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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Lupus Erythematosus, Systemic

In brief

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 facts

Study ID

NCT07438496

Run by

Janssen Research & Development, LLC

People needed

600

Starts

2026-03-05

Expected to finish

2031-11-07

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• History of severe, progressive and/or uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and/or any other medical or uncontrolled autoimmune disorder (s) or clinically significant abnormalities in screening laboratory
• Any unstable or progressive manifestation of SLE that is likely to warrant escalation in therapy beyond permitted background medications
• Confirmed or suspected clinical immunodeficiency syndrome not related to treatment of SLE or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
• Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins
• Suspected or known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients, or excipients used in the placebo formulation

Where it is running

• Providence Medical Foundation — Fullerton, California, United States (enrolling)
• Southland Arthritis and Osteoporosis Medical Center Inc dba Southland Arthritis — Hemet, California, United States (enrolling)
• Advanced Medical Research — La Palma, California, United States (enrolling)
• Medvin Clinical Research San Leandro — San Leandro, California, United States (enrolling)
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States (enrolling)
• Solace Clinical Research California — Tustin, California, United States (enrolling)
• Inland Rheumatology Clinical Trials Inc. — Upland, California, United States (enrolling)
• Arthritis & Rheumatic Disease Specialties — Aventura, Florida, United States (enrolling)
• Clinical Research of West Florida 1 — Clearwater, Florida, United States (enrolling)
• Avanti Clinical Research Corp — Hialeah, Florida, United States (enrolling)
• LeJenue Research Associates PLLC — Miami, Florida, United States (enrolling)
• Pro-Care Research Center, Corp. — Miami Gardens, Florida, United States (enrolling)
• Floridian Clinical Research LLC — Miami Lakes, Florida, United States (enrolling)
• Integral Rheumatology And Immunology Specialists — Plantation, Florida, United States (enrolling)
• Clinical Research of West Florida — Tampa, Florida, United States (enrolling)
• Atlanta Research Center for Rheumatology — Marietta, Georgia, United States (enrolling)
• Willow Rheumatology and Wellness PLLC — Willowbrook, Illinois, United States (enrolling)
• Accurate Clinical Research, Inc. — Lake Charles, Louisiana, United States (enrolling)
• Revive Research Institute — Sterling Heights, Michigan, United States (enrolling)
• Arthritis Rheumatic And Back Disease Associates — Voorhees Township, New Jersey, United States (enrolling)
• Joint and Muscle Research Institute — Charlotte, North Carolina, United States (enrolling)
• DJL Clinical Research, PLLC — Charlotte, North Carolina, United States (enrolling)
• Cross Creek Medical Clinic — Fayetteville, North Carolina, United States (enrolling)
• Paramount Medical Research & Consulting — Middleburg Heights, Ohio, United States (enrolling)
• David S Hallegua MD A Professional Corporation — Beverly Hills, California, United States (enrolling)

Full record on ClinicalTrials.gov

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