AzTrials
AzTrials

Idiopathic Pulmonary FibrosisPhase 3NCT06003426

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

A Phase 3 study testing BMS-986278 in people with Idiopathic Pulmonary Fibrosis, run by Bristol-Myers Squibb at 390 sites in 33 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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

Who is it for?
Ages 40 years and older
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
BMS-986278
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,255 participants
Where
390 sitesin 33 countries
Study dates
14 Sep 2023to 4 Jun 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

390 sites in 33 countries.

390 sites in 33 countries

United States70 sites

  • Local Institution - 0375

    Anderson, South Carolina, 29621

  • Local Institution - 0472

    Ann Arbor, Michigan, 48109-5000

  • Local Institution - 0363

    Aurora, Colorado, 80045

  • Local Institution - 0354

    Baltimore, Maryland, 21201-1544

  • Local Institution - 0189

    Birmingham, Alabama, 35294

  • Local Institution - 0380

    Boston, Massachusetts, 02114

  • Local Institution - 0040

    Boston, Massachusetts, 02135-2907

  • Local Institution - 0101

    Brandon, Florida, 33511-5706

  • Local Institution - 0188

    Charleston, South Carolina, 29425

  • Local Institution - 0096

    Chesterfield, Missouri, 63017-3425

  • Local Institution - 0178

    Chicago, Illinois, 60611

  • Local Institution - 0183

    Chicago, Illinois, 60612-3841

  • Local Institution - 0058

    Chicago, Illinois, 60637

  • Local Institution - 0201

    Cincinnati, Ohio, 45267-0595

  • Local Institution - 0436

    Clearwater, Florida, 33765

  • Local Institution - 0197

    Columbus, Ohio, 43201

  • Local Institution - 0073

    Dallas, Texas, 75235-5351

  • Local Institution - 0377

    Dallas, Texas, 75245-2017

  • Local Institution - 0425

    DeBary, Florida, 32713-1817

  • Local Institution - 0194

    Denver, Colorado, 80206

  • Local Institution - 0372

    Dublin, Georgia, 31021-2561

  • Local Institution - 0433

    Durham, North Carolina, 27710

  • Local Institution - 0191

    Everett, Washington, 98208-6526

  • Local Institution - 0079

    Gainesville, Florida, 32610

  • Local Institution - 0067

    Hershey, Pennsylvania, 17033-2360

  • Local Institution - 0352

    Hialeah, Florida, 33016

  • Local Institution - 0039

    Houston, Texas, 77030-4202

  • Local Institution - 0097

    Houston, Texas, 77030

  • Local Institution - 0180

    Iowa City, Iowa, 522242-1009

  • Local Institution - 0204

    Kansas City, Kansas, 66160

  • Local Institution - 0370

    Kissimmee, Florida, 34746-4654

  • Local Institution - 0396

    La Jolla, California, 92037-1027

  • Local Institution - 0502

    Leesburg, Florida, 34748-5077

  • Local Institution - 0193

    Los Angeles, California, 90033-5313

  • Local Institution - 0398

    Los Angeles, California, 90095-3075

  • Local Institution - 0393

    Louisville, Kentucky, 40202-1332

  • Local Institution - 0153

    Loxahatchee Groves, Florida, 33411

  • Local Institution - 0085

    Maywood, Illinois, 60153-3328

  • Local Institution - 0029

    McKinney, Texas, 75069

  • Local Institution - 0154

    Mount Kisco, New York, 10549-3417

  • Local Institution - 0400

    Nashville, Tennessee, 37204

  • Local Institution - 0175

    New Haven, Connecticut, 06510

  • Local Institution - 0151

    Newark, Delaware, 19713-1337

  • Local Institution - 0187

    Ocala, Florida, 34471

  • Local Institution - 0181

    Oklahoma City, Oklahoma, 73104-5417

  • Local Institution - 0389

    Orange, California, 92868-3201

  • Local Institution - 0418

    Pensacola, Florida, 32503-2670

  • Local Institution - 0325

    Peoria, Illinois, 61637-0001

  • Local Institution - 0406

    Philadelphia, Pennsylvania, 19104-5161

  • Local Institution - 0388

    Philadelphia, Pennsylvania, 19107-5109

  • Local Institution - 0199

    Philadelphia, Pennsylvania, 19140-5103

  • Local Institution - 0361

    Phoenix, Arizona, 85013-4220

  • Local Institution - 0202

    Pittsburgh, Pennsylvania, 15213

  • Local Institution - 0021

    Portland, Oregon, 97239-3011

  • Local Institution - 0184

    Richmond, Virginia, 23298

  • Local Institution - 0405

    Sacramento, California, 95817

  • Local Institution - 0027

    Salt Lake City, Utah, 84108

  • Local Institution - 0048

    San Antonio, Texas, 78229-4404

  • Local Institution - 0185

    San Francisco, California, 94143-2202

  • Local Institution - 0362

    Seattle, Washington, 98195

  • Local Institution - 0174

    St Louis, Missouri, 63110-1010

  • Local Institution - 0206

    St. Petersburg, Florida, 33704

  • Local Institution - 0186

    Stanford, California, 94305

  • Local Institution - 0364

    Tampa, Florida, 33606

  • Local Institution - 0417

    Toledo, Ohio, 43608-2603

  • Local Institution - 0373

    Tulsa, Oklahoma, 74133

  • Local Institution - 0367

    Washington D.C., District of Columbia, 20007-2113

  • Local Institution - 0366

    Wilmington, North Carolina, 28412

  • Local Institution - 0368

    Winston-Salem, North Carolina, 27103

  • Local Institution - 0346

    Wynnewood, Pennsylvania, 19096-3432

Other trials in United States

China42 sites

  • Local Institution - 0238

    Beijing, Beijing Municipality, 100020

  • Local Institution - 0470

    Beijing, BJ, 100050

  • Local Institution - 0257

    Beijing, BJ, 100730

  • Local Institution - 0244

    Changsha, 410011

  • Local Institution - 0243

    Chengdu, Sichuan, 610041

  • Local Institution - 0371

    Chengdu, 610072

  • Local Institution - 0242

    Guangzhou, GD, 510515

  • Local Institution - 0480

    Guangzhou, Guangdong, 510230

  • Local Institution - 0258

    Guangzhou, 510080

  • Local Institution - 0488

    Hangzhou, Zhejiang, 310009

  • Local Institution - 0249

    Hangzhou, ZJ, 310006

  • Local Institution - 0263

    Hefei, AH, 230001

  • Local Institution - 0222

    Hefei, AH, 230022

  • Local Institution - 0410

    Hefei, Anhui, 230601

  • Local Institution - 0237

    Hohhot, 010010

  • Local Institution - 0403

    Jinan, 250012

  • Local Institution - 0431

    Nanchang, JX, 330019

  • Local Institution - 0358

    Nanjing, 210008

  • Local Institution - 0351

    Ningbo, Zhejiang, 315010

  • Local Institution - 0255

    Shanghai, SH, 200030

  • Local Institution - 0230

    Shanghai, SH, 201112

  • Local Institution - 0266

    Shanghai, 200040

  • Local Institution - 0408

    Shanghai, 200233

  • Local Institution - 0232

    Shanghai, 200433

  • Local Institution - 0479

    Shenyang, Liaoning, 110044

  • Local Institution - 0241

    Shenyang, LN, 110001

  • Local Institution - 0292

    Shenyang, LN, 110004

  • Local Institution - 0295

    Shenzhen, Guangdong, 518036

  • Local Institution - 0492

    Shenzhen Shi, Guangdong, 518020

  • Local Institution - 0233

    Shijiazhuang, HE, 050000

  • Local Institution - 0261

    Shijiazhuang, 050051

  • Local Institution - 0424

    Suzhou, Jiangsu, 215006

  • Local Institution - 0391

    Tianjin, Tianjin Municipality, 300052

  • Local Institution - 0365

    Tianjin, Tianjin Municipality, 300222

  • Local Institution - 0369

    Wuhan, Hubei, 430022

  • Local Institution - 0252

    Wuhan, HUB, 430060

  • Local Institution - 0262

    Wuxi, Jiangsu, 214023

  • Local Institution - 0374

    Xi'an, 710100

  • Local Institution - 0483

    Xuzhou, JS, 221002

  • Local Institution - 0482

    Yichang Shi, HE, 443099

  • Local Institution - 0294

    Zhengzhou, HA, 450003

  • Local Institution - 0360

    Zhengzhou, HA, 450052

Other trials in China

Japan35 sites

  • Local Institution - 0105

    Bunkyō City, TKY, 1138431

  • Local Institution - 0226

    Bunkyo-ku, Tokyo, 113-8603

  • Local Institution - 0124

    Bunkyo-Ku, Tokyo, 113-8519

  • Local Institution - 0107

    Chiba, Chiba, 2608677

  • Local Institution - 0088

    Fukuoka, Fukuoka, 8108563

  • Local Institution - 0442

    Fukuoka, Fukuoka, 812-8582

  • Local Institution - 0301

    Fukuoka, 830-0011

  • Local Institution - 0106

    Ginowan-Shi, Okinawa, 901-2214

  • Local Institution - 0123

    Hamamatsu, Shizuoka, 431-3192

  • Local Institution - 0031

    Himeji-Shi, Hyōgo, 670-8520

  • Local Institution - 0355

    Hiroshima, Hirohima-ken, 734-8530

  • Local Institution - 0111

    Iizuka-shi, 820-8505

  • Local Institution - 0130

    Izumo-Shi, 693-8501

  • Local Institution - 0011

    Kamogawa-Shi, 296-0041

  • Local Institution - 0030

    Kobe, Hyōgo, 6500047

  • Local Institution - 0129

    Koriyama-shi, Fukushima, 9630197

  • Local Institution - 0086

    Kumamoto, 861-4101

  • Local Institution - 0353

    Matsusaka-shi, Mie-ken, 515-8544

  • Local Institution - 0033

    Minatoku, 105-8470

  • Local Institution - 0300

    Minatoku, 105-8471

  • Local Institution - 0302

    Mitaka-shi, Tokyo, 181-8611

  • Local Institution - 0077

    Nagasaki, NGS, 852-8501

  • Local Institution - 0045

    Nagoya, 466-8550

  • Local Institution - 0059

    Naka-gun, Gunma, 3191113

  • Local Institution - 0299

    Osakasayama-shi, Osaka, 589-8511

  • Local Institution - 0274

    Sakai, OSK, 591-8555

  • Local Institution - 0132

    Sapporo, Hokkaido, 0608543

  • Local Institution - 0015

    Seto, 489-8642

  • Local Institution - 0009

    Shimotsuge-shi, Tochigi, 329-0498

  • Local Institution - 0251

    Shinjuku-Ku, Tokyo, 160-0023

  • Local Institution - 0074

    Shinjyu-Ku, 162-8655

  • Local Institution - 0056

    Tenri-Shi, 632-8552

  • Local Institution - 0128

    Tokyo, 143-8541

  • Local Institution - 0298

    Yokohama, 236-0051

  • Local Institution - 0260

    Yoshida-Gun, 910-1193

Other trials in Japan

India18 sites

  • Local Institution - 0430

    Ahmedabad, Gujarat, 380060

  • Local Institution - 0256

    Bangalore, 560034

  • Local Institution - 0264

    Belagavi, Karnataka, 590010

  • Local Institution - 0386

    Bhopal, Madhya Pradesh, 462001

  • Local Institution - 0247

    Dehradun, Uttarakhand, 248001

  • Local Institution - 0289

    Jaipur, Rajasthan, 302023

  • Local Institution - 0225

    Kolkata, West Bengal, 700014

  • Local Institution - 0477

    Lucknow, Uttar Pradesh, 226003

  • Local Institution - 0228

    Lucknow, 226006

  • Local Institution - 0428

    Mohali, Punjab, 160062

  • Local Institution - 0395

    Nagpur, Maharashtra, 044009

  • Local Institution - 0414

    Nagpur, Maharashtra, 440012

  • Local Institution - 0285

    New Delhi, National Capital Territory of Delhi, 110017

  • Local Institution - 0429

    New Delhi, National Capital Territory of Delhi, 110029

  • Local Institution - 0275

    Pune, Maharashtra, 411001

  • Local Institution - 0498

    Pune, Maharashtra, 411001

  • Local Institution - 0457

    Pune, Maharashtra, 411004

  • Local Institution - 0282

    Surat, Gujarat, 395010

Other trials in India

Italy17 sites

  • Local Institution - 0095

    Ancona, 60126

  • Local Institution - 0118

    Bergamo, 24127

  • Local Institution - 0329

    Bologna, BO, 40138

  • Local Institution - 0034

    Florence, FI, 50134

  • Local Institution - 0057

    Foggia, 71122

  • Local Institution - 0126

    Forlì, 47121

  • Local Institution - 0119

    Milan, MI, 20122

  • Local Institution - 0069

    Milan, 20142

  • Local Institution - 0326

    Modena, Emilia-Romagna, 41125

  • Local Institution - 0121

    Monza, 20900

  • Local Institution - 0323

    Naples, 80131

  • Local Institution - 0125

    Palermo, 90127

  • Local Institution - 0122

    Pavia, 27100

  • Local Institution - 0127

    Pisa, PI, 56126

  • Local Institution - 0005

    Roma, RM, 00168

  • Local Institution - 0120

    Sassari, 7100

  • Local Institution - 0114

    Siena, 53100

Other trials in Italy

Argentina16 sites

  • Local Institution - 0019

    Buenos Aires, B, C1426ABO

  • Local Institution - 0283

    Buenos Aires, C1056ABJ

  • Local Institution - 0172

    Caba, B, C1425FVH

  • Local Institution - 0288

    Ciudad Autónoma Buenos Aires, C, 1181

  • Local Institution - 0218

    Córdoba, X, X5003DCE

  • Local Institution - 0170

    Florida, B, 1602

  • Local Institution - 0287

    Godoy Cruz, M, 5501

  • Local Institution - 0131

    Mar del Plata, Buenos Aires, 7600

  • Local Institution - 0286

    Mar del Plata, B, 7600

  • Local Institution - 0013

    Mendoza, M, 5500

  • Local Institution - 0356

    Mendoza, M, M5500

  • Local Institution - 0485

    Quilmes, Provincia de Buenos Aires, B, 1878

  • Local Institution - 0330

    Rosario, S, 2000

  • Local Institution - 0290

    San Juan Bautista, B, 1853

  • Local Institution - 0169

    San Miguel de Tucumán, T, T4000

  • Local Institution - 0173

    Santa Fe, 3000

Other trials in Argentina

South Korea16 sites

  • Local Institution - 0404

    Bucheon-si, 14584

  • Local Institution - 0227

    Bucheonsi Weonmigu, 14647

  • Local Institution - 0440

    Busan, 47392

  • Local Institution - 0441

    Dong-gu, Ulsan, 44033

  • Local Institution - 0284

    Donggu, 44033

  • Local Institution - 0240

    Goyang-si, Gyeonggi-do, 10380

  • Local Institution - 0271

    Goyang-si, Gyeonggi-do, 10475

  • Local Institution - 0250

    Gyeonggi-do, 13620

  • Local Institution - 0231

    Haeundae-Gu, 48108

  • Local Institution - 0246

    Iksansi, 54538

  • Local Institution - 0269

    Incheon, 21565

  • Local Institution - 0224

    Jongno-gu, Seoul, 03080

  • Local Institution - 0265

    Seoul, 03722

  • Local Institution - 0221

    Seoul, 05505

  • Local Institution - 0273

    Suwon, Gyeonggi-do, 16499

  • Local Institution - 0276

    Yongsan-gu, Seoul, 4401

Other trials in South Korea

Germany15 sites

  • Local Institution - 0037

    Ahrensburg, 22926

  • Local Institution - 0349

    Berlin, State of Berlin, 12351

  • Local Institution - 0003

    Berlin, State of Berlin, 14165

  • Local Institution - 0320

    Cologne, Northwest, 50678

  • Local Institution - 0004

    Coswig, 01640

  • Local Institution - 0092

    Essen, North Rhine-Westphalia, 45239

  • Local Institution - 0050

    Freiburg I. Breisgau, Baden-Wurttemberg, 79106

  • Local Institution - 0313

    Hamburg, Free and Hanseatic City of Hamburg, 20246

  • Local Institution - 0383

    Heidelberg, 69126

  • Local Institution - 0041

    Immenhausen, Hesse, 34376

  • Local Institution - 0017

    Leipzig, 04103

  • Local Institution - 0347

    Mainz, 55131

  • Local Institution - 0026

    Marburg, Hesse, 35037

  • Local Institution - 0272

    Munich, Bavaria, 81377

  • Local Institution - 0042

    Münnerstadt, Bavaria, 97702

Other trials in Germany

Canada14 sites

  • Local Institution - 0103

    Burlington, Ontario, L7N 3V2

  • Local Institution - 0426

    Greenfield Park, Quebec, J4V 2H1

  • Local Institution - 0216

    Hamilton, Ontario, L8N 4A6

  • Local Institution - 0100

    Kelowna, British Columbia, V1Y 3H5

  • Local Institution - 0434

    Montreal, Quebec, H2X 0C1

  • Local Institution - 0044

    Owen Sound, Ontario, N4K 6M9

  • Local Institution - 0215

    Québec, Quebec, G1V 4G5

  • Local Institution - 0495

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • Local Institution - 0062

    Sherwood Park, Alberta, T8H 0N2

  • Local Institution - 0213

    Toronto, Ontario, M5T 3A9

  • Local Institution - 0053

    Trois-Rivières, Quebec, G8T 7A1

  • Local Institution - 0478

    Trois-Rivières, Quebec, G9S4P3

  • Local Institution - 0061

    Vancouver, British Columbia, V5Z 1M9

  • Local Institution - 0171

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

Spain14 sites

  • Local Institution - 0135

    Barcelona, 08036

  • Local Institution - 0341

    Barcelona, 08907

  • Local Institution - 0166

    Girona, 17001

  • Local Institution - 0099

    Madrid, M, 28006

  • Local Institution - 0065

    Madrid, M, 28040

  • Local Institution - 0161

    Madrid, M, 28046

  • Local Institution - 0496

    Madrid, 28027

  • Local Institution - 0338

    Madrid, 28040

  • Local Institution - 0155

    Madrid, 28822

  • Local Institution - 0149

    Majadahonda, M, 28222

  • Local Institution - 0146

    Oviedo, 33011

  • Local Institution - 0335

    Pamplona, 31008

  • Local Institution - 0093

    Santander, CB, 39008

  • Local Institution - 0140

    Santiago de Compostela, C, 15706

Other trials in Spain

Brazil12 sites

  • Local Institution - 0490

    Barra Mansa, Rio de Janeiro, 27323-240

  • Local Institution - 0084

    Belo Horizonte, Minas Gerais, 30130-100

  • Local Institution - 0098

    Belo Horizonte, Minas Gerais, 30380 090

  • Local Institution - 0089

    Blumenau, Santa Catarina, 89030-100

  • Local Institution - 0304

    Porto Alegre, Rio Grande do Sul, 90035-074

  • Local Institution - 0049

    Porto Alegre, Rio Grande do Sul, 90160-093

  • Local Institution - 0307

    Porto Alegre, Rio Grande do Sul, 91010-004

  • Local Institution - 0359

    Rio de Janeiro, Rio de Janeiro, 20950-003

  • Local Institution - 0054

    Santo André, São Paulo, 09060-870

  • Local Institution - 0305

    São Bernardo do Campo, São Paulo, 09715-090

  • Local Institution - 0024

    São Paulo, São Paulo, 04023-062

  • Local Institution - 0486

    São Paulo, 01327-001

Other trials in Brazil

France12 sites

  • Local Institution - 0012

    Angers, 49933

  • Local Institution - 0066

    Bobigny, 93000

  • Local Institution - 0321

    Brest, 29609

  • Local Institution - 0047

    Bron, Auvergne-Rhône-Alpes, 69677

  • Local Institution - 0052

    Dijon, 21000

  • Local Institution - 0322

    Grenoble, Auvergne-Rhône-Alpes, 38043

  • Local Institution - 0334

    Marseille, Provence-Alpes-Côte d'Azur Region, 13015

  • Local Institution - 0083

    Nantes, Pays de la Loire Region, 44093

  • Local Institution - 0022

    Paris, 75018

  • Local Institution - 0342

    Pessac, 33604

  • Local Institution - 0023

    Toulouse, 31059

  • Local Institution - 0339

    Tours, 37044

Other trials in France

United Kingdom11 sites

  • Local Institution - 0378

    Birmingham, BIR, B9 5SS

  • Local Institution - 0411

    Birmingham, B15 2WB

  • Local Institution - 0415

    Bristol, BST, BS10 5NB

  • Local Institution - 0402

    Cambridge, Cambridgeshire, CB2 0AY

  • Local Institution - 0416

    Cottingham, Yorkshire and the Humber, HU16 5JQ

  • Local Institution - 0164

    Dundee, DND, DD1 9SY

  • Local Institution - 0072

    Edinburgh, EDH, EH16 4SA

  • Local Institution - 0438

    Leeds, LS9 7TF

  • Local Institution - 0337

    London, Greater London, SW3 6HP

  • Local Institution - 0407

    Oxford, Oxfordshire, OX3 7LE

  • Local Institution - 0336

    Peterborough, PTE, PE3 9GZ

Other trials in United Kingdom

Australia10 sites

  • Local Institution - 0309

    Adelaide, South Australia, 5000

  • Local Institution - 0443

    Box Hill, Victoria, 3128

  • Local Institution - 0210

    Brisbane, Queensland, 4032

  • Local Institution - 0209

    Camperdown, New South Wales, 2050

  • Local Institution - 0420

    Frankston, Victoria, 3199

  • Local Institution - 0229

    Greenslopes, Queensland, 4120

  • Local Institution - 0419

    Murdoch, Western Australia, 6150

  • Local Institution - 0385

    Nedlands, Western Australia, 6009

  • Local Institution - 0421

    South Brisbane, Queensland, 4101

  • Local Institution - 0239

    Westmead, New South Wales, 2145

Other trials in Australia

Taiwan9 sites

  • Local Institution - 0491

    Changhua, CHA, 500

  • Local Institution - 0235

    Douliu Shi, YUN, 640

  • Local Institution - 0481

    Kaohsiung City, Kao-Hsiung, 83301

  • Local Institution - 0259

    Kaohsiung City, 807

  • Local Institution - 0270

    New Taipei City, 220

  • Local Institution - 0484

    Taichung, TXG, 40447

  • Local Institution - 0267

    Taichung, 40705

  • Local Institution - 0254

    Taipei, 100

  • Local Institution - 0236

    Taipei, 112

Other trials in Taiwan

Portugal8 sites

  • Local Institution - 0002

    Faro, 8000-386

  • Local Institution - 0139

    Lisbon, 1169-024

  • Local Institution - 0142

    Lisbon, 1350-345

  • Local Institution - 0028

    Lisbon, 1769-001

  • Local Institution - 0134

    Loures, 2674-514

  • Local Institution - 0137

    Porto, 4099-001

  • Local Institution - 0165

    Porto, 4200-319

  • Local Institution - 0158

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Turkey (Türkiye)8 sites

  • Local Institution - 0177

    Ankara, 6590

  • Local Institution - 0150

    Bursa, 16059

  • Local Institution - 0176

    Gümüşhane, Gümüşhane Province, 29000

  • Local Institution - 0205

    Izmir, 35100

  • Local Institution - 0207

    Izmir, 35110

  • Local Institution - 0196

    Maltepe, 34844

  • Local Institution - 0200

    Pasaport, 35210

  • Local Institution - 0344

    Topkapı, 34093

Other trials in Turkey (Türkiye)

Chile6 sites

  • Local Institution - 0503

    Concepción, Biobio, 4070280

  • Local Institution - 0437

    Curicó, Maule Region, 3440000

  • Local Institution - 0051

    Quillota, Valparaiso, 2260000

  • Local Institution - 0068

    Santiago, RM, 7620157

  • Local Institution - 0214

    Santiago, RM, 8320000

  • Local Institution - 0211

    Talca, Maule Region, 3466706

Other trials in Chile

Colombia6 sites

  • Local Institution - 0291

    Bogotá, DC, 110111

  • Local Institution - 0138

    Bogotá, 11031

  • Local Institution - 0278

    Floridablanca, Santander Department, 681004

  • Local Institution - 0279

    Manizales, 17001

  • Local Institution - 0297

    Medellín, ANT, 050021

  • Local Institution - 0268

    Santiago de Cali, VAC, 760046

Other trials in Colombia

Greece6 sites

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Israel6 sites

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Poland6 sites

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Belgium5 sites

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Austria4 sites

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Ireland3 sites

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Finland2 sites

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Hungary2 sites

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About this study

Official title: 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.

Being tested
BMS-986278, BMS-986278 Placebo
Keywords
BMS-986278, LPA1 antagonist, IPF, Pulmonary fibrosis
Medical subject headings
Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-986278Drug

    Also called Admilparant

    Specified dose on specified days

  • BMS-986278 PlaceboDrug

    Specified dose on specified days

Study groups in NCT06003426
Study groupRoleWhat they receive
BMS-986278 Dose 1ExperimentalNot described
Receives: Drug: BMS-986278
BMS-986278 Dose 2ExperimentalNot described
Receives: Drug: BMS-986278
BMS-986278 PlaceboPlacebo comparatorNot described
Receives: Drug: BMS-986278 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants that experience spontaneous syncopal events

    Cohort 1

    Measured: At approximately 4 weeks

  2. Absolute change from baseline in forced vital capacity (FVC) measured in mL

    Cohort 2

    Measured: Up to Week 52

Secondary outcomes (32)

  1. Number of participants who discontinued treatment due to any low BP-related Adverse Events

    Cohort 1

    Measured: Up to approximately 3 years

  2. Disease progression

    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

    Measured: Up to approximately 3 years

  3. Change from baseline in Living with Pulmonary Fibrosis Questionnaire (L-PF) cough domain score

    Cohort 2

    Measured: Up to Week 52

  4. Change from baseline in L-PF dyspnea domain score

    Cohort 2

    Measured: Up to Week 52

  5. Change from baseline in walking distance measured in 6-minute walk test (6MWT)

    Cohort 2

    Measured: Up to Week 52

  6. 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

    Cohort 2

    Measured: Up to approximately 3 years

  7. Time to absolute percent ppFVC decline of ≥ 10% from baseline

    Cohort 2

    Measured: Up to approximately 3 years

  8. Time to first acute exacerbation of pulmonary fibrosis

    Cohort 2

    Measured: Up to approximately 3 years

  9. Time to first Respiratory-related hospitalization

    Cohort 2

    Measured: Up to approximately 3 years

  10. Time to first pulmonary fibrosis-related hospitalization

    Cohort 2

    Measured: Up to approximately 3 years

  11. Time to death

    Cohort 2

    Measured: Up to approximately 3 years

  12. Change from baseline in L-PF fatigue domain score

    Cohort 2

    Measured: Up to Week 52

  13. Change from baseline in L-PF impacts module score

    Cohort 2

    Measured: Up to Week 52

  14. Change from baseline in cough numeric rating scale (NRS)

    Cohort 2

    Measured: Up to Week 52

  15. Change from baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) health utility index score

    Cohort 2

    Measured: Up to Week 52

  16. Change from baseline in EQ-5D-5L visual analog scale score

    Cohort 2

    Measured: Up to Week 52

  17. Rate of decline from baseline in FVC (mL)

    Cohort 2

    Measured: Up to Week 52

  18. Rate of decline in ppFVC from baseline

    Cohort 2

    Measured: Up to Week 52

  19. Change in ppFVC from baseline

    Cohort 2

    Measured: Up to Week 52

  20. Proportion of participants with absolute decline in ppFVC ≥10%

    Cohort 2

    Measured: Up to Week 52

  21. Proportion of participants with relative decline in ppFVC ≥10%

    Cohort 2

    Measured: Up to Week 52

  22. Change from baseline in single-breath diffusing capacity of the lung for carbon monoxide (DLCO SB) (corrected for hemoglobin) (mL/min/mm Hg)

    Cohort 2

    Measured: Up to Week 52

  23. Change in percent predicted single breath diffusing capacity of the lung for carbon monoxide (ppDLCO SB) (corrected for hemoglobin) from baseline

    Cohort 2

    Measured: Up to Week 52

  24. Change from baseline in quantitative lung fibrosis (QLF) score via high-resolution computed tomography (HRCT)

    Cohort 2

    Measured: Up to Week 52

  25. Number of participants with Adverse Events (AEs)

    Cohorts 1 and 2

    Measured: Up to 28 days after last dose

  26. Number of participants with Serious AEs (SAEs)

    Cohorts 1 and 2

    Measured: Up to 28 days after last dose

  27. Number of participants with AEs leading to early discontinuation of investigational medicinal product (IMP)

    Cohorts 1 and 2

    Measured: Up to 28 days after last dose

  28. Number of participants with AEs related to IMP

    Cohorts 1 and 2

    Measured: Up to 28 days after last dose

  29. Number of treatment-emergent deaths

    Cohorts 1 and 2

    Measured: Up to 28 days after last dose

  30. Number of participants with clinical laboratory abnormalities

    Cohorts 1 and 2

    Measured: Up to 28 days after last dose

  31. Number of participants with electrocardiogram (ECG) abnormalities

    Cohorts 1 and 2

    Measured: Up to 28 days after last dose

  32. Number of participants with vital sign abnormalities

    Cohorts 1 and 2

    Measured: Up to 28 days after last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2023
  2. Study start14 Sep 2023
  3. Primary completion6 Oct 2026 (estimated)
  4. Study completion4 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,255 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06003426
Sponsor's protocol ID
IM027-068
Other IDs
2023-503697-21, 2023
Status last verified
Mar 2026
First submitted
15 Aug 2023
Last updated
24 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BMS-986278 in people with Idiopathic Pulmonary Fibrosis, run by Bristol-Myers Squibb at 390 sites in 33 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 390 sites in United States, China, Japan, India, Italy and 28 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants that experience spontaneous syncopal events (time frame: At approximately 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06003426.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.

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