	29
Measure Type: Number; Unit of Measure: percentage of participants
	7.1	86.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bimekizumab 320 mg Q4W
	Comments	Odds ratio of scalp IGA response for bimekizumab group compared with placebo group using CMH.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-values for the comparison of treatment groups are based on the CMH test from the general association.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	81.250
	Confidence Interval	(2-Sided) 95%; 8.216 to 803.544
	Estimation Comments	[Not Specified]

10. Secondary Outcome

Title	Percentage of Participants With Dermatology Life Quality Index (DLQI) 0/1 Response at Week 16
Description	The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect study participants' health related quality of life (QOL). This instrument asks study participants about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. It has been shown to be valid and reproducible in study participants with PSO. The DLQI total score ranges from 0 to 30, with higher scores indicating lower health related QOL. A 4-point change in the DLQI total score has been reported to be meaningful for the study participant (within-participant minimal important difference); while a DLQI total score of 0 or 1 indicates no impact of the skin disease on participant's life.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

Randomized Set consisted of all randomized study participants. Study participants with an intercurrent event (discontinuation of IMP prior to Week 16) or who had missing data at Week 16 are counted as non-responders (NRI).

Arm/Group Title	Placebo	Bimekizumab 320 mg Q4W
Arm/Group Description:	Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Overall Number of Participants Analyzed	15	32
Measure Type: Number; Unit of Measure: percentage of participants
	6.7	46.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bimekizumab 320 mg Q4W
	Comments	Odds ratio of DLQI total score response for bimekizumab group compared with placebo group using CMH.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.007
	Comments	P-values for the comparison of treatment groups are based on the CMH test from the general association.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	12.353
	Confidence Interval	(2-Sided) 95%; 1.447 to 105.443
	Estimation Comments	[Not Specified]

11. Secondary Outcome

Title	Percent Change From Baseline in Body Surface Area (BSA) Affected by PSO at Week 16
Description	The Total BSA affected by PSO was entered as a percentage from 0 to 100.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

Randomized Set consisted of all randomized study participants. Study participants with an intercurrent event (discontinuation of IMP prior to Week 16) or who had missing data at Week 16 are imputed using last observation carried forward (LOCF).

Arm/Group Title	Placebo	Bimekizumab 320 mg Q4W
Arm/Group Description:	Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Overall Number of Participants Analyzed	15	32
Least Squares Mean (Standard Error); Unit of Measure: percent change
	-3.028 (8.926)	-83.472 (6.026)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bimekizumab 320 mg Q4W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-80.444
	Confidence Interval	(2-Sided) 95%; -102.509 to -58.379
	Estimation Comments	[Not Specified]

12. Secondary Outcome

Title	Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study
Description	An adverse event is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs were defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP) through the end of the time at risk.
Time Frame	From Baseline to End of Safety Follow-Up (SFU) (up to Week 32)

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all study participants that received at least 1 dose of the IMP.

Arm/Group Title	Placebo	Bimekizumab 320 mg Q4W
Arm/Group Description:	Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Overall Number of Participants Analyzed	15	32
Measure Type: Number; Unit of Measure: percentage of participants
	40.0	50.0

13. Secondary Outcome

Title	Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs) Throughout the Study
Description	A serious adverse event (SAE) is any untoward medical occurrence that at any dose: 1) Results in death 2) Is life-threatening 3) Requires in participant hospitalisation or prolongation of existing hospitalisation 4) Resulted in persistent disability/incapacity 5) Is a congenital anomaly or birth defect 6) Other important medical events which based on medical or scientific judgement may jeopardise the participants, or may require medical or surgical intervention to prevent any of the above.
Time Frame	From Baseline to End of Safety Follow-Up (up to Week 32)

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all study participants that received at least 1 dose of the IMP.

Arm/Group Title	Placebo	Bimekizumab 320 mg Q4W
Arm/Group Description:	Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Overall Number of Participants Analyzed	15	32
Measure Type: Number; Unit of Measure: percentage of participants
	6.7	0

14. Secondary Outcome

Title	Percentage of Participants With TEAEs Leading to Permanent Discontinuation of Investigational Medicinal Product (IMP) Throughout the Study
Description	An adverse event is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs were defined as those AEs that have a start date on or following the first dose of IMP through the end of the time at risk.
Time Frame	From Baseline to End of Safety Follow-Up (up to Week 32)

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all study participants that received at least 1 dose of the IMP.

Arm/Group Title	Placebo	Bimekizumab 320 mg Q4W
Arm/Group Description:	Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Overall Number of Participants Analyzed	15	32
Measure Type: Number; Unit of Measure: percentage of participants
	0	0

15. Secondary Outcome

Title	Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) at Week 16
Description	The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression. The PHQ-9 score ranges from 0 to 27 with higher scores indicating a worse state. A score of 5 to 9 is considered to be minimal symptoms of depression. A score of 10 to 14 is considered minor depression, dysthymia, or mild major depression. A score of 15 to 19 is considered to indicate moderately severe major depression, and a score ≥20 is considered to be severe major depression. Change from Baseline is derived as post-Baseline score minus Baseline score, where a positive change indicates worsening and a negative change indicates improvement.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all study participants that received at least 1 dose of the IMP. Study participants with missing data at Week 16 were imputed using LOCF.

Arm/Group Title	Placebo	Bimekizumab 320 mg Q4W
Arm/Group Description:	Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Overall Number of Participants Analyzed	15	32
Mean (Standard Deviation); Unit of Measure: scores on a scale
	-2.1 (5.1)	-2.4 (3.2)

Adverse Events

Time Frame	From Baseline to End of Safety Follow-Up (up to Week 32)
Adverse Event Reporting Description	Treatment-emergent AEs (TEAEs) were defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP) through the end of the time at risk. TEAEs were analyzed for Safety Set.
Arm/Group Title	Placebo		Bimekizumab 320 mg Q4W
Arm/Group Description	Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.		Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
All-Cause Mortality
	Placebo		Bimekizumab 320 mg Q4W
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/15 (0.00%)		0/32 (0.00%)
Serious Adverse Events
	Placebo		Bimekizumab 320 mg Q4W
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/15 (6.67%)		0/32 (0.00%)
Injury, poisoning and procedural complications
Ankle fracture * 1	1/15 (6.67%)	1	0/32 (0.00%)	0
1 Term from vocabulary, MedDRA v19.0; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Placebo		Bimekizumab 320 mg Q4W
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/15 (40.00%)		11/32 (34.38%)
General disorders
Oedema peripheral * 1	1/15 (6.67%)	1	0/32 (0.00%)	0
Infections and infestations
Corona virus infection * 1	1/15 (6.67%)	1	7/32 (21.88%)	7
Tinea pedis * 1	0/15 (0.00%)	0	2/32 (6.25%)	2
Bacteriuria * 1	1/15 (6.67%)	1	1/32 (3.13%)	1
Urinary tract infection * 1	1/15 (6.67%)	1	0/32 (0.00%)	0
Investigations
Blood creatinine increased * 1	1/15 (6.67%)	1	0/32 (0.00%)	0
Psychiatric evaluation abnormal * 1	1/15 (6.67%)	1	0/32 (0.00%)	0
Musculoskeletal and connective tissue disorders
Back pain * 1	1/15 (6.67%)	1	0/32 (0.00%)	0
Pain in extremity * 1	1/15 (6.67%)	1	0/32 (0.00%)	0
Skin and subcutaneous tissue disorders
Eczema * 1	0/15 (0.00%)	0	2/32 (6.25%)	2
1 Term from vocabulary, MedDRA v19.0; * Indicates events were collected by non-systematic assessment

Limitations and Caveats

This study protocol was not submitted to FDA, and was not conducted under a US IND or IDE.

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

• Name/Title: UCB
• Organization: Cares
• Phone: 001 844 599 2273
• EMail: UCBCares@ucb.com

• Responsible Party: UCB Pharma ( UCB Biopharma SRL )
• ClinicalTrials.gov Identifier: NCT05020249
• Other Study ID Numbers: PS0032
• First Submitted: August 20, 2021
• First Posted: August 25, 2021
• Results First Submitted: August 24, 2023
• Results First Posted: March 22, 2024
• Last Update Posted: March 22, 2024