A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
Recruiting · NCT07438496 · Interventional (participants receive a specific treatment) · Lead sponsor: Janssen Research & Development, LLC
View the official record on ClinicalTrials.gov →Interventions studied
NipocalimabPlaceboStandard of care treatment
What this trial is about
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).
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 13 US states.
- David S Hallegua MD A Professional Corporation - Beverly Hills, California, United States
- Providence Medical Foundation - Fullerton, California, United States
- Southland Arthritis and Osteoporosis Medical Center Inc dba Southland Arthritis - Hemet, California, United States
- Advanced Medical Research - La Palma, California, United States
- Medvin Clinical Research San Leandro - San Leandro, California, United States
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center - Torrance, California, United States
- Solace Clinical Research California - Tustin, California, United States
- Inland Rheumatology Clinical Trials Inc. - Upland, California, United States
- Arthritis & Rheumatic Disease Specialties - Aventura, Florida, United States
- Clinical Research of West Florida 1 - Clearwater, Florida, United States
- Avanti Clinical Research Corp - Hialeah, Florida, United States
- LeJenue Research Associates PLLC - Miami, Florida, United States
- Pro-Care Research Center, Corp. - Miami Gardens, Florida, United States
- Floridian Clinical Research LLC - Miami Lakes, Florida, United States
- Integral Rheumatology And Immunology Specialists - Plantation, Florida, United States
- Clinical Research of West Florida - Tampa, Florida, United States
- Atlanta Research Center for Rheumatology - Marietta, Georgia, United States
- Willow Rheumatology and Wellness PLLC - Willowbrook, Illinois, United States
- Accurate Clinical Research, Inc. - Lake Charles, Louisiana, United States
- Revive Research Institute - Sterling Heights, Michigan, United States
- Rutgers New Jersey Medical School - Newark, New Jersey, United States
- Arthritis Rheumatic And Back Disease Associates - Voorhees Township, New Jersey, United States
- Joint and Muscle Research Institute - Charlotte, North Carolina, United States
- DJL Clinical Research, PLLC - Charlotte, North Carolina, United States
- Cross Creek Medical Clinic - Fayetteville, North Carolina, United States
- Paramount Medical Research & Consulting - Middleburg Heights, Ohio, United States
- Clinical Research Philadelphia - Philadelphia, Pennsylvania, United States
- West Tennessee Research Institute - Jackson, Tennessee, United States
- Amarillo Center for Clinical Research - Amarillo, Texas, United States
- Arthritis and Rheumatology Research Institute - Frisco, Texas, United States
- R and H Clinical Research - Katy, Texas, United States
- Southwest Rheumatology Research LLC - Mesquite, Texas, United States
- Texas Rheumatology Research Institute LLC - Plano, Texas, United States
- Epic Medical Research 1 - Red Oak, Texas, United States
- Fort Bend Rheumatology Associates PLLC - Sugar Land, Texas, United States
- Carilion Clinic Virginia Tech Carilion School of Medicine - Roanoke, Virginia, United States
- Chukyo Hospital - Aichi, Japan
- Uls Almada Seixal - Hosp. Garcia de Orta - Almada, Portugal
- Azienda Ospedaliero Universitaria Delle Marche - Ancona, Italy
- Ankara Universitesi Tip Fakültesi Ibn-i Sina Hastanesi - Ankara, Turkey (Türkiye)
- Ankara Bilkent Sehir Hastanesi - Ankara, Turkey (Türkiye)
- Laiko General Hospital of Athens - Athens, Greece
- University General Hospital Attikon General Hospital Of West Attica H Agia Varvara - Athens, Greece
- Phramongkutklao Hospital - Bangkok, Thailand
- Ramathibodi Hospital Mahidol University - Bangkok, Thailand
- Hospital Vall d'Hebron - Barcelona, Spain
- Hosp. de La Santa Creu I Sant Pau - Barcelona, Spain
- Universitatsspital Basel - Basel, Switzerland
- Royal National Hospital for Rheumatic Diseases - Bath, United Kingdom
- Peking University People's Hospital - Beijing, China
- Haukeland University Hospital - Bergen, Norway
- BOX HILL - Box Hill, Australia
- Centrul Medical de Diagnostic si Tratament Ambulator NEOMED - Brasov, Romania
- Fakultní nemocnice u sv. Anny v Brn - Brno, Czechia
- Spitalul Clinic Sfanta Maria - Bucharest, Romania
- CCBR Clinical Research - Bucharest, Romania
- Hiperdia Piata Sudului - Bucharest, Romania
- Semmelweis Egyetem Reumatologiai es Immunologiai Klinika - Budapest, Hungary
- Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz - Budapest, Hungary
- Qualiclinic Kft - Budapest, Hungary
Showing 60 of 249 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →