A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis
- Sponsor
- Janssen Research & Development, LLC
- Study ID
- NCT04883619
- Phase
- PHASE2
- Status
- Withdrawn
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Placebo — OTHERPlacebo will be administered intravenously.
- Nipocalimab — DRUGNipocalimab dose 1 and dose 2 will be administered intravenously.
- Standard-of-care treatment — DRUGStandard-of-care treatment including MMF or MPA and glucocorticoids will be administered intravenously through Week 52.
Study Details
The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active Lupus Nephritis (LN).
Key Dates
- Start date
- Jan 15, 2026
- Status verified
- Feb 2026
- Primary completion
- Feb 28, 2028
- Completion
- Feb 28, 2028
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: Group 1: PlaceboParticipants will receive placebo intravenously (IV) every two weeks (q2w) from Week 0 through Week 50 along with standard-of-care treatment of mycophenolate mofetil (MMF) or mycophenolic acid (MPA) and glucocorticoid. Participants who will complete the assessments at Week 52 and have achieved complete renal response (CRR) may have the option to participate in the long-term extension (LTE) until unblinding of the study.
- Experimental: Group 2: Nipocalimab Dose 1Participants will receive nipocalimab dose 1 IV q2w from Week 0 through Week 50 along with standard-of-care treatment of MMF or MPA and glucocorticoid. Participants who will complete the assessments at Week 52 and have achieved CRR may have the option to participate in the LTE of the study.
- Experimental: Group 3: Nipocalimab Dose 2Participants will receive nipocalimab dose 2 IV q2w from Week 0 through Week 50 along with standard-of-care treatment of MMF or MPA and glucocorticoid. Participants who will complete the assessments at Week 52 and have achieved CRR may have the option to participate in the LTE of the study.
Primary Outcome Measure
Percentage of Participants Achieving Complete Renal Response (CRR) [ Time Frame: Week 52 ]
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