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Recruiting Phase 3

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

NCT07438496 · tracked via the Priya Life Science Israel tracker
Phase
Phase 3
Started
2026-03-05
Last updated
2026-09-25

Condition(s) studied

Lupus Erythematosus, Systemic

Investigational drug(s) / intervention(s)

Nipocalimab →PlaceboStandard of care treatment

Nipocalimab: Nipocalimab will be administered.

Placebo: Placebo will be administered.

Standard of care treatment: Protocol-defined topical and systemic standard of care background treatments.

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:- * Medically stable on the basis of physical examination, medical history, vital signs and 12-lead electrocardiogram (ECG) performed at screening * Clinical diagnosis of systemic lupus erythematosus (SLE) for more than or equal to (\>=) 24 weeks prior to screening and meeting european league against rheumatism/american college of rheumatology (EULAR/ACR) classification criteria * Must have a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score \>= 6 and a clinical SLEDAI-2K \>= 4 at screening, AND a clinical SLEDAI-2K score \>= 4 points at Week 0. For eligibility, points attributed to "lupus headache," "alopecia," and "organic brain syndrome" are excluded * Participants of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hCG) test at screening and a negative urine (β- hCG) test at Week 0 prior to randomization * Has at least 1 BILAG-2004 A score or 2 BILAG-2004 B scores observed at screening Exclusion Criteria: * 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

Primary outcome measure(s)

  • Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 52 — Week 52
    SLE SRI-4 composite response is a composite response of at least a 4 point reduction in SLE Disease Activity Index 2000 (SLEDAI-2K), no British Isles Lupus Assessment Group-2004 (BILAG-2004) worsening, defined as no new A or less than or equal to \<= 1 new B items compared to baseline, no worsening in Physician's Global Assessment (PGA \[greater than {\>} 10 percent {%} increase from baseline\]).

Trial sites (260)

FacilityCityRegionStatus
David S Hallegua MD A Professional Corporation Beverly Hills California Recruiting
Providence Medical Foundation Fullerton California Recruiting
Southland Arthritis and Osteoporosis Medical Center Inc dba Southland Arthritis Hemet California Recruiting
Advanced Medical Research La Palma California Recruiting
Medvin Clinical Research San Leandro San Leandro California Recruiting
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California Recruiting
Solace Clinical Research California Tustin California Recruiting
Inland Rheumatology Clinical Trials Inc. Upland California Recruiting
Denver Arthritis Clinic Denver Colorado Recruiting
Arthritis & Rheumatic Disease Specialties Aventura Florida Recruiting
Clinical Research of West Florida 1 Clearwater Florida Recruiting
Avanti Clinical Research Corp Hialeah Florida Recruiting
LeJenue Research Associates PLLC Miami Florida Recruiting
Pro-Care Research Center, Corp. Miami Gardens Florida Recruiting
Floridian Clinical Research LLC Miami Lakes Florida Recruiting
Integral Rheumatology And Immunology Specialists Plantation Florida Recruiting
Clinical Research of West Florida Tampa Florida Recruiting
Atlanta Research Center for Rheumatology Marietta Georgia Recruiting
Willow Rheumatology and Wellness PLLC Willowbrook Illinois Recruiting
Accurate Clinical Research, Inc. Lake Charles Louisiana Recruiting
Revive Research Institute Sterling Heights Michigan Recruiting
Rutgers New Jersey Medical School Newark New Jersey Recruiting
Arthritis Rheumatic And Back Disease Associates Voorhees Township New Jersey Recruiting
Joint and Muscle Research Institute Charlotte North Carolina Recruiting
DJL Clinical Research, PLLC Charlotte North Carolina Recruiting
Cross Creek Medical Clinic Fayetteville North Carolina Recruiting
Paramount Medical Research & Consulting Middleburg Heights Ohio Recruiting
Clinical Research Philadelphia Philadelphia Pennsylvania Recruiting
West Tennessee Research Institute Jackson Tennessee Recruiting
Amarillo Medical Specialists Rheumatology Amarillo Texas Recruiting
Amarillo Center for Clinical Research Amarillo Texas Recruiting
Arthritis and Rheumatology Research Institute Frisco Texas Recruiting
R and H Clinical Research Katy Texas Recruiting
Southwest Rheumatology Research LLC Mesquite Texas Recruiting
Texas Rheumatology Research Institute LLC Plano Texas Recruiting
Epic Medical Research 1 Red Oak Texas Recruiting
Fort Bend Rheumatology Associates PLLC Sugar Land Texas Recruiting
Carilion Clinic Virginia Tech Carilion School of Medicine Roanoke Virginia Recruiting
ARCIS Salud SRL Aprillus asistencia e investigacion Buenos Aires Argentina Recruiting
Centro Privado de Medicina Familiar Buenos Aires Argentina Recruiting

+ 220 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07438496 on ClinicalTrials.gov ↗ ← All trials in Israel