A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
GARDENIA-SLE
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
2 other identifiers
interventional
600
29 countries
231
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2026
Longer than P75 for phase_3
231 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2026
CompletedFirst Posted
Study publicly available on registry
February 27, 2026
CompletedStudy Start
First participant enrolled
March 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 6, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 7, 2031
July 31, 2026
July 1, 2026
2.8 years
February 23, 2026
July 30, 2026
Conditions
Outcome Measures
Primary Outcomes (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 \[greater than {\>} 10 percent {%} increase from baseline\]).
Week 52
Secondary Outcomes (9)
Percentage of Participants Achieving SRI-4 Composite Response at Week 52 with High Baseline IFN Gene Signature (Interferon [IFN] high)
Week 52
Percentage of Participants Achieving SRI-4 Composite Response at Week 52 with Sustained Reduction in Oral Glucocorticoid (GC) Dose
Week 52
Percentage of Participants Who Achieve Lupus Low Disease Activity State (LLDAS) At Week 52
Week 52
Percentage of Participants with < 2 Active Joints at Week 52 in Participants with >= 2 Active Joints at Baseline
Week 52
Change From Baseline in Lupus Symptoms Joint Pain Score at Week 52
Baseline, Week 52
- +4 more secondary outcomes
Study Arms (2)
Nipocalimab
EXPERIMENTALParticipants 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.
Placebo
PLACEBO 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.
Interventions
Protocol-defined topical and systemic standard of care background treatments.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (231)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2026
First Posted
February 27, 2026
Study Start
March 5, 2026
Primary Completion (Estimated)
December 6, 2028
Study Completion (Estimated)
November 7, 2031
Last Updated
July 31, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
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