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NCT07438496PHASE3Recruiting

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

Janssen Research & Development, LLC

Start Date

3/5/2026

Completion Date

11/7/2031

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 Criteria

Age Range: 18 years to 75 years

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

Interventions

DRUG

Nipocalimab

DRUG

Placebo

DRUG

Standard of care treatment

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Conditions

Lupus Erythematosus, Systemic

Locations

David S Hallegua MD A Professional Corporation

Beverly Hills, California 90211

United States

Providence Medical Foundation

Fullerton, California 92835

United States

Southland Arthritis and Osteoporosis Medical Center Inc dba Southland Arthritis

Hemet, California 92543

United States

Advanced Medical Research

La Palma, California 90623

United States

Medvin Clinical Research San Leandro

San Leandro, California 94578

United States

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California 90502

United States

Solace Clinical Research California

Tustin, California 92780

United States

Inland Rheumatology Clinical Trials Inc.

Upland, California 91786

United States

Arthritis & Rheumatic Disease Specialties

Aventura, Florida 33180

United States

Clinical Research of West Florida 1

Clearwater, Florida 33765

United States

Avanti Clinical Research Corp

Hialeah, Florida 33013

United States

LeJenue Research Associates PLLC

Miami, Florida 33126

United States

Pro-Care Research Center, Corp.

Miami Gardens, Florida 33014

United States

Floridian Clinical Research LLC

Miami Lakes, Florida 33016

United States

Integral Rheumatology And Immunology Specialists

Plantation, Florida 33324

United States

Clinical Research of West Florida

Tampa, Florida 33606

United States

Atlanta Research Center for Rheumatology

Marietta, Georgia 30060

United States

Willow Rheumatology and Wellness PLLC

Willowbrook, Illinois 60527

United States

Accurate Clinical Research, Inc.

Lake Charles, Louisiana 70605

United States

Revive Research Institute

Sterling Heights, Michigan 48313

United States

Arthritis Rheumatic And Back Disease Associates

Voorhees Township, New Jersey 08043

United States

Joint and Muscle Research Institute

Charlotte, North Carolina 28204

United States

DJL Clinical Research, PLLC

Charlotte, North Carolina 28211

United States

Cross Creek Medical Clinic

Fayetteville, North Carolina 28304 4422

United States

Paramount Medical Research & Consulting

Middleburg Heights, Ohio 44130

United States

Clinical Research Philadelphia

Philadelphia, Pennsylvania 19114

United States

West Tennessee Research Institute

Jackson, Tennessee 38305

United States

Amarillo Center for Clinical Research

Amarillo, Texas 79124

United States

Arthritis and Rheumatology Research Institute

Frisco, Texas 75035

United States

R and H Clinical Research

Katy, Texas 77449

United States

Southwest Rheumatology Research LLC

Mesquite, Texas 75150

United States

Texas Rheumatology Research Institute LLC

Plano, Texas 75024

United States

Epic Medical Research 1

Red Oak, Texas 75154

United States

Fort Bend Rheumatology Associates PLLC

Sugar Land, Texas 77479

United States

Carilion Clinic Virginia Tech Carilion School of Medicine

Roanoke, Virginia 24011

United States

ARCIS Salud SRL Aprillus asistencia e investigacion

Buenos Aires, C1406AGA

Argentina

Centro Privado de Medicina Familiar

Buenos Aires, C1417EYG

Argentina

Hospital Central Militar Cirujano Mayor Dr Cosme Argerich

CABA, C1426BOS

Argentina

Centro de Investigacion en Enfermedades Reumaticas CIER

Ciudad de Buenos Aires, C1055

Argentina

Arsema

Ciudad de Buenos Aires, C1427

Argentina

Global Psy Asociacion Civil

La Plata, B1904

Argentina

Cer Instituto Medico

Quilmes, B1878DVB

Argentina

Instituto de Investigaciones Clinicas Quilmes

Quilmes, B1878GEG

Argentina

Sanatorio de la Mujer

Rosario, 2000

Argentina

MR Medicina Reumatologica

San Fernando, B1646GHP

Argentina

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, T4000AXL

Argentina

BOX HILL

Box Hill, 3128

Australia

Footscray Hospital, Western Health

Footscray, 3011

Australia

Ipswich Hospital

Ipswich, 4305

Australia

Hospital das Clinicas - UFG

Goiânia, 74605-020

Brazil

CMIP - Centro Mineiro de Pesquisa Ltda

Juiz de Fora, 36010 570

Brazil

Hospital De Clinicas De Porto Alegre

Porto Alegre, 90035-903

Brazil

LMK Servicos Medicos S S

Porto Alegre, 90480 000

Brazil

Associacao Hospitalar Moinhos de Vento

Porto Alegre, 90560032

Brazil

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

Porto Alegre, 90610 000

Brazil

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto

Ribeirão Preto, 14051140

Brazil

SER - Servicos Especializados em Reumatologia da Bahia

Salvador, 40150 150

Brazil

Fundacao do ABC Centro Universitario FMABC

Santo André, 09060 870

Brazil

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

São José do Rio Preto, 15090 000

Brazil

ESHO Empresa De Servicos Hospitalares S A

São Paulo, 01232 010

Brazil

CEDOES Centro de Pesquisa Clinica e Diagnostico do Espirito Santo Ltda

Vitória, 29055 450

Brazil

MC Medtech Services Ltd

Haskovo, 6304

Bulgaria

Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv

Plovdiv, 4004

Bulgaria

Diagnostic consulting center 1 Ruse EOOD

Rousse, 7002

Bulgaria

Diagnostic-Consultative Center (DCC) Aleksandrovska

Sofia, 1431

Bulgaria

Medical Center Hera EOOD

Sofia, 1510

Bulgaria

Military Medical Academy Multiprofile Hospital for Active Treatment Sofia

Sofia, 1606

Bulgaria

UMHAT 'Sveti Ivan Rilsky'

Sofia, 1612

Bulgaria

University Multi Profile Hospital for Active Treatment UMHAT St. Marina

Varna, 9010

Bulgaria

Peking University People's Hospital

Beijing, 100044

China

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

Cheng Du Shi, 610041

China

Dongguan People s Hospital

Dongguan, 523109

China

The First Affiliated Hospital Sun Yat-Sen University

Guangzhou, 510080

China

The Second Affiliated Hospital of Zhejiang University College of Medicine

Hangzhou, 311608

China

Anhui Provincial Hospital

Hefei, 230061

China

Jinhua municipal central hospital

Jinhua, 321013

China

Shandong Jining No.1 People's Hospital

Jining, 272073

China

Linfen Central Hospital

Linfen, 041000

China

The first affiliated hospital of Henan University of science and technology

Luoyang, 471003

China

The Second Affiliated Hospital of Nanchang University

Nanchang, 330008

China

Nanjing Drum Tower Hospital

Nanjing, 210009

China

Ningbo medical center lihuili hospital

Ningbo, 315041

China

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200001

China

Shenshan Medical Center Memorial Hospital of Sun Yat Sen University

Shanwei, 516601

China

Second Affiliated Hospital, SooChow University

Suzhou, 215004

China

Shanxi Bethune Hospital

Taiyuan, 030032

China

Xinxiang Central Hospital

Xinxiang, 453099

China

Fakultní nemocnice u sv. Anny v Brn

Brno, 602 00

Czechia

Revimex Pro s r o

Karvina Frystat, 733 01

Czechia

Revmatologicky ustav

Prague, 128 50

Czechia

Rigshospitalet

Copenhagen, 2100

Denmark

Zealand University Hospital

Køge, 4600

Denmark

Helsinki University Hospital

Helsinki, 00290

Finland

Northern Clinical Trial Coordinators

Oulu, 90150

Finland

Turku University Hospital

Turku, 20520

Finland

CHU de Caen

Caen, 14000

France

Hopital Michallon CHU Grenoble Alpes

La Tronche, 38700

France

Centre Hospitalier Le Mans

Le Mans, 72037

France

Hospices Civils de Lyon - HOPITAL DE LA CROIX ROUSSE

Lyon, 69004

France

Hopital Cochin

Paris, 75014

France

CHU Toulouse - Hopital de Rangueil

Toulouse, 31400

France

Universitätsklinikum Carl-Gustav-Carus Dresden

Dresden, 01307

Germany

CAIR Heidelberg

Heidelberg, 69121

Germany

Universitaetsklinikum Leipzig

Leipzig, 04103

Germany

St Elisabeth Hospital Meerbusch Lank

Meerbusch, 40668

Germany

Klinikum der Universitaet Muenchen

München, 80336

Germany

Medicover Muenchen Ost MVZ

München, 81667

Germany

Laiko General Hospital of Athens

Athens, 115 27

Greece

University General Hospital Attikon General Hospital Of West Attica H Agia Varvara

Athens, 12461

Greece

University General Hospital of Heraklion

Heraklion, 715 00

Greece

General University Hospital Of Larissa

Larissa, 41110

Greece

Semmelweis Egyetem Reumatologiai es Immunologiai Klinika

Budapest, 1023

Hungary

Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz

Budapest, 1027

Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032

Hungary

Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz

Gyula, 5700

Hungary

Pecsi Tudomanyegyetem Klinikai Kozpont

Pécs, 7632

Hungary

Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, 6725

Hungary

Vita Verum Medical Egeszsegugyi Szolgaltato Bt

Székesfehérvár, 8000

Hungary

Vital Medical Center Orvosi es Fogaszati Kozpont

Veszprém, 8200

Hungary

Obudai Egeszsegugyi Centrum Kft

Zalaegerszeg, 8900

Hungary

Bnai Zion Medical Center

Haifa, 31048

Israel

Rambam Health Care Campus

Haifa, 3109601

Israel

Carmel Medical Center

Haifa, 3436212

Israel

Hadassah Ein-Qarem Medical Center

Jerusalem, 9112001

Israel

Meir Medical Center

Kfar Saba, 4428164

Israel

Galilee Medical Center

Nahariya, 2210001

Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906

Israel

Azienda Ospedaliero Universitaria Delle Marche

Ancona, 60126

Italy

Ospedale San Raffaele di Milano

Milan, 20132

Italy

Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia

Perugia, 06129

Italy

Bio-Medico Campus University Hospital

Roma, 00128

Italy

Azienda Ospedaliera San Camillo-Forlanini

Roma, 00152

Italy

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, 00168

Italy

Istituto Clinico Humanitas

Rozzano, 20089

Italy

A.O. Ordine Mauriziano Di Torino - Ospedale Mauriziano Umberto

Torino, 10137

Italy

Ospedale S. Maria Della Misericordia

Udine, 33100

Italy

Azienda Ospedaliera Universitaria Integrata Verona

Verona, 37126

Italy

Chukyo Hospital

Aichi, 457 8510

Japan

Institute of Science Tokyo Hospital

Bunkyō City, 113 8519

Japan

Juntendo University Hospital Urayasu

Chiba, 279 0021

Japan

University of Yamanashi Hospital

Chūō, 409-3898

Japan

Tokyo Metropolitan Tama Medical Center

Fuchū, 183 8524

Japan

National Hospital Organization Kyushu Medical Center

Fukuoka, 810 8563

Japan

Fukushima Medical University Hospital

Fukushima, 960 1295

Japan

Tokai University Hospital

Isehara, 259-1193

Japan

Shinkenko Clinic

Naha, 900 0015

Japan

Kitano Hospital

Osaka, 530-8480

Japan

Hokkaido University Hospital

Sapporo, 060-8648

Japan

Tohoku Medical And Pharmaceutical University Hospital

Sendai, 983 0005

Japan

Shimane University Hospital

Shimane, 693-8501

Japan

National Center for Global Health and Medicine

Shinjuku- Ku, 162-8655

Japan

St. Luke's International Hospital

Tokyo, 104 8560

Japan

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Tokyo, 113 8677

Japan

Ome Medical Center

Tokyo, 198-0042

Japan

Toyama University Hospital

Toyama, 930 0194

Japan

Hospital Sultan Ismail

Johor Bahru, 81100

Malaysia

Hospital Sultanah Nur Zahirah

Kuala, 20400

Malaysia

University Malaya Medical Centre

Kuala Lumpur, 59100

Malaysia

Hospital Umum Sarawak

Kuching, 93586

Malaysia

Sunway Medical Centre

Petaling Jaya, 47500

Malaysia

Hospital Taiping

Taiping, 34000

Malaysia

Haukeland University Hospital

Bergen, 5009

Norway

Oslo universitetssykehus HF, Rikshospitalet

Oslo, 0372

Norway

Stavanger University Hospital

Stavanger, 4011

Norway

MICS Centrum Medyczne Bydgoszcz

Bydgoszcz, 85 065

Poland

Jan Biziel's University Hospital

Bydgoszcz, 85 168

Poland

Nzoz Bif Med

Bytom, 41 902

Poland

Provita Sp z o o

Katowice, 40 611

Poland

Malopolskie Badania Kliniczne Sp z o o

Krakow, 30-002

Poland

NZOZ Lecznica MAK MED S C

Nadarzyn, 05 830

Poland

Twoja Przychodnia - Centrum Medyczne Nowa Sol

Nowa Sól, 67 100

Poland

Twoja Przychodnia Poznanskie Centrum Medyczne

Poznan, 60-324

Poland

Innova Clinic sp z o o

Płońsk, 09 100

Poland

MICS Centrum Medyczne Warszawa

Warsaw, 00-874

Poland

Rheuma Medicus Sp z o o

Warsaw, 02 118

Poland

Uls Almada Seixal - Hosp. Garcia de Orta

Almada, 2805 267

Portugal

Uls Sao Jose - Hosp. Curry Cabral

Lisbon, 1069 166

Portugal

Uls Santa Maria - Hosp. Santa Maria

Lisbon, 1649 028

Portugal

Ulsam - Hosp. Conde de Bertiandos

Ponte de Lima, 4990-041

Portugal

Uls Santo Antonio - Hosp. Santo Antonio

Porto, 4050 342

Portugal

Centrul Medical de Diagnostic si Tratament Ambulator NEOMED

Brasov, 500283

Romania

Spitalul Clinic Sfanta Maria

Bucharest, 011172

Romania

CCBR Clinical Research

Bucharest, 030463

Romania

Hiperdia Piata Sudului

Bucharest, 041303

Romania

Spitalul Clinic Judetean de Urgenta Cluj

Cluj-Napoca, 400006

Romania

Medisof Diagnostic S R L

Craiova, 200347

Romania

Spitalul Clinic Judetean de Urgenta Bihor

Oradea, 410469

Romania

Medbanat s r l

Timișoara, 300766

Romania

Reumatologicka ambulancia MUDr Michaele Zarikova

Košice, 04011

Slovakia

MEDMAN s.r.o.

Martin, 036 01

Slovakia

Narodny Ustav Reumatickych Chorob

Piešťany, 921 12

Slovakia

Dong-A University Hospital

Busan, 49201

South Korea

Chonnam National University Hospital

Gwangju, 61469

South Korea

Seoul National University Bundang Hospital

Gyeonggi-do, 13620

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Hanyang University Medical Center

Seoul, 04763

South Korea

Ajou University Hospital

Suwon, 16499

South Korea

Hospital Vall d'Hebron

Barcelona, 08035

Spain

Hosp. de La Santa Creu I Sant Pau

Barcelona, 8026

Spain

Hosp. Gral. Juan Ramon Jimenez

Huelva, 21005

Spain

Hosp. Univ. Infanta Leonor

Madrid, 28031

Spain

Complejo Hosp de Navarra - Hosp de Navarra

Pamplona, 31008

Spain

Hosp. Univ. Marques de Valdecilla

Santander, 39008

Spain

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, 15706

Spain

Hosp. Infanta Luisa

Seville, 41010

Spain

Hosp. Univ. Rio Hortega

Valladolid, 47012

Spain

Hosp. Clinico Univ. Lozano Blesa

Zaragoza, 50009

Spain

Universitatsspital Basel

Basel, 4031

Switzerland

NTU Biomedical Park Hospital

Hsinchu, 302058

Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung City, 813414

Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301

Taiwan

National Taiwan University Hospital

Taipei, 10043

Taiwan

Taipei Veterans General Hospital

Taipei, 11217

Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan, 333

Taiwan

Phramongkutklao Hospital

Bangkok, 10400

Thailand

Ramathibodi Hospital Mahidol University

Bangkok, 10400

Thailand

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, 50200

Thailand

Ankara University Medical Faculty

Ankara, 06050

Turkey (Türkiye)

Ankara Bilkent Sehir Hastanesi

Ankara, 06800

Turkey (Türkiye)

Firat University Hospital

Elâzığ, 23200

Turkey (Türkiye)

Sanko Universitesi Hastanesi

Gaziantep, 27090

Turkey (Türkiye)

Marmara University Istanbul Pendik Education and Research Hospital

Istanbul, 34899

Turkey (Türkiye)

Necmettin Erbakan University Meram Medical Faculty

Konya, 42080

Turkey (Türkiye)

Addenbrookes Hospital

Cambridge, CB2 0QQ

United Kingdom

Guy's and St Thomas' NHS Foundation Trust

Greater London, SE1 9RT

United Kingdom

Newcastle Freeman Hospital

Newcastle upon Tyne, NE7 7DN

United Kingdom

Peterborough City Hospital

Peterborough, PE3 9GZ

United Kingdom

Royal Berkshire Hospital

Reading, RG1 5LE

United Kingdom

Southampton University Hospital

Southampton, SO16 6HU

United Kingdom

Haywood Hospital

Stoke-on-Trent, ST6 7AG

United Kingdom

Great Western Hospital

Swindon, SN3 6BB

United Kingdom