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Withdrawn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 — OTHER
    Placebo will be administered intravenously.
  • Nipocalimab — DRUG
    Nipocalimab dose 1 and dose 2 will be administered intravenously.
  • Standard-of-care treatment — DRUG
    Standard-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: Placebo
    Participants 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 1
    Participants 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 2
    Participants 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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