A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic 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 Idiopathic Pulmonary Fibrosis
2 other identifiers
interventional
1,255
32 countries
380
Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic 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 Sep 2023
Typical duration for phase_3
380 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 15, 2023
CompletedFirst Posted
Study publicly available on registry
August 22, 2023
CompletedStudy Start
First participant enrolled
September 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 6, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 4, 2027
March 24, 2026
March 1, 2026
3.1 years
August 15, 2023
March 20, 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
Up to 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
Up to Week 52
Change from baseline in L-PF dyspnea domain score
Up to Week 52
Change from baseline in walking distance measured in 6-minute walk test (6MWT)
Up to Week 52
- +27 more secondary outcomes
Study Arms (3)
BMS-986278 Dose 1
EXPERIMENTALBMS-986278 Dose 2
EXPERIMENTALBMS-986278 Placebo
PLACEBO COMPARATORInterventions
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- Subjects with IPF aged ≥ 40 years at the time of signing the informed consent.
- Diagnosis of IPF within 7 years prior to screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained at screening and verification of usual interstitial pneumonia.
- 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.
- 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:
- 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 or a previous malignancy with less than 2 years free of recurrence or a biopsy that is suspicious for malignancy and the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (390)
Local Institution - 0189
Birmingham, Alabama, 35294, United States
Local Institution - 0361
Phoenix, Arizona, 85013-4220, United States
Local Institution - 0396
La Jolla, California, 92037-1027, United States
Local Institution - 0193
Los Angeles, California, 90033-5313, United States
Local Institution - 0398
Los Angeles, California, 90095-3075, United States
Local Institution - 0389
Orange, California, 92868-3201, United States
Local Institution - 0405
Sacramento, California, 95817, United States
Local Institution - 0185
San Francisco, California, 94143-2202, United States
Local Institution - 0186
Stanford, California, 94305, United States
Local Institution - 0363
Aurora, Colorado, 80045, United States
Local Institution - 0194
Denver, Colorado, 80206, United States
Local Institution - 0175
New Haven, Connecticut, 06510, United States
Local Institution - 0151
Newark, Delaware, 19713-1337, United States
Local Institution - 0367
Washington D.C., District of Columbia, 20007-2113, United States
Local Institution - 0101
Brandon, Florida, 33511-5706, United States
Local Institution - 0436
Clearwater, Florida, 33765, United States
Local Institution - 0425
DeBary, Florida, 32713-1817, United States
Local Institution - 0079
Gainesville, Florida, 32610, United States
Local Institution - 0352
Hialeah, Florida, 33016, United States
Local Institution - 0370
Kissimmee, Florida, 34746-4654, United States
Local Institution - 0502
Leesburg, Florida, 34748-5077, United States
Local Institution - 0153
Loxahatchee Groves, Florida, 33411, United States
Local Institution - 0187
Ocala, Florida, 34471, United States
Local Institution - 0418
Pensacola, Florida, 32503-2670, United States
Local Institution - 0206
St. Petersburg, Florida, 33704, United States
Local Institution - 0364
Tampa, Florida, 33606, United States
Local Institution - 0372
Dublin, Georgia, 31021-2561, United States
Local Institution - 0178
Chicago, Illinois, 60611, United States
Local Institution - 0183
Chicago, Illinois, 60612-3841, United States
Local Institution - 0058
Chicago, Illinois, 60637, United States
Local Institution - 0085
Maywood, Illinois, 60153-3328, United States
Local Institution - 0325
Peoria, Illinois, 61637-0001, United States
Local Institution - 0180
Iowa City, Iowa, 522242-1009, United States
Local Institution - 0204
Kansas City, Kansas, 66160, United States
Local Institution - 0393
Louisville, Kentucky, 40202-1332, United States
Local Institution - 0354
Baltimore, Maryland, 21201-1544, United States
Local Institution - 0380
Boston, Massachusetts, 02114, United States
Local Institution - 0040
Boston, Massachusetts, 02135-2907, United States
Local Institution - 0472
Ann Arbor, Michigan, 48109-5000, United States
Local Institution - 0096
Chesterfield, Missouri, 63017-3425, United States
Local Institution - 0174
St Louis, Missouri, 63110-1010, United States
Local Institution - 0154
Mount Kisco, New York, 10549-3417, United States
Local Institution - 0433
Durham, North Carolina, 27710, United States
Local Institution - 0366
Wilmington, North Carolina, 28412, United States
Local Institution - 0368
Winston-Salem, North Carolina, 27103, United States
Local Institution - 0201
Cincinnati, Ohio, 45267-0595, United States
Local Institution - 0197
Columbus, Ohio, 43201, United States
Local Institution - 0417
Toledo, Ohio, 43608-2603, United States
Local Institution - 0181
Oklahoma City, Oklahoma, 73104-5417, United States
Local Institution - 0373
Tulsa, Oklahoma, 74133, United States
Local Institution - 0021
Portland, Oregon, 97239-3011, United States
Local Institution - 0067
Hershey, Pennsylvania, 17033-2360, United States
Local Institution - 0406
Philadelphia, Pennsylvania, 19104-5161, United States
Local Institution - 0388
Philadelphia, Pennsylvania, 19107-5109, United States
Local Institution - 0199
Philadelphia, Pennsylvania, 19140-5103, United States
Local Institution - 0202
Pittsburgh, Pennsylvania, 15213, United States
Local Institution - 0346
Wynnewood, Pennsylvania, 19096-3432, United States
Local Institution - 0375
Anderson, South Carolina, 29621, United States
Local Institution - 0188
Charleston, South Carolina, 29425, United States
Local Institution - 0400
Nashville, Tennessee, 37204, United States
Local Institution - 0073
Dallas, Texas, 75235-5351, United States
Local Institution - 0377
Dallas, Texas, 75245-2017, United States
Local Institution - 0039
Houston, Texas, 77030-4202, United States
Local Institution - 0097
Houston, Texas, 77030, United States
Local Institution - 0029
McKinney, Texas, 75069, United States
Local Institution - 0048
San Antonio, Texas, 78229-4404, United States
Local Institution - 0027
Salt Lake City, Utah, 84108, United States
Local Institution - 0184
Richmond, Virginia, 23298, United States
Local Institution - 0191
Everett, Washington, 98208-6526, United States
Local Institution - 0362
Seattle, Washington, 98195, United States
Local Institution - 0131
Mar del Plata, Buenos Aires, 7600, Argentina
Local Institution - 0019
Buenos Aires, B, C1426ABO, Argentina
Local Institution - 0172
Caba, B, C1425FVH, Argentina
Local Institution - 0170
Florida, B, 1602, Argentina
Local Institution - 0286
Mar del Plata, B, 7600, Argentina
Local Institution - 0485
Quilmes, Provincia de Buenos Aires, B, 1878, Argentina
Local Institution - 0290
San Juan Bautista, B, 1853, Argentina
Local Institution - 0288
Ciudad Autónoma Buenos Aires, C, 1181, Argentina
Local Institution - 0287
Godoy Cruz, M, 5501, Argentina
Local Institution - 0013
Mendoza, M, 5500, Argentina
Local Institution - 0356
Mendoza, M, M5500, Argentina
Local Institution - 0330
Rosario, S, 2000, Argentina
Local Institution - 0169
San Miguel de Tucumán, T, T4000, Argentina
Local Institution - 0218
Córdoba, X, X5003DCE, Argentina
Local Institution - 0283
Buenos Aires, C1056ABJ, Argentina
Local Institution - 0173
Santa Fe, 3000, Argentina
Local Institution - 0209
Camperdown, New South Wales, 2050, Australia
Local Institution - 0239
Westmead, New South Wales, 2145, Australia
Local Institution - 0210
Brisbane, Queensland, 4032, Australia
Local Institution - 0229
Greenslopes, Queensland, 4120, Australia
Local Institution - 0421
South Brisbane, Queensland, 4101, Australia
Local Institution - 0309
Adelaide, South Australia, 5000, Australia
Local Institution - 0443
Box Hill, Victoria, 3128, Australia
Local Institution - 0420
Frankston, Victoria, 3199, Australia
Local Institution - 0419
Murdoch, Western Australia, 6150, Australia
Local Institution - 0385
Nedlands, Western Australia, 6009, Australia
Local Institution - 0458
Salzburg, Salzburger Land, 5020, Austria
Local Institution - 0409
Linz, Upper Austria, 4020, Austria
Local Institution - 0025
Vienna, 1130, Austria
Local Institution - 0459
Vienna, 1210, Austria
Local Institution - 0332
Yvoir, Namur, 5530, Belgium
Local Institution - 0075
Brussels, 1200, Belgium
Local Institution - 0345
Kortrijk, 8500, Belgium
Local Institution - 0038
Leuven, 3000, Belgium
Local Institution - 0046
Liège, 4000, Belgium
Local Institution - 0084
Belo Horizonte, Minas Gerais, 30130-100, Brazil
Local Institution - 0098
Belo Horizonte, Minas Gerais, 30380 090, Brazil
Local Institution - 0490
Barra Mansa, Rio de Janeiro, 27323-240, Brazil
Local Institution - 0359
Rio de Janeiro, Rio de Janeiro, 20950-003, Brazil
Local Institution - 0304
Porto Alegre, Rio Grande do Sul, 90035-074, Brazil
Local Institution - 0049
Porto Alegre, Rio Grande do Sul, 90160-093, Brazil
Local Institution - 0307
Porto Alegre, Rio Grande do Sul, 91010-004, Brazil
Local Institution - 0089
Blumenau, Santa Catarina, 89030-100, Brazil
Local Institution - 0054
Santo André, São Paulo, 09060-870, Brazil
Local Institution - 0305
São Bernardo do Campo, São Paulo, 09715-090, Brazil
Local Institution - 0024
São Paulo, São Paulo, 04023-062, Brazil
Local Institution - 0486
São Paulo, 01327-001, Brazil
Local Institution - 0062
Sherwood Park, Alberta, T8H 0N2, Canada
Local Institution - 0100
Kelowna, British Columbia, V1Y 3H5, Canada
Local Institution - 0061
Vancouver, British Columbia, V5Z 1M9, Canada
Local Institution - 0171
Vancouver, British Columbia, V6Z 1Y6, Canada
Local Institution - 0103
Burlington, Ontario, L7N 3V2, Canada
Local Institution - 0216
Hamilton, Ontario, L8N 4A6, Canada
Local Institution - 0044
Owen Sound, Ontario, N4K 6M9, Canada
Local Institution - 0213
Toronto, Ontario, M5T 3A9, Canada
Local Institution - 0426
Greenfield Park, Quebec, J4V 2H1, Canada
Local Institution - 0434
Montreal, Quebec, H2X 0C1, Canada
Local Institution - 0215
Québec, Quebec, G1V 4G5, Canada
Local Institution - 0495
Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
Local Institution - 0053
Trois-Rivières, Quebec, G8T 7A1, Canada
Local Institution - 0478
Trois-Rivières, Quebec, G9S4P3, Canada
Local Institution - 0503
Concepción, Bio Bio, 4070280, Chile
Local Institution - 0437
Curicó, Maule Region, 3440000, Chile
Local Institution - 0211
Talca, Maule Region, 3466706, Chile
Local Institution - 0051
Quillota, Región de Valparaíso, 2260000, Chile
Local Institution - 0068
Santiago, RM, 7620157, Chile
Local Institution - 0214
Santiago, RM, 8320000, Chile
Local Institution - 0263
Hefei, AH, 230001, China
Local Institution - 0222
Hefei, AH, 230022, China
Local Institution - 0410
Hefei, Anhui, 230601, China
Local Institution - 0238
Beijing, Beijing Municipality, 100020, China
Local Institution - 0470
Beijing, BJ, 100050, China
Local Institution - 0257
Beijing, BJ, 100730, China
Local Institution - 0242
Guangzhou, GD, 510515, China
Local Institution - 0480
Guangzhou, Guangdong, 510230, China
Local Institution - 0295
Shenzhen, Guangdong, 518036, China
Local Institution - 0492
Shenzhen Shi, Guangdong, 518020, China
Local Institution - 0294
Zhengzhou, HA, 450003, China
Local Institution - 0360
Zhengzhou, HA, 450052, China
Local Institution - 0233
Shijiazhuang, HE, 050000, China
Local Institution - 0482
Yichang Shi, HE, 443099, China
Local Institution - 0369
Wuhan, Hubei, 430022, China
Local Institution - 0252
Wuhan, HUB, 430060, China
Local Institution - 0424
Suzhou, Jiangsu, 215006, China
Local Institution - 0262
Wuxi, Jiangsu, 214023, China
Local Institution - 0483
Xuzhou, JS, 221002, China
Local Institution - 0431
Nanchang, JX, 330019, China
Local Institution - 0479
Shenyang, Liaoning, 110044, China
Local Institution - 0241
Shenyang, LN, 110001, China
Local Institution - 0292
Shenyang, LN, 110004, China
Local Institution - 0255
Shanghai, SH, 200030, China
Local Institution - 0230
Shanghai, SH, 201112, China
Local Institution - 0243
Chengdu, Sichuan, 610041, China
Local Institution - 0391
Tianjin, Tianjin Municipality, 300052, China
Local Institution - 0365
Tianjin, Tianjin Municipality, 300222, China
Local Institution - 0488
Hangzhou, Zhejiang, 310009, China
Local Institution - 0351
Ningbo, Zhejiang, 315010, China
Local Institution - 0249
Hangzhou, ZJ, 310006, China
Local Institution - 0244
Changsha, 410011, China
Local Institution - 0371
Chengdu, 610072, China
Local Institution - 0258
Guangzhou, 510080, China
Local Institution - 0237
Hohhot, 010010, China
Local Institution - 0403
Jinan, 250012, China
Local Institution - 0358
Nanjing, 210008, China
Local Institution - 0266
Shanghai, 200040, China
Local Institution - 0408
Shanghai, 200233, China
Local Institution - 0232
Shanghai, 200433, China
Local Institution - 0261
Shijiazhuang, 050051, China
Local Institution - 0374
Xi'an, 710100, China
Local Institution - 0297
Medellín, ANT, 050021, Colombia
Local Institution - 0291
Bogotá, DC, 110111, Colombia
Local Institution - 0278
Floridablanca, Santander Department, 681004, Colombia
Local Institution - 0268
Santiago de Cali, VAC, 760046, Colombia
Local Institution - 0138
Bogotá, 11031, Colombia
Local Institution - 0279
Manizales, 17001, Colombia
Local Institution - 0064
Aarhus, Central Jutland, 8200, Denmark
Local Institution - 0010
Odense C, Region Syddanmark, 5000, Denmark
Local Institution - 0036
Hellerup, 2900, Denmark
Local Institution - 0350
Turku, Laensi-Suomen Laeaeni, 20521, Finland
Local Institution - 0328
Helsinki, 00290, Finland
Local Institution - 0047
Bron, Auvergne-Rhône-Alpes, 69677, France
Local Institution - 0322
Grenoble, Auvergne-Rhône-Alpes, 38043, France
Local Institution - 0083
Nantes, Pays de la Loire Region, 44093, France
Local Institution - 0334
Marseille, Provence-Alpes-Côte d'Azur Region, 13015, France
Local Institution - 0012
Angers, 49933, France
Local Institution - 0066
Bobigny, 93000, France
Local Institution - 0321
Brest, 29609, France
Local Institution - 0052
Dijon, 21000, France
Local Institution - 0022
Paris, 75018, France
Local Institution - 0342
Pessac, 33604, France
Local Institution - 0023
Toulouse, 31059, France
Local Institution - 0339
Tours, 37044, France
Local Institution - 0050
Freiburg I. Breisgau, Baden-Wurttemberg, 79106, Germany
Local Institution - 0272
Munich, Bavaria, 81377, Germany
Local Institution - 0042
Münnerstadt, Bavaria, 97702, Germany
Local Institution - 0313
Hamburg, Hamburg, 20246, Germany
Local Institution - 0041
Immenhausen, Hesse, 34376, Germany
Local Institution - 0026
Marburg, Hesse, 35037, Germany
Local Institution - 0092
Essen, North Rhine-Westphalia, 45239, Germany
Local Institution - 0320
Cologne, Northwest, 50678, Germany
Local Institution - 0349
Berlin, State of Berlin, 12351, Germany
Local Institution - 0003
Berlin, State of Berlin, 14165, Germany
Local Institution - 0037
Ahrensburg, 22926, Germany
Local Institution - 0004
Coswig, 01640, Germany
Local Institution - 0383
Heidelberg, 69126, Germany
Local Institution - 0017
Leipzig, 04103, Germany
Local Institution - 0347
Mainz, 55131, Germany
Local Institution - 0314
Marousi, Attica, 15125, Greece
Local Institution - 0318
Pylaia-Chortiatis, B, 570 10, Greece
Local Institution - 0110
Athens, 12462, Greece
Local Institution - 0108
Corfu, 491 00, Greece
Local Institution - 0102
Larissa, 413 34, Greece
Local Institution - 0109
Rio, 26504, Greece
Local Institution - 0018
Budapest, 1083, Hungary
Local Institution - 0343
Győr, 9024, Hungary
Local Institution - 0430
Ahmedabad, Gujarat, 380060, India
Local Institution - 0282
Surat, Gujarat, 395010, India
Local Institution - 0264
Belagavi, Karnataka, 590010, India
Local Institution - 0386
Bhopal, Madhya Pradesh, 462001, India
Local Institution - 0395
Nagpur, Maharashtra, 044009, India
Local Institution - 0414
Nagpur, Maharashtra, 440012, India
Local Institution - 0275
Pune, Maharashtra, 411001, India
Local Institution - 0498
Pune, Maharashtra, 411001, India
Local Institution - 0457
Pune, Maharashtra, 411004, India
Local Institution - 0285
New Delhi, National Capital Territory of Delhi, 110017, India
Local Institution - 0429
New Delhi, National Capital Territory of Delhi, 110029, India
Local Institution - 0428
Mohali, Punjab, 160062, India
Local Institution - 0289
Jaipur, Rajasthan, 302023, India
Local Institution - 0477
Lucknow, Uttar Pradesh, 226003, India
Local Institution - 0247
Dehradun, Uttarakhand, 248001, India
Local Institution - 0225
Kolkata, West Bengal, 700014, India
Local Institution - 0256
Bangalore, 560034, India
Local Institution - 0228
Lucknow, 226006, India
Local Institution - 0168
Drogheda, LH, A92 VW28, Ireland
Local Institution - 0497
Dublin, D04 T6F4, Ireland
Local Institution - 0117
Dublin, D15 X40D, Ireland
Local Institution - 0331
Haifa, HA, 3436212, Israel
Local Institution - 0348
Haifa, 3109601, Israel
Local Institution - 0113
Jerusalem, 91120, Israel
Local Institution - 0319
Petah Tikva, 4941492, Israel
Local Institution - 0035
Rehovot, 7661041, Israel
Local Institution - 0090
Tel Aviv, 64239, Israel
Local Institution - 0329
Bologna, BO, 40138, Italy
Local Institution - 0326
Modena, Emilia-Romagna, 41125, Italy
Local Institution - 0034
Florence, FI, 50134, Italy
Local Institution - 0119
Milan, MI, 20122, Italy
Local Institution - 0127
Pisa, PI, 56126, Italy
Local Institution - 0005
Roma, RM, 00168, Italy
Local Institution - 0095
Ancona, 60126, Italy
Local Institution - 0118
Bergamo, 24127, Italy
Local Institution - 0057
Foggia, 71122, Italy
Local Institution - 0126
Forlì, 47121, Italy
Local Institution - 0069
Milan, 20142, Italy
Local Institution - 0121
Monza, 20900, Italy
Local Institution - 0323
Naples, 80131, Italy
Local Institution - 0125
Palermo, 90127, Italy
Local Institution - 0122
Pavia, 27100, Italy
Local Institution - 0120
Sassari, 7100, Italy
Local Institution - 0114
Siena, 53100, Italy
Local Institution - 0107
Chiba, Chiba, 2608677, Japan
Local Institution - 0088
Fukuoka, Fukuoka, 8108563, Japan
Local Institution - 0442
Fukuoka, Fukuoka, 812-8582, Japan
Local Institution - 0129
Koriyama-shi, Fukushima, 9630197, Japan
Local Institution - 0059
Naka-gun, Gunma, 3191113, Japan
Local Institution - 0355
Hiroshima, Hirohima-ken, 734-8530, Japan
Local Institution - 0132
Sapporo, Hokkaido, 0608543, Japan
Local Institution - 0031
Himeji-Shi, Hyōgo, 670-8520, Japan
Local Institution - 0030
Kobe, Hyōgo, 6500047, Japan
Local Institution - 0353
Matsusaka-shi, Mie-ken, 515-8544, Japan
Local Institution - 0077
Nagasaki, NGS, 852-8501, Japan
Local Institution - 0106
Ginowan-Shi, Okinawa, 901-2214, Japan
Local Institution - 0299
Osakasayama-shi, Osaka, 589-8511, Japan
Local Institution - 0274
Sakai, OSK, 591-8555, Japan
Local Institution - 0123
Hamamatsu, Shizuoka, 431-3192, Japan
Local Institution - 0105
Bunkyō City, TKY, 1138431, Japan
Local Institution - 0009
Shimotsuge-shi, Tochigi, 329-0498, Japan
Local Institution - 0124
Bunkyo-Ku, Tokyo, 113-8519, Japan
Local Institution - 0226
Bunkyo-ku, Tokyo, 113-8603, Japan
Local Institution - 0302
Mitaka-shi, Tokyo, 181-8611, Japan
Local Institution - 0251
Shinjuku-Ku, Tokyo, 160-0023, Japan
Local Institution - 0301
Fukuoka, 830-0011, Japan
Local Institution - 0111
Iizuka-shi, 820-8505, Japan
Local Institution - 0130
Izumo-Shi, 693-8501, Japan
Local Institution - 0011
Kamogawa-Shi, 296-0041, Japan
Local Institution - 0086
Kumamoto, 861-4101, Japan
Local Institution - 0033
Minatoku, 105-8470, Japan
Local Institution - 0300
Minatoku, 105-8471, Japan
Local Institution - 0045
Nagoya, 466-8550, Japan
Local Institution - 0015
Seto, 489-8642, Japan
Local Institution - 0074
Shinjyu-Ku, 162-8655, Japan
Local Institution - 0056
Tenri-Shi, 632-8552, Japan
Local Institution - 0128
Tokyo, 143-8541, Japan
Local Institution - 0298
Yokohama, 236-0051, Japan
Local Institution - 0260
Yoshida-Gun, 910-1193, Japan
Local Institution - 0324
Metepec, Edo de Mexico, 52170, Mexico
Local Institution - 0382
Morelia, Michoacán, 58260, Mexico
Local Institution - 0167
Oaxaca City, Oaxaca, 68020, Mexico
Local Institution - 0394
Rotterdam, South Holland, 3061BC, Netherlands
Local Institution - 0379
Amsterdam, 1081 BT, Netherlands
Local Institution - 0152
Heerlen, 6419 PC, Netherlands
Local Institution - 0456
Nieuwegein, 3430 EM, Netherlands
Local Institution - 0220
Lima, LIM, 33, Peru
Local Institution - 0144
San Miguel, LIM, 15088, Peru
Local Institution - 0007
Lima, 31, Peru
Local Institution - 0143
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-065, Poland
Local Institution - 0145
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079, Poland
Local Institution - 0147
Bialystok, Podlaskie Voivodeship, 15-044, Poland
Local Institution - 0333
Gdansk, Pomeranian Voivodeship, 80-952, Poland
Local Institution - 0306
Olsztyn, Warmian-Masurian Voivodeship, 10-357, Poland
Local Institution - 0159
Lodz, 90-153, Poland
Local Institution - 0002
Faro, 8000-386, Portugal
Local Institution - 0139
Lisbon, 1169-024, Portugal
Local Institution - 0142
Lisbon, 1350-345, Portugal
Local Institution - 0028
Lisbon, 1769-001, Portugal
Local Institution - 0134
Loures, 2674-514, Portugal
Local Institution - 0137
Porto, 4099-001, Portugal
Local Institution - 0165
Porto, 4200-319, Portugal
Local Institution - 0158
Vila Nova de Gaia, 4434-502, Portugal
Local Institution - 0198
Guaynabo, PR, 968, Puerto Rico
Local Institution - 0240
Goyang-si, Gyeonggi-do, 10380, South Korea
Local Institution - 0271
Goyang-si, Gyeonggi-do, 10475, South Korea
Local Institution - 0224
Jongno-gu, Seoul, 03080, South Korea
Local Institution - 0276
Yongsan-gu, Seoul, 4401, South Korea
Local Institution - 0441
Dong-gu, Ulsan, 44033, South Korea
Local Institution - 0404
Bucheon-si, 14584, South Korea
Local Institution - 0227
Bucheonsi Weonmigu, 14647, South Korea
Local Institution - 0440
Busan, 47392, South Korea
Local Institution - 0284
Donggu, 44033, South Korea
Local Institution - 0250
Gyeonggi-do, 13620, South Korea
Local Institution - 0231
Haeundae-Gu, 48108, South Korea
Local Institution - 0246
Iksansi, 54538, South Korea
Local Institution - 0269
Incheon, 21565, South Korea
Local Institution - 0265
Seoul, 03722, South Korea
Local Institution - 0221
Seoul, 05505, South Korea
Local Institution - 0273
Suwon, Gyeonggi-do, 16499, South Korea
Local Institution - 0093
Santander, CB, 39008, Spain
Local Institution - 0140
Santiago de Compostela, C, 15706, Spain
Local Institution - 0099
Madrid, M, 28006, Spain
Local Institution - 0065
Madrid, M, 28040, Spain
Local Institution - 0161
Madrid, M, 28046, Spain
Local Institution - 0149
Majadahonda, M, 28222, Spain
Local Institution - 0135
Barcelona, 08036, Spain
Local Institution - 0341
Barcelona, 08907, Spain
Local Institution - 0166
Girona, 17001, Spain
Local Institution - 0496
Madrid, 28027, Spain
Local Institution - 0338
Madrid, 28040, Spain
Local Institution - 0155
Madrid, 28822, Spain
Local Institution - 0146
Oviedo, 33011, Spain
Local Institution - 0335
Pamplona, 31008, Spain
Local Institution - 0160
Basel, Canton of Basel-City, 4031, Switzerland
Local Institution - 0461
Bern, Canton of Bern, 3010, Switzerland
Local Institution - 0473
Geneva, Canton of Geneva, 1205, Switzerland
Local Institution - 0491
Changhua, CHA, 500, Taiwan
Local Institution - 0481
Kaohsiung City, Kao-Hsiung, 83301, Taiwan
Local Institution - 0484
Taichung, TXG, 40447, Taiwan
Local Institution - 0235
Douliu Shi, YUN, 640, Taiwan
Local Institution - 0259
Kaohsiung City, 807, Taiwan
Local Institution - 0270
New Taipei City, 220, Taiwan
Local Institution - 0267
Taichung, 40705, Taiwan
Local Institution - 0254
Taipei, 100, Taiwan
Local Institution - 0236
Taipei, 112, Taiwan
Local Institution - 0176
Gümüşhane, Gümüşhane Province, 29000, Turkey (Türkiye)
Local Institution - 0177
Ankara, 6590, Turkey (Türkiye)
Local Institution - 0150
Bursa, 16059, Turkey (Türkiye)
Local Institution - 0205
Izmir, 35100, Turkey (Türkiye)
Local Institution - 0207
Izmir, 35110, Turkey (Türkiye)
Local Institution - 0196
Maltepe, 34844, Turkey (Türkiye)
Local Institution - 0200
Pasaport, 35210, Turkey (Türkiye)
Local Institution - 0344
Topkapı, 34093, Turkey (Türkiye)
Local Institution - 0378
Birmingham, BIR, B9 5SS, United Kingdom
Local Institution - 0415
Bristol, BST, BS10 5NB, United Kingdom
Local Institution - 0402
Cambridge, Cambridgeshire, CB2 0AY, United Kingdom
Local Institution - 0164
Dundee, DND, DD1 9SY, United Kingdom
Local Institution - 0072
Edinburgh, EDH, EH16 4SA, United Kingdom
Local Institution - 0337
London, Greater London, SW3 6HP, United Kingdom
Local Institution - 0407
Oxford, Oxfordshire, OX3 7LE, United Kingdom
Local Institution - 0336
Peterborough, PTE, PE3 9GZ, United Kingdom
Local Institution - 0416
Cottingham, Yorkshire and the Humber, HU16 5JQ, United Kingdom
Local Institution - 0411
Birmingham, B15 2WB, United Kingdom
Local Institution - 0438
Leeds, LS9 7TF, 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 15, 2023
First Posted
August 22, 2023
Study Start
September 14, 2023
Primary Completion (Estimated)
October 6, 2026
Study Completion (Estimated)
June 4, 2027
Last Updated
March 24, 2026
Record last verified: 2026-03
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