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RECRUITING
NCT07438496
PHASE3

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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).

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2026-03-05

Completion Date

2031-11-07

Last Updated

2026-06-05

Healthy Volunteers

No

Interventions

DRUG

Nipocalimab

Nipocalimab will be administered.

DRUG

Placebo

Placebo will be administered.

DRUG

Standard of care treatment

Protocol-defined topical and systemic standard of care background treatments.

Locations (169)

David S Hallegua MD A Professional Corporation

Beverly Hills, 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

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

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

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

Arthritis and Rheumatology Research Institute

Allen, Texas, United States

Amarillo Center for Clinical Research

Amarillo, 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

ARCIS Salud SRL Aprillus asistencia e investigacion

Buenos Aires, Argentina

Centro Privado de Medicina Familiar

Buenos Aires, 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

MR Medicina Reumatologica

San Fernando, Argentina

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, Argentina

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 De Clinicas De Porto Alegre

Porto Alegre, Brazil

LMK Servicos Medicos S S

Porto Alegre, Brazil

Associacao Hospitalar Moinhos de Vento

Porto Alegre, Brazil

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

Porto Alegre, Brazil

SER - Servicos Especializados em Reumatologia da Bahia

Salvador, Brazil

Fundacao do ABC Centro Universitario FMABC

Santo André, Brazil

Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De Base

São José do Rio Preto, Brazil

ESHO Empresa De Servicos Hospitalares S A

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

West China School of Medicine/West China Hospital, Sichuan University

Cheng Du Shi, China

Dongguan People s Hospital

Dongguan, China

The Second Affiliated Hospital of Zhejiang University College of Medicine

Hangzhou, China

Jinhua municipal central hospital

Jinhua, China

Shandong Jining No.1 People's Hospital

Jining, China

Linfen Central Hospital

Linfen, China

Ningbo medical center lihuili hospital

Ningbo, 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

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

Northern Clinical Trial Coordinators

Oulu, Finland

Centre Hospitalier Le Mans

Le Mans, France

CHU Toulouse - Hopital de Rangueil

Toulouse, France

Universitätsklinikum Carl-Gustav-Carus Dresden

Dresden, Germany

CAIR Heidelberg

Heidelberg, 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

Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz

Budapest, 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

Istituto Clinico Humanitas

Rozzano, Italy

Tokai University Hospital

Isehara, Japan

Shinkenko Clinic

Naha, Japan

Kitano Hospital

Osaka, Japan

Hokkaido University Hospital

Sapporo, Japan

St. Luke's International Hospital

Tokyo, 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

Centrul Medical de Diagnostic si Tratament Ambulator NEOMED

Brasov, Romania

Spitalul Clinic Sfanta Maria

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

MEDMAN s.r.o.

Martin, Slovakia

Narodny Ustav Reumatickych Chorob

Piešťany, Slovakia

Chonnam National University Hospital

Gwangju, South Korea

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Seoul National University Hospital

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. Univ. Rio Hortega

Valladolid, Spain

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

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, Thailand

Ankara University Medical Faculty

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)

Necmettin Erbakan University Meram Medical Faculty

Konya, Turkey (Türkiye)

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