Trial Outcomes & Findings for A Study of Guselkumab in Participants With Active Lupus Nephritis (NCT NCT04376827)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

Week 24

Results posted on

2025-03-30

Participant Flow

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).

Participant milestones

Participant milestones
Measure	Placebo 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).	Guselkumab 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).
Double Blind Period: Week 0 to Week 52 STARTED	16	17
Double Blind Period: Week 0 to Week 52 COMPLETED	9	8
Double Blind Period: Week 0 to Week 52 NOT COMPLETED	7	9
LTE Phase:Week 52 to 96(LTE Termination) STARTED	4	1
LTE Phase:Week 52 to 96(LTE Termination) COMPLETED	0	0
LTE Phase:Week 52 to 96(LTE Termination) NOT COMPLETED	4	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo 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).	Guselkumab 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).
Double Blind Period: Week 0 to Week 52 Withdrawal by Subject	1	1
Double Blind Period: Week 0 to Week 52 Study Terminated by Sponsor	6	8
LTE Phase:Week 52 to 96(LTE Termination) Protocol-specified withdrawal criterion met	1	0
LTE Phase:Week 52 to 96(LTE Termination) Withdrawal by Subject	0	1
LTE Phase:Week 52 to 96(LTE Termination) Study Terminated by Sponsor	3	0

Baseline Characteristics

A Study of Guselkumab in Participants With Active Lupus Nephritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=16 Participants 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).	Guselkumab n=17 Participants 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 n=33 Participants Total of all reporting groups
Age, Continuous	38.8 years STANDARD_DEVIATION 11.69 • n=93 Participants	35.3 years STANDARD_DEVIATION 10.07 • n=4 Participants	37 years STANDARD_DEVIATION 10.86 • n=27 Participants
Age, Customized >= 55 years	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Age, Customized < 55 years	15 Participants n=93 Participants	16 Participants n=4 Participants	31 Participants n=27 Participants
Sex: Female, Male Female	14 Participants n=93 Participants	15 Participants n=4 Participants	29 Participants n=27 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=93 Participants	7 Participants n=4 Participants	11 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=93 Participants	10 Participants n=4 Participants	22 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) Asian	3 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	12 Participants n=93 Participants	14 Participants n=4 Participants	26 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment ARGENTINA	5 Participants n=93 Participants	4 Participants n=4 Participants	9 Participants n=27 Participants
Region of Enrollment MEXICO	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Region of Enrollment RUSSIAN FEDERATION	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Region of Enrollment TAIWAN	3 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants
Region of Enrollment THAILAND	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment UKRAINE	5 Participants n=93 Participants	7 Participants n=4 Participants	12 Participants n=27 Participants
Region of Enrollment UNITED STATES	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants

PRIMARY outcome

Timeframe: Week 24

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

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.

Outcome measures

Outcome measures
Measure	Guselkumab n=17 Participants 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).	Placebo n=16 Participants 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).
Percentage of Participants Achieving at Least 50 Percent (%) Decrease From Baseline in Proteinuria at Week 24	35.3 percentage of participants	56.3 percentage of participants

SECONDARY outcome

Timeframe: Week 24

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

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).

Outcome measures

Outcome measures
Measure	Guselkumab n=17 Participants 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).	Placebo n=16 Participants 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).
Percentage of Participants Who Achieved Complete Renal Response (CRR) at Week 24	17.6 percentage of participants	18.8 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Guselkumab n=11 Participants 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).	Placebo n=12 Participants 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).
Percentage of Participants Who Achieved CRR at Week 52	9.1 percentage of participants	25.0 percentage of participants

SECONDARY outcome

Timeframe: From Week 16 through Week 24

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

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.

Outcome measures

Outcome measures
Measure	Guselkumab n=17 Participants 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).	Placebo n=16 Participants 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).
Percentage of Participants Achieving a Sustained Reduction in Steroid Dose <=10 mg/d of Prednisone or Equivalent From Week 16 Through Week 24	94.1 percentage of participants	87.5 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Guselkumab n=11 Participants 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).	Placebo n=12 Participants 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).
Percentage of Participants Achieving at Least 50% Decrease in Proteinuria From Baseline at Week 52	27.3 percentage of participants	25.0 percentage of participants

SECONDARY outcome

Timeframe: Week 24

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

Percentage of participants with UPCR \<0.5 mg/mg at Week 24 were reported.

Outcome measures

Outcome measures
Measure	Guselkumab n=17 Participants 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).	Placebo n=16 Participants 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).
Percentage of Participants With Urine Protein to Creatinine Ratio (UPCR) < 0.5 mg/mg at Week 24	29.4 percentage of participants	25.0 percentage of participants

SECONDARY outcome

Timeframe: Week 24

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

Percentage of participants with UPCR less than 0.75 mg/mg at Week 24 were reported.

Outcome measures

Outcome measures
Measure	Guselkumab n=17 Participants 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).	Placebo n=16 Participants 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).
Percentage of Participants With UPCR < 0.75 mg/mg at Week 24	35.3 percentage of participants	37.5 percentage of participants

SECONDARY outcome

Timeframe: Up to Week 24

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

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).

Outcome measures

Outcome measures
Measure	Guselkumab n=17 Participants 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).	Placebo n=16 Participants 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).
Percentage of Participants Who Achieved CRR Through Week 24	23.5 Percentage of participants	37.5 Percentage of participants

SECONDARY outcome

Timeframe: Up to Week 52

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

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).

Outcome measures

Outcome measures
Measure	Guselkumab n=17 Participants 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).	Placebo n=16 Participants 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).
Percentage of Participants With Treatment Failure (TF) Through Week 52	35.3 Percentage of participants	18.8 Percentage of participants

SECONDARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Guselkumab n=17 Participants 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).	Placebo n=16 Participants 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).
Number of Participants With Adverse Events (AEs)	12 Participants	12 Participants

SECONDARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Guselkumab n=17 Participants 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).	Placebo n=16 Participants 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).
Number of Participants With Serious Adverse Events (SAEs)	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Guselkumab n=17 Participants 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).	Placebo n=16 Participants 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).
Number of Participants With Related AEs	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 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)

Population: 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.

Number of participants with AEs leading to discontinuation of study intervention were reported.

Outcome measures

Outcome measures
Measure	Guselkumab n=17 Participants 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).	Placebo n=16 Participants 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).
Number of Participants With AEs Leading to Discontinuation of Study Intervention	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 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)

Population: 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.

Number of participants with infections as assessed by the investigator were reported.

Outcome measures

Outcome measures
Measure	Guselkumab n=17 Participants 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).	Placebo n=16 Participants 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).
Number of Participants With Infections	6 Participants	5 Participants

SECONDARY outcome

Timeframe: 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)

Population: 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.

Number of participants with serious infections as assessed by the investigator were reported.

Outcome measures

Outcome measures
Measure	Guselkumab n=17 Participants 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).	Placebo n=16 Participants 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).
Number of Participants With Serious Infections	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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)

Population: 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.

Number of participants with infections requiring oral or parenteral antimicrobial treatment planned to be were reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Guselkumab n=17 Participants 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).	Placebo n=16 Participants 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).
Number of Participants With AEs Temporally Associated With an Infusion	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 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)

Population: 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.

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.