A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Conditions

• Lupus Erythematosus, Systemic

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Nipocalimab — DRUG
  Nipocalimab will be administered.
• Placebo — DRUG
  Placebo will be administered.
• Standard of care treatment — DRUG
  Protocol-defined topical and systemic standard of care background treatments.

Study Details

The purpose of this study is to evaluate how well nipocalimab works as compared to placebo in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks its own healthy tissues, causing swelling and redness in various organs).

Key Dates

Start date

Mar 5, 2026

Status verified

Jun 2026

Primary completion

Dec 6, 2028

Completion

Nov 7, 2031

Study Design

Enrollment

600 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Nipocalimab
  Participants will receive nipocalimab up to Week 52 in the double blind treatment period along with standard of care treatments. At Week 52, eligible participants from both studies will have the option to enter an open-label long-term extension (OLE) period, where they will continue to receive nipocalimab until Week 156 or until the study intervention is discontinued.
• Placebo Comparator: Placebo
  Participants will receive placebo up to Week 52 in the double blind treatment period along with standard of care treatment. At Week 52, eligible participants from both studies will have the option to enter an OLE period, where they will continue to receive nipocalimab until Week 156 or until the study intervention is discontinued.

Primary Outcome Measure

Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 52 [ Time Frame: Week 52 ]

Central Contacts

• Study Contact
  844-434-4210
  [email protected]

Locations (29)

Find similar trials in Beverly Hills, CA

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