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

NCT07438496 · Janssen Research & Development, LLC
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Official title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
About this study
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 criteria
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, excluding points attributed to "lupus headache," "alopecia," and "organic brain syndrome" * 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
Study design
Enrollment target: 600 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-03-05
Estimated completion: 2031-11-07
Last updated: 2026-04-13
Interventions
Drug: NipocalimabDrug: PlaceboDrug: Standard of care treatment
Primary outcomes
  • Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 52 (Week 52)
Sponsor
Janssen Research & Development, LLC · industry
Contacts & investigators
ContactStudy Contact · contact · Participate-In-This-Study1@its.jnj.com · 844-434-4210
All locations (27)
Southland Arthritis and Osteoporosis Medical Center Inc dba Southland ArthritisRecruiting
Hemet, California, United States
Advanced Medical ResearchRecruiting
La Palma, California, United States
Solace Clinical Research CaliforniaRecruiting
Tustin, California, United States
Inland Rheumatology Clinical Trials Inc.Recruiting
Upland, California, United States
Arthritis & Rheumatic Disease SpecialtiesRecruiting
Aventura, Florida, United States
Clinical Research of West Florida 1Recruiting
Clearwater, Florida, United States
LeJenue Research Associates PLLCRecruiting
Miami, Florida, United States
Clinical Research of West FloridaRecruiting
Tampa, Florida, United States
Willow Rheumatology and Wellness PLLCRecruiting
Willowbrook, Illinois, United States
Accurate Clinical Research, Inc.Recruiting
Lake Charles, Louisiana, United States
Joint and Muscle Research InstituteRecruiting
Charlotte, North Carolina, United States
Paramount Medical Research & ConsultingRecruiting
Middleburg Heights, Ohio, United States
Clinical Research PhiladelphiaRecruiting
Philadelphia, Pennsylvania, United States
West Tennessee Research InstituteRecruiting
Jackson, Tennessee, United States
Arthritis and Rheumatology Research InstituteRecruiting
Allen, Texas, United States
Amarillo Center for Clinical ResearchRecruiting
Amarillo, Texas, United States
Southwest Rheumatology Research LLCRecruiting
Mesquite, Texas, United States
Fundacao do ABC Centro Universitario FMABCRecruiting
Santo André, Brazil
Rambam Health Care CampusRecruiting
Haifa, Israel
Hadassah Ein-Qarem Medical CenterRecruiting
Jerusalem, Israel
Meir Medical CenterRecruiting
Kfar Saba, Israel
Hospital Sultan IsmailRecruiting
Johor Bahru, Malaysia
Sunway Medical CentreRecruiting
Petaling Jaya, Malaysia
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan
Linkou Chang Gung Memorial HospitalRecruiting
Taoyuan District, Taiwan
Ankara University Medical FacultyRecruiting
Ankara, Turkey (Türkiye)
Necmettin Erbakan University Meram Medical FacultyRecruiting
Konya, Turkey (Türkiye)
A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · TrialPath