A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
Status: Recruiting
Location: See all (167) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
United States
California
David S Hallegua MD A Professional Corporation
RECRUITING
Beverly Hills
Southland Arthritis and Osteoporosis Medical Center Inc dba Southland Arthritis
RECRUITING
Hemet
Advanced Medical Research
RECRUITING
La Palma
Solace Clinical Research California
RECRUITING
Tustin
Inland Rheumatology Clinical Trials Inc.
RECRUITING
Upland
Florida
Arthritis & Rheumatic Disease Specialties
RECRUITING
Aventura
Clinical Research of West Florida 1
RECRUITING
Clearwater
Avanti Clinical Research Corp
RECRUITING
Hialeah
LeJenue Research Associates PLLC
RECRUITING
Miami
Pro-Care Research Center, Corp.
RECRUITING
Miami Gardens
Floridian Clinical Research LLC
RECRUITING
Miami Lakes
Clinical Research of West Florida
RECRUITING
Tampa
Georgia
Atlanta Research Center for Rheumatology
RECRUITING
Marietta
Illinois
Willow Rheumatology and Wellness PLLC
RECRUITING
Willowbrook
Louisiana
Accurate Clinical Research, Inc.
RECRUITING
Lake Charles
Michigan
Revive Research Institute
RECRUITING
Sterling Heights
North Carolina
DJL Clinical Research, PLLC
RECRUITING
Charlotte
Joint and Muscle Research Institute
RECRUITING
Charlotte
Cross Creek Medical Clinic
RECRUITING
Fayetteville
Ohio
Paramount Medical Research & Consulting
RECRUITING
Middleburg Heights
Pennsylvania
Clinical Research Philadelphia
RECRUITING
Philadelphia
Tennessee
West Tennessee Research Institute
RECRUITING
Jackson
Texas
Arthritis and Rheumatology Research Institute
RECRUITING
Allen
Amarillo Center for Clinical Research
RECRUITING
Amarillo
R and H Clinical Research
RECRUITING
Katy
Southwest Rheumatology Research LLC
RECRUITING
Mesquite
Texas Rheumatology Research Institute LLC
RECRUITING
Plano
Epic Medical Research 1
RECRUITING
Red Oak
Fort Bend Rheumatology Associates PLLC
RECRUITING
Sugar Land
Other Locations
Argentina
ARCIS Salud SRL Aprillus asistencia e investigacion
RECRUITING
Buenos Aires
Centro Privado de Medicina Familiar
RECRUITING
Buenos Aires
Arsema
RECRUITING
Ciudad De Buenos Aires
Centro de Investigacion en Enfermedades Reumaticas CIER
RECRUITING
Ciudad De Buenos Aires
Global Psy Asociacion Civil
RECRUITING
La Plata
Cer Instituto Medico
RECRUITING
Quilmes
Instituto de Investigaciones Clinicas Quilmes
RECRUITING
Quilmes
MR Medicina Reumatologica
RECRUITING
San Fernando
Centro de Investigaciones Medicas Tucuman
RECRUITING
San Miguel De Tucumán
Australia
Footscray Hospital, Western Health
RECRUITING
Footscray
Ipswich Hospital
RECRUITING
Ipswich
Brazil
Hospital das Clinicas - UFG
RECRUITING
Goiânia
CMIP - Centro Mineiro de Pesquisa Ltda
RECRUITING
Juiz De Fora
Associacao Hospitalar Moinhos de Vento
RECRUITING
Porto Alegre
Hospital De Clinicas De Porto Alegre
RECRUITING
Porto Alegre
LMK Servicos Medicos S S
RECRUITING
Porto Alegre
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
RECRUITING
Porto Alegre
SER - Servicos Especializados em Reumatologia da Bahia
RECRUITING
Salvador
Fundacao do ABC Centro Universitario FMABC
RECRUITING
Santo André
Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De Base
RECRUITING
São José Do Rio Preto
ESHO Empresa De Servicos Hospitalares S A
RECRUITING
São Paulo
CEDOES Centro de Pesquisa Clinica e Diagnostico do Espirito Santo Ltda
RECRUITING
Vitória
Bulgaria
MC Medtech Services Ltd
RECRUITING
Haskovo
Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv
RECRUITING
Plovdiv
Diagnostic consulting center 1 Ruse EOOD
RECRUITING
Rousse
Diagnostic-Consultative Center (DCC) Aleksandrovska
RECRUITING
Sofia
Medical Center Hera EOOD
RECRUITING
Sofia
Military Medical Academy Multiprofile Hospital for Active Treatment Sofia
RECRUITING
Sofia
UMHAT 'Sveti Ivan Rilsky'
RECRUITING
Sofia
University Multi Profile Hospital for Active Treatment UMHAT St. Marina
RECRUITING
Varna
China
Peking University People's Hospital
RECRUITING
Beijing
West China School of Medicine/West China Hospital, Sichuan University
RECRUITING
Cheng Du Shi
Dongguan People s Hospital
RECRUITING
Dongguan
The Second Affiliated Hospital of Zhejiang University College of Medicine
RECRUITING
Hangzhou
Jinhua municipal central hospital
RECRUITING
Jinhua
Shandong Jining No.1 People's Hospital
RECRUITING
Jining
Linfen Central Hospital
RECRUITING
Linfen
Ningbo medical center lihuili hospital
RECRUITING
Ningbo
Shenshan Medical Center Memorial Hospital of Sun Yat Sen University
RECRUITING
Shanwei
Second Affiliated Hospital, SooChow University
RECRUITING
Suzhou
Shanxi Bethune Hospital
RECRUITING
Taiyuan
Denmark
Rigshospitalet
RECRUITING
Copenhagen
Zealand University Hospital
RECRUITING
Køge
Finland
Helsinki University Hospital
RECRUITING
Helsinki
Northern Clinical Trial Coordinators
RECRUITING
Oulu
France
Centre Hospitalier Le Mans
RECRUITING
Le Mans
CHU Toulouse - Hopital de Rangueil
RECRUITING
Toulouse
Germany
Universitätsklinikum Carl-Gustav-Carus Dresden
RECRUITING
Dresden
CAIR Heidelberg
RECRUITING
Heidelberg
Klinikum der Universitaet Muenchen
RECRUITING
München
Medicover Muenchen Ost MVZ
RECRUITING
München
Greece
Laiko General Hospital of Athens
RECRUITING
Athens
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
RECRUITING
Athens
University General Hospital of Heraklion
RECRUITING
Heraklion
General University Hospital Of Larissa
RECRUITING
Larissa
Hungary
Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
RECRUITING
Budapest
Vita Verum Medical Egeszsegugyi Szolgaltato Bt
RECRUITING
Székesfehérvár
Vital Medical Center Orvosi es Fogaszati Kozpont
RECRUITING
Veszprém
Obudai Egeszsegugyi Centrum Kft
RECRUITING
Zalaegerszeg
Israel
Bnai Zion Medical Center
RECRUITING
Haifa
Carmel Medical Center
RECRUITING
Haifa
Rambam Health Care Campus
RECRUITING
Haifa
Hadassah Ein-Qarem Medical Center
RECRUITING
Jerusalem
Meir Medical Center
RECRUITING
Kfar Saba
Galilee Medical Center
RECRUITING
Nahariya
Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Italy
Azienda Ospedaliero Universitaria Delle Marche
RECRUITING
Ancona
Istituto Clinico Humanitas
RECRUITING
Rozzano
Japan
Tokai University Hospital
RECRUITING
Isehara
Shinkenko Clinic
RECRUITING
Naha
Kitano Hospital
RECRUITING
Osaka
Hokkaido University Hospital
RECRUITING
Sapporo
St. Luke's International Hospital
RECRUITING
Tokyo
Malaysia
Hospital Sultan Ismail
RECRUITING
Johor Bahru
Hospital Sultanah Nur Zahirah
RECRUITING
Kuala
University Malaya Medical Centre
RECRUITING
Kuala Lumpur
Hospital Umum Sarawak
RECRUITING
Kuching
Sunway Medical Centre
RECRUITING
Petaling Jaya
Hospital Taiping
RECRUITING
Taiping
Norway
Haukeland University Hospital
RECRUITING
Bergen
Oslo universitetssykehus HF, Rikshospitalet
RECRUITING
Oslo
Stavanger University Hospital
RECRUITING
Stavanger
Poland
Jan Biziel's University Hospital
RECRUITING
Bydgoszcz
MICS Centrum Medyczne Bydgoszcz
RECRUITING
Bydgoszcz
Nzoz Bif Med
RECRUITING
Bytom
Provita Sp z o o
RECRUITING
Katowice
Malopolskie Badania Kliniczne Sp z o o
RECRUITING
Krakow
NZOZ Lecznica MAK MED S C
RECRUITING
Nadarzyn
Twoja Przychodnia - Centrum Medyczne Nowa Sol
RECRUITING
Nowa Sól
Innova Clinic sp z o o
RECRUITING
Płońsk
Twoja Przychodnia Poznanskie Centrum Medyczne
RECRUITING
Poznan
MICS Centrum Medyczne Warszawa
RECRUITING
Warsaw
Rheuma Medicus Sp z o o
RECRUITING
Warsaw
Portugal
Uls Almada Seixal - Hosp. Garcia de Orta
RECRUITING
Almada
Uls Santa Maria - Hosp. Santa Maria
RECRUITING
Lisbon
Uls Sao Jose - Hosp. Curry Cabral
RECRUITING
Lisbon
Ulsam - Hosp. Conde de Bertiandos
RECRUITING
Ponte De Lima
Republic of Korea
Chonnam National University Hospital
RECRUITING
Gwangju
Seoul National University Bundang Hospital
RECRUITING
Gyeonggi-do
Seoul National University Hospital
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
Romania
Centrul Medical de Diagnostic si Tratament Ambulator NEOMED
RECRUITING
Brasov
Spitalul Clinic Sfanta Maria
RECRUITING
Bucharest
Spitalul Clinic Judetean de Urgenta Cluj
RECRUITING
Cluj-napoca
Medisof Diagnostic S R L
RECRUITING
Craiova
Spitalul Clinic Judetean de Urgenta Bihor
RECRUITING
Oradea
Medbanat s r l
RECRUITING
Timișoara
Slovakia
MEDMAN s.r.o.
RECRUITING
Martin
Narodny Ustav Reumatickych Chorob
RECRUITING
Piešťany
Spain
Hosp. de La Santa Creu I Sant Pau
RECRUITING
Barcelona
Hospital Vall d'Hebron
RECRUITING
Barcelona
Hosp. Gral. Juan Ramon Jimenez
RECRUITING
Huelva
Hosp. Univ. Infanta Leonor
RECRUITING
Madrid
Complejo Hosp de Navarra - Hosp de Navarra
RECRUITING
Pamplona
Hosp. Univ. Marques de Valdecilla
RECRUITING
Santander
Hosp. Clinico Univ. de Santiago
RECRUITING
Santiago De Compostela
Hosp. Univ. Rio Hortega
RECRUITING
Valladolid
Taiwan
NTU Biomedical Park Hospital
RECRUITING
Hsinchu
Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
Kaohsiung Veterans General Hospital
RECRUITING
Kaohsiung City
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Linkou Chang Gung Memorial Hospital
RECRUITING
Taoyuan
Thailand
Phramongkutklao Hospital
RECRUITING
Bangkok
Ramathibodi Hospital Mahidol University
RECRUITING
Bangkok
Maharaj Nakorn Chiang Mai Hospital
RECRUITING
Chiang Mai
Turkey
Ankara Bilkent Sehir Hastanesi
RECRUITING
Ankara
Ankara University Medical Faculty
RECRUITING
Ankara
Firat University Hospital
RECRUITING
Elâzığ
Sanko Universitesi Hastanesi
RECRUITING
Gaziantep
Marmara University Istanbul Pendik Education and Research Hospital
RECRUITING
Istanbul
Necmettin Erbakan University Meram Medical Faculty
RECRUITING
Konya
United Kingdom
Newcastle Freeman Hospital
RECRUITING
Newcastle Upon Tyne
Peterborough City Hospital
RECRUITING
Peterborough
Royal Berkshire Hospital
RECRUITING
Reading
Southampton University Hospital
RECRUITING
Southampton
Haywood Hospital
RECRUITING
Stoke-on-trent
Great Western Hospital
RECRUITING
Swindon
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2026-03-05
Estimated Completion Date: 2031-11-07
Participants
Target number of participants: 600
Treatments
Experimental: Nipocalimab
Participants will receive nipocalimab up to Week 52 in the double blind treatment period along with standard of care treatments. At Week 52, eligible participants from both studies will have the option to enter an open-label long-term extension (OLE) period, where they will continue to receive nipocalimab until Week 156 or until the study intervention is discontinued.
Placebo_comparator: Placebo
Participants will receive placebo up to Week 52 in the double blind treatment period along with standard of care treatment. At Week 52, eligible participants from both studies will have the option to enter an OLE period, where they will continue to receive nipocalimab until Week 156 or until the study intervention is discontinued.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC