A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis

March 20, 2026 updated by: Bristol-Myers Squibb

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

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1255

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.
  • Other protocol-defined Inclusion/Exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BMS-986278 Dose 1
Drug: BMS-986278
Specified dose on specified days
Other Names:
  • Admilparant
Experimental: BMS-986278 Dose 2
Drug: BMS-986278
Specified dose on specified days
Other Names:
  • Admilparant
Placebo Comparator: BMS-986278 Placebo
Drug: BMS-986278 Placebo
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants that experience spontaneous syncopal events
Time Frame: At approximately 4 weeks
Cohort 1
At approximately 4 weeks
Absolute change from baseline in forced vital capacity (FVC) measured in mL
Time Frame: Up to Week 52
Cohort 2
Up to Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame: Up to 28 days after last dose
Cohorts 1 and 2
Up to 28 days after last dose
Number of participants with vital sign abnormalities
Time Frame: Up to 28 days after last dose
Cohorts 1 and 2
Up to 28 days after last dose
Number of participants who discontinued treatment due to any low BP-related Adverse Events
Time Frame: Up to approximately 3 years
Cohort 1
Up to approximately 3 years
Disease progression
Time Frame: Up to approximately 3 years

Cohort 2

Disease progression will be measured by the time to first disease progression event in at least 1 of the following parameters:

  • Absolute percent predicted forced vital capacity (ppFVC) decline of ≥ 10% from baseline
  • Acute exacerbation of pulmonary fibrosis
  • Respiratory-related hospitalization
  • All-cause mortality
Up to approximately 3 years
Time to absolute percent ppFVC decline of ≥ 10% from baseline
Time Frame: Up to approximately 3 years
Cohort 2
Up to approximately 3 years
Time to first acute exacerbation of pulmonary fibrosis
Time Frame: Up to approximately 3 years
Cohort 2
Up to approximately 3 years
Change from baseline in Living with Pulmonary Fibrosis Questionnaire (L-PF) cough domain score
Time Frame: Up to Week 52
Cohort 2
Up to Week 52
Change from baseline in L-PF dyspnea domain score
Time Frame: Up to Week 52
Cohort 2
Up to Week 52
Change from baseline in walking distance measured in 6-minute walk test (6MWT)
Time Frame: Up to Week 52
Cohort 2
Up to Week 52
Time to the first occurrence of any of the components of the composite endpoint: time to first acute exacerbation of pulmonary fibrosis, first Respiratory-related hospitalization, or all-cause mortality
Time Frame: Up to approximately 3 years
Cohort 2
Up to approximately 3 years
Time to first Respiratory-related hospitalization
Time Frame: Up to approximately 3 years
Cohort 2
Up to approximately 3 years
Time to first pulmonary fibrosis-related hospitalization
Time Frame: Up to approximately 3 years
Cohort 2
Up to approximately 3 years
Time to death
Time Frame: Up to approximately 3 years
Cohort 2
Up to approximately 3 years
Change from baseline in L-PF fatigue domain score
Time Frame: Up to Week 52
Cohort 2
Up to Week 52
Change from baseline in L-PF impacts module score
Time Frame: Up to Week 52
Cohort 2
Up to Week 52
Change from baseline in cough numeric rating scale (NRS)
Time Frame: Up to Week 52
Cohort 2
Up to Week 52
Change from baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) health utility index score
Time Frame: Up to Week 52
Cohort 2
Up to Week 52
Change from baseline in EQ-5D-5L visual analog scale score
Time Frame: Up to Week 52
Cohort 2
Up to Week 52
Rate of decline from baseline in FVC (mL)
Time Frame: Up to Week 52
Cohort 2
Up to Week 52
Rate of decline in ppFVC from baseline
Time Frame: Up to Week 52
Cohort 2
Up to Week 52
Change in ppFVC from baseline
Time Frame: Up to Week 52
Cohort 2
Up to Week 52
Proportion of participants with absolute decline in ppFVC ≥10%
Time Frame: Up to Week 52
Cohort 2
Up to Week 52
Proportion of participants with relative decline in ppFVC ≥10%
Time Frame: Up to Week 52
Cohort 2
Up to Week 52
Change from baseline in single-breath diffusing capacity of the lung for carbon monoxide (DLCO SB) (corrected for hemoglobin) (mL/min/mm Hg)
Time Frame: Up to Week 52
Cohort 2
Up to Week 52
Change in percent predicted single breath diffusing capacity of the lung for carbon monoxide (ppDLCO SB) (corrected for hemoglobin) from baseline
Time Frame: Up to Week 52
Cohort 2
Up to Week 52
Change from baseline in quantitative lung fibrosis (QLF) score via high-resolution computed tomography (HRCT)
Time Frame: Up to Week 52
Cohort 2
Up to Week 52
Number of participants with Adverse Events (AEs)
Time Frame: Up to 28 days after last dose
Cohorts 1 and 2
Up to 28 days after last dose
Number of participants with Serious AEs (SAEs)
Time Frame: Up to 28 days after last dose
Cohorts 1 and 2
Up to 28 days after last dose
Number of participants with AEs leading to early discontinuation of investigational medicinal product (IMP)
Time Frame: Up to 28 days after last dose
Cohorts 1 and 2
Up to 28 days after last dose
Number of participants with AEs related to IMP
Time Frame: Up to 28 days after last dose
Cohorts 1 and 2
Up to 28 days after last dose
Number of treatment-emergent deaths
Time Frame: Up to 28 days after last dose
Cohorts 1 and 2
Up to 28 days after last dose
Number of participants with clinical laboratory abnormalities
Time Frame: Up to 28 days after last dose
Cohorts 1 and 2
Up to 28 days after last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2023

Primary Completion (Estimated)

October 6, 2026

Study Completion (Estimated)

June 4, 2027

Study Registration Dates

First Submitted

August 15, 2023

First Submitted That Met QC Criteria

August 15, 2023

First Posted (Actual)

August 22, 2023

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM027-068
  • 2023-503697-21 (Other Identifier: EU CTR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Idiopathic Pulmonary Fibrosis

Clinical Trials on BMS-986278

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe