RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Janssen Research & Development, LLC • ClinicalTrials.gov ID: NCT07438496

Registry updated: 2026-09-25

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Description

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).

Interventions

Nipocalimab (Drug)
Nipocalimab will be administered.
Placebo (Drug)
Placebo will be administered.
Standard of care treatment (Drug)
Protocol-defined topical and systemic standard of care background treatments.

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 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

Conditions

Lupus Erythematosus, Systemic

Locations

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
Denver Arthritis Clinic — Denver, Colorado, 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 Medical Specialists Rheumatology — Amarillo, Texas, 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
ARCIS Salud SRL Aprillus asistencia e investigacion — Buenos Aires, Argentina
Centro Privado de Medicina Familiar — Buenos Aires, Argentina
Hospital Central Militar Cirujano Mayor Dr Cosme Argerich — CABA, Argentina
Centro de Investigacion en Enfermedades Reumaticas CIER — Ciudad de Buenos Aires, Argentina
Arsema — Ciudad de Buenos Aires, Argentina
Global Psy Asociacion Civil — La Plata, Argentina
Cer Instituto Medico — Quilmes, Argentina
Instituto de Investigaciones Clinicas Quilmes — Quilmes, Argentina
Sanatorio de la Mujer — Rosario, Argentina
MR Medicina Reumatologica — San Fernando, Argentina
Centro de Investigaciones Medicas Tucuman — San Miguel de Tucumán, Argentina
BOX HILL — Box Hill, Australia
Footscray Hospital, Western Health — Footscray, Australia
Ipswich Hospital — Ipswich, Australia
Hospital das Clinicas - UFG — Goiânia, Brazil
CMIP - Centro Mineiro de Pesquisa Ltda — Juiz de Fora, Brazil
Hospital Moinhos de Vento — Porto Alegre, Brazil
Hospital De Clinicas De Porto Alegre — Porto Alegre, Brazil
LMK Servicos Medicos S S — Porto Alegre, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS — Porto Alegre, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto — Ribeirão Preto, Brazil
SER - Servicos Especializados em Reumatologia da Bahia — Salvador, Brazil
IDOR - Regional Bahia — Salvador, Brazil
Funfarme Sjrp — São José do Rio Preto, Brazil
Hospital Samaritano de Sao Paulo — São Paulo, Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP — São Paulo, Brazil
Cepes - Fmabc — São Paulo, Brazil
CEDOES Centro de Pesquisa Clinica e Diagnostico do Espirito Santo Ltda — Vitória, Brazil
MC Medtech Services Ltd — Haskovo, Bulgaria
Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv — Plovdiv, Bulgaria
Diagnostic consulting center 1 Ruse EOOD — Rousse, Bulgaria
Diagnostic-Consultative Center (DCC) Aleksandrovska — Sofia, Bulgaria
Medical Center Hera EOOD — Sofia, Bulgaria
Military Medical Academy Multiprofile Hospital for Active Treatment Sofia — Sofia, Bulgaria
UMHAT 'Sveti Ivan Rilsky' — Sofia, Bulgaria
University Multi Profile Hospital for Active Treatment UMHAT St. Marina — Varna, Bulgaria
Peking University People's Hospital — Beijing, China
Xiangya Hospital Central South University — Changsha, China
West China School of Medicine/West China Hospital, Sichuan University — Cheng Du Shi, China
Dongguan People s Hospital — Dongguan, China
The First Affiliated Hospital Sun Yat-Sen University — Guangzhou, China
The Second Affiliated Hospital of Zhejiang University College of Medicine — Hangzhou, China
Anhui Provincial Hospital — Hefei, China
Jinhua municipal central hospital — Jinhua, China
Shandong Jining No.1 People's Hospital — Jining, China
Linfen Central Hospital — Linfen, China
The first affiliated hospital of Henan University of science and technology — Luoyang, China
The Second Affiliated Hospital of Nanchang University — Nanchang, China
Nanjing Drum Tower Hospital — Nanjing, China
The First Affiliated Hospital of Guangxi Medical University — Nanning, China
Ningbo medical center lihuili hospital — Ningbo, China
Renji Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, China
Shenshan Medical Center Memorial Hospital of Sun Yat Sen University — Shanwei, China
Second Affiliated Hospital, SooChow University — Suzhou, China
Shanxi Bethune Hospital — Taiyuan, China
The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, China
Xinxiang Central Hospital — Xinxiang, China
Fakultní nemocnice u sv. Anny v Brn — Brno, Czechia
Revimex Pro s r o — Karvina Frystat, Czechia
Revmatologicky ustav — Prague, Czechia
Rigshospitalet — Copenhagen, Denmark
Zealand University Hospital — Køge, Denmark
Helsinki University Hospital — Helsinki, Finland
Paijat Hame Central Hospital — Lahti, Finland
Northern Clinical Trial Coordinators — Oulu, Finland
Turku University Hospital — Turku, Finland
CHU de Caen — Caen, France
Hopital Michallon CHU Grenoble Alpes — La Tronche, France
Centre Hospitalier Le Mans — Le Mans, France
Hospices Civils de Lyon - HOPITAL DE LA CROIX ROUSSE — Lyon, France
Hopital Cochin — Paris, France
CHU Toulouse - Hopital de Rangueil — Toulouse, France
TSMU The First University Clinic — Tbilisi, Georgia
LLC Geo Hospitals — Tbilisi, Georgia
Tbilisi Heart and Vascular Clinic Ltd — Tbilisi, Georgia
Clinic on Mtskheta Street — Tbilisi, Georgia
LTD The First Medical Center — Tbilisi, Georgia
Caucasus Medical Centre — Tbilisi, Georgia
Ltd Innova — Tbilisi, Georgia
Universitaetsklinikum Carl-Gustav-Carus Dresden — Dresden, Germany
CAIR Heidelberg — Heidelberg, Germany
Universitaetsklinikum Leipzig — Leipzig, Germany
St Elisabeth Hospital Meerbusch Lank — Meerbusch, Germany
Klinikum der Universitaet Muenchen — München, Germany
Medicover Muenchen Ost MVZ — München, Germany
Laiko General Hospital of Athens — Athens, Greece
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara — Athens, Greece
University General Hospital of Heraklion — Heraklion, Greece
General University Hospital Of Larissa — Larissa, Greece
Semmelweis Egyetem Reumatologiai es Immunologiai Klinika — Budapest, Hungary
Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz — Budapest, Hungary
Qualiclinic Kft — Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont — Debrecen, Hungary
Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz — Gyula, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont — Pécs, Hungary
Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont — Szeged, Hungary
Vita Verum Medical Egeszsegugyi Szolgaltato Bt — Székesfehérvár, Hungary
Vital Medical Center Orvosi es Fogaszati Kozpont — Veszprém, Hungary
Obudai Egeszsegugyi Centrum Kft — Zalaegerszeg, Hungary
Bnai Zion Medical Center — Haifa, Israel
Rambam Health Care Campus — Haifa, Israel
Carmel Medical Center — Haifa, Israel
Hadassah Ein-Qarem Medical Center — Jerusalem, Israel
Meir Medical Center — Kfar Saba, Israel
Galilee Medical Center — Nahariya, Israel
Tel Aviv Sourasky Medical Center — Tel Aviv, Israel
Azienda Ospedaliero Universitaria Delle Marche — Ancona, Italy
Policlinico San Marco — Catania, Italy
Ospedale San Raffaele di Milano — Milan, Italy
Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia — Perugia, Italy
Bio-Medico Campus University Hospital — Roma, Italy
Azienda Ospedaliera San Camillo-Forlanini — Roma, Italy
Fondazione Policlinico Universitario A Gemelli IRCCS — Roma, Italy
Istituto Clinico Humanitas — Rozzano, Italy
A.O. Ordine Mauriziano Di Torino - Ospedale Mauriziano Umberto — Torino, Italy
Ospedale S. Maria Della Misericordia — Udine, Italy
Azienda Ospedaliera Universitaria Integrata Verona — Verona, Italy
Chukyo Hospital — Aichi, Japan
Institute of Science Tokyo Hospital — Bunkyō City, Japan
Juntendo University Hospital Urayasu — Chiba, Japan
University of Yamanashi Hospital — Chūō, Japan
Tokyo Metropolitan Tama Medical Center — Fuchū, Japan
National Hospital Organization Kyushu Medical Center — Fukuoka, Japan
Fukushima Medical University Hospital — Fukushima, Japan
Tokai University Hospital — Isehara, Japan
Shinkenko Clinic — Naha, Japan
Kitano Hospital — Osaka, Japan
Hokkaido University Hospital — Sapporo, Japan
Tohoku Medical And Pharmaceutical University Hospital — Sendai, Japan
Shimane University Hospital — Shimane, Japan
National Center for Global Health and Medicine — Shinjuku- Ku, Japan
St. Luke's International Hospital — Tokyo, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital — Tokyo, Japan
Ome Medical Center — Tokyo, Japan
Toyama University Hospital — Toyama, Japan
Hospital Sultan Ismail — Johor Bahru, Malaysia
Hospital Sultanah Nur Zahirah — Kuala, Malaysia
University Malaya Medical Centre — Kuala Lumpur, Malaysia
Hospital Umum Sarawak — Kuching, Malaysia
Sunway Medical Centre — Petaling Jaya, Malaysia
Hospital Taiping — Taiping, Malaysia
Haukeland University Hospital — Bergen, Norway
Oslo universitetssykehus HF, Rikshospitalet — Oslo, Norway
Stavanger University Hospital — Stavanger, Norway
MICS Centrum Medyczne Bydgoszcz — Bydgoszcz, Poland
Jan Biziel's University Hospital — Bydgoszcz, Poland
Nzoz Bif Med — Bytom, Poland
Provita Sp z o o — Katowice, Poland
Malopolskie Badania Kliniczne Sp z o o — Krakow, Poland
NZOZ Lecznica MAK MED S C — Nadarzyn, Poland
Twoja Przychodnia - Centrum Medyczne Nowa Sol — Nowa Sól, Poland
Twoja Przychodnia Poznanskie Centrum Medyczne — Poznan, Poland
Innova Clinic sp z o o — Płońsk, Poland
MICS Centrum Medyczne Warszawa — Warsaw, Poland
Rheuma Medicus Sp z o o — Warsaw, Poland
Uls Almada Seixal - Hosp. Garcia de Orta — Almada, Portugal
Uls Sao Jose - Hosp. Curry Cabral — Lisbon, Portugal
Uls Santa Maria - Hosp. Santa Maria — Lisbon, Portugal
Ulsam - Hosp. Conde de Bertiandos — Ponte de Lima, Portugal
Uls Santo Antonio - Hosp. Santo Antonio — Porto, Portugal
Uls Gaia Espinho — Vila Nova de Gaia, Portugal
Centrul Medical de Diagnostic si Tratament Ambulator NEOMED — Brasov, Romania
Spitalul Clinic Sfanta Maria — Bucharest, Romania
CCBR Clinical Research — Bucharest, Romania
Hiperdia Piata Sudului — Bucharest, Romania
Spitalul Clinic Judetean de Urgenta Cluj — Cluj-Napoca, Romania
Medisof Diagnostic S R L — Craiova, Romania
Spitalul Clinic Judetean de Urgenta Bihor — Oradea, Romania
Medbanat s r l — Timișoara, Romania
Institute Of Rheumatology 1 — Belgrade, Serbia
Institute of Rheumatology — Belgrade, Serbia
University Clinical Center of Vojvodina — Novi Sad, Serbia
Reumatologicka ambulancia MUDr Michaele Zarikova — Košice, Slovakia
MEDMAN s.r.o. — Martin, Slovakia
Narodny Ustav Reumatickych Chorob — Piešťany, Slovakia
Arthritis Clinical Research Centre — Cape Town, South Africa
Dong-A University Hospital — Busan, South Korea
Chonnam National University Hospital — Gwangju, South Korea
Seoul National University Bundang Hospital — Gyeonggi-do, South Korea
Seoul National University Hospital — Seoul, South Korea
Hanyang University Medical Center — Seoul, South Korea
Asan Medical Center — Seoul, South Korea
Ajou University Hospital — Suwon, South Korea
Hospital Vall d'Hebron — Barcelona, Spain
Hosp. de La Santa Creu I Sant Pau — Barcelona, Spain
Hosp. Gral. Juan Ramon Jimenez — Huelva, Spain
Hosp. Univ. Infanta Leonor — Madrid, Spain
Complejo Hosp de Navarra - Hosp de Navarra — Pamplona, Spain
Hosp. Univ. Marques de Valdecilla — Santander, Spain
Hosp. Clinico Univ. de Santiago — Santiago de Compostela, Spain
Hosp. Infanta Luisa — Seville, Spain
Hosp. Univ. Rio Hortega — Valladolid, Spain
Hosp. Clinico Univ. Lozano Blesa — Zaragoza, Spain
Universitatsspital Basel — Basel, Switzerland
Hopitaux Universitaires de Geneve - HUG — Geneva, Switzerland
UniversitaetsSpital Zuerich — Zurich, Switzerland
NTU Biomedical Park Hospital — Hsinchu, Taiwan
Kaohsiung Veterans General Hospital — Kaohsiung City, Taiwan
Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City, Taiwan
National Taiwan University Hospital — Taipei, Taiwan
Taipei Veterans General Hospital — Taipei, Taiwan
Linkou Chang Gung Memorial Hospital — Taoyuan, Taiwan
Phramongkutklao Hospital — Bangkok, Thailand
Ramathibodi Hospital Mahidol University — Bangkok, Thailand
Saraburi Hospital — Changwat Sara Buri, Thailand
Maharaj Nakorn Chiang Mai Hospital — Chiang Mai, Thailand
Ankara Universitesi Tip Fakültesi Ibn-i Sina Hastanesi — Ankara, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi — Ankara, Turkey (Türkiye)
Firat University Hospital — Elâzığ, Turkey (Türkiye)
Sanko Universitesi Hastanesi — Gaziantep, Turkey (Türkiye)
Marmara University Istanbul Pendik Education and Research Hospital — Istanbul, Turkey (Türkiye)
Izmir Ataturk Egitim ve Arastirma Hastanesi — Izmir, Turkey (Türkiye)
Necmettin Erbakan University Meram Medical Faculty — Konya, Turkey (Türkiye)
Royal National Hospital for Rheumatic Diseases — Bath, United Kingdom
Addenbrookes Hospital — Cambridge, United Kingdom
Guy's and St Thomas' NHS Foundation Trust — Greater London, United Kingdom
Newcastle Freeman Hospital — Newcastle upon Tyne, United Kingdom
Peterborough City Hospital — Peterborough, United Kingdom
Royal Berkshire Hospital — Reading, United Kingdom
Southampton University Hospital — Southampton, United Kingdom
Haywood Hospital — Stoke-on-Trent, United Kingdom
Great Western Hospital — Swindon, United Kingdom

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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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