A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
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
Interventions
Nipocalimab
Placebo
Standard of care treatment
Conditions
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