AzTrials
AzTrials

Progressive Pulmonary FibrosisPhase 3NCT06025578

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

A Phase 3 study testing BMS-986278 in people with Progressive Pulmonary Fibrosis, run by Bristol-Myers Squibb at 459 sites in 35 countries.

Active, not recruiting

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

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 21 years and older
Conditions the study is for
Progressive Pulmonary Fibrosis
What is being tested?
BMS-986278
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,057 participants
Where
459 sitesin 35 countries
Study dates
25 Oct 2023to 27 Dec 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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of interstitial lung disease (ILD) with features consistent with progressive ILD within 24 months prior to screening, and ≥ 10% extent of fibrosis on screening high-resolution computed tomography (HRCT).
  • If on pirfenidone or nintedanib, participants must have been on a stable dose for at least 90 days prior to screening.
  • If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within 28 days prior to screening.
  • Mycophenolate mofetil (MMF), mycophenolic acid (MA), azathioprine (AZA), and Tacrolimus are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on MMF, MA, AZA, or tacrolimus, participants must not have taken these medications within 28 days prior to screening.
  • Traditional disease-modifying antirheumatic drug (DMARDs) (eg. Methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on traditional DMARD, participants must not have taken these medications within 28 days prior to screening.
  • Biologic DMARDs (eg. TNF blockers and IL-1 inhibitors) and Janus kinase inhibitors (JAK inhibitors eg. tofacitinib, upadacitinib) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on Biologic DMARD or JAK inhibitor, participants must not have taken these medications within 28 days prior to screening.
  • Women who are of childbearing potential must have a highly effective form of contraception and must provide a negative urine/serum pregnancy test.
  • Men who are sexually active with women of childbearing potential agree to use male barrier contraception.

Who cannot join

  • Idiopathic pulmonary fibrosis with usual interstitial pneumonia (UIP) verification at screening.
  • History of stroke or transient ischemic attack within 3 months prior to screening.
  • Participants who exhibit symptoms of heart failure at rest.
  • Participants who have a current malignancy; a previous malignancy with less than 2 years free of recurrence; and a biopsy that is suspicious for malignancy and the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations.
  • Use of systemic corticosteroids equivalent to prednisone > 15 mg/day is not allowed within 4 weeks prior to screening and during the study.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Trial locations and contacts

459 sites in 35 countries.

459 sites in 35 countries

United States81 sites

  • Local Institution - 0531

    Anderson, South Carolina, 29621

  • Local Institution - 0207

    Ann Arbor, Michigan, 48109-5000

  • Local Institution - 0070

    Atlanta, Georgia, 30322-1013

  • Local Institution - 0321

    Aurora, Colorado, 80045

  • Local Institution - 0305

    Baltimore, Maryland, 21201-1544

  • Local Institution - 0046

    Birmingham, Alabama, 35294

  • Local Institution - 0404

    Boston, Massachusetts, 02114-2621

  • Local Institution - 0195

    Brandon, Florida, 33511-5706

  • Local Institution - 0504

    Burlington, Vermont, 05401

  • Local Institution - 0380

    Celebration, Florida, 34747-1818

  • Local Institution - 0071

    Charleston, South Carolina, 29425

  • Local Institution - 0004

    Chesterfield, Missouri, 63017

  • Local Institution - 0435

    Chicago, Illinois, 60611

  • Local Institution - 0023

    Chicago, Illinois, 60637-1447

  • Local Institution - 0419

    Cincinnati, Ohio, 45267

  • Local Institution - 0013

    Clearwater, Florida, 33765

  • Local Institution - 0186

    Cleveland, Ohio, 44106

  • Local Institution - 0209

    Columbus, Ohio, 43201

  • Local Institution - 0024

    Dallas, Texas, 75235-5351

  • Local Institution - 0317

    Dallas, Texas, 75246

  • Local Institution - 0396

    DeBary, Florida, 32713-1817

  • Local Institution - 0376

    Denver, Colorado, 80206

  • Local Institution - 0031

    Detroit, Michigan, 48202

  • Local Institution - 0368

    Dublin, Georgia, 31021-2561

  • Local Institution - 0428

    Durham, North Carolina, 27710

  • Local Institution - 0040

    Evanston, Illinois, 60201-1779

  • Local Institution - 0190

    Everett, Washington, 98208-6526

  • Local Institution - 0036

    Gainesville, Florida, 32608

  • Local Institution - 0193

    Gainesville, Florida, 32610

  • Local Institution - 0050

    Grand Rapids, Michigan, 49546-8293

  • Local Institution - 0373

    Greenville, South Carolina, 29615

  • Local Institution - 0205

    Hershey, Pennsylvania, 17033-2360

  • Local Institution - 0028

    Houston, Texas, 77030-4202

  • Local Institution - 0041

    Houston, Texas, 77030

  • Local Institution - 0080

    Iowa City, Iowa, 522242-1009

  • Local Institution - 0049

    Kansas City, Kansas, 66103-2937

  • Local Institution - 0336

    La Jolla, California, 92037-1027

  • Local Institution - 0212

    Los Angeles, California, 90033-5313

  • Local Institution - 0019

    Los Angeles, California, 90095-3075

  • Local Institution - 0045

    Louisville, Kentucky, 40207-4652

  • Local Institution - 0361

    Louisville, Kentucky, 40218-2497

  • Local Institution - 0073

    Loxahatchee Groves, Florida, 33411

  • Local Institution - 0082

    Maywood, Illinois, 60153-3328

  • Local Institution - 0221

    McKinney, Texas, 75069

  • Local Institution - 0384

    Minneapolis, Minnesota, 55455-4800

  • Local Institution - 0068

    Mount Kisco, New York, 10549-3417

  • Local Institution - 0363

    Nashville, Tennessee, 37204

  • Local Institution - 0211

    New Haven, Connecticut, 06510

  • Local Institution - 0357

    New York, New York, 10029-6574

  • Local Institution - 0067

    Newark, Delaware, 19713-1337

  • Local Institution - 0535

    Newport Beach, California, 92663-3661

  • Local Institution - 0220

    Ocala, Florida, 34470

  • Local Institution - 0198

    Oklahoma City, Oklahoma, 73104-5417

  • Local Institution - 0366

    Orange, California, 92868-3201

  • Local Institution - 0452

    Pensacola, Florida, 32503

  • Local Institution - 0334

    Philadelphia, Pennsylvania, 19104-5161

  • Local Institution - 0348

    Philadelphia, Pennsylvania, 19107-5109

  • Local Institution - 0196

    Philadelphia, Pennsylvania, 19140-5103

  • Local Institution - 0314

    Phoenix, Arizona, 85013-4220

  • Local Institution - 0037

    Portland, Oregon, 97239-3011

  • Local Institution - 0525

    Reno, Nevada, 89502-1576

  • Local Institution - 0414

    Richmond, Virginia, 23298-5002

  • Local Institution - 0509

    Royal Oak, Michigan, 48073-6712

  • Local Institution - 0341

    Sacramento, California, 95817

  • Local Institution - 0014

    Salt Lake City, Utah, 84108

  • Local Institution - 0217

    San Antonio, Texas, 78229-4404

  • Local Institution - 0015

    San Francisco, California, 94143-2202

  • Local Institution - 0043

    Seattle, Washington, 98195

  • Local Institution - 0079

    Springfield, Massachusetts, 01199-1002

  • Local Institution - 0223

    St Louis, Missouri, 63110-1010

  • Local Institution - 0389

    St. Petersburg, Florida, 33704

  • Local Institution - 0418

    Stamford, Connecticut, 06904

  • Local Institution - 0352

    Stanford, California, 94305

  • Local Institution - 0316

    Tampa, Florida, 33601-1289

  • Local Institution - 0343

    Toledo, Ohio, 43608-2603

  • Local Institution - 0033

    Towson, Maryland, 21204-7700

  • Local Institution - 0008

    Tulsa, Oklahoma, 74133

  • Local Institution - 0354

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

  • Local Institution - 0392

    Wilmington, North Carolina, 28401-7307

  • Local Institution - 0325

    Winston-Salem, North Carolina, 27103

  • Local Institution - 0364

    Wynnewood, Pennsylvania, 19096

Other trials in United States

China45 sites

  • Local Institution - 0113

    Beijing, Beijing Municipality, 100020

  • Local Institution - 0086

    Beijing, BJ, 100050

  • Local Institution - 0100

    Beijing, BJ, 100730

  • Local Institution - 0426

    Changsha, 410011

  • Local Institution - 0318

    Chengdu, Sichuan, 610041

  • Local Institution - 0313

    Chengdu, 610072

  • Local Institution - 0431

    Guangzhou, GD, 510515

  • Local Institution - 0308

    Guangzhou, Guangdong, 510062

  • Local Institution - 0494

    Guangzhou, Guangdong, 510120

  • Local Institution - 0508

    Hangzhou, Zhejiang, 310009

  • Local Institution - 0319

    Hangzhou, Zhejiang, 310016

  • Local Institution - 0429

    Hangzhou, ZJ, 310006

  • Local Institution - 0087

    Hefei, AH, 230022

  • Local Institution - 0084

    Hefei, 230001

  • Local Institution - 0105

    Hohhot, 010010

  • Local Institution - 0433

    Jinan, 250033

  • Local Institution - 0322

    Lanzhou, Gansu, 730000

  • Local Institution - 0443

    Nanchang, JX, 330019

  • Local Institution - 0327

    Nanjing, JS, 210008

  • Local Institution - 0298

    Ningbo, Zhejiang, 315010

  • Local Institution - 0454

    Ningxia, Yinchuan, 750000

  • Local Institution - 0329

    Shanghai, Shanghai Municipality, 200002

  • Local Institution - 0386

    Shanghai, Shanghai Municipality, 200233

  • Local Institution - 0096

    Shanghai, Shanghai Municipality, 200433

  • Local Institution - 0088

    Shanghai, SH, 200030

  • Local Institution - 0324

    Shanghai, SH, 201112

  • Local Institution - 0098

    Shanghai Shi, Shanghai Municipality, 200032

  • Local Institution - 0083

    Shanghai Shi, Shanghai Sheng, 200092

  • Local Institution - 0323

    Shenyang, Liaoning, 110001

  • Local Institution - 0497

    Shenyang, Liaoning, 110044

  • Local Institution - 0085

    Shenzhen, Guangdong, 518036

  • Local Institution - 0510

    Shenzhen Shi, Guangdong, 518020

  • Local Institution - 0309

    Shijiazhuang, Hebi, 50005

  • Local Institution - 0434

    Shijiazhuang, 050051

  • Local Institution - 0458

    Suzhou, Jiangsu, 215006

  • Local Institution - 0372

    Tianjin, Tianjin Municipality, 300052

  • Local Institution - 0326

    Tianjin, TJ, 300222

  • Local Institution - 0312

    Wuhan, Hubei, 430002

  • Local Institution - 0432

    Wuhan, HUB, 430060

  • Local Institution - 0172

    Wuxi, Jiangsu, 214023

  • Local Institution - 0311

    Xi'an, Shan3xi, 710117

  • Local Institution - 0496

    Xuzhou, JS, 221002

  • Local Institution - 0495

    Yichang Shi, HE, 443099

  • Local Institution - 0425

    Zhengzhou, HA, 450003

  • Local Institution - 0455

    Zhengzhou, HN, 450000

Other trials in China

Japan45 sites

  • Local Institution - 0226

    Bunkyō City, TKY, 1138431

  • Local Institution - 0228

    Bunkyō City, 113-8655

  • Local Institution - 0229

    Bunkyo-ku, Tokyo, 113-8603

  • Local Institution - 0133

    Bunkyo-Ku, Tokyo, 113-8519

  • Local Institution - 0061

    Chiba, Chiba, 2608677

  • Local Institution - 0302

    Chikushino-shi, Fukuoka, 8188502

  • Local Institution - 0233

    Fukuoka, Fukuoka, 8108563

  • Local Institution - 0461

    Fukuoka, Fukuoka, 812-8582

  • Local Institution - 0231

    Fukuoka, 830-0011

  • Local Institution - 0138

    Hamamatsu, Shizuoka, 431-3192

  • Local Institution - 0018

    Himeji-Shi, Hyōgo, 670-8520

  • Local Institution - 0300

    Hiroshima, Hirohima-ken, 734-8530

  • Local Institution - 0052

    Iizuka-shi, 820-8505

  • Local Institution - 0127

    Izumo-Shi, 693-8501

  • Local Institution - 0029

    Kamogawa-shi, Chiba, 296-8602

  • Local Institution - 0145

    Kobe, Hyōgo, 6500047

  • Local Institution - 0128

    Koriyama-shi, Fukushima, 9630197

  • Local Institution - 0021

    Kumamoto, 861-4193

  • Local Institution - 0307

    Matsusaka-shi, Mie-ken, 515-8544

  • Local Institution - 0253

    Meguro-ku, Tokyo, 153-8515

  • Local Institution - 0010

    Minato-ku, Tokyo, 105-8470

  • Local Institution - 0234

    Minato-ku, Tokyo, 105-8471

  • Local Institution - 0310

    Mitaka-shi, Tokyo, 181-8611

  • Local Institution - 0157

    Nagasaki, NGS, 852-8501

  • Local Institution - 0001

    Naka-gun, Gunma, 3191113

  • Local Institution - 0227

    Osakasayama-shi, Osaka, 589-8511

  • Local Institution - 0261

    Sagamihara, Kanagawa, 2520375

  • Local Institution - 0149

    Sakai, OSK, 591-8555

  • Local Institution - 0144

    Sapporo, Hokkaido, 0608543

  • Local Institution - 0063

    Sapporo, Hokkaido, 0608648

  • Local Institution - 0129

    Seto, 489-8642

  • Local Institution - 0034

    Shimotsuge-shi, Tochigi, 329-0498

  • Local Institution - 0320

    Shinjuku-ku, Tokyo, 160-8582

  • Local Institution - 0054

    Shinjuku-Ku, Tokyo, 160-0023

  • Local Institution - 0055

    Shinjuku-Ku, Tokyo, 162-0054

  • Local Institution - 0147

    Shinjyu-Ku, 162-8655

  • Local Institution - 0235

    Showa-Ku, Aichi-ken, 466-8560

  • Local Institution - 0328

    Takatsuki-Shi, 569-8686

  • Local Institution - 0002

    Tenri-Shi, 632-8552

  • Local Institution - 0230

    Tokushina-Shi, Tokushima, 770-8503

  • Local Institution - 0158

    Tokyo, 143-8541

  • Local Institution - 0051

    Toyoake-shi, Aichi-ken, 470-1192

  • Local Institution - 0523

    Ube-shi, Yamaguchi, 755-0241

  • Local Institution - 0232

    Yokohama, 236-0051

  • Local Institution - 0289

    Yoshida-gun, Fukui, 910-1193

Other trials in Japan

India21 sites

  • Local Institution - 0415

    Ahmedabad, Gujarat, 380060

  • Local Institution - 0291

    Bangalore, 560034

  • Local Institution - 0246

    Belagavi, Karnataka, 590010

  • Local Institution - 0382

    Bhopal, Madhya Pradesh, 462001

  • Local Institution - 0262

    Dehradun, Uttarakhand, 248001

  • Local Institution - 0247

    Jaipur, Rajasthan, 302018

  • Local Institution - 0266

    Jaipur, Rajasthan, 302023

  • Local Institution - 0264

    Kolkata, West Bengal, 700014

  • Local Institution - 0272

    Kolkata, West Bengal, 700027

  • Local Institution - 0490

    Lucknow, Uttar Pradesh, 226003

  • Local Institution - 0250

    Lucknow, 226006

  • Local Institution - 0249

    Mohali, Punjab, 160062

  • Local Institution - 0335

    Nagpur, Maharashtra, 044009

  • Local Institution - 0379

    Nagpur, Maharashtra, 440012

  • Local Institution - 0330

    New Delhi, National Capital Territory of Delhi, 110017

  • Local Institution - 0421

    New Delhi, National Capital Territory of Delhi, 110029

  • Local Institution - 0297

    Pune, Maharashtra, 411001

  • Local Institution - 0524

    Pune, Maharashtra, 411001

  • Local Institution - 0176

    Pune, Maharashtra, 411004

  • Local Institution - 0276

    Pune, Maharashtra, 411043

  • Local Institution - 0167

    Surat, Gujarat, 395010

Other trials in India

Italy18 sites

  • Local Institution - 0139

    Ancona, AN, 60126

  • Local Institution - 0123

    Bergamo, 24127

  • Local Institution - 0155

    Florence, FI, 50134

  • Local Institution - 0011

    Foggia, 71122

  • Local Institution - 0124

    Forlì, 47121

  • Local Institution - 0180

    Milan, MI, 20122

  • Local Institution - 0251

    Milan, MI, 20132

  • Local Institution - 0009

    Milan, 20142

  • Local Institution - 0282

    Modena, Emilia-Romagna, 41125

  • Local Institution - 0143

    Monza, 20900

  • Local Institution - 0267

    Naples, 80131

  • Local Institution - 0295

    Palermo, 90127

  • Local Institution - 0290

    Pavia, 27100

  • Local Institution - 0174

    Pisa, PI, 56126

  • Local Institution - 0137

    Roma, RM, 00168

  • Local Institution - 0148

    Sassari, 7100

  • Local Institution - 0442

    Siena, 53100

  • Local Institution - 0166

    Trieste, TS, 34149

Other trials in Italy

Spain18 sites

  • Local Institution - 0169

    Badalona, B, 08916

  • Local Institution - 0390

    Barcelona, B, 08035

  • Local Institution - 0204

    Barcelona, 08017

  • Local Institution - 0449

    Barcelona, 08036

  • Local Institution - 0293

    Barcelona, 08907

  • Local Institution - 0177

    Madrid, M, 28006

  • Local Institution - 0163

    Madrid, M, 28040

  • Local Institution - 0184

    Madrid, M, 28046

  • Local Institution - 0518

    Madrid, 28027

  • Local Institution - 0274

    Madrid, 28040

  • Local Institution - 0438

    Madrid, 28822

  • Local Institution - 0188

    Majadahonda, M, 28222

  • Local Institution - 0519

    Málaga, MA, 29010

  • Local Institution - 0208

    Oviedo, Principality of Asturias, 33011

  • Local Institution - 0270

    Pamplona, 31008

  • Local Institution - 0178

    Santander, CB, 39008

  • Local Institution - 0203

    Santiago de Compostela, Galicia, 15706

  • Local Institution - 0197

    Valencia, V, 46015

Other trials in Spain

Germany17 sites

  • Local Institution - 0132

    Ahrensburg, 22926

  • Local Institution - 0154

    Berlin, State of Berlin, 14165

  • Local Institution - 0287

    Berlin, 12351

  • Local Institution - 0393

    Cologne, Northwest, 50678

  • Local Institution - 0140

    Coswig, 01640

  • Local Institution - 0151

    Essen, North Rhine-Westphalia, 45239

  • Local Institution - 0135

    Freiburg I. Breisgau, Baden-Wurttemberg, 79106

  • Local Institution - 0248

    Hamburg, 20251

  • Local Institution - 0340

    Heidelberg, 69126

  • Local Institution - 0141

    Immenhausen, Hesse, 34376

  • Local Institution - 0134

    Leipzig, 04103

  • Local Institution - 0258

    Mainz, 55131

  • Local Institution - 0152

    Munich, Bavaria, 81377

  • Local Institution - 0159

    Münnerstadt, Bavaria, 97702

  • Local Institution - 0142

    Münster, Northwest, 48149

  • Local Institution - 0160

    Stralsund, Mecklenburg-Vorpommern, 18435

  • Local Institution - 0125

    Wangen I. Allgaeu, Baden-Wurttemberg, 88239

Other trials in Germany

South Korea16 sites

  • Local Institution - 0344

    Bucheon-si, 14584

  • Local Institution - 0062

    Bucheonsi Weonmigu, 14647

  • Local Institution - 0448

    Busan, 47392

  • Local Institution - 0453

    Dong-gu, Ulsan, 44033

  • Local Institution - 0081

    Goyang-si, Gyeonggi-do, 10380

  • Local Institution - 0430

    Goyang-si, Gyeonggi-do, 10475

  • Local Institution - 0058

    Gyeonggi-do, 13620

  • Local Institution - 0216

    Haeundae-Gu, 48108

  • Local Institution - 0057

    Iksansi, 54538

  • Local Institution - 0056

    Incheon, 21565

  • Local Institution - 0306

    Jongno-gu, Seoul, 03080

  • Local Institution - 0210

    Seoul, 03722

  • Local Institution - 0332

    Seoul, 06355

  • Local Institution - 0060

    Songpa-gu, Seoul, 138-736

  • Local Institution - 0072

    Suwon, 443-380

  • Local Institution - 0284

    Yongsan-gu, Seoul, 4401

Other trials in South Korea

Argentina15 sites

  • Local Institution - 0025

    Buenos Aires, B, C1426ABO

  • Local Institution - 0165

    Buenos Aires, C1056ABJ

  • Local Institution - 0039

    Caba, B, C1425FVH

  • Local Institution - 0162

    Ciudad Autónoma Buenos Aires, C, 1181

  • Local Institution - 0032

    Córdoba, Córdoba Province, K5003DCE

  • Local Institution - 0003

    Florida, B, 1602

  • Local Institution - 0288

    Godoy Cruz, M, 5501

  • Local Institution - 0020

    Mar del Plata, Buenos Aires, 7600

  • Local Institution - 0182

    Mar del Plata, B, 7600

  • Local Institution - 0401

    Mendoza, M, M5500

  • Local Institution - 0501

    Quilmes, Provincia de Buenos Aires, B, 1878

  • Local Institution - 0400

    Rosario, S, 2000

  • Local Institution - 0446

    San Juan Bautista, Buenos Aires, 1888

  • Local Institution - 0005

    San Miguel de Tucuman, Tucumán, T, T4000

  • Local Institution - 0450

    Santa Fe, 3000

Other trials in Argentina

Brazil14 sites

  • Local Institution - 0507

    Barra Mansa, Rio de Janeiro, 27323-240

  • Local Institution - 0038

    Belo Horizonte, Minas Gerais, 30130-100

  • Local Institution - 0017

    Belo Horizonte, Minas Gerais, 30380 090

  • Local Institution - 0048

    Blumenau, Santa Catarina, 89030-100

  • Local Institution - 0047

    Botucatu, São Paulo, 18618-687

  • Local Institution - 0243

    Porto Alegre, Rio Grande do Sul, 90035-074

  • Local Institution - 0016

    Porto Alegre, Rio Grande do Sul, 90160-092

  • Local Institution - 0522

    Porto Alegre, Rio Grande do Sul, 91010-004

  • Local Institution - 0042

    Porto Alegre, 90610-000

  • Local Institution - 0388

    Rio de Janeiro, Rio de Janeiro, 20950-003

  • Local Institution - 0403

    Santo André, São Paulo, 09060-870

  • Local Institution - 0026

    São Bernardo do Campo, São Paulo, 09715-090

  • Local Institution - 0502

    São Paulo, 01327-001

  • Local Institution - 0006

    São Paulo, 04032-052

Other trials in Brazil

Canada14 sites

  • Local Institution - 0053

    Burlington, Ontario, L7N 3V2

  • Local Institution - 0111

    Hamilton, Ontario, L8N 4A6

  • Local Institution - 0097

    Kelowna, British Columbia, V1W 1V3

  • Local Institution - 0440

    Montreal, Quebec, H2X 0C1

  • Local Institution - 0075

    Owen Sound, Ontario, N4K 6M9

  • Local Institution - 0102

    Québec, Quebec, G1V 4G5

  • Local Institution - 0514

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • Local Institution - 0099

    Sherbrooke, Quebec, J1H 5N4

  • Local Institution - 0108

    Sherwood Park, Alberta, T8H 0N2

  • Local Institution - 0106

    Toronto, Ontario, M5T 3A9

  • Local Institution - 0074

    Trois-Rivières, Quebec, G8T 7A1

  • Local Institution - 0492

    Trois-Rivières, Quebec, G9S4P3

  • Local Institution - 0107

    Vancouver, British Columbia, V5Z 1M9

  • Local Institution - 0462

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

France14 sites

  • Local Institution - 0534

    Angers, Pays de la Loire Region, 49933

  • Local Institution - 0130

    Bobigny, 93009

  • Local Institution - 0278

    Brest, 29609

  • Local Institution - 0156

    Bron, Auvergne-Rhône-Alpes, 69677

  • Local Institution - 0136

    Dijon, 21000

  • Local Institution - 0254

    Grenoble, Auvergne-Rhône-Alpes, 38043

  • Local Institution - 0252

    Lille, 59037

  • Local Institution - 0279

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

  • Local Institution - 0126

    Nantes, Pays de la Loire Region, 44093

  • Local Institution - 0374

    Nice, 06000

  • Local Institution - 0236

    Paris, Île-de-France Region, 75018

  • Local Institution - 0260

    Pessac, 33604

  • Local Institution - 0146

    Toulouse, 31059

  • Local Institution - 0263

    Tours, 37044

Other trials in France

Mexico13 sites

  • Local Institution - 0218

    Aguascalientes, Aguascalientes, 20116

  • Local Institution - 0493

    Chihuahua City, 31200

  • Local Institution - 0030

    Córdoba, Veracruz, 94550

  • Local Institution - 0194

    Guadalajara, Jalisco, 44160

  • Local Institution - 0511

    Guadalajara, Jalisco, 44340

  • Local Institution - 0362

    Guadalajara, 44130

  • Local Institution - 0406

    Mérida, Yucatán, 97070

  • Local Institution - 0405

    Mérida, Yucatán, 97300

  • Local Institution - 0521

    México, DIF, 14050

  • Local Institution - 0007

    Mexico City, 14080

  • Local Institution - 0355

    Morelia, Michoacán, 58260

  • Local Institution - 0375

    Oaxaca City, Oaxaca, 68000

  • Local Institution - 0189

    Oaxaca City, Oaxaca, 68020

Other trials in Mexico

Australia11 sites

  • Local Institution - 0275

    Adelaide, South Australia, 5000

  • Local Institution - 0359

    Box Hill, Victoria, 3128

  • Local Institution - 0090

    Brisbane, Queensland, 4032

  • Local Institution - 0065

    Camperdown, New South Wales, 2050

  • Local Institution - 0091

    Greenslopes, Queensland, 4120

  • Local Institution - 0299

    Heidelberg,VIC, Victoria, 3084

  • Local Institution - 0059

    Melbourne, Victoria, 3004

  • Local Institution - 0303

    Murdoch, Western Australia, 6150

  • Local Institution - 0459

    Nedlands, Western Australia, 6009

  • Local Institution - 0342

    South Brisbane, Queensland, 4101

  • Local Institution - 0089

    Westmead, New South Wales, 2145

Other trials in Australia

United Kingdom11 sites

  • Local Institution - 0377

    Birmingham, BIR, B9 5SS

  • Local Institution - 0394

    Birmingham, B15 2WB

  • Local Institution - 0337

    Cambridge, Cambridgeshire, CB2 0AY

  • Local Institution - 0358

    Cottingham, Yorkshire and the Humber, HU16 5JQ

  • Local Institution - 0183

    Dundee, DND, DD1 9SY

  • Local Institution - 0171

    Edinburgh, EDH, EH16 4SA

  • Local Institution - 0219

    Exeter, South West, EX2 5DW

  • Local Institution - 0444

    Leeds, West Yorkshire, LS9 7TF

  • Local Institution - 0292

    London, Greater London, SW3 6NP

  • Local Institution - 0370

    Oxford, Oxfordshire, OX3 7LE

  • Local Institution - 0285

    Peterborough, PTE, PE3 9GZ

Other trials in United Kingdom

Colombia10 sites

  • Local Institution - 0402

    Bogota, Cundinamarca, 110231

  • Local Institution - 0408

    Bogotá, DC, 110111

  • Local Institution - 0451

    Bogotá, DC, 110131

  • Local Institution - 0095

    Bogotá, 11031

  • Local Institution - 0175

    Floridablanca, Santander Department, 681004

  • Local Institution - 0168

    Manizales, CL, 170004

  • Local Institution - 0413

    Medellín, ANT, 050021

  • Local Institution - 0515

    Medellín, ANT, 050034

  • Local Institution - 0286

    Santiago de Cali, VAC, 760046

  • Local Institution - 0076

    Zipaquirá, Cundinamarca, 250252

Other trials in Colombia

Chile9 sites

  • Local Institution - 0532

    Concepción, Biobio, 4070280

  • Local Institution - 0101

    Curicó, Maule Region, 3440000

  • Local Institution - 0094

    Quillota, Valparaiso, 2260000

  • Local Institution - 0109

    Santiago, RM, 7620157

  • Local Institution - 0112

    Santiago, RM, 8320000

  • Local Institution - 0447

    Santiago, 750691

  • Local Institution - 0104

    Talca, Maule Region, 3466706

  • Local Institution - 0530

    Viña del Mar, Valparaiso, 2531172

  • Local Institution - 0489

    Viña del Mar, 1702

Other trials in Chile

Poland9 sites

  • Local Institution - 0153

    Będzin, 42-500

  • Local Institution - 0201

    Bialystok, Podlaskie Voivodeship, 15-044

  • Local Institution - 0192

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-065

  • Local Institution - 0206

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079

  • Local Institution - 0283

    Gdansk, Pomeranian Voivodeship, 80-952

  • Local Institution - 0131

    Katowice, 40-635

  • Local Institution - 0259

    Krakow, Lesser Poland Voivodeship, 30-688

  • Local Institution - 0187

    Lodz, 90-153

  • Local Institution - 0271

    Olsztyn, Warmian-Masurian Voivodeship, 10-357

Other trials in Poland

Greece8 sites

  • Local Institution - 0118

    Athens, 12462

  • Local Institution - 0064

    Corfu, 491 00

  • Local Institution - 0410

    Heraklion, Iraklio Kritis, 715 00

  • Local Institution - 0115

    Ioannina, Epirus, 45500

  • Local Institution - 0114

    Larissa, 413 34

  • Local Institution - 0244

    Marousi, Attica, 15125

  • Local Institution - 0122

    Rio, 26504

  • Local Institution - 0268

    Thessaloniki, 57010

Other trials in Greece

Israel8 sites

  • Local Institution - 0027

    Be’er Ya‘aqov, M, 7030000

  • Local Institution - 0339

    Beersheba, D, 8410101

  • Local Institution - 0116

    Haifa, HA, 3436212

  • Local Institution - 0273

    Haifa, 3109601

  • Local Institution - 0120

    Jerusalem, 9112001

  • Local Institution - 0119

    Petah Tikva, 4941492

  • Local Institution - 0121

    Rehovot, Central District, 76100

  • Local Institution - 0117

    Tel Aviv, TA, 6423906

Other trials in Israel

Portugal8 sites

  • Local Institution - 0164

    Braga, 4710-243

  • Local Institution - 0202

    Lisbon, 1169-024

  • Local Institution - 0460

    Lisbon, 1350-352

  • Local Institution - 0173

    Lisbon, 1769-001

  • Local Institution - 0185

    Loures, 2674-514

  • Local Institution - 0199

    Porto, 4099-001

  • Local Institution - 0179

    Porto, 4200-319

  • Local Institution - 0161

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Taiwan8 sites

  • Local Institution - 0506

    Changhua, CHA, 500

  • Local Institution - 0296

    Douliu Shi, YUN, 640

  • Local Institution - 0500

    Kaohsiung City, Kao-Hsiung, 83301

  • Local Institution - 0255

    Kaohsiung City, KHH, 807

  • Local Institution - 0498

    Taichung, TXG, 40447

  • Local Institution - 0417

    Taichung, 40705

  • Local Institution - 0269

    Taipei, 100

  • Local Institution - 0277

    Taipei, 112

Other trials in Taiwan

Peru7 sites

  • Local Institution - 0022

    Lima, LIM, 15036

  • Local Institution - 0409

    Lima, LIM, 33

  • Local Institution - 0012

    Lima, 15073

  • Local Institution - 0044

    Lima, 31

  • Local Institution - 0077

    Piura, PIU, 20001

  • Local Institution - 0369

    San Borja, Lima region, 15036

  • Local Institution - 0225

    San Miguel, LIM, 15088

Other trials in Peru

Netherlands6 sites

  • Local Institution - 0350

    Amsterdam, 1081 BT

  • Local Institution - 0338

    Amsterdam, North Holland

  • Local Institution - 0439

    Heerlen, 6419 PC

  • Local Institution - 0315

    Leiden, South Holland, 2333 ZA

  • Local Institution - 0472

    Nieuwegein, Utrecht, 3430

  • Local Institution - 0399

    Rotterdam, South Holland, 3061BC

Other trials in Netherlands

Belgium5 sites

  • Local Institution - 0242

    Brussels, 1200

  • Local Institution - 0257

    Kortrijk, 8500

  • Local Institution - 0239

    Leuven, VBR, 3000

  • Local Institution - 0237

    Liège, 4000

  • Local Institution - 0240

    Yvoir, Namur, 5530

Other trials in Belgium

Austria4 sites

  • Local Institution - 0349

    Linz, Upper Austria, 4020

  • Local Institution - 0474

    Salzburg, Salzburger Land, 5020

  • Local Institution - 0387

    Vienna, 1130

  • Local Institution - 0475

    Vienna, 1210

Other trials in Austria

Denmark4 sites

  • Local Institution - 0110

    Aarhus, Central Jutland, 8200

  • Local Institution - 0333

    Copenhagen, 2100

  • Local Institution - 0092

    Hellerup, 2900

  • Local Institution - 0103

    Odense C, Region Syddanmark, 5000

Other trials in Denmark

Ireland4 sites

  • Local Institution - 0150

    Drogheda, LH, A92 VW28

  • Local Institution - 0513

    Dublin, D04 T6F4

  • Local Institution - 0213

    Dublin, D15 X40D

  • Local Institution - 0345

    Dublin, D24 NR0A

Other trials in Ireland

Turkey (Türkiye)4 sites

  • Local Institution - 0191

    Bursa, 16059

  • Local Institution - 0215

    Izmir, 35100

  • Local Institution - 0222

    Izmir, 35110

  • Local Institution - 0281

    Topkapı, 34093

Other trials in Turkey (Türkiye)

Malaysia3 sites

  • Local Institution - 0482

    Cheras, Kuala Lumpur, 56000

  • Local Institution - 0480

    Kuala Lumpur, Kuala Lumpur, 53000

  • Local Institution - 0484

    Kuching, 93586

Other trials in Malaysia

Switzerland3 sites

  • Local Institution - 0170

    Basel, Canton of Basel-City, 4031

  • Local Institution - 0477

    Bern, Canton of Bern, 3010

  • Local Institution - 0486

    Geneva, Canton of Geneva, 1205

Other trials in Switzerland

Finland2 sites

  • Local Institution - 0301

    Helsinki, Etelae-Suomen Laeaeni, 00029

  • Local Institution - 0265

    Turku, Laensi-Suomen Laeaeni, 20521

Other trials in Finland

Hungary2 sites

  • Local Institution - 0035

    Budapest, 1083

  • Local Institution - 0280

    Győr, 9024

Other trials in Hungary

Czechia1 site

  • Local Institution - 0238

    Prague, 140 52

Other trials in Czechia

Puerto Rico1 site

  • Local Institution - 0214

    Guaynabo, PR, 968

Other trials in Puerto Rico

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 Progressive Pulmonary Fibrosis

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

Being tested
BMS-986278, BMS-986278 Placebo
Keywords
BMS-986278, LPA1 antagonist, Pulmonary fibrosis, Interstitial lung disease, Rheumatoid Arthritis, Connective Tissue Disorders, Sarcoidosis, Scleroderma, Fibrosis, Antifibrotic therapy
Medical subject headings
Pulmonary Fibrosis, Lung Diseases, Interstitial, Arthritis, Rheumatoid, Connective Tissue Diseases, Sarcoidosis, Scleroderma, Diffuse, Fibrosis

What participants receive

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

  • BMS-986278Drug

    Specified dose on specified days

  • BMS-986278 PlaceboDrug

    Specified dose on specified days

Study groups in NCT06025578
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: At 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: At Week 52 and up to approximately 3 years

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

    Cohort 2

    Measured: At Week 52 and up to approximately 3 years

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

    Cohort 2

    Measured: At 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 all-cause mortality

    Cohort 2

    Measured: Up to approximately 3 years

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

    Cohort 2

    Measured: At Week 52 and up to approximately 3 years

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

    Cohort 2

    Measured: At Week 52 and up to approximately 3 years

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

    Cohort 2

    Measured: At Week 52 and up to approximately 3 years

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

    Cohort 2

    Measured: At Week 52

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

    Cohort 2

    Measured: At Week 52

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

    Cohort 2

    Measured: At Week 52

  18. Rate of decline in ppFVC from baseline

    Cohort 2

    Measured: At Week 52

  19. Change in ppFVC from baseline

    Cohort 2

    Measured: At Week 52

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

    Cohort 2

    Measured: At Week 52

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

    Cohort 2

    Measured: At 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: At 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: At Week 52

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

    Cohort 2

    Measured: At Week 52

  25. Number of participants with Adverse Events (AEs)

    Cohort 2

    Measured: Up to 28 days after last dose

  26. Number of participants with Serious AEs (SAEs)

    Cohort 2

    Measured: Up to 28 days after last dose

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

    Cohort 2

    Measured: Up to 28 days after last dose

  28. Number of participants with AEs related to IMP

    Cohort 2

    Measured: Up to 28 days after last dose

  29. Number of treatment-emergent deaths

    Cohort 2

    Measured: Up to 28 days after last dose

  30. Number of participants with clinical laboratory abnormalities

    Cohort 2

    Measured: Up to 28 days after last dose

  31. Number of participants with electrocardiogram (ECG) abnormalities

    Cohort 2

    Measured: Up to 28 days after last dose

  32. Number of participants with vital sign abnormalities

    Cohort 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 posted6 Sep 2023
  2. Study start25 Oct 2023
  3. Primary completion27 Dec 2027 (estimated)
  4. Study completion27 Dec 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
1,057 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06025578
Sponsor's protocol ID
IM027-1015
Other IDs
2023-503699-25, 2023
Status last verified
Apr 2026
First submitted
30 Aug 2023
Last updated
23 Apr 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 Progressive Pulmonary Fibrosis, run by Bristol-Myers Squibb at 459 sites in 35 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 8 inclusion and 6 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 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 459 sites in United States, China, Japan, India, Italy and 30 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 NCT06025578.

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 23 Apr 2026.

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