A Study of Guselkumab in Participants With Active Lupus Nephritis (ORCHID-LN)

• ClinicalTrials.gov Identifier: NCT04376827
• Recruitment Status: Terminated
• First Posted: May 6, 2020
• Results First Posted: April 16, 2024
• Last Update Posted: April 16, 2024
• Sponsor: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Janssen Research & Development, LLC

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Lupus Nephritis
• Interventions: Drug: Guselkumab Dose 1; Drug: Placebo; Drug: Guselkumab Dose 2; Drug: Standard-of-care treatment
• Enrollment: 33

Participant Flow

Recruitment Details
Pre-assignment Details	Randomization was stratified by geographic region (North America, Latin America, Asia Pacific and Europe) and Urine Protein to Creatinine Ratio (UPCR) level (less than [<] 3 milligrams per milligram [mg/mg] and greater than or equal to [>=] 3 mg/mg).

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description	In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Period Title: Double Blind Period: Week 0 to Week 52
Started	16	17
Completed	9	8
Not Completed	7	9
Reason Not Completed
Withdrawal by Subject	1	1
Study Terminated by Sponsor	6	8
Period Title: LTE Phase:Week 52 to 96(LTE Termination)
Started	4	1
Completed	0	0
Not Completed	4	1
Reason Not Completed
Protocol-specified withdrawal criterion met	1	0
Withdrawal by Subject	0	1
Study Terminated by Sponsor	3	0

Baseline Characteristics

Arm/Group Title		Placebo	Guselkumab	Total
Arm/Group Description		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	Total of all reporting groups
Overall Number of Baseline Participants		16	17	33
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	16 participants	17 participants	33 participants
		38.8 (11.69)	35.3 (10.07)	37 (10.86)
Age, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	16 participants	17 participants	33 participants
>= 55 years		1 6.3%	1 5.9%	2 6.1%
< 55 years		15 93.8%	16 94.1%	31 93.9%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	16 participants	17 participants	33 participants
	Female	14 87.5%	15 88.2%	29 87.9%
	Male	2 12.5%	2 11.8%	4 12.1%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	16 participants	17 participants	33 participants
	Hispanic or Latino	4 25.0%	7 41.2%	11 33.3%
	Not Hispanic or Latino	12 75.0%	10 58.8%	22 66.7%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	16 participants	17 participants	33 participants
	American Indian or Alaska Native	1 6.3%	2 11.8%	3 9.1%
	Asian	3 18.8%	1 5.9%	4 12.1%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%
	White	12 75.0%	14 82.4%	26 78.8%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	16 participants	17 participants	33 participants
ARGENTINA		5 31.3%	4 23.5%	9 27.3%
MEXICO		1 6.3%	3 17.6%	4 12.1%
RUSSIAN FEDERATION		2 12.5%	1 5.9%	3 9.1%
TAIWAN		3 18.8%	0 0.0%	3 9.1%
THAILAND		0 0.0%	1 5.9%	1 3.0%
UKRAINE		5 31.3%	7 41.2%	12 36.4%
UNITED STATES		0 0.0%	1 5.9%	1 3.0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving at Least 50 Percent (%) Decrease From Baseline in Proteinuria at Week 24
Description	Percentage of participants achieving at least 50% decrease in proteinuria from baseline at Week 24 was reported. Proteinuria analysis was based on urine protein creatinine ratio (UPCR) and was defined as the presence of an excess of serum proteins in the urine, which may be an early sign of kidney disease.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) included all randomized participants who received at least 1 dose of study intervention.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description:	In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed	16	17
Measure Type: Number; Unit of Measure: percentage of participants
	56.3	35.3

2. Secondary Outcome

Title	Percentage of Participants Who Achieved Complete Renal Response (CRR) at Week 24
Description	Percentage of participants who achieved CRR at Week 24 were reported. CRR was defined as UPCR less than (<) 0.5 milligrams per milligrams (mg/mg), estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 60 milliliter per minute per 1.73 meter square (mL/min/1.73m^2) or no confirmed decrease >=20% from baseline and prednisone dose less than or equal to (<=) 10 milligrams per day (mg/d). Participant was considered as achieved CRR who did not discontinue study intervention for any reason excluding COVID-19 related discontinuations or met the medication intercurrent event (exceeded baseline glucocorticoid dose, increase above 10 mg/d prednisone equivalent after Week 12, use of new or increased dose of concomitant medication related to LN or other immunosuppressive agents, within 8 weeks prior to the outcome measure (OM) time point (Week 24) or initiation of prohibited medications at any time prior to the endpoint time point (Week 24).
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of study intervention.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description:	In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed	16	17
Measure Type: Number; Unit of Measure: percentage of participants
	18.8	17.6

3. Secondary Outcome

Title	Percentage of Participants Who Achieved CRR at Week 52
Description	Percentage of participants who achieved CRR at Week 52 were reported. CRR was defined as UPCR less than (<) 0.5 mg/mg, eGFR >= 60 mL/min/1.73m^2 or no confirmed decrease >=20% from baseline and prednisone dose <= 10 mg/d. Participant was considered as achieved CRR who did not discontinue study intervention for any reason excluding COVID-19 related discontinuations or met the medication intercurrent event (exceeded baseline glucocorticoid dose, increase above 10 mg/d prednisone equivalent after Week 12, use of new or increased dose of concomitant medication related to LN or other immunosuppressive agents, within 8 weeks prior to the outcome measure time point (Week 52) or initiation of prohibited medications at any time prior to the outcome measure time point (Week 52).
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

The Full Analyses Set for Week 52 (FASC52) included all randomized participants who received at least 1 dose of any study intervention and had the opportunity to complete the Week 52 visit prior to study termination. Here 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description:	In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed	12	11
Measure Type: Number; Unit of Measure: percentage of participants
	25.0	9.1

4. Secondary Outcome

Title	Percentage of Participants Achieving a Sustained Reduction in Steroid Dose <=10 mg/d of Prednisone or Equivalent From Week 16 Through Week 24
Description	Percentage of participants achieving a sustained reduction in steroid dose less than or equal to (<=) 10 mg/day of prednisone or equivalent from week 16 through Week 24were reported.
Time Frame	From Week 16 through Week 24

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of study intervention.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description:	In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed	16	17
Measure Type: Number; Unit of Measure: percentage of participants
	87.5	94.1

5. Secondary Outcome

Title	Percentage of Participants Achieving at Least 50% Decrease in Proteinuria From Baseline at Week 52
Description	Percentage of participants achieving at least 50% decrease in proteinuria from baseline at Week 52 were reported. Proteinuria analysis was based on urine protein creatinine ratio (UPCR) and was defined as the presence of an excess of serum proteins in the urine, which may be an early sign of kidney disease.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

FASC52 included all randomized participants who received at least 1 dose of any study intervention and had the opportunity to complete the Week 52 visit prior to study termination. Here 'N' (number of participants analysed) signifies participants evaluable for this outcome measure.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description:	In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed	12	11
Measure Type: Number; Unit of Measure: percentage of participants
	25.0	27.3

6. Secondary Outcome

Title	Percentage of Participants With Urine Protein to Creatinine Ratio (UPCR) < 0.5 mg/mg at Week 24
Description	Percentage of participants with UPCR <0.5 mg/mg at Week 24 were reported.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of study intervention.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description:	In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed	16	17
Measure Type: Number; Unit of Measure: percentage of participants
	25.0	29.4

7. Secondary Outcome

Title	Percentage of Participants With UPCR < 0.75 mg/mg at Week 24
Description	Percentage of participants with UPCR less than 0.75 mg/mg at Week 24 were reported.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of study intervention.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description:	In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed	16	17
Measure Type: Number; Unit of Measure: percentage of participants
	37.5	35.3

8. Secondary Outcome

Title	Percentage of Participants Who Achieved CRR Through Week 24
Description	Percentage of participants who achieved CRR through Week 24 was reported. CRR was defined as UPCR<0.5 mg/mg, eGFR >= 60 mL/min/1.73m^2 or no confirmed decrease>=20% from baseline and prednisone dose <= 10 mg/d. Participant was considered as achieved CRR who did not discontinue study intervention for any reason excluding COVID-19 related discontinuations or met the medication intercurrent event (exceeded baseline glucocorticoid dose, increase above 10 mg/d prednisone equivalent after Week 12, use of new or increased dose of concomitant medication related to lupus nephritis (LN) or other immunosuppressive agents, within 8 weeks prior to the outcome measure time point (Week 24) or initiation of prohibited medications at any time prior to the outcome measure time point (Week 24).
Time Frame	Up to Week 24

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of any study intervention.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description:	In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed	16	17
Measure Type: Number; Unit of Measure: Percentage of participants
	37.5	23.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Guselkumab
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.7807
	Comments	[Not Specified]
	Method	log-rank test
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.62
	Confidence Interval	(2-Sided) 80%; 0.27 to 1.41
	Estimation Comments	Hazard ratio and 80% CI: estimated by Cox proportional hazards model adjusting for baseline UPCR level (<3 mg/mg and >=3 mg/mg).

9. Secondary Outcome

Title	Percentage of Participants With Treatment Failure (TF) Through Week 52
Description	Percentage of participants with TF through Week 52 was reported. TF was defined as time to the first occurrence of TF from baseline. Participant was considered to have treatment failure, who did not continue study intervention for any reason excluding COVID-19 related discontinuations or met the medication intercurrent event (exceeded baseline glucocorticoid dose, increase above 10 mg/d prednisone equivalent after Week 12, use of new or increased dose of concomitant medication related to LN or other immunosuppressive agents, within 8 weeks prior to the outcome measure time point (Week 52) or initiation of prohibited medications at any time prior to the outcome measure time point (Week 52).
Time Frame	Up to Week 52

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of any study intervention.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description:	In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed	16	17
Measure Type: Number; Unit of Measure: Percentage of participants
	18.8	35.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Guselkumab
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.4654
	Comments	[Not Specified]
	Method	long-rank test
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.52
	Confidence Interval	(2-Sided) 80%; 0.62 to 3.85
	Estimation Comments	Hazard ratio and 80% CI: estimated by Cox proportional hazards model adjusting for baseline UPCR level (<3 mg/mg and >=3 mg/mg).

10. Secondary Outcome

Title	Number of Participants With Adverse Events (AEs)
Description	Number of participants with AEs were reported. An AE was defined as any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product did not necessarily have a causal relationship with the treatment. Therefore, it could be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.
Time Frame	DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)

Outcome Measure Data

Analysis Population Description

Safety analysis set (SAS) included all participants who received at least one dose of study intervention. Since a small number of participants only entered the LTE phase than the planned enrollment count, no separate adverse events analysis was performed for the LTE phase participants and thus, data of both DB period and LTE phase were presented together for this outcome measure under the arms: placebo and guselkumab.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description:	In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed	16	17
Measure Type: Count of Participants; Unit of Measure: Participants
	12 75.0%	12 70.6%

11. Secondary Outcome

Title	Number of Participants With Serious Adverse Events (SAEs)
Description	Number of Participants with SAEs were reported. An AE was defined as any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product did not necessarily have a causal relationship with the treatment. Therefore, it could be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, or was medically important.
Time Frame	DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)

Outcome Measure Data

Analysis Population Description

SAS included all participants who received at least one dose of study intervention. Since a small number of participants only entered the LTE phase than the planned enrollment count, no separate adverse events analysis was performed for the LTE phase participants and thus, data of both DB period and LTE phase were presented together for this outcome measure under the arms: placebo and guselkumab.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description:	In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed	16	17
Measure Type: Count of Participants; Unit of Measure: Participants
	1 6.3%	1 5.9%

12. Secondary Outcome

Title	Number of Participants With Related AEs
Description	Number of participants with related AEs were reported. An AE was defined as any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product did not necessarily have a causal relationship with the treatment. Therefore, it could be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. Related AE was defined as the AE assessed by the investigator related to study agent.
Time Frame	DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)

Outcome Measure Data

Analysis Population Description

SAS included all participants who received at least one dose of study intervention. Since a small number of participants only entered the LTE phase than the planned enrollment count, no separate adverse events analysis was performed for the LTE phase participants and thus, data of both DB period and LTE phase were presented together for this outcome measure under the arms: placebo and guselkumab.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description:	In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed	16	17
Measure Type: Count of Participants; Unit of Measure: Participants
	2 12.5%	2 11.8%

13. Secondary Outcome

Title	Number of Participants With AEs Leading to Discontinuation of Study Intervention
Description	Number of participants with AEs leading to discontinuation of study intervention were reported.
Time Frame	DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)

Outcome Measure Data

Analysis Population Description

SAS included all participants who received at least one dose of study intervention. Since a small number of participants only entered the LTE phase than the planned enrollment count, no separate adverse events analysis was performed for the LTE phase participants and thus, data of both DB period and LTE phase were presented together for this outcome measure under the arms: placebo and guselkumab.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description:	In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed	16	17
Measure Type: Count of Participants; Unit of Measure: Participants
	1 6.3%	2 11.8%

14. Secondary Outcome

Title	Number of Participants With Infections
Description	Number of participants with infections as assessed by the investigator were reported.
Time Frame	DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)

Outcome Measure Data

Analysis Population Description

SAS included all participants who received at least one dose of study intervention. Since a small number of participants only entered the LTE phase than the planned enrollment count, no separate adverse events analysis was performed for the LTE phase participants and thus, data of both DB period and LTE phase were presented together for this outcome measure under the arms: placebo and guselkumab.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description:	In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed	16	17
Measure Type: Count of Participants; Unit of Measure: Participants
	5 31.3%	6 35.3%

15. Secondary Outcome

Title	Number of Participants With Serious Infections
Description	Number of participants with serious infections as assessed by the investigator were reported.
Time Frame	DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)

Outcome Measure Data

Analysis Population Description

SAS included all participants who received at least one dose of study intervention. Since a small number of participants only entered the LTE phase than the planned enrollment count, no separate adverse events analysis was performed for the LTE phase participants and thus, data of both DB period and LTE phase were presented together for this outcome measure under the arms: placebo and guselkumab.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description:	In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed	16	17
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%

16. Secondary Outcome

Title	Number of Participants With Infections Requiring Oral or Parenteral Antimicrobial Treatment
Description	Number of participants with infections requiring oral or parenteral antimicrobial treatment planned to be were reported.
Time Frame	DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)

Outcome Measure Data

Analysis Population Description

SAS included all participants who received at least one dose of study intervention. For this outcome measure, no data was collected and analyzed due to premature termination of the study.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description:	In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

17. Secondary Outcome

Title	Number of Participants With AEs Temporally Associated With an Infusion
Description	Number of participants with AEs temporally (a reaction that occurred during or within 1 hour after infusion) associated with an infusion were reported. AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product does not necessarily have a causal relationship with the treatment. Therefore, it can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.
Time Frame	DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)

Outcome Measure Data

Analysis Population Description

SAS included all participants who received at least one dose of study intervention. Since a small number of participants only entered the LTE phase than the planned enrollment count, no separate adverse events analysis was performed for the LTE phase participants and thus, data of both DB period and LTE phase were presented together for this outcome measure under the arms: placebo and guselkumab.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description:	In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed	16	17
Measure Type: Count of Participants; Unit of Measure: Participants
	1 6.3%	0 0.0%

18. Secondary Outcome

Title	Number of Participants With AEs With Injection-site Reactions
Description	Number of participants with injection-site reactions as assessed by the investigator were reported. An injection-site reaction is any adverse reaction at a SC study intervention injection-site.
Time Frame	DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)

Outcome Measure Data

Analysis Population Description

SAS included all participants who received at least one dose of study intervention. Since a small number of participants only entered the LTE phase than the planned enrollment count, no separate adverse events analysis was performed for the LTE phase participants and thus, data of both DB period and LTE phase were presented together for this outcome measure under the arms: placebo and guselkumab.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description:	In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed	16	17
Measure Type: Count of Participants; Unit of Measure: Participants
	1 6.3%	0 0.0%

19. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Activated Partial Thromboplastin Time
Description	Change from baseline in clinical laboratory parameter: activated partial thromboplastin time was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS included all participants who received at least one dose of study intervention. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies number of participants with available data for this OM. Since a small number of participants only entered LTE phase than planned enrollment count, planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this OM.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		12	13
Mean (Standard Deviation); Unit of Measure: Seconds
Week 24	Number Analyzed	12 participants	13 participants
		0.78 (1.734)	0.96 (3.869)
Week 52	Number Analyzed	4 participants	0 participants
		0.88 (1.387)

20. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Basophils
Description	Change from baseline in clinical laboratory parameter: basophils was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS included all subjects who received at least one dose of study intervention. Here 'n' (number analyzed) signifies number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies to number of participants with available data for this OM. Since a small number of participants only entered LTE phase than planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this OM.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		13	12
Mean (Standard Deviation); Unit of Measure: 10^9 cells per liter
Week 24	Number Analyzed	13 participants	12 participants
		-0.009 (0.0512)	-0.009 (0.0502)
Week 52	Number Analyzed	2 participants	0 participants
		-0.070 (0.0990)

21. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Eosinophils
Description	Change from baseline in clinical laboratory parameter: eosinophils was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		13	12
Mean (Standard Deviation); Unit of Measure: 10^9 cells per liter
Week 24	Number Analyzed	13 participants	12 participants
		0.022 (0.0472)	-0.041 (0.1620)
Week 52	Number Analyzed	2 participants	0 participants
		0.000 (0.0283)

22. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Description	Change from baseline in clinical laboratory parameter: erythrocytes mean corpuscular hemoglobin was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		13	12
Mean (Standard Deviation); Unit of Measure: petagram (pg)
Week 24	Number Analyzed	13 participants	12 participants
		0.1 (1.38)	-0.8 (1.06)
Week 52	Number Analyzed	2 participants	0 participants
		-1.5 (2.12)

23. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Erythrocytes Mean Corpuscular Volume
Description	Change from baseline in clinical laboratory parameter: erythrocytes mean corpuscular volume was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		13	11
Mean (Standard Deviation); Unit of Measure: femtoliter (fL)
Week 24	Number Analyzed	13 participants	11 participants
		0.5 (6.35)	-3.3 (5.37)
Week 52	Number Analyzed	2 participants	0 participants
		-4.0 (0.00)

24. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Erythrocytes
Description	Change from baseline in clinical laboratory parameter: erythrocytes was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS included all subjects who received at least one dose of study intervention. Here 'n' (number analyzed) signifies number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this OM. Since a small number of participants only entered the LTE phase than planned enrollment count, planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this OM.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		13	12
Mean (Standard Deviation); Unit of Measure: 10^12 cells per liter
Week 24	Number Analyzed	13 participants	12 participants
		-0.16 (0.582)	0.12 (0.577)
Week 52	Number Analyzed	2 participants	0 participants
		-0.40 (0.566)

25. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Hematocrit
Description	Change from baseline in clinical Laboratory parameter: hematocrit was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS included all participants who received at least one dose of study intervention. Here 'n' refers to the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this OM. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this OM.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		13	11
Mean (Standard Deviation); Unit of Measure: percentage of blood cells
Week 24	Number Analyzed	13 participants	11 participants
		-0.013 (0.0411)	-0.004 (0.0356)
Week 52	Number Analyzed	2 participants	0 participants
		-0.055 (0.0495)

26. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Hemoglobin
Description	Change from baseline in clinical laboratory parameter: hemoglobin was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		13	12
Mean (Standard Deviation); Unit of Measure: grams per liter (g/L)
Week 24	Number Analyzed	13 participants	12 participants
		-5.2 (15.57)	-0.3 (14.82)
Week 52	Number Analyzed	2 participants	0 participants
		-17.0 (22.63)

27. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter Leukocytes
Description	Change from baseline in clinical laboratory parameter: leukocytes was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants of both with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		13	12
Mean (Standard Deviation); Unit of Measure: 10^9 cells per liter
Week 24	Number Analyzed	13 participants	12 participants
		-0.622 (3.8729)	-1.157 (3.1246)
Week 52	Number Analyzed	2 participants	0 participants
		-5.120 (7.7499)

28. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Lymphocytes
Description	Change from baseline in clinical laboratory parameter: lymphocytes was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies to number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants of both with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		13	12
Mean (Standard Deviation); Unit of Measure: 10^9 cells per Liter
Week 24	Number Analyzed	13 participants	12 participants
		0.006 (0.5213)	-0.032 (0.3860)
Week 52	Number Analyzed	2 participants	0 participants
		-0.545 (1.0960)

29. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Monocytes
Description	Change from baseline in clinical laboratory parameter: monocytes was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies to the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		13	12
Mean (Standard Deviation); Unit of Measure: 10^9 cells per liter
Week 24	Number Analyzed	13 participants	12 participants
		-0.014 (0.3277)	-0.002 (0.1268)
Week 52	Number Analyzed	2 participants	0 participants
		-0.510 (0.7354)

30. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Hematology Parameter: Segmented Neutrophils
Description	Change from baseline in clinical laboratory parameter: segmented neutrophils was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		13	12
Mean (Standard Deviation); Unit of Measure: 10^9 cells per liter
Week 24	Number Analyzed	13 participants	12 participants
		-0.630 (3.2494)	-1.074 (2.9652)
Week 52	Number Analyzed	2 participants	0 participants
		-3.990 (5.8548)

31. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Platelets
Description	Change from baseline in clinical laboratory parameter: platelets was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		13	12
Mean (Standard Deviation); Unit of Measure: 10^9 cells per liter
Week 24	Number Analyzed	13 participants	12 participants
		-36.7 (61.43)	-17.8 (61.89)
Week 52	Number Analyzed	2 participants	0 participants
		-70.5 (67.18)

32. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Prothrombin International Normalized Ratio
Description	Change from baseline in clinical laboratory parameter: prothrombin international normalized ratio was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		13	13
Mean (Standard Deviation); Unit of Measure: Ratio
Week 24	Number Analyzed	13 participants	13 participants
		0.02 (0.090)	0.01 (0.064)
Week 52	Number Analyzed	4 participants	0 participants
		0.00 (0.000)

33. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Prothrombin Time
Description	Change from baseline in clinical laboratory parameter: prothrombin time was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		13	13
Mean (Standard Deviation); Unit of Measure: second
Week 24	Number Analyzed	13 participants	13 participants
		0.18 (0.766)	0.16 (0.425)
Week 52	Number Analyzed	4 participants	0 participants
		-0.03 (0.359)

34. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Reticulocytes/Erythrocytes
Description	Change from baseline in clinical laboratory hematology parameter:reticulocytes/erythrocytes was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		13	11
Mean (Standard Deviation); Unit of Measure: percentage of blood cells
Week 24	Number Analyzed	13 participants	11 participants
		-0.0007 (0.00485)	-0.0001 (0.00541)
Week 52	Number Analyzed	2 participants	0 participants
		0.0000 (0.01414)

35. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Alanine Aminotransferase
Description	Change from baseline in clinical laboratory parameter: alanine aminotransferase was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		14	16
Mean (Standard Deviation); Unit of Measure: Enzyme units per liter
Week 24	Number Analyzed	14 participants	16 participants
		2.6 (10.98)	-3.1 (6.57)
Week 52	Number Analyzed	4 participants	0 participants
		2.3 (4.92)

36. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Albumin
Description	Change from baseline in clinical laboratory parameter: albumin was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		14	16
Mean (Standard Deviation); Unit of Measure: Grams per Liter (g/L)
Week 24	Number Analyzed	14 participants	16 participants
		2.4 (5.57)	1.9 (4.58)
Week 52	Number Analyzed	4 participants	1 participants
		3.5 (5.32)	-3.0 [1] (NA)

[1]

Here, NA signifies that SD could not be calculated for single participant.

37. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Alkaline Phosphatase
Description	Change from baseline in clinical laboratory parameter: alkaline phosphatase was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		14	16
Mean (Standard Deviation); Unit of Measure: Enzyme units per liter
Week 24	Number Analyzed	14 participants	16 participants
		1.9 (16.75)	1.7 (8.07)
Week 52	Number Analyzed	4 participants	1 participants
		6.5 (5.00)	6.0 [1] (NA)

[1]

Here, NA signifies that SD could not be calculated for single participant.

38. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Aspartate Aminotransferase
Description	Change from baseline in clinical laboratory parameter: aspartate aminotransferase was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants of both with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		13	13
Mean (Standard Deviation); Unit of Measure: Enzyme units per liter
Week 24	Number Analyzed	13 participants	13 participants
		0.0 (4.97)	-0.7 (5.41)
Week 52	Number Analyzed	4 participants	1 participants
		1.5 (2.38)	1.0 [1] (NA)

[1]

Here, NA signifies that SD could not be calculated for single participant.

39. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Bicarbonate
Description	Change from baseline in clinical laboratory parameter: bicarbonate was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		13	12
Mean (Standard Deviation); Unit of Measure: mmol/L
Week 24	Number Analyzed	13 participants	12 participants
		-0.78 (4.97)	0.21 (5.41)
Week 52	Number Analyzed	2 participants	0 participants
		-2.20 (2.38)

40. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Bilirubin
Description	Change from baseline in clinical laboratory parameter: bilirubin was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		14	16
Mean (Standard Deviation); Unit of Measure: micromole per liter
Week 24	Number Analyzed	14 participants	16 participants
		0.1 (1.98)	0.3 (2.46)
Week 52	Number Analyzed	4 participants	1 participants
		-0.3 (2.06)	4.0 [1] (NA)

[1]

Here, NA signifies that SD could not be calculated for single participant.

41. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameters: Calcium
Description	Change from baseline in clinical laboratory parameter: calcium was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		14	16
Mean (Standard Deviation); Unit of Measure: mmol/L
Week 24	Number Analyzed	14 participants	16 participants
		0.039 (0.1172)	0.073 (0.0958)
Week 52	Number Analyzed	4 participants	1 participants
		0.000 (0.1871)	0.010 [1] (NA)

[1]

Here, NA signifies that SD could not be calculated for single participant.

42. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Chloride
Description	Change from baseline in clinical laboratory parameter: chloride was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		14	16
Mean (Standard Deviation); Unit of Measure: mmol/L
Week 24	Number Analyzed	14 participants	16 participants
		0.1 (4.50)	0.7 (0.0958)
Week 52	Number Analyzed	4 participants	1 participants
		2.0 (4.83)	2.0 [1] (NA)

[1]

Here, NA signifies that SD could not be calculated for single participant.

43. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameters: Cholesterol
Description	Change from baseline in clinical laboratory parameter: cholesterol was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		14	15
Mean (Standard Deviation); Unit of Measure: mmol/L
Week 24	Number Analyzed	14 participants	15 participants
		-1.325 (1.3026)	0.017 (0.7818)
Week 52	Number Analyzed	4 participants	1 participants
		-2.235 (1.6588)	0.210 [1] (NA)

[1]

Here, NA signifies that SD could not be calculated for single participant.

44. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Creatine Kinase
Description	Change from baseline in clinical laboratory parameter: creatine kinase was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		14	16
Mean (Standard Deviation); Unit of Measure: Enzyme units per liter
Week 24	Number Analyzed	14 participants	16 participants
		3.3 (42.22)	-0.5 (53.94)
Week 52	Number Analyzed	4 participants	1 participants
		-8.8 (36.65)	-2.0 [1] (NA)

[1]

Here, NA signifies that SD could not be calculated for single participant.

45. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Creatinine
Description	Change from baseline in clinical laboratory parameter: creatinine was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		14	16
Mean (Standard Deviation); Unit of Measure: micromole per liter
Week 24	Number Analyzed	14 participants	16 participants
		0.6 (18.30)	6.7 (16.78)
Week 52	Number Analyzed	4 participants	1 participants
		-3.3 (7.54)	-5.0 [1] (NA)

[1]

Here, NA signifies that SD could not be calculated for single participant.

46. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Protein
Description	Change from baseline in clinical laboratory parameter: protein was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		14	16
Mean (Standard Deviation); Unit of Measure: g/L
Week 24	Number Analyzed	14 participants	16 participants
		3.0 (8.83)	2.9 (16.78)
Week 52	Number Analyzed	4 participants	1 participants
		7.0 (7.39)	1.0 [1] (NA)

[1]

Here, NA signifies that SD could not be calculated for single participant.

47. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Phosphate
Description	Change from baseline in clinical laboratory parameter: phosphate was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		14	16
Mean (Standard Deviation); Unit of Measure: mmol/L
Week 24	Number Analyzed	14 participants	16 participants
		0.060 (0.1498)	0.030 (0.2916)
Week 52	Number Analyzed	4 participants	1 participants
		-0.035 (0.2213)	0.220 [1] (NA)

[1]

Here, NA signifies that SD could not be calculated for single participant.

48. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Sodium
Description	Change from baseline in clinical laboratory parameter: sodium was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		14	16
Mean (Standard Deviation); Unit of Measure: mmol/L
Week 24	Number Analyzed	14 participants	16 participants
		-0.7 (2.30)	0.4 (4.24)
Week 52	Number Analyzed	4 participants	1 participants
		1.0 (1.41)	3.0 [1] (NA)

[1]

Here, NA signifies that SD could not be calculated for single participant.

49. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameters: Potassium
Description	Change from baseline in clinical laboratory parameter: potassium was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		14	16
Mean (Standard Deviation); Unit of Measure: mmol/L
Week 24	Number Analyzed	14 participants	16 participants
		0.19 (0.704)	0.13 (0.402)
Week 52	Number Analyzed	4 participants	1 participants
		0.03 (0.457)	0.00 [1] (NA)

[1]

Here, NA signifies that SD could not be calculated for single participant.

50. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameters: Urea Nitrogen
Description	Change from baseline in clinical laboratory parameter: urea nitrogen was reported.
Time Frame	Baseline (Week 0), Week 24, and Week 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		14	16
Mean (Standard Deviation); Unit of Measure: mmol/L
Week 24	Number Analyzed	14 participants	16 participants
		-1.23 (3.106)	0.71 (2.177)
Week 52	Number Analyzed	4 participants	1 participants
		-1.60 (1.564)	0.50 [1] (NA)

[1]

Here, NA signifies that SD could not be calculated for single participant.

51. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA)
Description	Change from baseline in clinical laboratory parameter: GFR from Creatinine Adjusted for BSA was reported.
Time Frame	Baseline (Week 0), Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) refers to the number of participants evaluable at each specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants of both with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		14	16
Mean (Standard Deviation); Unit of Measure: milliliter/minute/1.73 meter square
Week 24	Number Analyzed	14 participants	16 participants
		0.44 (21.639)	-5.87 (17.150)
Week 52	Number Analyzed	4 participants	1 participants
		6.75 (22.588)	5.60 [1] (NA)

[1]

Here, NA signifies that SD could not be calculated for single participant.

52. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Gamma Glutamyl and Transferase Lactate Dehydrogenase
Description	Change from baseline in clinical laboratory parameter: gamma glutamyl transferase and lactate dehydrogenase were reported.
Time Frame	Baseline (Week 0), Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) refers to the number of participants evaluable at each specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants of both with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		14	16
Mean (Standard Deviation); Unit of Measure: Enzyme units per liter
gamma glutamyl transferase: Week 24	Number Analyzed	14 participants	16 participants
		-0.6 (15.01)	-3.0 (9.70)
gamma glutamyl transferase: Week 52	Number Analyzed	4 participants	1 participants
		1.0 (8.60)	-2.0 [1] (NA)
Lactate dehydogenase: Week 24	Number Analyzed	13 participants	12 participants
		-14.5 (47.90)	-2.5 (17.52)
Lactate dehydogenase: Week 52	Number Analyzed	2 participants	1 participants
		-62.5 (40.31)	7.0 [1] (NA)

[1]

Here, NA signifies that SD could not be calculated for single participant.

53. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Glucose and Magnesium
Description	Change from baseline in clinical laboratory parameter: glucose and magnesium were reported.
Time Frame	Baseline, Weeks 24, 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at each specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants of both with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		14	16
Mean (Standard Deviation); Unit of Measure: millimoles per liter (mmol/L)
Glucose: Week 24	Number Analyzed	14 participants	16 participants
		-0.23 (1.041)	-0.04 (0.908)
Glucose:: Week 52	Number Analyzed	4 participants	1 participants
		-0.03 (0.126)	0.20 [1] (NA)
Magnesium: Week 24	Number Analyzed	14 participants	16 participants
		-0.024 (0.0696)	-0.022 (0.0607)
Magnesium: Week 52	Number Analyzed	14 participants	16 participants
		-0.068 (0.0842)	-0.010 [1] (NA)

[1]

Here, NA signifies that SD could not be calculated for single participant.

54. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Protein
Description	Change from baseline in clinical laboratory parameter: protein was reported.
Time Frame	Baseline (Week 0), Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		14	16
Mean (Standard Deviation); Unit of Measure: gram per Liter (g/L)
Week 24	Number Analyzed	14 participants	16 participants
		3.0 (8.83)	2.9 (6.55)
Week 52	Number Analyzed	4 participants	1 participants
		7.0 (7.39)	1.0 [1] (NA)

[1]

Here, NA signifies that SD could not be calculated for single participant.

55. Secondary Outcome

Title	Change From Baseline in Chemistry Parameters: Protein/Creatinine
Description	Change from baseline in chemistry parameter: protein/creatinine was reported.
Time Frame	Baseline, Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at each specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		15	16
Mean (Standard Deviation); Unit of Measure: mg/mg
Week 24	Number Analyzed	14 participants	16 participants
		-1.509 (1.9494)	-0.821 (2.4250)
Week 52	Number Analyzed	4 participants	7 participants
		-1.586 (1.7966)	-0.352 (1.6960)

56. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Urate
Description	Change from baseline in clinical laboratory parameter: urate was reported.
Time Frame	Baseline, Weeks 24, 52

Outcome Measure Data

Analysis Population Description

SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at each specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		14	16
Mean (Standard Deviation); Unit of Measure: micromole per liter
Week 24	Number Analyzed	14 participants	16 participants
		-73.4 (104.11)	8.4 (48.61)
Week 52	Number Analyzed	4 participants	1 participants
		-79.5 (79.38)	-2.0 [1] (NA)

[1]

Here, NA signifies that SD could not be calculated for single participant.

57. Secondary Outcome

Title	Change From Baseline in Clinical Laboratory Parameter: Urine Protein
Description	Change from baseline in clinical laboratory parameter: urine protein was reported.
Time Frame	Baseline (Week 0), Weeks 24 and 52

Outcome Measure Data

Analysis Population Description

SAS population.Here 'n' (number analyzed) signifies the number of participants evaluable at each specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants of both with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure.

Arm/Group Title		Placebo	Guselkumab
Arm/Group Description:		In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		15	17
Mean (Standard Deviation); Unit of Measure: milligram per liter
Week 24	Number Analyzed	15 participants	16 participants
		-1322.1 (1865.82)	-310.3 (1494.58)
Week 52	Number Analyzed	6 participants	7 participants
		-1821.7 (2334.78)	-166.4 (1099.54)

58. Secondary Outcome

Title	Number of Participants With Maximum US National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Toxicity Grade (Grade 4) in Clinical Laboratory Parameters: Hematology and Chemistry
Description	Number of participants with maximum US NCI-CTCAE toxicity grade (Grade 4) in clinical laboratory parameters: hematology and chemistry were reported. Toxicity were graded as Grade 1: Mild, Grade 2: Moderate; Grade 3: Severe. Grade 4: Life-threatening and Grade 5: Death.
Time Frame	DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)

Outcome Measure Data

Analysis Population Description

SAS included all participants who received at least one dose of study intervention. Since a small number of participants only entered the LTE phase than the planned enrollment count, no separate adverse events analysis was performed for the LTE phase participants and thus, data of both DB period and LTE phase were presented together for this outcome measure under the arms: placebo and guselkumab.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description:	In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed	16	17
Measure Type: Count of Participants; Unit of Measure: Participants
Alanine Aminotransferase Increased	0 0.0%	0 0.0%
Alkaline Phosphatase Increased	0 0.0%	0 0.0%
Aspartate Aminotransferase Increased	0 0.0%	0 0.0%
Blood Bilirubin Increased	0 0.0%	0 0.0%
CPK Increased	0 0.0%	0 0.0%
Cholesterol High	0 0.0%	0 0.0%
Creatinine Increase	0 0.0%	0 0.0%
GGT Increased	0 0.0%	0 0.0%
Hypermagnesemia	0 0.0%	0 0.0%
Hypernatremia	0 0.0%	0 0.0%
Hypertriglyceridemia	0 0.0%	0 0.0%
Hypoalbuminemia	0 0.0%	0 0.0%
Hypoglycemia	0 0.0%	0 0.0%
Hypokalemia	0 0.0%	0 0.0%
Hypomagnesemia	0 0.0%	0 0.0%
Hyponatremia	0 0.0%	0 0.0%
Activated Partial Thromboplastin Time Prolonged	0 0.0%	0 0.0%
Anemia	0 0.0%	0 0.0%
Hemoglobin Increased	0 0.0%	0 0.0%
Leukocytosis	0 0.0%	0 0.0%
Lymphocyte Count Decreased	0 0.0%	0 0.0%
Lymphocyte Count Increased	0 0.0%	0 0.0%
Neutrophil Count Decreased	0 0.0%	0 0.0%
Platelet Count Decreased	0 0.0%	0 0.0%
White Blood Cell Decreased	0 0.0%	0 0.0%

59. Secondary Outcome

Title	Percentage of Participants With Abnormal Vital Signs: Systolic and Diastolic Blood Pressure
Description	Percentage of participants with abnormal vital signs: Systolic and Diastolic blood pressure were reported.
Time Frame	Up to Week 60

Outcome Measure Data

Analysis Population Description

SAS included all participants who received at least one dose of study intervention.

Arm/Group Title	Placebo	Guselkumab
Arm/Group Description:	In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed	16	17
Measure Type: Number; Unit of Measure: percentage of participants
Systolic Blood Pressure: <85 mmHg	0	0
Systolic Blood Pressure::>180 mmHg	6.3	5.9
Diastolic Blood Pressure: <55 mmHg	6.3	0
Diastolic Blood Pressure: >115 mmHg	6.3	0

60. Secondary Outcome

Title	Serum Concentration of Guselkumab
Description	Serum Concentration of guselkumab were reported.
Time Frame	Predose: Weeks 0,4,8,12,16,20,24, 36; Post-dose: Week 0 (1 hour after intravenous administration), Day 2, Week 52 and 60

Outcome Measure Data

Analysis Population Description

Pharmacokinetic analysis set included all participants who received at least 1 administration of guselkumab and had at least one post-dose sample collection. Here 'n' (number analyzed) signifies number of participants evaluable at specified timepoints. Data for this OM was not planned to be collected and analyzed for placebo arm. Since small number of participants only entered LTE phase than the planned enrollment, planned serum concentration analysis was not performed for LTE phase for this OM.

Arm/Group Title		Guselkumab
Arm/Group Description:		In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		16
Mean (Standard Deviation); Unit of Measure: microgram/milliliter
Week 0, predose	Number Analyzed	16 participants
		0.00 (0.000)
Week 0, 1h after IV administration	Number Analyzed	16 participants
		146.20 (41.273)
Day 2, post-dose	Number Analyzed	16 participants
		96.55 (33.805)
Week 4, predose	Number Analyzed	16 participants
		11.20 (7.175)
Week 8, predose	Number Analyzed	15 participants
		12.85 (9.549)
Week 12, predose	Number Analyzed	14 participants
		18.17 (11.784)
Week 16, pre-dose	Number Analyzed	13 participants
		9.89 (5.016)
Week 20, predose	Number Analyzed	14 participants
		7.63 (4.689)
Week 24, predose	Number Analyzed	12 participants
		6.42 (3.447)
Week 36, predose	Number Analyzed	10 participants
		6.57 (1.827)
Week 52, post-dose	Number Analyzed	6 participants
		6.13 (3.262)
Week 60, post-dose	Number Analyzed	4 participants
		0.39 (0.641)

61. Secondary Outcome

Title	Number of Participants With Treatment-boosted Anti-drug Antibodies (ADA) Response
Description	Treatment-boosted ADA positive participants: participants who were positive at baseline and whose titers increased 2-fold at any time after treatment. Titer values were categorized as<=1:10, 10 to 100, 100 to 1000, >1000.
Time Frame	From Baseline (Week 0) through Week 24 and Week 60

Outcome Measure Data

Analysis Population Description

Immunogenecity analysis set inlcuded all participants who received at least 1 administration of guselkumab and had at least one post-dose sample collection. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Data for this outcome measure was not planned to be collected and analyzed for the placebo arm.

Arm/Group Title		Guselkumab
Arm/Group Description:		In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
Overall Number of Participants Analyzed		17
Measure Type: Count of Participants; Unit of Measure: Participants
Week 24	Number Analyzed	17 participants
		1 5.9%
Week 60	Number Analyzed	16 participants
		1 6.3%

Adverse Events

Time Frame	DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Adverse Event Reporting Description	SAS included all participants who received at least one dose of study intervention. Since a small number of participants only entered the LTE period than the planned enrollment count, no separate adverse events analysis was performed for the LTE phase participants and thus, data of both DB period and LTE phase were presented together for AEs (SAEs and non- SAEs) and all cause mortality data under the arms: placebo and guselkumab.
Arm/Group Title	Placebo	Guselkumab
Arm/Group Description	In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52, and completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).	In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination).
All-Cause Mortality
	Placebo	Guselkumab
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/16 (0.00%)	0/17 (0.00%)
Serious Adverse Events
	Placebo	Guselkumab
	Affected / at Risk (%)	Affected / at Risk (%)
Total	1/16 (6.25%)	1/17 (5.88%)
Nervous system disorders
Basal Ganglia Stroke * 1	1/16 (6.25%)	0/17 (0.00%)
Renal and urinary disorders
Lupus Nephritis * 1	0/16 (0.00%)	1/17 (5.88%)
1 Term from vocabulary, MedDRA Version 25.1; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Placebo	Guselkumab
	Affected / at Risk (%)	Affected / at Risk (%)
Total	12/16 (75.00%)	12/17 (70.59%)
Blood and lymphatic system disorders
Anaemia * 1	1/16 (6.25%)	3/17 (17.65%)
Iron Deficiency Anaemia * 1	1/16 (6.25%)	0/17 (0.00%)
Leukopenia * 1	2/16 (12.50%)	0/17 (0.00%)
Lymphopenia * 1	3/16 (18.75%)	0/17 (0.00%)
Thrombocytopenia * 1	1/16 (6.25%)	0/17 (0.00%)
Cardiac disorders
Left Ventricular Hypertrophy * 1	0/16 (0.00%)	1/17 (5.88%)
Endocrine disorders
Hypothyroidism * 1	0/16 (0.00%)	1/17 (5.88%)
Eye disorders
Ocular Myasthenia * 1	0/16 (0.00%)	1/17 (5.88%)
Gastrointestinal disorders
Abdominal Pain Upper * 1	2/16 (12.50%)	0/17 (0.00%)
Chronic Gastritis * 1	0/16 (0.00%)	1/17 (5.88%)
Diarrhoea * 1	1/16 (6.25%)	0/17 (0.00%)
Gastrooesophageal Reflux Disease * 1	0/16 (0.00%)	2/17 (11.76%)
Nausea * 1	1/16 (6.25%)	0/17 (0.00%)
Toothache * 1	1/16 (6.25%)	0/17 (0.00%)
General disorders
Fatigue * 1	1/16 (6.25%)	0/17 (0.00%)
Injection Site Erythema * 1	1/16 (6.25%)	0/17 (0.00%)
Pyrexia * 1	1/16 (6.25%)	0/17 (0.00%)
Infections and infestations
Bacterial Vaginosis * 1	0/16 (0.00%)	1/17 (5.88%)
Bronchitis * 1	0/16 (0.00%)	1/17 (5.88%)
Covid-19 * 1	3/16 (18.75%)	0/17 (0.00%)
Gastroenteritis * 1	1/16 (6.25%)	0/17 (0.00%)
Herpes Zoster * 1	2/16 (12.50%)	1/17 (5.88%)
Influenza * 1	0/16 (0.00%)	2/17 (11.76%)
Pneumonia Bacterial * 1	1/16 (6.25%)	0/17 (0.00%)
Pyelonephritis Chronic * 1	0/16 (0.00%)	1/17 (5.88%)
Upper Respiratory Tract Infection * 1	1/16 (6.25%)	0/17 (0.00%)
Urinary Tract Infection * 1	2/16 (12.50%)	2/17 (11.76%)
Injury, poisoning and procedural complications
Medication Error * 1	0/16 (0.00%)	2/17 (11.76%)
Skin Laceration * 1	1/16 (6.25%)	0/17 (0.00%)
Investigations
Alanine Aminotransferase Increased * 1	0/16 (0.00%)	1/17 (5.88%)
Blood Bicarbonate Decreased * 1	1/16 (6.25%)	0/17 (0.00%)
Blood Creatine Phosphokinase Increased * 1	1/16 (6.25%)	0/17 (0.00%)
Blood Pressure Increased * 1	0/16 (0.00%)	1/17 (5.88%)
Heart Rate Increased * 1	0/16 (0.00%)	1/17 (5.88%)
Liver Function Test Increased * 1	0/16 (0.00%)	1/17 (5.88%)
White Blood Cell Count Increased * 1	0/16 (0.00%)	1/17 (5.88%)
Metabolism and nutrition disorders
Dyslipidaemia * 1	0/16 (0.00%)	1/17 (5.88%)
Hyperkalaemia * 1	1/16 (6.25%)	1/17 (5.88%)
Hyperlipidaemia * 1	0/16 (0.00%)	1/17 (5.88%)
Hyperuricaemia * 1	2/16 (12.50%)	1/17 (5.88%)
Hypokalaemia * 1	1/16 (6.25%)	0/17 (0.00%)
Vitamin D Deficiency * 1	1/16 (6.25%)	0/17 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia * 1	1/16 (6.25%)	0/17 (0.00%)
Back Pain * 1	1/16 (6.25%)	0/17 (0.00%)
Muscle Spasms * 1	1/16 (6.25%)	0/17 (0.00%)
Muscular Weakness * 1	1/16 (6.25%)	0/17 (0.00%)
Pain in Extremity * 1	1/16 (6.25%)	0/17 (0.00%)
Sle Arthritis * 1	1/16 (6.25%)	0/17 (0.00%)
Systemic Lupus Erythematosus * 1	0/16 (0.00%)	1/17 (5.88%)
Nervous system disorders
Headache * 1	0/16 (0.00%)	2/17 (11.76%)
Hypoaesthesia * 1	1/16 (6.25%)	0/17 (0.00%)
Post Herpetic Neuralgia * 1	0/16 (0.00%)	1/17 (5.88%)
Sciatica * 1	1/16 (6.25%)	0/17 (0.00%)
Tension Headache * 1	1/16 (6.25%)	0/17 (0.00%)
Renal and urinary disorders
Lupus Nephritis * 1	2/16 (12.50%)	5/17 (29.41%)
Skin and subcutaneous tissue disorders
Dry Skin * 1	1/16 (6.25%)	0/17 (0.00%)
Skin Striae * 1	0/16 (0.00%)	1/17 (5.88%)
Urticaria * 1	0/16 (0.00%)	1/17 (5.88%)
Vascular disorders
Hypertension * 1	2/16 (12.50%)	2/17 (11.76%)
Hypotension * 1	1/16 (6.25%)	0/17 (0.00%)
1 Term from vocabulary, MedDRA Version 25.1; * Indicates events were collected by non-systematic assessment

Limitations and Caveats

Due to enrollment challenges, the Sponsor decided to stop screening of new participants and stop the study early. Since a small number of participants only entered the LTE phase than the planned enrollment count, some of the planned safety analyses were not performed for the LTE phase participants.

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.

If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will with hold such publication for up to an additional 60 days.

Results Point of Contact

• Name/Title: Senior Director Clinical Research MD
• Organization: Janssen Research & Development, LLC
• Phone: 844-434-4210
• EMail: ClinicalTrialDisclosure@its.jnj.com

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT04376827
• Other Study ID Numbers: CR108766; 2018-003155-38 ( EudraCT Number ); CNTO1959LUN2001 ( Other Identifier: Janssen Research & Development, LLC )
• First Submitted: May 4, 2020
• First Posted: May 6, 2020
• Results First Submitted: February 1, 2024
• Results First Posted: April 16, 2024
• Last Update Posted: April 16, 2024