Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
A Phase 3b/4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants With Moderate-to-Severe Plaque Psoriasis
3 other identifiers
interventional
3,040
25 countries
357
Brief Summary
A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2025
Longer than P75 for phase_3
357 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
August 4, 2025
CompletedFirst Posted
Study publicly available on registry
August 12, 2025
CompletedStudy Start
First participant enrolled
September 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 16, 2031
May 7, 2026
May 1, 2026
5.3 years
August 4, 2025
May 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite cardiovascular adjudicated 3-point major adverse cardiovascular event (MACE) plus coronary revascularization
MACE defined as non-fatal myocardial infarction \[MI\], nonfatal stroke, and cardiovascular death
Up to 5 years
Secondary Outcomes (18)
Number of participants with non-fatal MI
Up to 5 years
Number of participants with non-fatal stroke
Up to 5 years
Death due to cardiovascular events
Up to 5 years
Number of participants with coronary revascularization
Up to 5 years
Number of participants with 3-point MACE (non-fatal MI, non-fatal stroke, and cardiovascular death)
Up to 5 years
- +13 more secondary outcomes
Study Arms (2)
Arm A
EXPERIMENTALArm B
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Participants with moderate-to-severe plaque psoriasis:
- Deemed by the Investigator to be a candidate for phototherapy or systemic treatment for psoriasis, including ustekinumab;
- Have at least 1 of the following cardiovascular risk factors:
- Current cigarette smoker
- Diagnosis of hypertension
- Diagnosis of hyperlipidemia
- Diabetes mellitus type 1 or 2
- History of one or more of the following cardiovascular events: Coronary intervention (PCI) or coronary artery bypass grafting (CABG), myocardial infarction (heart attack), cardiac arrest, hospitalization for unstable angina, acute coronary syndrome, stroke, or transient ischemic attack
- Obesity
- Family history of premature coronary heart disease or sudden death in a first-degree male relative younger than 55 years of age or in a first-degree female relative younger than 65 years of age.
You may not qualify if:
- Participants must not have recent history of 1 of the following cardiovascular events: MI, stroke, or coronary revascularization, or VTE within 90 days prior to Day 1.
- Participants must not have unstable CVD, defined as a recent clinical cardiovascular event (eg, unstable angina, rapid atrial fibrillation), or a cardiac hospitalization (eg, pacemaker implantation, HF) within 90 days prior to Day 1.
- Participants must not have evidence of active cancer or history of cancer (solid organ or hematologic malignancy including myelodysplastic syndrome) or lymphoproliferative disease within the previous 5 years (other than resected cutaneous basal cell or squamous cell carcinoma, or carcinoma of cervix in situ that has been treated with no evidence of recurrence).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (357)
Local Institution - 0088
Birmingham, Alabama, 35249, United States
Medical Dermatology Specialists - Phoenix
Phoenix, Arizona, 85006-2722, United States
Saguaro Dermatology - Phoenix
Phoenix, Arizona, 85008, United States
Omni Dermatology
Phoenix, Arizona, 85018, United States
Alliance Dermatology
Phoenix, Arizona, 85032, United States
Local Institution - 0322
Scottsdale, Arizona, 85254, United States
Local Institution - 0188
Scottsdale, Arizona, 85255, United States
Scottsdale Clinical Trials
Scottsdale, Arizona, 85260, United States
Omni Dermatology
Tempe, Arizona, 85282, United States
Clinical Trials Institute of Northwest Arkansas
Fayetteville, Arkansas, 72703-6245, United States
Northwest Arkansas Clinical Trials Center (NWACTC), PLLC
Rogers, Arkansas, 72758, United States
California Dermatology & Clinical Research Institute
Encinitas, California, 92024-7700, United States
T. Joseph Raoof MD Inc
Encino, California, 91436, United States
First OC Dermatology - Fountain Valley
Fountain Valley, California, 92708, United States
Center For Dermatology Clinical Research, Inc.
Fremont, California, 94538, United States
Marvel Clinical Research
Huntington Beach, California, 92647, United States
Dermatology Research Associates - Howard Sofen, MD
Los Angeles, California, 90045, United States
Local Institution - 0192
Los Angeles, California, 90056-1660, United States
Northridge Clinical Trials - Elite Clinical Network
Northridge, California, 91325, United States
Cura Clinical Research - Palmdale
Palmdale, California, 93551, United States
Pasadena Clinical Trials
Pasadena, California, 91101, United States
Empire Clinical Research - Pomona
Pomona, California, 91767, United States
Integrative Skin Science and Research
Sacramento, California, 95815, United States
UC Davis Dermatology Clinic
Sacramento, California, 95816, United States
Local Institution - 0078
San Diego, California, 92123-1523, United States
Cura Clinical Research - Santa Clarita
Santa Clarita, California, 91355, United States
Clinical Science Institute
Santa Monica, California, 90404, United States
Advanced Dermatology and Skin Cancer Institute - Beverly Hills
Sherman Oaks, California, 91403, United States
Unison Clinical Trials
Sherman Oaks, California, 91403, United States
Golden State Dermatology - Ygnacio Valley Road
Walnut Creek, California, 94598-3335, United States
Local Institution - 0494
Castle Rock, Colorado, 80109, United States
Local Institution - 0334
Washington D.C., District of Columbia, 20746, United States
Skin Care Research LLC (SCR) - Boca Raton
Boca Raton, Florida, 33486, United States
Driven Research LLC
Coral Gables, Florida, 33134, United States
Florida Academic Dermatology Center
Coral Gables, Florida, 33134, United States
Accel Research Sites - Maitland Clinical Research Unit
Maitland, Florida, 32751, United States
Miami Dermatology and Laser Research
Miami, Florida, 33133, United States
International GCC Research
Miami, Florida, 33135, United States
BioResearch Partner (BRP) - Miami
Miami, Florida, 33155, United States
Local Institution - 0029
Miami Lakes, Florida, 33014, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
LENUS Research
Sweetwater, Florida, 33172, United States
Local Institution - 0089
Tampa, Florida, 33615, United States
Hamilton Dermatology (Atlanta Dermatology, Vein & Research Center, LLC)
Alpharetta, Georgia, 30022, United States
Local Institution - 0434
Atlanta, Georgia, 30305, United States
Velocity Clinical Research, Savannah
Savannah, Georgia, 31406, United States
Local Institution - 0395
Chicago, Illinois, 60614, United States
Endeavor Health Clinical Trials
Skokie, Illinois, 60077, United States
Deaconess Clinic Downtown
Evansville, Indiana, 47708, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250, United States
Southern Indiana Clinical trials
New Albany, Indiana, 47150, United States
Equity Medical - Bowling Green
Bowling Green, Kentucky, 42104, United States
Physician Skin Care, PLLC
Louisville, Kentucky, 40217, United States
Local Institution - 0030
Owensboro, Kentucky, 42301, United States
Clinical Trials Management, LLC - Northshore Office
Covington, Louisiana, 70433, United States
Shondra L. Smith, MD - Dermatology and Advanced Aesthetics
Lake Charles, Louisiana, 70605, United States
Clinical Trials Management
Metairie, Louisiana, 70006, United States
Local Institution - 0069
New Orleans, Louisiana, 70112, United States
Lawrence J. Green, MD. LLC
Rockville, Maryland, 20850, United States
U.S. Dermatology Partners Rockville
Rockville, Maryland, 20850, United States
Metro Boston Clinical Partners
Brighton, Massachusetts, 02135, United States
Kuchnir Dermatology & Dermatologic Surgery
Milford, Massachusetts, 01757, United States
Local Institution - 0287
Quincy, Massachusetts, 02169-4339, United States
Oakland Hills Dermatology
Auburn Hills, Michigan, 48326-3396, United States
Michigan Center for Skin Care Research
Clinton Township, Michigan, 48038-1137, United States
Somerset Skin Centre
Troy, Michigan, 48084-5260, United States
Michigan Dermatology Institute - Waterford
Waterford, Michigan, 48328-3277, United States
Minnesota Clinical Study Center (MCSC)
New Brighton, Minnesota, 55112, United States
Local Institution - 0433
Columbia, Missouri, 65201-6625, United States
Saint Louis University
St Louis, Missouri, 63110, United States
Local Institution - 0397
Omaha, Nebraska, 68114-2508, United States
Local Institution - 0454
Las Vegas, Nevada, 89145, United States
Las Vegas Clinical Trials, LLC
North Las Vegas, Nevada, 89030-7193, United States
Local Institution - 0097
Portsmouth, New Hampshire, 03801, United States
StracSkin
Portsmouth, New Hampshire, 03801, United States
Local Institution - 0079
Teaneck, New Jersey, 07666, United States
Local Institution - 0359
Verona, New Jersey, 07044, United States
Forest Hills Dermatology Group
Kew Gardens, New York, 11415, United States
The Skin Center Dermatology Group
New City, New York, 10956-7153, United States
Local Institution - 0410
New York, New York, 10029-6574, United States
Skin Search Rochester
Rochester, New York, 14623-1507, United States
Elyse S. Rafal, MD PC - Rafal Center for Dermatology & Cosmetic Surgery
Stony Brook, New York, 11790-2598, United States
Equity Medical - New York
The Bronx, New York, 10455, United States
Accellacare - Cary
Cary, North Carolina, 27518, United States
Local Institution - 0332
Chapel Hill, North Carolina, 27516, United States
Local Institution - 0165
Chapel Hill, North Carolina, 27517, United States
Local Institution - 0406
Hickory, North Carolina, 28602, United States
Wilmington Dermatology Center-WDC Cosmetic and Research
Wilmington, North Carolina, 28405, United States
Local Institution - 0177
Bexley, Ohio, 43209-2421, United States
Local Institution - 0392
Canal Winchester, Ohio, 43110-2069, United States
Apex Clinical Research Center - Canton
Canton, Ohio, 44718, United States
Wright State Physicians
Fairborn, Ohio, 45324, United States
Dermatologists of Southwest Ohio
Mason, Ohio, 45040, United States
Apex Clinical Research Center
Mayfield Heights, Ohio, 44124, United States
Dermatology Partners Inc. - Medina Clinical Research
Medina, Ohio, 44256-9312, United States
Unity Clinical Research (UCR)
Oklahoma City, Oklahoma, 73118-2864, United States
Central Sooner Research (CSR) - Oklahoma City
Oklahoma City, Oklahoma, 73170, United States
Velocity Clinical Research, Medford
Medford, Oregon, 97504, United States
Oregon Medical Research Center
Portland, Oregon, 97201, United States
Oregon Dermatology and Research Center
Portland, Oregon, 97210, United States
Best Skin Research
Camp Hill, Pennsylvania, 17011-2308, United States
Local Institution - 0131
Exton, Pennsylvania, 19341, United States
UPMC Department of Dermatology
Pittsburgh, Pennsylvania, 15213, United States
Palmetto Clinical Trial Services - Administrative Office
Anderson, South Carolina, 29621, United States
Local Institution - 0422
Greenville, South Carolina, 29615, United States
Palmetto Clinical Trial Services - Administrative Office
Greenville, South Carolina, 29615, United States
Local Institution - 0418
North Charleston, South Carolina, 29405, United States
Local Institution - 0084
Rapid City, South Dakota, 57702-9208, United States
Local Institution - 0407
Goodlettsville, Tennessee, 37072-2301, United States
Local Institution - 0338
Hermitage, Tennessee, 37076, United States
International Clinical Research (IC Research) - Murfreesboro
Murfreesboro, Tennessee, 37130, United States
Local Institution - 0408
Nashville, Tennessee, 37205, United States
Arlington Center for Dermatology
Arlington, Texas, 76011, United States
Studies in Dermatology, LLC
Cypress, Texas, 77429, United States
Modern Research Associates, PLLC
Dallas, Texas, 75231, United States
Local Institution - 0468
Dallas, Texas, 75390, United States
Local Institution - 0500
Houston, Texas, 77065, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218, United States
Center For Clinical Studies
Webster, Texas, 77598, United States
Local Institution - 0333
Norfolk, Virginia, 23502, United States
Frontier Dermatology
Mill Creek, Washington, 98012, United States
Premier Clinical Research
Spokane, Washington, 99202, United States
Consultorios Reumatológicos Pampa
C.a.b.a., Buenos Aires, 1428, Argentina
Local Institution - 0429
Buenos Aires, Buenos Aires F.D., C1060ABN, Argentina
Instituto de Neumonologia y Dermatologia
Buenos Aires, Buenos Aires F.D., C1425BEA, Argentina
Buenos Aires Skin S.A
Buenos Aires, C, C1055AAO, Argentina
STAT Research S.A.
Ciudad Autonoma Buenos Aires, C, C1126AAB, Argentina
Psoriahue
Ciudad Autonoma Buenos Aires, C, C1425DKG, Argentina
CEMEDIAB - Centro Medico Diabetologico
Ciudad Autónoma Buenos Aires, C, 1205, Argentina
Derma Internacional S.A.
Autonomous City of Buenos Aires, 1199, Argentina
CONEXA Investigacion Clinica S.A.
Buenos Aires, 1012, Argentina
Hospital De Clinicas - Jose De San Martin
Buenos Aires, C1120AAF, Argentina
Hospital Italiano de Buenos Aires
CABA, 1199, Argentina
Instituto de Investigaciones Clínicas Córdoba S.A.
Córdoba, X5000, Argentina
Viviana Parra Instituto Parra Dermatología
Mendoza, 5500, Argentina
The Skin Hospital
Darlinghurst, New South Wales, 2010, Australia
St George Dermatology & Skin Cancer Centre
Kogarah, New South Wales, 2217, Australia
Local Institution - 0216
Westmead, New South Wales, 2145, Australia
Local Institution - 0311
Woolloongabba, Queensland, 4102, Australia
Veracity Clinical Research Pty Ltd.
Woolloongabba, Queensland, 4102, Australia
Skin Health Institute Inc.
Carlton, Victoria, 3053, Australia
Monash Medical Centre Clayton
Clayton, Victoria, 3168, Australia
Dr Rodney Sinclair Pty Ltd.
East Melbourne, Victoria, 3002, Australia
Local Institution - 0063
Woluwe-Saint-Lambert, BRU, 1200, Belgium
Local Institution - 0243
Maldegem, Oost- Vlaanderen, 9990, Belgium
Local Institution - 0239
Ghent, VOV, 9000, Belgium
Local Institution - 0037
Juiz de Fora, Minas Gerais, 36010-570, Brazil
Local Institution - 0416
Curitiba, Paraná, 80230-130, Brazil
Local Institution - 0384
Curitiba, Paraná, 80730-380, Brazil
Local Institution - 0385
João Pessoa, Paraíba, 58040-020, Brazil
Local Institution - 0390
Porto Alegre, Rio Grande do Sul, 90410-000, Brazil
Centro de Pesquisa Clínica da Associação Hospitalar Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90560-032, Brazil
Faculdade de Medicina da UNESP-Upeclin - Faculdade de Medicina de Botucatu - UNESP
Botucatu, São Paulo, 18618-686, Brazil
Local Institution - 0383
Campinas, São Paulo, 13086-888, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFMRP
Ribeirão Preto, São Paulo, 14051-140, Brazil
Local Institution - 0400
São José do Rio Preto, São Paulo, 15090-000, Brazil
Local Institution - 0490
Vila Clementino, São Paulo-SP, 04038-002, Brazil
Local Institution - 0039
São Paulo, 01323-020, Brazil
Local Institution - 0450
São Paulo, 04075-000, Brazil
Local Institution - 0481
Burgas, 8000, Bulgaria
Local Institution - 0480
Lovech, 5500, Bulgaria
Local Institution - 0479
Pleven, 5800, Bulgaria
Local Institution - 0483
Plovdiv, 4000, Bulgaria
Local Institution - 0486
Plovdiv, 4000, Bulgaria
Local Institution - 0482
Rousse, 7002, Bulgaria
Local Institution - 0487
Sofia, 1404, Bulgaria
Local Institution - 0484
Sofia, 1527, Bulgaria
Local Institution - 0485
Stara Zagora, 6003, Bulgaria
Local Institution - 0126
Calgary, Alberta, T2G 1B1, Canada
Dermatology Research Institute
Calgary, Alberta, T2J 7E1, Canada
Beacon Dermatology
Calgary, Alberta, T3E 0B2, Canada
Laser Rejuvenation Clinics Edmonton D.T. Inc.
Edmonton, Alberta, T5J 3S9, Canada
Stratica Dermatology
Edmonton, Alberta, T5K 1X3, Canada
Alberta Dermasurgery Centre
Edmonton, Alberta, T6G 1C3, Canada
Vida Clinic Research
Edmonton, Alberta, T6H 4J8, Canada
Interior Dermatology Centre
Kelowna, British Columbia, V1W 4V5, Canada
Skin Care West
Nanaimo, British Columbia, V9V 1A3, Canada
Local Institution - 0120
Surrey, British Columbia, V3R 6A7, Canada
Enverus Medical Research
Surrey, British Columbia, V3V 0C6, Canada
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4, Canada
Dr Tracey Brown-Maher Dermatology Clinic and Research Centre
St. John's, Newfoundland and Labrador, A1E 1V4, Canada
CCA Medical Research
Ajax, Ontario, L1S 7K8, Canada
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, L4M 7G1, Canada
Local Institution - 0005
Hamilton, Ontario, L8N 1Y2, Canada
Centricity Research London Victoria Multispecialty
London, Ontario, N6A 2C2, Canada
Lovegrove Dermatology
London, Ontario, N6A 5R9, Canada
DermEffects
London, Ontario, N6H 5L5, Canada
Lynderm Research Inc.
Markham, Ontario, L3P 1X3, Canada
DermEdge
Mississauga, Ontario, L4Y 4C5, Canada
Ryan Clinical Research Inc
Newmarket, Ontario, L3Y 5G8, Canada
North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7, Canada
The Centre for Clinical Trials Inc.
Oakville, Ontario, L6J 7W5, Canada
JRB Research Inc.
Ottawa, Ontario, K1K 4L2, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2, Canada
The Centre for Dermatology
Richmond Hill, Ontario, L4B 1A5, Canada
North York Research Inc.
Toronto, Ontario, M2N 3A6, Canada
Toronto Research Centre
Toronto, Ontario, M3H 5Y8, Canada
Centre de Recherche Saint-Louis
Montreal, Quebec, H1Y 3L1, Canada
Centre de Recherche Saint-Louis
Sherbrooke, Quebec, J1G 1X9, Canada
Sima Recherche
Verdun, Quebec, H4G 3E7, Canada
Centre de Recherche Saint-Louis
Québec, G1W 4R4, Canada
Centro Médico Skin Med
Santiago, Santiago Metropolitan, 7580206, Chile
Clinica Dermacross
Santiago, Santiago Metropolitan, 7640881, Chile
Centro Internacional de Estudios Clinicos
Santiago, Santiago Metropolitan, 8420383, Chile
Medical Skin Center
Viña del Mar, Valparaiso, 2542577, Chile
Local Institution - 0352
Bengbu, Anhui, 233017, China
Local Institution - 0050
Beijing, Beijing Municipality, 100050, China
Local Institution - 0140
Beijing, Beijing Municipality, 100191, China
Local Institution - 0226
Chongqing, Chongqing Municipality, 630014, China
Local Institution - 0049
Fuzhou, FJ, 350005, China
Local Institution - 0353
Guangzhou, Guangdong, 510000, China
Local Institution - 0129
Shenzhen, Guangdong, 518058, China
Local Institution - 0438
Shijiazhuang, Hebei, 50000, China
Local Institution - 0293
Harbin, Heilongjiang, 150081, China
Local Institution - 0439
Zhengzhou, Henan, 450003, China
Local Institution - 0047
Wuhan, Hubei, 430022, China
Local Institution - 0046
Wuhan, Hubei, 430030, China
Local Institution - 0414
Wuhan, Hubei, 430031, China
Local Institution - 0356
Zhenjiang, Jiangsu, 210031, China
Local Institution - 0417
Changchun, Jilin, 130021, China
Local Institution - 0054
Shenyang, Liaoning, 110001, China
Local Institution - 0504
Xi'an, Shaanxi, 710004, China
Local Institution - 0055
Taiyuan, Shan1xi, 030001, China
Local Institution - 0194
Jinan, Shandong, 250012, China
Local Institution - 0108
Jinan, Shandong, 250022, China
Local Institution - 0053
Chengdu, Sichuan Provience, 610041, China
Local Institution - 0044
Hangzhou, Zhejiang, 310006, China
Local Institution - 0277
Hangzhou, Zhejiang, 310009, China
Local Institution - 0052
Ningbo, Zhejiang, 315010, China
Local Institution - 0207
Changsha Shi, 410011, China
Local Institution - 0051
Hangzhou, 310009, China
Local Institution - 0401
Nanjing, 210029, China
Local Institution - 0386
Shenzhen, 518052, China
Local Institution - 0202
Prague, PR, 100 34, Czechia
Local Institution - 0440
Brno, 656 91, Czechia
Local Institution - 0151
Olomouc, 779 00, Czechia
Local Institution - 0389
Prague, 110 00, Czechia
Local Institution - 0121
Prague, 130 00, Czechia
Local Institution - 0502
Prague, 16000, Czechia
Local Institution - 0150
Ústí nad Labem, 401 13, Czechia
Local Institution - 0196
Copenhagen, Capital Region, 2400, Denmark
Local Institution - 0324
Aarhus, 8200, Denmark
Local Institution - 0290
Hellerup, 2900, Denmark
Local Institution - 0457
Herlev, 2730, Denmark
Local Institution - 0238
Nantes, 44093, France
Local Institution - 0153
Nice, 06000, France
Local Institution - 0217
Rennes, 35000, France
Local Institution - 0328
Saint-Pierre (La Réunion), 97448, France
Local Institution - 0101
Freiburg im Breisgau, Baden-Wurttemberg, 79104, Germany
Local Institution - 0127
Langenau, Baden-Wurttemberg, 89129, Germany
Local Institution - 0299
Mahlow, Brandenburg, 15831, Germany
Local Institution - 0117
Witten, Northwest, 58453, Germany
Local Institution - 0237
Mainz, Rhineland-Palatinate, 55101, Germany
Local Institution - 0245
Quedlinburg, Saint, 06484, Germany
Local Institution - 0255
Dresden, Saxony, 01307, Germany
Local Institution - 0382
Leipzig, Saxony, 04103, Germany
Local Institution - 0340
Kiel, Schleswig-Holstein, 24148, Germany
Local Institution - 0291
Berlin, State of Berlin, 10117, Germany
Local Institution - 0476
Berlin, 13086, Germany
Local Institution - 0001
Bramsche, 49565, Germany
Local Institution - 0109
Dresden, 01097, Germany
Local Institution - 0200
Erlangen, 91054, Germany
Local Institution - 0130
Frankfurt am Main, 60590, Germany
Local Institution - 0473
Friedrichshafen, 88045, Germany
Local Institution - 0472
Halle, 06108, Germany
Local Institution - 0471
Hamburg, 20095, Germany
Local Institution - 0106
Heidelberg, 69120, Germany
Local Institution - 0115
Mainz, 55128, Germany
Local Institution - 0112
Memmingen, 87700, Germany
Local Institution - 0295
Merzig, 66663, Germany
Local Institution - 0260
Tübingen, 72076, Germany
Local Institution - 0206
Szeged, Csongrád megye, 6720, Hungary
Local Institution - 0209
Budapest, 1033, Hungary
Local Institution - 0266
Debrecen, 4026, Hungary
Local Institution - 0220
Debrecen, 4027, Hungary
Local Institution - 0404
Veszprém, 8200, Hungary
Local Institution - 0269
L’Aquila, AQ, 67100, Italy
Local Institution - 0305
Modena, MO, 41126, Italy
Local Institution - 0307
Bologna, 40138, Italy
Local Institution - 0249
Naples, 80131, Italy
Local Institution - 0309
Roma, 00168, Italy
Nagoya City University Hospital
Nagoya-sh, Aichi-ken, 467-8602, Japan
Local Institution - 0451
Toyoake Shi, Aichi-ken, 4701192, Japan
Local Institution - 0374
Asahikawa-shi, Hokkaido, 078-8510, Japan
Local Institution - 0378
Suita, Osaka, 565-0871, Japan
Local Institution - 0377
Suita-shi, Osaka, 565-0871, Japan
Local Institution - 0452
Ōtsu, Shiga, 5202192, Japan
St. Luke's International Hospital
Chūōku, Tokyo-to, 104-8560, Japan
Fukuoka University Hospital
Fukuoka, 8140180, Japan
Local Institution - 0376
Gifu, 501-1194, Japan
Teikyo University Hospital
Itabashi-Ku, 173-8605, Japan
Local Institution - 0375
Kanazawa, 920-8641, Japan
Local Institution - 0379
Kurume, Fukuoka, 830-0011, Japan
Local Institution - 0456
Okayama, 700-8558, Japan
Local Institution - 0380
Sakaishi, 593-8324, Japan
Local Institution - 0415
Sakaishi, 593-8324, Japan
Local Institution - 0467
Mexicali, Estado de Baja California, 21100, Mexico
Local Institution - 0321
Guadalajara, Jalisco, 44638, Mexico
Local Institution - 0470
Zapopan, Jalisco, 45190, Mexico
Local Institution - 0113
Monterrey, Nuevo León, 64460, Mexico
Local Institution - 0469
Monterrey, Nuevo León, 64460, Mexico
Local Institution - 0118
Mérida, Yucatán, 97070, Mexico
Local Institution - 0466
Chihuahua City, 31350, Mexico
Local Institution - 0465
Mexico City, 14080, Mexico
Local Institution - 0265
Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland
Local Institution - 0425
Puławy, Lublin Voivodeship, 24-100, Poland
Local Institution - 0424
Warsaw, Masovian Voivodeship, 03-291, Poland
Local Institution - 0252
Rzeszów, Podkarpackie Voivodeship, 35-055, Poland
Local Institution - 0292
Bialystok, Podlaskie Voivodeship, 15-375, Poland
Local Institution - 0195
Katowice, Silesian Voivodeship, 40-081, Poland
Local Institution - 0423
Olsztyn, Warmian-Masurian Voivodeship, 10-117, Poland
Local Institution - 0428
Poznan, Wielkopolska, 60-309, Poland
Local Institution - 0296
Bialystok, 15-351, Poland
Local Institution - 0091
Gdansk, 80-546, Poland
Local Institution - 0444
Gdynia, 81-338, Poland
Local Institution - 0162
Katowice, 40-040, Poland
Local Institution - 0154
Katowice, 40-611, Poland
Local Institution - 0276
Lodz, 90-265, Poland
Local Institution - 0413
Mikołów, 43-190, Poland
Local Institution - 0421
Skierniewice, 96-100, Poland
Local Institution - 0308
Warsaw, 02-951, Poland
Local Institution - 0205
Wroclaw, 51-685, Poland
Local Institution - 0244
Kielce, Świętokrzyskie Voivodeship, 25-316, Poland
Centro Reumatologico Caguas
Caguas, 00725, Puerto Rico
Local Institution - 0405
Craiova, Dolj, 200440, Romania
Local Institution - 0403
Iași, IS, 700401, Romania
Local Institution - 0388
Reghin, MS, 545300, Romania
Local Institution - 0441
Timișoara, Timiș County, 300757, Romania
Local Institution - 0225
Brasov, 500285, Romania
Local Institution - 0412
Bucharest, 011464, Romania
Local Institution - 0402
Bucharest, 020125, Romania
Local Institution - 0398
Constanța, 900591, Romania
Local Institution - 0458
Iași, 707020, Romania
Local Institution - 0065
Seongnam-si, Gyeonggi-do, Gyeonggi-do, 13496, South Korea
Local Institution - 0067
Seongnam-si, 13620, South Korea
Local Institution - 0060
Seoul, 03722, South Korea
Local Institution - 0337
Las Palmas de Gran Canaria, Las Palmas, 35019, Spain
Local Institution - 0242
Alcorcón, Madrid, 28922, Spain
Local Institution - 0445
Málaga, MA, 29016, Spain
Local Institution - 0236
Seville, SE, 41009, Spain
Local Institution - 0258
Madrid, 28041, Spain
Local Institution - 0211
Lund, M, 222 22, Sweden
Local Institution - 0223
Borås, 506 30, Sweden
Kaohsiung Veterans General Hospital
Zuoying Dist, Kaohsiung, 813414, Taiwan
Chang Gung Medical Foundation - Kaohsiung Branch
Niaosong, KHH, 83301, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Mackay Memorial Hospital-Taipei Branch
Taipei, 10449, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Memorial Hospital (CGMH) - Linkou Branch
Taoyuan City, 33305, Taiwan
Velocity Clinical Research - North London
London, Greater London, N3 2JU, United Kingdom
University Hospital Southampton NHS Foundation Trust - Southampton General Hospital
Southampton, Hampshire, SO16 6YD, United Kingdom
Barts Health NHS Trust
London, LND, E11 1NR, United Kingdom
Salford Care Organisation
Salford, SLF, M6 8HD, United Kingdom
Local Institution - 0499
Bristol, South West, BS82RA, United Kingdom
Velocity Clinical Research, High Wycombe
High Wycombe, HP11 2QW, United Kingdom
NHS Fife - Victoria Hospital
Kirkcaldy, KY2 5AH, United Kingdom
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
London, SE1 9RT, United Kingdom
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Central Study Contacts
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain NCT # and Site #.
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2025
First Posted
August 12, 2025
Study Start
September 22, 2025
Primary Completion (Estimated)
January 16, 2031
Study Completion (Estimated)
January 16, 2031
Last Updated
May 7, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See Plan Description
- Access Criteria
- See Plan Description
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html