A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis
2 other identifiers
interventional
1,057
34 countries
448
Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2023
Typical duration for phase_3
448 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 30, 2023
CompletedFirst Posted
Study publicly available on registry
September 6, 2023
CompletedStudy Start
First participant enrolled
October 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 27, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 27, 2027
April 23, 2026
April 1, 2026
4.2 years
August 30, 2023
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of participants that experience spontaneous syncopal events
Cohort 1
At approximately 4 weeks
Absolute change from baseline in forced vital capacity (FVC) measured in mL
Cohort 2
At Week 52
Secondary Outcomes (32)
Number of participants who discontinued treatment due to any low BP-related Adverse Events
Up to approximately 3 years
Disease progression
Up to approximately 3 years
Change from baseline in Living with Pulmonary Fibrosis Questionnaire (L-PF) cough domain score
At Week 52 and up to approximately 3 years
Change from baseline in L-PF dyspnea domain score
At Week 52 and up to approximately 3 years
Change from baseline in walking distance measured in 6-minute walk test (6MWT)
At Week 52
- +27 more secondary outcomes
Study Arms (3)
BMS-986278 Dose 1
EXPERIMENTALBMS-986278 Dose 2
EXPERIMENTALBMS-986278 Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Diagnosis of interstitial lung disease (ILD) with features consistent with progressive ILD within 24 months prior to screening, and ≥ 10% extent of fibrosis on screening high-resolution computed tomography (HRCT).
- If on pirfenidone or nintedanib, participants must have been on a stable dose for at least 90 days prior to screening.
- If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within 28 days prior to screening.
- Mycophenolate mofetil (MMF), mycophenolic acid (MA), azathioprine (AZA), and Tacrolimus are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on MMF, MA, AZA, or tacrolimus, participants must not have taken these medications within 28 days prior to screening.
- Traditional disease-modifying antirheumatic drug (DMARDs) (eg. Methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on traditional DMARD, participants must not have taken these medications within 28 days prior to screening.
- Biologic DMARDs (eg. TNF blockers and IL-1 inhibitors) and Janus kinase inhibitors (JAK inhibitors eg. tofacitinib, upadacitinib) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on Biologic DMARD or JAK inhibitor, participants must not have taken these medications within 28 days prior to screening.
- Women who are of childbearing potential must have a highly effective form of contraception and must provide a negative urine/serum pregnancy test.
- Men who are sexually active with women of childbearing potential agree to use male barrier contraception.
You may not qualify if:
- Idiopathic pulmonary fibrosis with usual interstitial pneumonia (UIP) verification at screening.
- History of stroke or transient ischemic attack within 3 months prior to screening.
- Participants who exhibit symptoms of heart failure at rest.
- Participants who have a current malignancy; a previous malignancy with less than 2 years free of recurrence; and a biopsy that is suspicious for malignancy and the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations.
- Use of systemic corticosteroids equivalent to prednisone \> 15 mg/day is not allowed within 4 weeks prior to screening and during the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (459)
Local Institution - 0046
Birmingham, Alabama, 35294, United States
Local Institution - 0314
Phoenix, Arizona, 85013-4220, United States
Local Institution - 0336
La Jolla, California, 92037-1027, United States
Local Institution - 0212
Los Angeles, California, 90033-5313, United States
Local Institution - 0019
Los Angeles, California, 90095-3075, United States
Local Institution - 0535
Newport Beach, California, 92663-3661, United States
Local Institution - 0366
Orange, California, 92868-3201, United States
Local Institution - 0341
Sacramento, California, 95817, United States
Local Institution - 0015
San Francisco, California, 94143-2202, United States
Local Institution - 0352
Stanford, California, 94305, United States
Local Institution - 0321
Aurora, Colorado, 80045, United States
Local Institution - 0376
Denver, Colorado, 80206, United States
Local Institution - 0211
New Haven, Connecticut, 06510, United States
Local Institution - 0418
Stamford, Connecticut, 06904, United States
Local Institution - 0067
Newark, Delaware, 19713-1337, United States
Local Institution - 0354
Washington D.C., District of Columbia, 20007-2113, United States
Local Institution - 0195
Brandon, Florida, 33511-5706, United States
Local Institution - 0380
Celebration, Florida, 34747-1818, United States
Local Institution - 0013
Clearwater, Florida, 33765, United States
Local Institution - 0396
DeBary, Florida, 32713-1817, United States
Local Institution - 0036
Gainesville, Florida, 32608, United States
Local Institution - 0193
Gainesville, Florida, 32610, United States
Local Institution - 0073
Loxahatchee Groves, Florida, 33411, United States
Local Institution - 0220
Ocala, Florida, 34470, United States
Local Institution - 0452
Pensacola, Florida, 32503, United States
Local Institution - 0389
St. Petersburg, Florida, 33704, United States
Local Institution - 0316
Tampa, Florida, 33601-1289, United States
Local Institution - 0070
Atlanta, Georgia, 30322-1013, United States
Local Institution - 0368
Dublin, Georgia, 31021-2561, United States
Local Institution - 0435
Chicago, Illinois, 60611, United States
Local Institution - 0023
Chicago, Illinois, 60637-1447, United States
Local Institution - 0040
Evanston, Illinois, 60201-1779, United States
Local Institution - 0082
Maywood, Illinois, 60153-3328, United States
Local Institution - 0080
Iowa City, Iowa, 522242-1009, United States
Local Institution - 0049
Kansas City, Kansas, 66103-2937, United States
Local Institution - 0045
Louisville, Kentucky, 40207-4652, United States
Local Institution - 0361
Louisville, Kentucky, 40218-2497, United States
Local Institution - 0305
Baltimore, Maryland, 21201-1544, United States
Local Institution - 0033
Towson, Maryland, 21204-7700, United States
Local Institution - 0404
Boston, Massachusetts, 02114-2621, United States
Local Institution - 0079
Springfield, Massachusetts, 01199-1002, United States
Local Institution - 0207
Ann Arbor, Michigan, 48109-5000, United States
Local Institution - 0031
Detroit, Michigan, 48202, United States
Local Institution - 0050
Grand Rapids, Michigan, 49546-8293, United States
Local Institution - 0509
Royal Oak, Michigan, 48073-6712, United States
Local Institution - 0384
Minneapolis, Minnesota, 55455-4800, United States
Local Institution - 0004
Chesterfield, Missouri, 63017, United States
Local Institution - 0223
St Louis, Missouri, 63110-1010, United States
Local Institution - 0525
Reno, Nevada, 89502-1576, United States
Local Institution - 0068
Mount Kisco, New York, 10549-3417, United States
Local Institution - 0357
New York, New York, 10029-6574, United States
Local Institution - 0428
Durham, North Carolina, 27710, United States
Local Institution - 0392
Wilmington, North Carolina, 28401-7307, United States
Local Institution - 0325
Winston-Salem, North Carolina, 27103, United States
Local Institution - 0419
Cincinnati, Ohio, 45267, United States
Local Institution - 0186
Cleveland, Ohio, 44106, United States
Local Institution - 0209
Columbus, Ohio, 43201, United States
Local Institution - 0343
Toledo, Ohio, 43608-2603, United States
Local Institution - 0198
Oklahoma City, Oklahoma, 73104-5417, United States
Local Institution - 0008
Tulsa, Oklahoma, 74133, United States
Local Institution - 0037
Portland, Oregon, 97239-3011, United States
Local Institution - 0205
Hershey, Pennsylvania, 17033-2360, United States
Local Institution - 0334
Philadelphia, Pennsylvania, 19104-5161, United States
Local Institution - 0348
Philadelphia, Pennsylvania, 19107-5109, United States
Local Institution - 0196
Philadelphia, Pennsylvania, 19140-5103, United States
Local Institution - 0364
Wynnewood, Pennsylvania, 19096, United States
Local Institution - 0531
Anderson, South Carolina, 29621, United States
Local Institution - 0071
Charleston, South Carolina, 29425, United States
Local Institution - 0373
Greenville, South Carolina, 29615, United States
Local Institution - 0363
Nashville, Tennessee, 37204, United States
Local Institution - 0024
Dallas, Texas, 75235-5351, United States
Local Institution - 0317
Dallas, Texas, 75246, United States
Local Institution - 0028
Houston, Texas, 77030-4202, United States
Local Institution - 0041
Houston, Texas, 77030, United States
Local Institution - 0221
McKinney, Texas, 75069, United States
Local Institution - 0217
San Antonio, Texas, 78229-4404, United States
Local Institution - 0014
Salt Lake City, Utah, 84108, United States
Local Institution - 0504
Burlington, Vermont, 05401, United States
Local Institution - 0414
Richmond, Virginia, 23298-5002, United States
Local Institution - 0190
Everett, Washington, 98208-6526, United States
Local Institution - 0043
Seattle, Washington, 98195, United States
Local Institution - 0020
Mar del Plata, Buenos Aires, 7600, Argentina
Local Institution - 0446
San Juan Bautista, Buenos Aires, 1888, Argentina
Local Institution - 0025
Buenos Aires, B, C1426ABO, Argentina
Local Institution - 0039
Caba, B, C1425FVH, Argentina
Local Institution - 0003
Florida, B, 1602, Argentina
Local Institution - 0182
Mar del Plata, B, 7600, Argentina
Local Institution - 0501
Quilmes, Provincia de Buenos Aires, B, 1878, Argentina
Local Institution - 0162
Ciudad Autónoma Buenos Aires, C, 1181, Argentina
Local Institution - 0032
Córdoba, Córdoba Province, K5003DCE, Argentina
Local Institution - 0288
Godoy Cruz, M, 5501, Argentina
Local Institution - 0401
Mendoza, M, M5500, Argentina
Local Institution - 0400
Rosario, S, 2000, Argentina
Local Institution - 0005
San Miguel de Tucuman, Tucumán, T, T4000, Argentina
Local Institution - 0165
Buenos Aires, C1056ABJ, Argentina
Local Institution - 0450
Santa Fe, 3000, Argentina
Local Institution - 0065
Camperdown, New South Wales, 2050, Australia
Local Institution - 0089
Westmead, New South Wales, 2145, Australia
Local Institution - 0090
Brisbane, Queensland, 4032, Australia
Local Institution - 0091
Greenslopes, Queensland, 4120, Australia
Local Institution - 0342
South Brisbane, Queensland, 4101, Australia
Local Institution - 0275
Adelaide, South Australia, 5000, Australia
Local Institution - 0359
Box Hill, Victoria, 3128, Australia
Local Institution - 0299
Heidelberg,VIC, Victoria, 3084, Australia
Local Institution - 0059
Melbourne, Victoria, 3004, Australia
Local Institution - 0303
Murdoch, Western Australia, 6150, Australia
Local Institution - 0459
Nedlands, Western Australia, 6009, Australia
Local Institution - 0474
Salzburg, Salzburger Land, 5020, Austria
Local Institution - 0349
Linz, Upper Austria, 4020, Austria
Local Institution - 0387
Vienna, 1130, Austria
Local Institution - 0475
Vienna, 1210, Austria
Local Institution - 0240
Yvoir, Namur, 5530, Belgium
Local Institution - 0239
Leuven, VBR, 3000, Belgium
Local Institution - 0242
Brussels, 1200, Belgium
Local Institution - 0257
Kortrijk, 8500, Belgium
Local Institution - 0237
Liège, 4000, Belgium
Local Institution - 0038
Belo Horizonte, Minas Gerais, 30130-100, Brazil
Local Institution - 0017
Belo Horizonte, Minas Gerais, 30380 090, Brazil
Local Institution - 0507
Barra Mansa, Rio de Janeiro, 27323-240, Brazil
Local Institution - 0388
Rio de Janeiro, Rio de Janeiro, 20950-003, Brazil
Local Institution - 0243
Porto Alegre, Rio Grande do Sul, 90035-074, Brazil
Local Institution - 0016
Porto Alegre, Rio Grande do Sul, 90160-092, Brazil
Local Institution - 0522
Porto Alegre, Rio Grande do Sul, 91010-004, Brazil
Local Institution - 0048
Blumenau, Santa Catarina, 89030-100, Brazil
Local Institution - 0047
Botucatu, São Paulo, 18618-687, Brazil
Local Institution - 0403
Santo André, São Paulo, 09060-870, Brazil
Local Institution - 0026
São Bernardo do Campo, São Paulo, 09715-090, Brazil
Local Institution - 0042
Porto Alegre, 90610-000, Brazil
Local Institution - 0502
São Paulo, 01327-001, Brazil
Local Institution - 0006
São Paulo, 04032-052, Brazil
Local Institution - 0108
Sherwood Park, Alberta, T8H 0N2, Canada
Local Institution - 0097
Kelowna, British Columbia, V1W 1V3, Canada
Local Institution - 0107
Vancouver, British Columbia, V5Z 1M9, Canada
Local Institution - 0462
Vancouver, British Columbia, V6Z 1Y6, Canada
Local Institution - 0053
Burlington, Ontario, L7N 3V2, Canada
Local Institution - 0111
Hamilton, Ontario, L8N 4A6, Canada
Local Institution - 0075
Owen Sound, Ontario, N4K 6M9, Canada
Local Institution - 0106
Toronto, Ontario, M5T 3A9, Canada
Local Institution - 0440
Montreal, Quebec, H2X 0C1, Canada
Local Institution - 0102
Québec, Quebec, G1V 4G5, Canada
Local Institution - 0514
Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
Local Institution - 0099
Sherbrooke, Quebec, J1H 5N4, Canada
Local Institution - 0074
Trois-Rivières, Quebec, G8T 7A1, Canada
Local Institution - 0492
Trois-Rivières, Quebec, G9S4P3, Canada
Local Institution - 0532
Concepción, Biobio, 4070280, Chile
Local Institution - 0101
Curicó, Maule Region, 3440000, Chile
Local Institution - 0104
Talca, Maule Region, 3466706, Chile
Local Institution - 0109
Santiago, RM, 7620157, Chile
Local Institution - 0112
Santiago, RM, 8320000, Chile
Local Institution - 0094
Quillota, Valparaiso, 2260000, Chile
Local Institution - 0530
Viña del Mar, Valparaiso, 2531172, Chile
Local Institution - 0447
Santiago, 750691, Chile
Local Institution - 0489
Viña del Mar, 1702, Chile
Local Institution - 0087
Hefei, AH, 230022, China
Local Institution - 0113
Beijing, Beijing Municipality, 100020, China
Local Institution - 0086
Beijing, BJ, 100050, China
Local Institution - 0100
Beijing, BJ, 100730, China
Local Institution - 0322
Lanzhou, Gansu, 730000, China
Local Institution - 0431
Guangzhou, GD, 510515, China
Local Institution - 0308
Guangzhou, Guangdong, 510062, China
Local Institution - 0494
Guangzhou, Guangdong, 510120, China
Local Institution - 0085
Shenzhen, Guangdong, 518036, China
Local Institution - 0510
Shenzhen Shi, Guangdong, 518020, China
Local Institution - 0425
Zhengzhou, HA, 450003, China
Local Institution - 0309
Shijiazhuang, Hebi, 50005, China
Local Institution - 0495
Yichang Shi, HE, 443099, China
Local Institution - 0455
Zhengzhou, HN, 450000, China
Local Institution - 0312
Wuhan, Hubei, 430002, China
Local Institution - 0432
Wuhan, HUB, 430060, China
Local Institution - 0458
Suzhou, Jiangsu, 215006, China
Local Institution - 0172
Wuxi, Jiangsu, 214023, China
Local Institution - 0327
Nanjing, JS, 210008, China
Local Institution - 0496
Xuzhou, JS, 221002, China
Local Institution - 0443
Nanchang, JX, 330019, China
Local Institution - 0323
Shenyang, Liaoning, 110001, China
Local Institution - 0497
Shenyang, Liaoning, 110044, China
Local Institution - 0311
Xi'an, Shan3xi, 710117, China
Local Institution - 0329
Shanghai, Shanghai Municipality, 200002, China
Local Institution - 0386
Shanghai, Shanghai Municipality, 200233, China
Local Institution - 0096
Shanghai, Shanghai Municipality, 200433, China
Local Institution - 0098
Shanghai Shi, Shanghai Municipality, 200032, China
Local Institution - 0083
Shanghai Shi, Shanghai Sheng, 200092, China
Local Institution - 0088
Shanghai, SH, 200030, China
Local Institution - 0324
Shanghai, SH, 201112, China
Local Institution - 0318
Chengdu, Sichuan, 610041, China
Local Institution - 0372
Tianjin, Tianjin Municipality, 300052, China
Local Institution - 0326
Tianjin, TJ, 300222, China
Local Institution - 0454
Ningxia, Yinchuan, 750000, China
Local Institution - 0508
Hangzhou, Zhejiang, 310009, China
Local Institution - 0319
Hangzhou, Zhejiang, 310016, China
Local Institution - 0298
Ningbo, Zhejiang, 315010, China
Local Institution - 0429
Hangzhou, ZJ, 310006, China
Local Institution - 0426
Changsha, 410011, China
Local Institution - 0313
Chengdu, 610072, China
Local Institution - 0084
Hefei, 230001, China
Local Institution - 0105
Hohhot, 010010, China
Local Institution - 0433
Jinan, 250033, China
Local Institution - 0434
Shijiazhuang, 050051, China
Local Institution - 0413
Medellín, ANT, 050021, Colombia
Local Institution - 0515
Medellín, ANT, 050034, Colombia
Local Institution - 0168
Manizales, CL, 170004, Colombia
Local Institution - 0402
Bogota, Cundinamarca, 110231, Colombia
Local Institution - 0076
Zipaquirá, Cundinamarca, 250252, Colombia
Local Institution - 0408
Bogotá, DC, 110111, Colombia
Local Institution - 0451
Bogotá, DC, 110131, Colombia
Local Institution - 0175
Floridablanca, Santander Department, 681004, Colombia
Local Institution - 0286
Santiago de Cali, VAC, 760046, Colombia
Local Institution - 0095
Bogotá, 11031, Colombia
Local Institution - 0238
Prague, 140 52, Czechia
Local Institution - 0110
Aarhus, Central Jutland, 8200, Denmark
Local Institution - 0103
Odense C, Region Syddanmark, 5000, Denmark
Local Institution - 0333
Copenhagen, 2100, Denmark
Local Institution - 0092
Hellerup, 2900, Denmark
Local Institution - 0301
Helsinki, Etelae-Suomen Laeaeni, 00029, Finland
Local Institution - 0265
Turku, Laensi-Suomen Laeaeni, 20521, Finland
Local Institution - 0156
Bron, Auvergne-Rhône-Alpes, 69677, France
Local Institution - 0254
Grenoble, Auvergne-Rhône-Alpes, 38043, France
Local Institution - 0534
Angers, Pays de la Loire Region, 49933, France
Local Institution - 0126
Nantes, Pays de la Loire Region, 44093, France
Local Institution - 0279
Marseille, Provence-Alpes-Côte d'Azur Region, 13015, France
Local Institution - 0130
Bobigny, 93009, France
Local Institution - 0278
Brest, 29609, France
Local Institution - 0136
Dijon, 21000, France
Local Institution - 0252
Lille, 59037, France
Local Institution - 0374
Nice, 06000, France
Local Institution - 0260
Pessac, 33604, France
Local Institution - 0146
Toulouse, 31059, France
Local Institution - 0263
Tours, 37044, France
Local Institution - 0236
Paris, Île-de-France Region, 75018, France
Local Institution - 0135
Freiburg I. Breisgau, Baden-Wurttemberg, 79106, Germany
Local Institution - 0125
Wangen I. Allgaeu, Baden-Wurttemberg, 88239, Germany
Local Institution - 0152
Munich, Bavaria, 81377, Germany
Local Institution - 0159
Münnerstadt, Bavaria, 97702, Germany
Local Institution - 0141
Immenhausen, Hesse, 34376, Germany
Local Institution - 0160
Stralsund, Mecklenburg-Vorpommern, 18435, Germany
Local Institution - 0151
Essen, North Rhine-Westphalia, 45239, Germany
Local Institution - 0393
Cologne, Northwest, 50678, Germany
Local Institution - 0142
Münster, Northwest, 48149, Germany
Local Institution - 0154
Berlin, State of Berlin, 14165, Germany
Local Institution - 0132
Ahrensburg, 22926, Germany
Local Institution - 0287
Berlin, 12351, Germany
Local Institution - 0140
Coswig, 01640, Germany
Local Institution - 0248
Hamburg, 20251, Germany
Local Institution - 0340
Heidelberg, 69126, Germany
Local Institution - 0134
Leipzig, 04103, Germany
Local Institution - 0258
Mainz, 55131, Germany
Local Institution - 0244
Marousi, Attica, 15125, Greece
Local Institution - 0115
Ioannina, Epirus, 45500, Greece
Local Institution - 0410
Heraklion, Iraklio Kritis, 715 00, Greece
Local Institution - 0118
Athens, 12462, Greece
Local Institution - 0064
Corfu, 491 00, Greece
Local Institution - 0114
Larissa, 413 34, Greece
Local Institution - 0122
Rio, 26504, Greece
Local Institution - 0268
Thessaloniki, 57010, Greece
Local Institution - 0035
Budapest, 1083, Hungary
Local Institution - 0280
Győr, 9024, Hungary
Local Institution - 0415
Ahmedabad, Gujarat, 380060, India
Local Institution - 0167
Surat, Gujarat, 395010, India
Local Institution - 0246
Belagavi, Karnataka, 590010, India
Local Institution - 0382
Bhopal, Madhya Pradesh, 462001, India
Local Institution - 0335
Nagpur, Maharashtra, 044009, India
Local Institution - 0379
Nagpur, Maharashtra, 440012, India
Local Institution - 0297
Pune, Maharashtra, 411001, India
Local Institution - 0524
Pune, Maharashtra, 411001, India
Local Institution - 0176
Pune, Maharashtra, 411004, India
Local Institution - 0276
Pune, Maharashtra, 411043, India
Local Institution - 0330
New Delhi, National Capital Territory of Delhi, 110017, India
Local Institution - 0421
New Delhi, National Capital Territory of Delhi, 110029, India
Local Institution - 0249
Mohali, Punjab, 160062, India
Local Institution - 0247
Jaipur, Rajasthan, 302018, India
Local Institution - 0266
Jaipur, Rajasthan, 302023, India
Local Institution - 0490
Lucknow, Uttar Pradesh, 226003, India
Local Institution - 0262
Dehradun, Uttarakhand, 248001, India
Local Institution - 0264
Kolkata, West Bengal, 700014, India
Local Institution - 0272
Kolkata, West Bengal, 700027, India
Local Institution - 0291
Bangalore, 560034, India
Local Institution - 0250
Lucknow, 226006, India
Local Institution - 0150
Drogheda, LH, A92 VW28, Ireland
Local Institution - 0513
Dublin, D04 T6F4, Ireland
Local Institution - 0213
Dublin, D15 X40D, Ireland
Local Institution - 0345
Dublin, D24 NR0A, Ireland
Local Institution - 0121
Rehovot, Central District, 76100, Israel
Local Institution - 0339
Beersheba, D, 8410101, Israel
Local Institution - 0116
Haifa, HA, 3436212, Israel
Local Institution - 0027
Be’er Ya‘aqov, M, 7030000, Israel
Local Institution - 0117
Tel Aviv, TA, 6423906, Israel
Local Institution - 0273
Haifa, 3109601, Israel
Local Institution - 0120
Jerusalem, 9112001, Israel
Local Institution - 0119
Petah Tikva, 4941492, Israel
Local Institution - 0139
Ancona, AN, 60126, Italy
Local Institution - 0282
Modena, Emilia-Romagna, 41125, Italy
Local Institution - 0155
Florence, FI, 50134, Italy
Local Institution - 0180
Milan, MI, 20122, Italy
Local Institution - 0251
Milan, MI, 20132, Italy
Local Institution - 0174
Pisa, PI, 56126, Italy
Local Institution - 0137
Roma, RM, 00168, Italy
Local Institution - 0166
Trieste, TS, 34149, Italy
Local Institution - 0123
Bergamo, 24127, Italy
Local Institution - 0011
Foggia, 71122, Italy
Local Institution - 0124
Forlì, 47121, Italy
Local Institution - 0009
Milan, 20142, Italy
Local Institution - 0143
Monza, 20900, Italy
Local Institution - 0267
Naples, 80131, Italy
Local Institution - 0295
Palermo, 90127, Italy
Local Institution - 0290
Pavia, 27100, Italy
Local Institution - 0148
Sassari, 7100, Italy
Local Institution - 0442
Siena, 53100, Italy
Local Institution - 0235
Showa-Ku, Aichi-ken, 466-8560, Japan
Local Institution - 0051
Toyoake-shi, Aichi-ken, 470-1192, Japan
Local Institution - 0061
Chiba, Chiba, 2608677, Japan
Local Institution - 0029
Kamogawa-shi, Chiba, 296-8602, Japan
Local Institution - 0289
Yoshida-gun, Fukui, 910-1193, Japan
Local Institution - 0302
Chikushino-shi, Fukuoka, 8188502, Japan
Local Institution - 0233
Fukuoka, Fukuoka, 8108563, Japan
Local Institution - 0461
Fukuoka, Fukuoka, 812-8582, Japan
Local Institution - 0128
Koriyama-shi, Fukushima, 9630197, Japan
Local Institution - 0001
Naka-gun, Gunma, 3191113, Japan
Local Institution - 0300
Hiroshima, Hirohima-ken, 734-8530, Japan
Local Institution - 0144
Sapporo, Hokkaido, 0608543, Japan
Local Institution - 0063
Sapporo, Hokkaido, 0608648, Japan
Local Institution - 0018
Himeji-Shi, Hyōgo, 670-8520, Japan
Local Institution - 0145
Kobe, Hyōgo, 6500047, Japan
Local Institution - 0261
Sagamihara, Kanagawa, 2520375, Japan
Local Institution - 0307
Matsusaka-shi, Mie-ken, 515-8544, Japan
Local Institution - 0157
Nagasaki, NGS, 852-8501, Japan
Local Institution - 0227
Osakasayama-shi, Osaka, 589-8511, Japan
Local Institution - 0149
Sakai, OSK, 591-8555, Japan
Local Institution - 0138
Hamamatsu, Shizuoka, 431-3192, Japan
Local Institution - 0226
Bunkyō City, TKY, 1138431, Japan
Local Institution - 0034
Shimotsuge-shi, Tochigi, 329-0498, Japan
Local Institution - 0230
Tokushina-Shi, Tokushima, 770-8503, Japan
Local Institution - 0133
Bunkyo-Ku, Tokyo, 113-8519, Japan
Local Institution - 0229
Bunkyo-ku, Tokyo, 113-8603, Japan
Local Institution - 0253
Meguro-ku, Tokyo, 153-8515, Japan
Local Institution - 0010
Minato-ku, Tokyo, 105-8470, Japan
Local Institution - 0234
Minato-ku, Tokyo, 105-8471, Japan
Local Institution - 0310
Mitaka-shi, Tokyo, 181-8611, Japan
Local Institution - 0054
Shinjuku-Ku, Tokyo, 160-0023, Japan
Local Institution - 0320
Shinjuku-ku, Tokyo, 160-8582, Japan
Local Institution - 0055
Shinjuku-Ku, Tokyo, 162-0054, Japan
Local Institution - 0523
Ube-shi, Yamaguchi, 755-0241, Japan
Local Institution - 0228
Bunkyō City, 113-8655, Japan
Local Institution - 0231
Fukuoka, 830-0011, Japan
Local Institution - 0052
Iizuka-shi, 820-8505, Japan
Local Institution - 0127
Izumo-Shi, 693-8501, Japan
Local Institution - 0021
Kumamoto, 861-4193, Japan
Local Institution - 0129
Seto, 489-8642, Japan
Local Institution - 0147
Shinjyu-Ku, 162-8655, Japan
Local Institution - 0328
Takatsuki-Shi, 569-8686, Japan
Local Institution - 0002
Tenri-Shi, 632-8552, Japan
Local Institution - 0158
Tokyo, 143-8541, Japan
Local Institution - 0232
Yokohama, 236-0051, Japan
Local Institution - 0482
Cheras, Kuala Lumpur, 56000, Malaysia
Local Institution - 0480
Kuala Lumpur, Kuala Lumpur, 53000, Malaysia
Local Institution - 0484
Kuching, 93586, Malaysia
Local Institution - 0218
Aguascalientes, Aguascalientes, 20116, Mexico
Local Institution - 0521
México, DIF, 14050, Mexico
Local Institution - 0194
Guadalajara, Jalisco, 44160, Mexico
Local Institution - 0511
Guadalajara, Jalisco, 44340, Mexico
Local Institution - 0355
Morelia, Michoacán, 58260, Mexico
Local Institution - 0375
Oaxaca City, Oaxaca, 68000, Mexico
Local Institution - 0189
Oaxaca City, Oaxaca, 68020, Mexico
Local Institution - 0030
Córdoba, Veracruz, 94550, Mexico
Local Institution - 0406
Mérida, Yucatán, 97070, Mexico
Local Institution - 0405
Mérida, Yucatán, 97300, Mexico
Local Institution - 0493
Chihuahua City, 31200, Mexico
Local Institution - 0362
Guadalajara, 44130, Mexico
Local Institution - 0007
Mexico City, 14080, Mexico
Local Institution - 0315
Leiden, South Holland, 2333 ZA, Netherlands
Local Institution - 0399
Rotterdam, South Holland, 3061BC, Netherlands
Local Institution - 0472
Nieuwegein, Utrecht, 3430, Netherlands
Local Institution - 0350
Amsterdam, 1081 BT, Netherlands
Local Institution - 0338
Amsterdam, North Holland, Netherlands
Local Institution - 0439
Heerlen, 6419 PC, Netherlands
Local Institution - 0369
San Borja, Lima region, 15036, Peru
Local Institution - 0022
Lima, LIM, 15036, Peru
Local Institution - 0409
Lima, LIM, 33, Peru
Local Institution - 0225
San Miguel, LIM, 15088, Peru
Local Institution - 0077
Piura, PIU, 20001, Peru
Local Institution - 0012
Lima, 15073, Peru
Local Institution - 0044
Lima, 31, Peru
Local Institution - 0192
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-065, Poland
Local Institution - 0206
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079, Poland
Local Institution - 0259
Krakow, Lesser Poland Voivodeship, 30-688, Poland
Local Institution - 0201
Bialystok, Podlaskie Voivodeship, 15-044, Poland
Local Institution - 0283
Gdansk, Pomeranian Voivodeship, 80-952, Poland
Local Institution - 0271
Olsztyn, Warmian-Masurian Voivodeship, 10-357, Poland
Local Institution - 0153
Będzin, 42-500, Poland
Local Institution - 0131
Katowice, 40-635, Poland
Local Institution - 0187
Lodz, 90-153, Poland
Local Institution - 0164
Braga, 4710-243, Portugal
Local Institution - 0202
Lisbon, 1169-024, Portugal
Local Institution - 0460
Lisbon, 1350-352, Portugal
Local Institution - 0173
Lisbon, 1769-001, Portugal
Local Institution - 0185
Loures, 2674-514, Portugal
Local Institution - 0199
Porto, 4099-001, Portugal
Local Institution - 0179
Porto, 4200-319, Portugal
Local Institution - 0161
Vila Nova de Gaia, 4434-502, Portugal
Local Institution - 0214
Guaynabo, PR, 968, Puerto Rico
Local Institution - 0081
Goyang-si, Gyeonggi-do, 10380, South Korea
Local Institution - 0430
Goyang-si, Gyeonggi-do, 10475, South Korea
Local Institution - 0306
Jongno-gu, Seoul, 03080, South Korea
Local Institution - 0060
Songpa-gu, Seoul, 138-736, South Korea
Local Institution - 0284
Yongsan-gu, Seoul, 4401, South Korea
Local Institution - 0453
Dong-gu, Ulsan, 44033, South Korea
Local Institution - 0344
Bucheon-si, 14584, South Korea
Local Institution - 0062
Bucheonsi Weonmigu, 14647, South Korea
Local Institution - 0448
Busan, 47392, South Korea
Local Institution - 0058
Gyeonggi-do, 13620, South Korea
Local Institution - 0216
Haeundae-Gu, 48108, South Korea
Local Institution - 0057
Iksansi, 54538, South Korea
Local Institution - 0056
Incheon, 21565, South Korea
Local Institution - 0210
Seoul, 03722, South Korea
Local Institution - 0332
Seoul, 06355, South Korea
Local Institution - 0072
Suwon, 443-380, South Korea
Local Institution - 0169
Badalona, B, 08916, Spain
Local Institution - 0390
Barcelona, B, 08035, Spain
Local Institution - 0178
Santander, CB, 39008, Spain
Local Institution - 0203
Santiago de Compostela, Galicia, 15706, Spain
Local Institution - 0519
Málaga, MA, 29010, Spain
Local Institution - 0177
Madrid, M, 28006, Spain
Local Institution - 0163
Madrid, M, 28040, Spain
Local Institution - 0184
Madrid, M, 28046, Spain
Local Institution - 0188
Majadahonda, M, 28222, Spain
Local Institution - 0208
Oviedo, Principality of Asturias, 33011, Spain
Local Institution - 0197
Valencia, V, 46015, Spain
Local Institution - 0204
Barcelona, 08017, Spain
Local Institution - 0449
Barcelona, 08036, Spain
Local Institution - 0293
Barcelona, 08907, Spain
Local Institution - 0518
Madrid, 28027, Spain
Local Institution - 0274
Madrid, 28040, Spain
Local Institution - 0438
Madrid, 28822, Spain
Local Institution - 0270
Pamplona, 31008, Spain
Local Institution - 0170
Basel, Canton of Basel-City, 4031, Switzerland
Local Institution - 0477
Bern, Canton of Bern, 3010, Switzerland
Local Institution - 0486
Geneva, Canton of Geneva, 1205, Switzerland
Local Institution - 0506
Changhua, CHA, 500, Taiwan
Local Institution - 0500
Kaohsiung City, Kao-Hsiung, 83301, Taiwan
Local Institution - 0255
Kaohsiung City, KHH, 807, Taiwan
Local Institution - 0498
Taichung, TXG, 40447, Taiwan
Local Institution - 0296
Douliu Shi, YUN, 640, Taiwan
Local Institution - 0417
Taichung, 40705, Taiwan
Local Institution - 0269
Taipei, 100, Taiwan
Local Institution - 0277
Taipei, 112, Taiwan
Local Institution - 0191
Bursa, 16059, Turkey (Türkiye)
Local Institution - 0215
Izmir, 35100, Turkey (Türkiye)
Local Institution - 0222
Izmir, 35110, Turkey (Türkiye)
Local Institution - 0281
Topkapı, 34093, Turkey (Türkiye)
Local Institution - 0377
Birmingham, BIR, B9 5SS, United Kingdom
Local Institution - 0337
Cambridge, Cambridgeshire, CB2 0AY, United Kingdom
Local Institution - 0183
Dundee, DND, DD1 9SY, United Kingdom
Local Institution - 0171
Edinburgh, EDH, EH16 4SA, United Kingdom
Local Institution - 0292
London, Greater London, SW3 6NP, United Kingdom
Local Institution - 0370
Oxford, Oxfordshire, OX3 7LE, United Kingdom
Local Institution - 0285
Peterborough, PTE, PE3 9GZ, United Kingdom
Local Institution - 0219
Exeter, South West, EX2 5DW, United Kingdom
Local Institution - 0444
Leeds, West Yorkshire, LS9 7TF, United Kingdom
Local Institution - 0358
Cottingham, Yorkshire and the Humber, HU16 5JQ, United Kingdom
Local Institution - 0394
Birmingham, B15 2WB, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2023
First Posted
September 6, 2023
Study Start
October 25, 2023
Primary Completion (Estimated)
December 27, 2027
Study Completion (Estimated)
December 27, 2027
Last Updated
April 23, 2026
Record last verified: 2026-04
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