A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus

Completed · Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active systemic lupus erythematosus (SLE).

Key facts

Study ID

NCT04882878

Run by

Janssen Research & Development, LLC

People needed

228

Starts

2021-08-20

Expected to finish

2024-12-26

Last updated by the study team

2025-12-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has a clinical diagnosis of systemic lupus erythematosus (SLE) greater than or equal to (>=) 6 months prior to the screening visit and according to Systemic Lupus International Collaborating Clinics (SLICC)-2012 classification criteria: at least 4 criteria fulfilled, with at least 1 clinical criterion and 1 immunologic criterion
• Has at least 1 BILAG (british isles lupus assessment group) A and/or 2 BILAG B scores observed during screening
• Must have at least moderately active SLE, as defined as systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score >= 6 at screening visit. Must also have SLEDAI 2K >= 4 for clinical features (that is, SLEDAI-2K score excluding headache and laboratory abnormalities) present at Week 0 prior to randomization
• Has a CLASI (cutaneous lupus erythematosus disease area and severity index) activity score of at least 6 (excluding diffuse non-inflammatory alopecia) or at least 4 joints with pain and signs of inflammation (active joints) at screening or at Week 0, or both
• At least 1 unequivocally positive autoantibody test including antinuclear antibodies (ANA) (>= 1:80) and/or anti-double stranded deoxyribonucleic acid (dsDNA) antibodies (level >= 75 international units/milliliter [IU/mL]) and/or anti-Smith antibodies (>120 Absorbance unit/milliliter [AU/mL]) detected during screening
• Must be receiving 1 or more of the following protocol-permitted, systemic standard-of-care treatments prior to first administration of study intervention at a stable dose: oral glucocorticoids, antimalarial or up to 2 immunomodulatory drugs

You may not qualify if…

• Current or history of, severe, progressive, or uncontrolled renal disease, with the exception of active lupus nephritis (LN). Have severe active LN as determined by sponsor (or designee) adjudication. Control of renal disease must be documented with at least 2 measurements of proteinuria or urine protein/creatinine ratio (UPCR) over the 6 months prior to screening
• Has any unstable or progressive manifestation of SLE that is likely to warrant escalation in therapy beyond permitted background medications
• Confirmed or suspected inflammatory diseases that might confound the evaluations of efficacy
• Has a severe infection including opportunistic infections requiring parenteral anti-infectives, and/or hospitalization within 8 weeks prior to screening
• Has received a single B-cell targeting agent within 3 months prior to first administration of study intervention

Where it is running

• Desert Medical Advances — Rancho Mirage, California, United States
• Wolverine Clinical Trials — Santa Ana, California, United States
• Millennium Clinical Trials LLC — Westlake Village, California, United States
• Bay Area Arthritis and Osteoporosis — Brandon, Florida, United States
• GNP Research — Cooper City, Florida, United States
• South Coast Research Center — Miami, Florida, United States
• Advanced Clinical Research of Orlando — Ocoee, Florida, United States
• Omega Research Consultants — Orlando, Florida, United States
• Millennium Research — Ormond Beach, Florida, United States
• North Georgia Rheumatology, PC — Lawrenceville, Georgia, United States
• Atlanta Research Center for Rheumatology — Marietta, Georgia, United States
• West County Rheumatology — St Louis, Missouri, United States
• DJL Clinical Research, PLLC — Charlotte, North Carolina, United States
• Paramount Medical Research & Consulting — Middleburg Heights, Ohio, United States
• Dr. Ramesh Gupta — Memphis, Tennessee, United States
• Arthritis and Rheumatology Research Institute — Allen, Texas, United States
• Precision Comprehensive Clinical Research Solutions — Colleyville, Texas, United States
• Southwest Rheumatology Research LLC — Mesquite, Texas, United States
• Epic Medical Research — Red Oak, Texas, United States
• Rheumatology and Pulmonary Clinic — Beckley, West Virginia, United States
• Centro Médico Reumatológico (OMI) — Buenos Aires, Argentina
• Centro Privado de Medicina Familiar — Buenos Aires, Argentina
• ARCIS Salud SRL Aprillus asistencia e investigacion — CABA, Argentina
• Clinica Adventista Belgrano — Ciudad de Buenos Aires, Argentina
• Valerius Medical Group & Research Center — Los Alamitos, California, United States

Full record on ClinicalTrials.gov

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