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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: 2026-06-05
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 (169)
David S Hallegua MD A Professional CorporationRecruiting
Beverly Hills, California, United States
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
Avanti Clinical Research CorpRecruiting
Hialeah, Florida, United States
LeJenue Research Associates PLLCRecruiting
Miami, Florida, United States
Pro-Care Research Center, Corp.Recruiting
Miami Gardens, Florida, United States
Floridian Clinical Research LLCRecruiting
Miami Lakes, Florida, United States
Clinical Research of West FloridaRecruiting
Tampa, Florida, United States
Atlanta Research Center for RheumatologyRecruiting
Marietta, Georgia, United States
Willow Rheumatology and Wellness PLLCRecruiting
Willowbrook, Illinois, United States
Accurate Clinical Research, Inc.Recruiting
Lake Charles, Louisiana, United States
Revive Research InstituteRecruiting
Sterling Heights, Michigan, United States
Joint and Muscle Research InstituteRecruiting
Charlotte, North Carolina, United States
DJL Clinical Research, PLLCRecruiting
Charlotte, North Carolina, United States
Cross Creek Medical ClinicRecruiting
Fayetteville, 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
R and H Clinical ResearchRecruiting
Katy, Texas, United States
Southwest Rheumatology Research LLCRecruiting
Mesquite, Texas, United States
Texas Rheumatology Research Institute LLCRecruiting
Plano, Texas, United States
Epic Medical Research 1Recruiting
Red Oak, Texas, United States
Fort Bend Rheumatology Associates PLLCRecruiting
Sugar Land, Texas, United States
ARCIS Salud SRL Aprillus asistencia e investigacionRecruiting
Buenos Aires, Argentina
Centro Privado de Medicina FamiliarRecruiting
Buenos Aires, Argentina
Centro de Investigacion en Enfermedades Reumaticas CIERRecruiting
Ciudad de Buenos Aires, Argentina
ArsemaRecruiting
Ciudad de Buenos Aires, Argentina
Global Psy Asociacion CivilRecruiting
La Plata, Argentina
Cer Instituto MedicoRecruiting
Quilmes, Argentina
Instituto de Investigaciones Clinicas QuilmesRecruiting
Quilmes, Argentina
MR Medicina ReumatologicaRecruiting
San Fernando, Argentina
Centro de Investigaciones Medicas TucumanRecruiting
San Miguel de Tucumán, Argentina
Footscray Hospital, Western HealthRecruiting
Footscray, Australia
Ipswich HospitalRecruiting
Ipswich, Australia
Hospital das Clinicas - UFGRecruiting
Goiânia, Brazil
CMIP - Centro Mineiro de Pesquisa LtdaRecruiting
Juiz de Fora, Brazil
Hospital De Clinicas De Porto AlegreRecruiting
Porto Alegre, Brazil
LMK Servicos Medicos S SRecruiting
Porto Alegre, Brazil
Associacao Hospitalar Moinhos de VentoRecruiting
Porto Alegre, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRSRecruiting
Porto Alegre, Brazil
SER - Servicos Especializados em Reumatologia da BahiaRecruiting
Salvador, Brazil
Fundacao do ABC Centro Universitario FMABCRecruiting
Santo André, Brazil
Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De BaseRecruiting
São José do Rio Preto, Brazil
ESHO Empresa De Servicos Hospitalares S ARecruiting
São Paulo, Brazil
CEDOES Centro de Pesquisa Clinica e Diagnostico do Espirito Santo LtdaRecruiting
Vitória, Brazil
MC Medtech Services LtdRecruiting
Haskovo, Bulgaria
Multiprofile Hosptal for Active Treatment Eurohospital PlovdivRecruiting
Plovdiv, Bulgaria
Diagnostic consulting center 1 Ruse EOODRecruiting
Rousse, Bulgaria
Diagnostic-Consultative Center (DCC) AleksandrovskaRecruiting
Sofia, Bulgaria
Medical Center Hera EOODRecruiting
Sofia, Bulgaria
Military Medical Academy Multiprofile Hospital for Active Treatment SofiaRecruiting
Sofia, Bulgaria
UMHAT 'Sveti Ivan Rilsky'Recruiting
Sofia, Bulgaria
University Multi Profile Hospital for Active Treatment UMHAT St. MarinaRecruiting
Varna, Bulgaria
Peking University People's HospitalRecruiting
Beijing, China
West China School of Medicine/West China Hospital, Sichuan UniversityRecruiting
Cheng Du Shi, China
Dongguan People s HospitalRecruiting
Dongguan, China
The Second Affiliated Hospital of Zhejiang University College of MedicineRecruiting
Hangzhou, China
Jinhua municipal central hospitalRecruiting
Jinhua, China
Shandong Jining No.1 People's HospitalRecruiting
Jining, China
Linfen Central HospitalRecruiting
Linfen, China
Ningbo medical center lihuili hospitalRecruiting
Ningbo, China
Shenshan Medical Center Memorial Hospital of Sun Yat Sen UniversityRecruiting
Shanwei, China
Second Affiliated Hospital, SooChow UniversityRecruiting
Suzhou, China
Shanxi Bethune HospitalRecruiting
Taiyuan, China
Revimex Pro s r oRecruiting
Karvina Frystat, Czechia
Revmatologicky ustavRecruiting
Prague, Czechia
RigshospitaletRecruiting
Copenhagen, Denmark
Zealand University HospitalRecruiting
Køge, Denmark
Helsinki University HospitalRecruiting
Helsinki, Finland
Northern Clinical Trial CoordinatorsRecruiting
Oulu, Finland
Centre Hospitalier Le MansRecruiting
Le Mans, France
CHU Toulouse - Hopital de RangueilRecruiting
Toulouse, France
Universitätsklinikum Carl-Gustav-Carus DresdenRecruiting
Dresden, Germany
CAIR HeidelbergRecruiting
Heidelberg, Germany
Klinikum der Universitaet MuenchenRecruiting
München, Germany
Medicover Muenchen Ost MVZRecruiting
München, Germany
Laiko General Hospital of AthensRecruiting
Athens, Greece
University General Hospital Attikon General Hospital Of West Attica H Agia VarvaraRecruiting
Athens, Greece
University General Hospital of HeraklionRecruiting
Heraklion, Greece
General University Hospital Of LarissaRecruiting
Larissa, Greece
Betegapolo Irgalmas Rend Budai Irgalmasrendi KorhazRecruiting
Budapest, Hungary
Vita Verum Medical Egeszsegugyi Szolgaltato BtRecruiting
Székesfehérvár, Hungary
Vital Medical Center Orvosi es Fogaszati KozpontRecruiting
Veszprém, Hungary
Obudai Egeszsegugyi Centrum KftRecruiting
Zalaegerszeg, Hungary
Bnai Zion Medical CenterRecruiting
Haifa, Israel
Rambam Health Care CampusRecruiting
Haifa, Israel
Carmel Medical CenterRecruiting
Haifa, Israel
Hadassah Ein-Qarem Medical CenterRecruiting
Jerusalem, Israel
Meir Medical CenterRecruiting
Kfar Saba, Israel
Galilee Medical CenterRecruiting
Nahariya, Israel
Tel Aviv Sourasky Medical CenterRecruiting
Tel Aviv, Israel
Azienda Ospedaliero Universitaria Delle MarcheRecruiting
Ancona, Italy
Istituto Clinico HumanitasRecruiting
Rozzano, Italy
Tokai University HospitalRecruiting
Isehara, Japan
Shinkenko ClinicRecruiting
Naha, Japan
Kitano HospitalRecruiting
Osaka, Japan
Hokkaido University HospitalRecruiting
Sapporo, Japan
St. Luke's International HospitalRecruiting
Tokyo, Japan
Hospital Sultan IsmailRecruiting
Johor Bahru, Malaysia
Hospital Sultanah Nur ZahirahRecruiting
Kuala, Malaysia
University Malaya Medical CentreRecruiting
Kuala Lumpur, Malaysia
Hospital Umum SarawakRecruiting
Kuching, Malaysia
Sunway Medical CentreRecruiting
Petaling Jaya, Malaysia
Hospital TaipingRecruiting
Taiping, Malaysia
Haukeland University HospitalRecruiting
Bergen, Norway
Oslo universitetssykehus HF, RikshospitaletRecruiting
Oslo, Norway
Stavanger University HospitalRecruiting
Stavanger, Norway
MICS Centrum Medyczne BydgoszczRecruiting
Bydgoszcz, Poland
Jan Biziel's University HospitalRecruiting
Bydgoszcz, Poland
Nzoz Bif MedRecruiting
Bytom, Poland
Provita Sp z o oRecruiting
Katowice, Poland
Malopolskie Badania Kliniczne Sp z o oRecruiting
Krakow, Poland
NZOZ Lecznica MAK MED S CRecruiting
Nadarzyn, Poland
Twoja Przychodnia - Centrum Medyczne Nowa SolRecruiting
Nowa Sól, Poland
Twoja Przychodnia Poznanskie Centrum MedyczneRecruiting
Poznan, Poland
Innova Clinic sp z o oRecruiting
Płońsk, Poland
MICS Centrum Medyczne WarszawaRecruiting
Warsaw, Poland
Rheuma Medicus Sp z o oRecruiting
Warsaw, Poland
Uls Almada Seixal - Hosp. Garcia de OrtaRecruiting
Almada, Portugal
Uls Sao Jose - Hosp. Curry CabralRecruiting
Lisbon, Portugal
Uls Santa Maria - Hosp. Santa MariaRecruiting
Lisbon, Portugal
Ulsam - Hosp. Conde de BertiandosRecruiting
Ponte de Lima, Portugal
Centrul Medical de Diagnostic si Tratament Ambulator NEOMEDRecruiting
Brasov, Romania
Spitalul Clinic Sfanta MariaRecruiting
Bucharest, Romania
Spitalul Clinic Judetean de Urgenta ClujRecruiting
Cluj-Napoca, Romania
Medisof Diagnostic S R LRecruiting
Craiova, Romania
Spitalul Clinic Judetean de Urgenta BihorRecruiting
Oradea, Romania
Medbanat s r lRecruiting
Timișoara, Romania
MEDMAN s.r.o.Recruiting
Martin, Slovakia
Narodny Ustav Reumatickych ChorobRecruiting
Piešťany, Slovakia
Chonnam National University HospitalRecruiting
Gwangju, South Korea
Seoul National University Bundang HospitalRecruiting
Gyeonggi-do, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Ajou University HospitalRecruiting
Suwon, South Korea
Hospital Vall d'HebronRecruiting
Barcelona, Spain
Hosp. de La Santa Creu I Sant PauRecruiting
Barcelona, Spain
Hosp. Gral. Juan Ramon JimenezRecruiting
Huelva, Spain
Hosp. Univ. Infanta LeonorRecruiting
Madrid, Spain
Complejo Hosp de Navarra - Hosp de NavarraRecruiting
Pamplona, Spain
Hosp. Univ. Marques de ValdecillaRecruiting
Santander, Spain
Hosp. Clinico Univ. de SantiagoRecruiting
Santiago de Compostela, Spain
Hosp. Univ. Rio HortegaRecruiting
Valladolid, Spain
NTU Biomedical Park HospitalRecruiting
Hsinchu, Taiwan
Kaohsiung Veterans General HospitalRecruiting
Kaohsiung City, Taiwan
Kaohsiung Chang Gung Memorial HospitalRecruiting
Kaohsiung City, Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan
Linkou Chang Gung Memorial HospitalRecruiting
Taoyuan, Taiwan
Phramongkutklao HospitalRecruiting
Bangkok, Thailand
Ramathibodi Hospital Mahidol UniversityRecruiting
Bangkok, Thailand
Maharaj Nakorn Chiang Mai HospitalRecruiting
Chiang Mai, Thailand
Ankara University Medical FacultyRecruiting
Ankara, Turkey (Türkiye)
Ankara Bilkent Sehir HastanesiRecruiting
Ankara, Turkey (Türkiye)
Firat University HospitalRecruiting
Elâzığ, Turkey (Türkiye)
Sanko Universitesi HastanesiRecruiting
Gaziantep, Turkey (Türkiye)
Marmara University Istanbul Pendik Education and Research HospitalRecruiting
Istanbul, Turkey (Türkiye)
Necmettin Erbakan University Meram Medical FacultyRecruiting
Konya, Turkey (Türkiye)
Newcastle Freeman HospitalRecruiting
Newcastle upon Tyne, United Kingdom
Peterborough City HospitalRecruiting
Peterborough, United Kingdom
Royal Berkshire HospitalRecruiting
Reading, United Kingdom
Southampton University HospitalRecruiting
Southampton, United Kingdom
Haywood HospitalRecruiting
Stoke-on-Trent, United Kingdom
Great Western HospitalRecruiting
Swindon, United Kingdom