AzTrials
AzTrials

Lupus Erythematosus, SystemicPhase 3GARDENIA-SLENCT07438496

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

A Phase 3 study testing Nipocalimab in people with Lupus Erythematosus, Systemic, run by Janssen Research & Development, LLC at 272 sites in 33 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lupus Erythematosus, Systemic
What is being tested?
Nipocalimab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
600 participants
Where
272 sitesin 33 countries
Study dates
5 Mar 2026to 7 Nov 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

272 sites in 33 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

272 sites in 33 countries

United States40 sites, 39 recruiting

  • Amarillo Medical Specialists Rheumatology

    Amarillo, Texas, 79121

    Recruiting

  • Amarillo Center for Clinical Research

    Amarillo, Texas, 79124

    Recruiting

  • Morehouse School of Medicine

    Atlanta, Georgia, 30310

    Recruiting

  • Arthritis & Rheumatic Disease Specialties

    Aventura, Florida, 33180

    Recruiting

  • David S Hallegua MD A Professional Corporation

    Beverly Hills, California, 90211

    Recruiting

  • Joint and Muscle Research Institute

    Charlotte, North Carolina, 28204

    Recruiting

  • DJL Clinical Research, PLLC

    Charlotte, North Carolina, 28211

    Recruiting

  • Clinical Research of West Florida 1

    Clearwater, Florida, 33765

    Recruiting

  • Denver Arthritis Clinic

    Denver, Colorado, 80230

    Recruiting

  • Cross Creek Medical Clinic

    Fayetteville, North Carolina, 28304 4422

    Recruiting

  • Arthritis and Rheumatology Research Institute

    Frisco, Texas, 75035

    Recruiting

  • Southland Arthritis and Osteoporosis Medical Center Inc dba Southland Arthritis

    Hemet, California, 92543

    Recruiting

  • Avanti Clinical Research Corp

    Hialeah, Florida, 33013

    Recruiting

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305

    Recruiting

  • R and H Clinical Research

    Katy, Texas, 77449

    Recruiting

  • Advanced Medical Research

    La Palma, California, 90623

    Recruiting

  • Accurate Clinical Research, Inc.

    Lake Charles, Louisiana, 70605

    Recruiting

  • Atlanta Research Center for Rheumatology

    Marietta, Georgia, 30060

    Recruiting

  • Southwest Rheumatology Research LLC

    Mesquite, Texas, 75150

    Recruiting

  • LeJenue Research Associates PLLC

    Miami, Florida, 33126

    Recruiting

  • Pro-Care Research Center, Corp.

    Miami Gardens, Florida, 33014

    Recruiting

  • Floridian Clinical Research LLC

    Miami Lakes, Florida, 33016

    Completed

  • Paramount Medical Research & Consulting

    Middleburg Heights, Ohio, 44130

    Recruiting

  • Providence Medical Foundation

    Mission Viejo, California, 92691

    Recruiting

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07103

    Recruiting

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma, 73104

    Recruiting

  • Clinical Research Philadelphia

    Philadelphia, Pennsylvania, 19114

    Recruiting

  • Texas Rheumatology Research Institute LLC

    Plano, Texas, 75024

    Recruiting

  • Integral Rheumatology And Immunology Specialists

    Plantation, Florida, 33324

    Recruiting

  • Epic Medical Research 1

    Red Oak, Texas, 75154

    Recruiting

  • Carilion Clinic Virginia Tech Carilion School of Medicine

    Roanoke, Virginia, 24011

    Recruiting

  • Medvin Clinical Research San Leandro

    San Leandro, California, 94578

    Recruiting

  • Revive Research Institute

    Sterling Heights, Michigan, 48313

    Recruiting

  • Fort Bend Rheumatology Associates PLLC

    Sugar Land, Texas, 77479

    Recruiting

  • Clinical Research of West Florida

    Tampa, Florida, 33606

    Recruiting

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California, 90502

    Recruiting

  • Solace Clinical Research California

    Tustin, California, 92780

    Recruiting

  • Inland Rheumatology Clinical Trials Inc.

    Upland, California, 91786

    Recruiting

  • Arthritis Rheumatic And Back Disease Associates

    Voorhees Township, New Jersey, 08043

    Recruiting

  • Willow Rheumatology and Wellness PLLC

    Willowbrook, Illinois, 60527

    Recruiting

Other trials in United States

China21 sites, 21 recruiting

  • Peking University People's Hospital

    Beijing, 100044

    Recruiting

  • Xiangya Hospital Central South University

    Changsha, 410008

    Recruiting

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

    Cheng Du Shi, 610041

    Recruiting

  • Dongguan People s Hospital

    Dongguan, 523109

    Recruiting

  • The First Affiliated Hospital Sun Yat-Sen University

    Guangzhou, 510080

    Recruiting

  • The Second Affiliated Hospital of Zhejiang University College of Medicine

    Hangzhou, 311608

    Recruiting

  • Anhui Provincial Hospital

    Hefei, 230061

    Recruiting

  • Jinhua municipal central hospital

    Jinhua, 321000

    Recruiting

  • Shandong Jining No.1 People's Hospital

    Jining, 272073

    Recruiting

  • Linfen Central Hospital

    Linfen, 041000

    Recruiting

  • The first affiliated hospital of Henan University of science and technology

    Luoyang, 471003

    Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, 330008

    Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, 210009

    Recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, 530021

    Recruiting

  • Ningbo medical center lihuili hospital

    Ningbo, 315041

    Recruiting

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200001

    Recruiting

  • Shenshan Medical Center Memorial Hospital of Sun Yat Sen University

    Shanwei, 516601

    Recruiting

  • Second Affiliated Hospital, SooChow University

    Suzhou, 215004

    Recruiting

  • Shanxi Bethune Hospital

    Taiyuan, 030032

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

    Recruiting

  • Xinxiang Central Hospital

    Xinxiang, 453099

    Recruiting

Other trials in China

Japan18 sites, 18 recruiting

  • Chukyo Hospital

    Aichi, 457 8510

    Recruiting

  • Institute of Science Tokyo Hospital

    Bunkyō City, 113 8519

    Recruiting

  • Juntendo University Hospital Urayasu

    Chiba, 279 0021

    Recruiting

  • University of Yamanashi Hospital

    Chūō, 409-3898

    Recruiting

  • Tokyo Metropolitan Tama Medical Center

    Fuchū, 183 8524

    Recruiting

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810 8563

    Recruiting

  • Fukushima Medical University Hospital

    Fukushima, 960 1295

    Recruiting

  • Tokai University Hospital

    Isehara, 259-1193

    Recruiting

  • Shinkenko Clinic

    Naha, 900 0015

    Recruiting

  • Kitano Hospital

    Osaka, 530-8480

    Recruiting

  • Hokkaido University Hospital

    Sapporo, 060-8648

    Recruiting

  • Tohoku Medical And Pharmaceutical University Hospital

    Sendai, 983 0005

    Recruiting

  • Shimane University Hospital

    Shimane, 693-8501

    Recruiting

  • National Center for Global Health and Medicine

    Shinjuku- Ku, 162-8655

    Recruiting

  • St. Luke's International Hospital

    Tokyo, 104 8560

    Recruiting

  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

    Tokyo, 113 8677

    Recruiting

  • Ome Medical Center

    Tokyo, 198-0042

    Recruiting

  • Toyama University Hospital

    Toyama, 930 0194

    Recruiting

Other trials in Japan

Brazil14 sites, 14 recruiting

  • Hospital das Clinicas - UFG

    Goiânia, 74605 020

    Recruiting

  • CMIP - Centro Mineiro de Pesquisa Ltda

    Juiz de Fora, 36010 570

    Recruiting

  • Hospital Moinhos de Vento

    Porto Alegre, 90035-001

    Recruiting

  • Hospital De Clinicas De Porto Alegre

    Porto Alegre, 90035-903

    Recruiting

  • LMK Servicos Medicos S S

    Porto Alegre, 90480 000

    Recruiting

  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

    Porto Alegre, 90610 000

    Recruiting

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto

    Ribeirão Preto, 14051140

    Recruiting

  • SER - Servicos Especializados em Reumatologia da Bahia

    Salvador, 40150 150

    Recruiting

  • IDOR - Regional Bahia

    Salvador, 41253-190

    Recruiting

  • Funfarme Sjrp

    São José do Rio Preto, 15090-000

    Recruiting

  • Hospital Samaritano de Sao Paulo

    São Paulo, 01243 020

    Recruiting

  • Hospital Das Clinicas Da Faculdade De Medicina Da USP

    São Paulo, 05403 900

    Recruiting

  • Cepes - Fmabc

    São Paulo, 09060-870

    Recruiting

  • CEDOES Centro de Pesquisa Clinica e Diagnostico do Espirito Santo Ltda

    Vitória, 29055 450

    Recruiting

Other trials in Brazil

Argentina11 sites, 11 recruiting

  • ARCIS Salud SRL Aprillus asistencia e investigacion

    Buenos Aires, C1406AGA

    Recruiting

  • Centro Privado de Medicina Familiar

    Buenos Aires, C1417EYG

    Recruiting

  • Hospital Central Militar Cirujano Mayor Dr Cosme Argerich

    CABA, C1426BOS

    Recruiting

  • Centro de Investigacion en Enfermedades Reumaticas CIER

    Ciudad de Buenos Aires, C1055

    Recruiting

  • Arsema

    Ciudad de Buenos Aires, C1427

    Recruiting

  • Global Psy Asociacion Civil

    La Plata, B1904

    Recruiting

  • Cer Instituto Medico

    Quilmes, B1878DVB

    Recruiting

  • Instituto de Investigaciones Clinicas Quilmes

    Quilmes, B1878GEG

    Recruiting

  • Sanatorio de la Mujer

    Rosario, 2000

    Recruiting

  • MR Medicina Reumatologica

    San Fernando, B1646GHP

    Recruiting

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, T4000AXL

    Recruiting

Other trials in Argentina

Italy11 sites, 11 recruiting

  • Azienda Ospedaliero Universitaria Delle Marche

    Ancona, 60126

    Recruiting

  • Policlinico San Marco

    Catania, 95121

    Recruiting

  • Ospedale San Raffaele di Milano

    Milan, 20132

    Recruiting

  • Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia

    Perugia, 06129

    Recruiting

  • Bio-Medico Campus University Hospital

    Roma, 00128

    Recruiting

  • Azienda Ospedaliera San Camillo-Forlanini

    Roma, 00152

    Recruiting

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Roma, 00168

    Recruiting

  • Istituto Clinico Humanitas

    Rozzano, 20089

    Recruiting

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

    Torino, 10137

    Recruiting

  • Ospedale S. Maria Della Misericordia

    Udine, 33100

    Recruiting

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, 37126

    Recruiting

Other trials in Italy

Poland11 sites, 11 recruiting

  • MICS Centrum Medyczne Bydgoszcz

    Bydgoszcz, 85 065

    Recruiting

  • Jan Biziel's University Hospital

    Bydgoszcz, 85 168

    Recruiting

  • Nzoz Bif Med

    Bytom, 41 902

    Recruiting

  • Provita Sp z o o

    Katowice, 40 611

    Recruiting

  • Malopolskie Badania Kliniczne Sp z o o

    Krakow, 30-002

    Recruiting

  • NZOZ Lecznica MAK MED S C

    Nadarzyn, 05 830

    Recruiting

  • Twoja Przychodnia - Centrum Medyczne Nowa Sol

    Nowa Sól, 67 100

    Recruiting

  • Innova Clinic sp z o o

    Płońsk, 09 100

    Recruiting

  • Twoja Przychodnia Poznanskie Centrum Medyczne

    Poznan, 60-324

    Recruiting

  • MICS Centrum Medyczne Warszawa

    Warsaw, 00-874

    Recruiting

  • Rheuma Medicus Sp z o o

    Warsaw, 02 118

    Recruiting

Other trials in Poland

Hungary10 sites, 9 recruiting

  • Semmelweis Egyetem Reumatologiai es Immunologiai Klinika

    Budapest, 1023

    Recruiting

  • Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz

    Budapest, 1027

    Recruiting

  • Qualiclinic Kft

    Budapest, 1134

    Recruiting

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

    Recruiting

  • Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz

    Gyula, 5700

    Recruiting

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, 7632

    Recruiting

  • Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, 6725

    Recruiting

  • Vita Verum Medical Egeszsegugyi Szolgaltato Bt

    Székesfehérvár, 8000

    Completed

  • Vital Medical Center Orvosi es Fogaszati Kozpont

    Veszprém, 8200

    Recruiting

  • Obudai Egeszsegugyi Centrum Kft

    Zalaegerszeg, 8900

    Recruiting

Other trials in Hungary

Spain10 sites, 10 recruiting

  • Hospital Vall d'Hebron

    Barcelona, 08035

    Recruiting

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 8026

    Recruiting

  • Hosp. Gral. Juan Ramon Jimenez

    Huelva, 21005

    Recruiting

  • Hosp. Univ. Infanta Leonor

    Madrid, 28031

    Recruiting

  • Complejo Hosp de Navarra - Hosp de Navarra

    Pamplona, 31008

    Recruiting

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

    Recruiting

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706

    Recruiting

  • Hosp. Infanta Luisa

    Seville, 41010

    Recruiting

  • Hosp. Univ. Rio Hortega

    Valladolid, 47012

    Recruiting

  • Hosp. Clinico Univ. Lozano Blesa

    Zaragoza, 50009

    Recruiting

Other trials in Spain

United Kingdom9 sites, 9 recruiting

  • Royal National Hospital for Rheumatic Diseases

    Bath, BA1 3NG

    Recruiting

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

    Recruiting

  • Guy's and St Thomas' NHS Foundation Trust

    Greater London, SE1 9RT

    Recruiting

  • Newcastle Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

    Recruiting

  • Peterborough City Hospital

    Peterborough, PE3 9GZ

    Recruiting

  • Royal Berkshire Hospital

    Reading, RG1 5LE

    Recruiting

  • Southampton University Hospital

    Southampton, SO16 6HU

    Recruiting

  • Haywood Hospital

    Stoke-on-Trent, ST6 7AG

    Recruiting

  • Great Western Hospital

    Swindon, SN3 6BB

    Recruiting

Other trials in United Kingdom

Bulgaria8 sites, 8 recruiting

  • MC Medtech Services Ltd

    Haskovo, 6304

    Recruiting

  • Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv

    Plovdiv, 4004

    Recruiting

  • Diagnostic consulting center 1 Ruse EOOD

    Rousse, 7002

    Recruiting

  • Diagnostic-Consultative Center (DCC) Aleksandrovska

    Sofia, 1431

    Recruiting

  • Medical Center Hera EOOD

    Sofia, 1510

    Recruiting

  • Military Medical Academy Multiprofile Hospital for Active Treatment Sofia

    Sofia, 1606

    Recruiting

  • UMHAT 'Sveti Ivan Rilsky'

    Sofia, 1612

    Recruiting

  • University Multi Profile Hospital for Active Treatment UMHAT St. Marina

    Varna, 9010

    Recruiting

Other trials in Bulgaria

Romania8 sites, 8 recruiting

  • Centrul Medical de Diagnostic si Tratament Ambulator NEOMED

    Brasov, 500283

    Recruiting

  • Spitalul Clinic Sfanta Maria

    Bucharest, 011172

    Recruiting

  • CCBR Clinical Research

    Bucharest, 030463

    Recruiting

  • Hiperdia Piata Sudului

    Bucharest, 041303

    Recruiting

  • Spitalul Clinic Judetean de Urgenta Cluj

    Cluj-Napoca, 400006

    Recruiting

  • Medisof Diagnostic S R L

    Craiova, 200347

    Recruiting

  • Spitalul Clinic Judetean de Urgenta Bihor

    Oradea, 410469

    Recruiting

  • Medbanat s r l

    Timișoara, 300766

    Recruiting

Other trials in Romania

Georgia7 sites, 7 recruiting

  • TSMU The First University Clinic

    Tbilisi, 0141

    Recruiting

  • LLC Geo Hospitals

    Tbilisi, 0144

    Recruiting

  • Tbilisi Heart and Vascular Clinic Ltd

    Tbilisi, 0159

    Recruiting

  • Clinic on Mtskheta Street

    Tbilisi, 0160

    Recruiting

  • LTD The First Medical Center

    Tbilisi, 0180

    Recruiting

  • Caucasus Medical Centre

    Tbilisi, 0186

    Recruiting

  • Ltd Innova

    Tbilisi, 0186

    Recruiting

Other trials in Georgia

Israel7 sites, 7 recruiting

  • Bnai Zion Medical Center

    Haifa, 31048

    Recruiting

  • Rambam Health Care Campus

    Haifa, 3109601

    Recruiting

  • Carmel Medical Center

    Haifa, 3436212

    Recruiting

  • Hadassah Ein-Qarem Medical Center

    Jerusalem, 9112001

    Recruiting

  • Meir Medical Center

    Kfar Saba, 4428164

    Recruiting

  • Galilee Medical Center

    Nahariya, 2210001

    Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

    Recruiting

Other trials in Israel

South Korea7 sites, 7 recruiting

  • Dong-A University Hospital

    Busan, 49201

    Recruiting

  • Chonnam National University Hospital

    Gwangju, 61469

    Recruiting

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Hanyang University Medical Center

    Seoul, 04763

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Recruiting

  • Ajou University Hospital

    Suwon, 16499

    Recruiting

Other trials in South Korea

Turkey (Türkiye)7 sites, 7 recruiting

  • Ankara Universitesi Tip Fakültesi Ibn-i Sina Hastanesi

    Ankara, 06050

    Recruiting

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06800

    Recruiting

  • Firat University Hospital

    Elâzığ, 23200

    Recruiting

  • Sanko Universitesi Hastanesi

    Gaziantep, 27090

    Recruiting

  • Marmara University Istanbul Pendik Education and Research Hospital

    Istanbul, 34899

    Recruiting

  • Izmir Ataturk Egitim ve Arastirma Hastanesi

    Izmir, 35150

    Recruiting

  • Necmettin Erbakan University Meram Medical Faculty

    Konya, 42080

    Recruiting

Other trials in Turkey (Türkiye)

France6 sites, 6 recruiting

  • CHU de Caen

    Caen, 14000

    Recruiting

  • Hopital Michallon CHU Grenoble Alpes

    La Tronche, 38700

    Recruiting

  • Centre Hospitalier Le Mans

    Le Mans, 72037

    Recruiting

  • Hospices Civils de Lyon - HOPITAL DE LA CROIX ROUSSE

    Lyon, 69004

    Recruiting

  • Hopital Cochin

    Paris, 75014

    Recruiting

  • CHU Toulouse - Hopital de Rangueil

    Toulouse, 31400

    Recruiting

Other trials in France

Germany6 sites, 6 recruiting

  • Universitaetsklinikum Carl-Gustav-Carus Dresden

    Dresden, 01307

    Recruiting

  • CAIR Heidelberg

    Heidelberg, 69121

    Recruiting

  • Universitaetsklinikum Leipzig

    Leipzig, 04103

    Recruiting

  • St Elisabeth Hospital Meerbusch Lank

    Meerbusch, 40668

    Recruiting

  • Klinikum der Universitaet Muenchen

    München, 80336

    Recruiting

  • Medicover Muenchen Ost MVZ

    München, 81667

    Recruiting

Other trials in Germany

Malaysia6 sites, 6 recruiting

  • Hospital Sultan Ismail

    Johor Bahru, 81100

    Recruiting

  • Hospital Sultanah Nur Zahirah

    Kuala, 20400

    Recruiting

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

    Recruiting

  • Hospital Umum Sarawak

    Kuching, 93586

    Recruiting

  • Sunway Medical Centre

    Petaling Jaya, 47500

    Recruiting

  • Hospital Taiping

    Taiping, 34000

    Recruiting

Other trials in Malaysia

Mexico6 sites, 6 recruiting

  • Investigación y Biomedicina de Chihuahua

    Chihuahua City, 31000

    Recruiting

  • Medical Care & Research SA de CV

    Mérida, 97070

    Recruiting

  • Centro Medico del Angel

    Mexicali, 21100

    Recruiting

  • RM Pharma Specialists

    Mexico City, 03100

    Recruiting

  • Hospital SMIQ

    Querétaro, 76070

    Recruiting

  • Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi

    San Luis Potosí City, 78213

    Recruiting

Other trials in Mexico

Portugal6 sites, 6 recruiting

  • Uls Almada Seixal - Hosp. Garcia de Orta

    Almada, 2805 267

    Recruiting

  • Uls Sao Jose - Hosp. Curry Cabral

    Lisbon, 1069 166

    Recruiting

  • Uls Santa Maria - Hosp. Santa Maria

    Lisbon, 1649 028

    Recruiting

  • Ulsam - Hosp. Conde de Bertiandos

    Ponte de Lima, 4990-041

    Recruiting

  • Uls Santo Antonio - Hosp. Santo Antonio

    Porto, 4050 342

    Recruiting

  • Uls Gaia Espinho

    Vila Nova de Gaia, 4434 502

    Recruiting

Other trials in Portugal

Taiwan6 sites, 6 recruiting

  • NTU Biomedical Park Hospital

    Hsinchu, 302058

    Recruiting

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 813414

    Recruiting

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

    Recruiting

  • National Taiwan University Hospital

    Taipei, 10043

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Recruiting

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 333

    Recruiting

Other trials in Taiwan

Finland4 sites, 4 recruiting

  • Helsinki University Hospital

    Helsinki, 00290

    Recruiting

  • Paijat Hame Central Hospital

    Lahti, FI-15850

    Recruiting

  • Northern Clinical Trial Coordinators

    Oulu, 90150

    Recruiting

  • Turku University Hospital

    Turku, 20520

    Recruiting

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About this study

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

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).

Being tested
Nipocalimab, Placebo, Standard of care treatment
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NipocalimabDrug

    Nipocalimab will be administered.

  • PlaceboDrug

    Placebo will be administered.

  • Standard of care treatmentDrug

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

Study groups in NCT07438496
Study groupRoleWhat they receive
NipocalimabExperimentalParticipants 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.
Receives: Drug: Nipocalimab; Drug: Standard of care treatment
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Nipocalimab; Drug: Placebo; Drug: Standard of care treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 52

    SLE SRI-4 composite response is a composite response of at least a 4 point reduction in SLE Disease Activity Index 2000 (SLEDAI-2K), no British Isles Lupus Assessment Group-2004 (BILAG-2004) worsening, defined as no new A or less than or equal to <= 1 new B items compared to baseline, no worsening in Physician's Global Assessment (PGA [greater than {>} 10 percent {%} increase from baseline]).

    Measured: Week 52

Secondary outcomes (9)

  1. Percentage of Participants Achieving SRI-4 Composite Response at Week 52 with High Baseline IFN Gene Signature (Interferon [IFN] high)

    SLE SRI-4 composite response is a composite response of at least a 4 point reduction in SLEDAI-2K, no BILAG-2004 worsening, defined as no new A or <= 1 new B items compared to baseline, no worsening in PGA (> 10% increase from baseline). IFN high is defined as elevated peripheral type 1 IFN gene signature at baseline.

    Measured: Week 52

  2. Percentage of Participants Achieving SRI-4 Composite Response at Week 52 with Sustained Reduction in Oral Glucocorticoid (GC) Dose

    SLE SRI-4 composite response is a composite response of at least a 4 point reduction in SLEDAI-2K, no BILAG-2004 worsening, defined as no new A or <= 1 new B items compared to baseline, no worsening in PGA (> 10% increase from baseline). Sustained reduction in oral GC dose at Week 52 is defined as achieving <= 5 mg/day oral prednisone (or equivalent) AND no increase of that dose from Week 32 through Week 52.

    Measured: Week 52

  3. Percentage of Participants Who Achieve Lupus Low Disease Activity State (LLDAS) At Week 52

    LLDAS is defined as follows: SLEDAI-2K <= 4, with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever) and no hemolytic anemia or gastrointestinal activity measured as maintaining a D (no disease activity but suggests the system had previously been affected) or E (no current or previous disease activity) score in BILAG gastrointestinal body system, no new lupus disease activity compared with the previous assessment measured as no new or worsening individual BILAG parameters, physician's global assessment of disease activity <= 1 on a 3-point visual analog scale from no disease activity to severe disease activity, a current prednisolone (or equivalent) dose <= 7.5 milligram (mg) daily and well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents.

    Measured: Week 52

  4. Percentage of Participants with < 2 Active Joints at Week 52 in Participants with >= 2 Active Joints at Baseline

    Percentage of participants with < 2 active joints at Week 52 in participants with >= 2 active joints at baseline will be reported.

    Measured: Week 52

  5. Change From Baseline in Lupus Symptoms Joint Pain Score at Week 52

    Lupus symptoms joint pain score at Week 52 will be reported.

    Measured: Baseline, Week 52

  6. Percentage of Participants Achieving Sustained Reduction in Oral GC Dose at Week 52 in Participants Treated with Oral GC >5 mg/Day Prednisone (or equivalent) at Baseline

    Percentage of participants achieving sustained reduction in oral GC dose at Week 52 in participants treated with oral GC >5 mg/Day prednisone (or equivalent) at baseline will be reported.

    Measured: Week 52

  7. Change from Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT) Fatigue Score at Week 52

    FACIT-Fatigue version 4.0 is a 13-item questionnaire that assesses participant-reported fatigue and its impact upon daily activities and function over the past 7 days. Participants will be asked to answer each question using a 5-point Likert scale (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; and 4=Very much). FACIT-Fatigue has a total score range from 0 to 52, with 0 being the worst possible score and 52 the best.

    Measured: Baseline, Week 52

  8. Percentage of Participants With BILAG Flare Free Status Through Week 52

    A participant has a flare-free status if no flare has been reported during the 52-week treatment period. A flare was defined as either 1 or more new BILAG-2004 A (severe disease activity) or 2 or more new BILAG-2004 B (moderate disease activity) items compared to the previous visit.

    Measured: Up to Week 52

  9. Percentage of Participants Achieving SRI-4 Composite Response at Week 52 with High Baseline Autoantibodies (Autoantibody High)

    SLE SRI-4 composite response is a composite response of at least a 4 point reduction in SLEDAI-2K, no BILAG-2004 worsening, defined as no new A or <= 1 new B items compared to baseline, no worsening in PGA (> 10% increase from baseline). Autoantibody high participants is defined as participants with high autoantibody at baseline.

    Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2026
  2. Study start5 Mar 2026
  3. Primary completion6 Dec 2028 (estimated)
  4. Study completion7 Nov 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned to one of the 2 identical studies (conducted under this single protocol) to make a total of 300 participants in each study. Participants in each study will be randomly assigned to one of the arms nipocalimab or placebo respectively.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07438496
Sponsor's protocol ID
80202135SLE3001
Other IDs
2025-523552-31-00, 2025
Acronym
GARDENIA-SLE
Status last verified
Nov 2026
First submitted
23 Feb 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nipocalimab in people with Lupus Erythematosus, Systemic, run by Janssen Research & Development, LLC at 272 sites in 33 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 272 sites in United States, China, Japan, Brazil, Argentina and 28 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 52 (time frame: Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07438496.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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