A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
Janssen Research & Development, LLC
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
- Age range
- 18–75 years
- Sex
- All
- 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 according to 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, ex…
Interventions
- DrugNipocalimab
Nipocalimab will be administered.
- DrugPlacebo
Placebo will be administered.
- DrugStandard of care treatment
Protocol-defined topical and systemic standard of care background treatments.
Locations (69)
- David S Hallegua MD A Professional CorporationBeverly Hills, California
- Southland Arthritis and Osteoporosis Medical Center Inc dba Southland ArthritisHemet, California
- Advanced Medical ResearchLa Palma, California
- Solace Clinical Research CaliforniaTustin, California
- Inland Rheumatology Clinical Trials Inc.Upland, California
- Arthritis & Rheumatic Disease SpecialtiesAventura, Florida