New drug nipocalimab aims to tame lupus in major trial

NCT ID NCT07438496

Recruiting now Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This phase 3 study tests whether nipocalimab can help control moderate to severe systemic lupus erythematosus (SLE), a chronic autoimmune disease. About 600 adults will receive either nipocalimab or a placebo, on top of standard treatments. The main goal is to see if more people achieve a meaningful reduction in disease activity after 52 weeks.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: nipocalimab
What this could lead to: If successful, nipocalimab could become a new treatment option to help control lupus symptoms and reduce disease flares.
What could go wrong: This is still an experimental drug. Even in phase 3, it may not work better than placebo, and side effects are possible. Results may not apply to all lupus patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

LUPUS ERYTHEMATOSUS, SYSTEMIC

Contacts and locations

Locations

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

Torino, 10137, Italy
ARCIS Salud SRL Aprillus asistencia e investigacion
RECRUITING

Buenos Aires, C1406AGA, Argentina
Accurate Clinical Research, Inc.
RECRUITING

Lake Charles, Louisiana, 70605, United States
Addenbrookes Hospital
RECRUITING

Cambridge, CB2 0QQ, United Kingdom
Advanced Medical Research
RECRUITING

La Palma, California, 90623, United States
Ajou University Hospital
RECRUITING

Suwon, 16499, South Korea
Amarillo Center for Clinical Research
RECRUITING

Amarillo, Texas, 79124, United States
Anhui Provincial Hospital
RECRUITING

Hefei, 230061, China
Ankara Bilkent Sehir Hastanesi
RECRUITING

Ankara, 06800, Turkey (Türkiye)
Ankara University Medical Faculty
RECRUITING

Ankara, 06050, Turkey (Türkiye)
Arsema
RECRUITING

Ciudad de Buenos Aires, C1427, Argentina
Arthritis & Rheumatic Disease Specialties
RECRUITING

Aventura, Florida, 33180, United States
Arthritis Rheumatic And Back Disease Associates
RECRUITING

Voorhees Township, New Jersey, 08043, United States
Arthritis and Rheumatology Research Institute
RECRUITING

Frisco, Texas, 75035, United States
Associacao Hospitalar Moinhos de Vento
RECRUITING

Porto Alegre, 90560032, Brazil
Atlanta Research Center for Rheumatology
RECRUITING

Marietta, Georgia, 30060, United States
Avanti Clinical Research Corp
RECRUITING

Hialeah, Florida, 33013, United States
Azienda Ospedaliera San Camillo-Forlanini
RECRUITING

Roma, 00152, Italy
Azienda Ospedaliera Universitaria Integrata Verona
RECRUITING

Verona, 37126, Italy
Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia
RECRUITING

Perugia, 06129, Italy
Azienda Ospedaliero Universitaria Delle Marche
RECRUITING

Ancona, 60126, Italy
BOX HILL
RECRUITING

Box Hill, 3128, Australia
Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
RECRUITING

Gyula, 5700, Hungary
Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
RECRUITING

Budapest, 1027, Hungary
Bio-Medico Campus University Hospital
RECRUITING

Roma, 00128, Italy
Bnai Zion Medical Center
RECRUITING

Haifa, 31048, Israel
CAIR Heidelberg
RECRUITING

Heidelberg, 69121, Germany
CCBR Clinical Research
RECRUITING

Bucharest, 030463, Romania
CEDOES Centro de Pesquisa Clinica e Diagnostico do Espirito Santo Ltda
RECRUITING

Vitória, 29055 450, Brazil
CHU Toulouse - Hopital de Rangueil
RECRUITING

Toulouse, 31400, France
CHU de Caen
RECRUITING

Caen, 14000, France
CMIP - Centro Mineiro de Pesquisa Ltda
RECRUITING

Juiz de Fora, 36010 570, Brazil
Carilion Clinic Virginia Tech Carilion School of Medicine
RECRUITING

Roanoke, Virginia, 24011, United States
Carmel Medical Center
RECRUITING

Haifa, 3436212, Israel
Centre Hospitalier Le Mans
RECRUITING

Le Mans, 72037, France
Centro Privado de Medicina Familiar
RECRUITING

Buenos Aires, C1417EYG, Argentina
Centro de Investigacion en Enfermedades Reumaticas CIER
RECRUITING

Ciudad de Buenos Aires, C1055, Argentina
Centro de Investigaciones Medicas Tucuman
RECRUITING

San Miguel de Tucumán, T4000AXL, Argentina
Centrul Medical de Diagnostic si Tratament Ambulator NEOMED
RECRUITING

Brasov, 500283, Romania
Cer Instituto Medico
RECRUITING

Quilmes, B1878DVB, Argentina
Chonnam National University Hospital
RECRUITING

Gwangju, 61469, South Korea
Chukyo Hospital
RECRUITING

Aichi, 457 8510, Japan
Clinical Research Philadelphia
RECRUITING

Philadelphia, Pennsylvania, 19114, United States
Clinical Research of West Florida
RECRUITING

Tampa, Florida, 33606, United States
Clinical Research of West Florida 1
RECRUITING

Clearwater, Florida, 33765, United States
Complejo Hosp de Navarra - Hosp de Navarra
RECRUITING

Pamplona, 31008, Spain
Cross Creek Medical Clinic
RECRUITING

Fayetteville, North Carolina, 28304 4422, United States
DJL Clinical Research, PLLC
RECRUITING

Charlotte, North Carolina, 28211, United States
David S Hallegua MD A Professional Corporation
RECRUITING

Beverly Hills, California, 90211, United States
Debreceni Egyetem Klinikai Kozpont
RECRUITING

Debrecen, 4032, Hungary
Diagnostic consulting center 1 Ruse EOOD
RECRUITING

Rousse, 7002, Bulgaria
Diagnostic-Consultative Center (DCC) Aleksandrovska
RECRUITING

Sofia, 1431, Bulgaria
Dong-A University Hospital
RECRUITING

Busan, 49201, South Korea
Dongguan People s Hospital
RECRUITING

Dongguan, 523109, China
ESHO Empresa De Servicos Hospitalares S A
RECRUITING

São Paulo, 01232 010, Brazil
Epic Medical Research 1
RECRUITING

Red Oak, Texas, 75154, United States
Fakultní nemocnice u sv. Anny v Brn
RECRUITING

Brno, 602 00, Czechia
Firat University Hospital
RECRUITING

Elâzığ, 23200, Turkey (Türkiye)
Floridian Clinical Research LLC
RECRUITING

Miami Lakes, Florida, 33016, United States
Fondazione Policlinico Universitario A Gemelli IRCCS
RECRUITING

Roma, 00168, Italy
Footscray Hospital, Western Health
RECRUITING

Footscray, 3011, Australia
Fort Bend Rheumatology Associates PLLC
RECRUITING

Sugar Land, Texas, 77479, United States
Fukushima Medical University Hospital
RECRUITING

Fukushima, 960 1295, Japan
Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De Base
RECRUITING

São José do Rio Preto, 15090 000, Brazil
Fundacao do ABC Centro Universitario FMABC
RECRUITING

Santo André, 09060 870, Brazil
Galilee Medical Center
RECRUITING

Nahariya, 2210001, Israel
General University Hospital Of Larissa
RECRUITING

Larissa, 41110, Greece
Global Psy Asociacion Civil
RECRUITING

La Plata, B1904, Argentina
Great Western Hospital
RECRUITING

Swindon, SN3 6BB, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
RECRUITING

Greater London, SE1 9RT, United Kingdom
Hadassah Ein-Qarem Medical Center
RECRUITING

Jerusalem, 9112001, Israel
Hanyang University Medical Center
RECRUITING

Seoul, 04763, South Korea
Haukeland University Hospital
RECRUITING

Bergen, 5009, Norway
Haywood Hospital
RECRUITING

Stoke-on-Trent, ST6 7AG, United Kingdom
Helsinki University Hospital
RECRUITING

Helsinki, 00290, Finland
Hiperdia Piata Sudului
RECRUITING

Bucharest, 041303, Romania
Hokkaido University Hospital
RECRUITING

Sapporo, 060-8648, Japan
Hopital Cochin
RECRUITING

Paris, 75014, France
Hopital Michallon CHU Grenoble Alpes
RECRUITING

La Tronche, 38700, France
Hosp. Clinico Univ. Lozano Blesa
RECRUITING

Zaragoza, 50009, Spain
Hosp. Clinico Univ. de Santiago
RECRUITING

Santiago de Compostela, 15706, Spain
Hosp. Gral. Juan Ramon Jimenez
RECRUITING

Huelva, 21005, Spain
Hosp. Infanta Luisa
RECRUITING

Seville, 41010, Spain
Hosp. Univ. Infanta Leonor
RECRUITING

Madrid, 28031, Spain
Hosp. Univ. Marques de Valdecilla
RECRUITING

Santander, 39008, Spain
Hosp. Univ. Rio Hortega
RECRUITING

Valladolid, 47012, Spain
Hosp. de La Santa Creu I Sant Pau
RECRUITING

Barcelona, 8026, Spain
Hospices Civils de Lyon - HOPITAL DE LA CROIX ROUSSE
RECRUITING

Lyon, 69004, France
Hospital Central Militar Cirujano Mayor Dr Cosme Argerich
RECRUITING

CABA, C1426BOS, Argentina
Hospital De Clinicas De Porto Alegre
RECRUITING

Porto Alegre, 90035-903, Brazil
Hospital Sultan Ismail
RECRUITING

Johor Bahru, 81100, Malaysia
Hospital Sultanah Nur Zahirah
RECRUITING

Kuala, 20400, Malaysia
Hospital Taiping
RECRUITING

Taiping, 34000, Malaysia
Hospital Umum Sarawak
RECRUITING

Kuching, 93586, Malaysia
Hospital Vall d'Hebron
RECRUITING

Barcelona, 08035, Spain
Hospital das Clinicas - UFG
RECRUITING

Goiânia, 74605-020, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
RECRUITING

Ribeirão Preto, 14051140, Brazil
Inland Rheumatology Clinical Trials Inc.
RECRUITING

Upland, California, 91786, United States
Innova Clinic sp z o o
RECRUITING

Płońsk, 09 100, Poland
Institute of Science Tokyo Hospital
RECRUITING

Bunkyō City, 113 8519, Japan
Instituto de Investigaciones Clinicas Quilmes
RECRUITING

Quilmes, B1878GEG, Argentina
Integral Rheumatology And Immunology Specialists
RECRUITING

Plantation, Florida, 33324, United States
Ipswich Hospital
RECRUITING

Ipswich, 4305, Australia
Istituto Clinico Humanitas
RECRUITING

Rozzano, 20089, Italy
Jan Biziel's University Hospital
RECRUITING

Bydgoszcz, 85 168, Poland
Jinhua municipal central hospital
RECRUITING

Jinhua, 321013, China
Joint and Muscle Research Institute
RECRUITING

Charlotte, North Carolina, 28204, United States
Juntendo University Hospital Urayasu
RECRUITING

Chiba, 279 0021, Japan
Kaohsiung Chang Gung Memorial Hospital
RECRUITING

Kaohsiung City, 83301, Taiwan
Kaohsiung Veterans General Hospital
RECRUITING

Kaohsiung City, 813414, Taiwan
Kitano Hospital
RECRUITING

Osaka, 530-8480, Japan
Klinikum der Universitaet Muenchen
RECRUITING

München, 80336, Germany
LMK Servicos Medicos S S
RECRUITING

Porto Alegre, 90480 000, Brazil
Laiko General Hospital of Athens
RECRUITING

Athens, 115 27, Greece
LeJenue Research Associates PLLC
RECRUITING

Miami, Florida, 33126, United States
Linfen Central Hospital
RECRUITING

Linfen, 041000, China
Linkou Chang Gung Memorial Hospital
RECRUITING

Taoyuan, 333, Taiwan
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
RECRUITING

Torrance, California, 90502, United States
MC Medtech Services Ltd
RECRUITING

Haskovo, 6304, Bulgaria
MEDMAN s.r.o.
RECRUITING

Martin, 036 01, Slovakia
MICS Centrum Medyczne Bydgoszcz
RECRUITING

Bydgoszcz, 85 065, Poland
MICS Centrum Medyczne Warszawa
RECRUITING

Warsaw, 00-874, Poland
MR Medicina Reumatologica
RECRUITING

San Fernando, B1646GHP, Argentina
Maharaj Nakorn Chiang Mai Hospital
RECRUITING

Chiang Mai, 50200, Thailand
Malopolskie Badania Kliniczne Sp z o o
RECRUITING

Krakow, 30-002, Poland
Marmara University Istanbul Pendik Education and Research Hospital
RECRUITING

Istanbul, 34899, Turkey (Türkiye)
Medbanat s r l
RECRUITING

Timișoara, 300766, Romania
Medical Center Hera EOOD
RECRUITING

Sofia, 1510, Bulgaria
Medicover Muenchen Ost MVZ
RECRUITING

München, 81667, Germany
Medisof Diagnostic S R L
RECRUITING

Craiova, 200347, Romania
Medvin Clinical Research San Leandro
RECRUITING

San Leandro, California, 94578, United States
Meir Medical Center
RECRUITING

Kfar Saba, 4428164, Israel
Military Medical Academy Multiprofile Hospital for Active Treatment Sofia
RECRUITING

Sofia, 1606, Bulgaria
Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv
RECRUITING

Plovdiv, 4004, Bulgaria
NTU Biomedical Park Hospital
RECRUITING

Hsinchu, 302058, Taiwan
NZOZ Lecznica MAK MED S C
RECRUITING

Nadarzyn, 05 830, Poland
Nanjing Drum Tower Hospital
RECRUITING

Nanjing, 210009, China
Narodny Ustav Reumatickych Chorob
RECRUITING

Piešťany, 921 12, Slovakia
National Center for Global Health and Medicine
RECRUITING

Shinjuku- Ku, 162-8655, Japan
National Hospital Organization Kyushu Medical Center
RECRUITING

Fukuoka, 810 8563, Japan
National Taiwan University Hospital
RECRUITING

Taipei, 10043, Taiwan
Necmettin Erbakan University Meram Medical Faculty
RECRUITING

Konya, 42080, Turkey (Türkiye)
Newcastle Freeman Hospital
RECRUITING

Newcastle upon Tyne, NE7 7DN, United Kingdom
Ningbo medical center lihuili hospital
RECRUITING

Ningbo, 315041, China
Northern Clinical Trial Coordinators
RECRUITING

Oulu, 90150, Finland
Nzoz Bif Med
RECRUITING

Bytom, 41 902, Poland
Obudai Egeszsegugyi Centrum Kft
RECRUITING

Zalaegerszeg, 8900, Hungary
Ome Medical Center
RECRUITING

Tokyo, 198-0042, Japan
Oslo universitetssykehus HF, Rikshospitalet
RECRUITING

Oslo, 0372, Norway
Ospedale S. Maria Della Misericordia
RECRUITING

Udine, 33100, Italy
Ospedale San Raffaele di Milano
RECRUITING

Milan, 20132, Italy
Paramount Medical Research & Consulting
RECRUITING

Middleburg Heights, Ohio, 44130, United States
Pecsi Tudomanyegyetem Klinikai Kozpont
RECRUITING

Pécs, 7632, Hungary
Peking University People's Hospital
RECRUITING

Beijing, 100044, China
Peterborough City Hospital
RECRUITING

Peterborough, PE3 9GZ, United Kingdom
Phramongkutklao Hospital
RECRUITING

Bangkok, 10400, Thailand
Pro-Care Research Center, Corp.
RECRUITING

Miami Gardens, Florida, 33014, United States
Providence Medical Foundation
RECRUITING

Fullerton, California, 92835, United States
Provita Sp z o o
RECRUITING

Katowice, 40 611, Poland
R and H Clinical Research
RECRUITING

Katy, Texas, 77449, United States
Ramathibodi Hospital Mahidol University
RECRUITING

Bangkok, 10400, Thailand
Rambam Health Care Campus
RECRUITING

Haifa, 3109601, Israel
Renji Hospital, Shanghai Jiaotong University School of Medicine
RECRUITING

Shanghai, 200001, China
Reumatologicka ambulancia MUDr Michaele Zarikova
RECRUITING

Košice, 04011, Slovakia
Revimex Pro s r o
RECRUITING

Karvina Frystat, 733 01, Czechia
Revive Research Institute
RECRUITING

Sterling Heights, Michigan, 48313, United States
Revmatologicky ustav
RECRUITING

Prague, 128 50, Czechia
Rheuma Medicus Sp z o o
RECRUITING

Warsaw, 02 118, Poland
Rigshospitalet
RECRUITING

Copenhagen, 2100, Denmark
Royal Berkshire Hospital
RECRUITING

Reading, RG1 5LE, United Kingdom
SER - Servicos Especializados em Reumatologia da Bahia
RECRUITING

Salvador, 40150 150, Brazil
Sanatorio de la Mujer
RECRUITING

Rosario, 2000, Argentina
Sanko Universitesi Hastanesi
RECRUITING

Gaziantep, 27090, Turkey (Türkiye)
Second Affiliated Hospital, SooChow University
RECRUITING

Suzhou, 215004, China
Semmelweis Egyetem Reumatologiai es Immunologiai Klinika
RECRUITING

Budapest, 1023, Hungary
Seoul National University Bundang Hospital
RECRUITING

Gyeonggi-do, 13620, South Korea
Seoul National University Hospital
RECRUITING

Seoul, 03080, South Korea
Shandong Jining No.1 People's Hospital
RECRUITING

Jining, 272073, China
Shanxi Bethune Hospital
RECRUITING

Taiyuan, 030032, China
Shenshan Medical Center Memorial Hospital of Sun Yat Sen University
RECRUITING

Shanwei, 516601, China
Shimane University Hospital
RECRUITING

Shimane, 693-8501, Japan
Shinkenko Clinic
RECRUITING

Naha, 900 0015, Japan
Solace Clinical Research California
RECRUITING

Tustin, California, 92780, United States
Southampton University Hospital
RECRUITING

Southampton, SO16 6HU, United Kingdom
Southland Arthritis and Osteoporosis Medical Center Inc dba Southland Arthritis
RECRUITING

Hemet, California, 92543, United States
Southwest Rheumatology Research LLC
RECRUITING

Mesquite, Texas, 75150, United States
Spitalul Clinic Judetean de Urgenta Bihor
RECRUITING

Oradea, 410469, Romania
Spitalul Clinic Judetean de Urgenta Cluj
RECRUITING

Cluj-Napoca, 400006, Romania
Spitalul Clinic Sfanta Maria
RECRUITING

Bucharest, 011172, Romania
St Elisabeth Hospital Meerbusch Lank
RECRUITING

Meerbusch, 40668, Germany
St. Luke's International Hospital
RECRUITING

Tokyo, 104 8560, Japan
Stavanger University Hospital
RECRUITING

Stavanger, 4011, Norway
Sunway Medical Centre
RECRUITING

Petaling Jaya, 47500, Malaysia
Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont
RECRUITING

Szeged, 6725, Hungary
Taipei Veterans General Hospital
RECRUITING

Taipei, 11217, Taiwan
Tel Aviv Sourasky Medical Center
RECRUITING

Tel Aviv, 6423906, Israel
Texas Rheumatology Research Institute LLC
RECRUITING

Plano, Texas, 75024, United States
The First Affiliated Hospital Sun Yat-Sen University
RECRUITING

Guangzhou, 510080, China
The Second Affiliated Hospital of Nanchang University
RECRUITING

Nanchang, 330008, China
The Second Affiliated Hospital of Zhejiang University College of Medicine
RECRUITING

Hangzhou, 311608, China
The first affiliated hospital of Henan University of science and technology
RECRUITING

Luoyang, 471003, China
Tohoku Medical And Pharmaceutical University Hospital
RECRUITING

Sendai, 983 0005, Japan
Tokai University Hospital
RECRUITING

Isehara, 259-1193, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
RECRUITING

Tokyo, 113 8677, Japan
Tokyo Metropolitan Tama Medical Center
RECRUITING

Fuchū, 183 8524, Japan
Toyama University Hospital
RECRUITING

Toyama, 930 0194, Japan
Turku University Hospital
RECRUITING

Turku, 20520, Finland
Twoja Przychodnia - Centrum Medyczne Nowa Sol
RECRUITING

Nowa Sól, 67 100, Poland
Twoja Przychodnia Poznanskie Centrum Medyczne
RECRUITING

Poznan, 60-324, Poland
UMHAT 'Sveti Ivan Rilsky'
RECRUITING

Sofia, 1612, Bulgaria
Uls Almada Seixal - Hosp. Garcia de Orta
RECRUITING

Almada, 2805 267, Portugal
Uls Santa Maria - Hosp. Santa Maria
RECRUITING

Lisbon, 1649 028, Portugal
Uls Santo Antonio - Hosp. Santo Antonio
RECRUITING

Porto, 4050 342, Portugal
Uls Sao Jose - Hosp. Curry Cabral
RECRUITING

Lisbon, 1069 166, Portugal
Ulsam - Hosp. Conde de Bertiandos
RECRUITING

Ponte de Lima, 4990-041, Portugal
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
RECRUITING

Porto Alegre, 90610 000, Brazil
Universitaetsklinikum Leipzig
RECRUITING

Leipzig, 04103, Germany
Universitatsspital Basel
RECRUITING

Basel, 4031, Switzerland
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
RECRUITING

Athens, 12461, Greece
University General Hospital of Heraklion
RECRUITING

Heraklion, 715 00, Greece
University Malaya Medical Centre
RECRUITING

Kuala Lumpur, 59100, Malaysia
University Multi Profile Hospital for Active Treatment UMHAT St. Marina
RECRUITING

Varna, 9010, Bulgaria
University of Yamanashi Hospital
RECRUITING

Chūō, 409-3898, Japan
Universitätsklinikum Carl-Gustav-Carus Dresden
RECRUITING

Dresden, 01307, Germany
Vita Verum Medical Egeszsegugyi Szolgaltato Bt
COMPLETED

Székesfehérvár, 8000, Hungary
Vital Medical Center Orvosi es Fogaszati Kozpont
RECRUITING

Veszprém, 8200, Hungary
West China School of Medicine/West China Hospital, Sichuan University
RECRUITING

Cheng Du Shi, 610041, China
West Tennessee Research Institute
RECRUITING

Jackson, Tennessee, 38305, United States
Willow Rheumatology and Wellness PLLC
RECRUITING

Willowbrook, Illinois, 60527, United States
Xinxiang Central Hospital
RECRUITING

Xinxiang, 453099, China
Zealand University Hospital
RECRUITING

Køge, 4600, Denmark

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