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ACTIVE NOT RECRUITING

NCT06025578

PHASE3

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

Sponsor: Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1057

Start Date

2023-10-25

Completion Date

2027-12-27

Last Updated

2026-04-23

Healthy Volunteers

Conditions

Progressive Pulmonary Fibrosis

Interventions

DRUG

BMS-986278

Specified dose on specified days

DRUG

BMS-986278 Placebo

Specified dose on specified days

Inclusion Criteria * 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. Exclusion Criteria * 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.

Locations (459)

Local Institution - 0046

Birmingham, Alabama, United States

Local Institution - 0314

Phoenix, Arizona, United States

Local Institution - 0336

La Jolla, California, United States

Local Institution - 0212

Los Angeles, California, United States

Local Institution - 0019

Los Angeles, California, United States

Local Institution - 0535

Newport Beach, California, United States

Local Institution - 0366

Orange, California, United States

Local Institution - 0341

Sacramento, California, United States

Local Institution - 0015

San Francisco, California, United States

Local Institution - 0352

Stanford, California, United States

Local Institution - 0321

Aurora, Colorado, United States

Local Institution - 0376

Denver, Colorado, United States

Local Institution - 0211

New Haven, Connecticut, United States

Local Institution - 0418

Stamford, Connecticut, United States

Local Institution - 0067

Newark, Delaware, United States

Local Institution - 0354

Washington D.C., District of Columbia, United States

Local Institution - 0195

Brandon, Florida, United States

Local Institution - 0380

Celebration, Florida, United States

Local Institution - 0013

Clearwater, Florida, United States

Local Institution - 0396

DeBary, Florida, United States

Local Institution - 0036

Gainesville, Florida, United States

Local Institution - 0193

Gainesville, Florida, United States

Local Institution - 0073

Loxahatchee Groves, Florida, United States

Local Institution - 0220

Ocala, Florida, United States

Local Institution - 0452

Pensacola, Florida, United States

Local Institution - 0389

St. Petersburg, Florida, United States

Local Institution - 0316

Tampa, Florida, United States

Local Institution - 0070

Atlanta, Georgia, United States

Local Institution - 0368

Dublin, Georgia, United States

Local Institution - 0435

Chicago, Illinois, United States

Local Institution - 0023

Chicago, Illinois, United States

Local Institution - 0040

Evanston, Illinois, United States

Local Institution - 0082

Maywood, Illinois, United States

Local Institution - 0080

Iowa City, Iowa, United States

Local Institution - 0049

Kansas City, Kansas, United States

Local Institution - 0045

Louisville, Kentucky, United States

Local Institution - 0361

Louisville, Kentucky, United States

Local Institution - 0305

Baltimore, Maryland, United States

Local Institution - 0033

Towson, Maryland, United States

Local Institution - 0404

Boston, Massachusetts, United States

Local Institution - 0079

Springfield, Massachusetts, United States

Local Institution - 0207

Ann Arbor, Michigan, United States

Local Institution - 0031

Detroit, Michigan, United States

Local Institution - 0050

Grand Rapids, Michigan, United States

Local Institution - 0509

Royal Oak, Michigan, United States

Local Institution - 0384

Minneapolis, Minnesota, United States

Local Institution - 0004

Chesterfield, Missouri, United States

Local Institution - 0223

St Louis, Missouri, United States

Local Institution - 0525

Reno, Nevada, United States

Local Institution - 0068

Mount Kisco, New York, United States

Local Institution - 0357

New York, New York, United States

Local Institution - 0428

Durham, North Carolina, United States

Local Institution - 0392

Wilmington, North Carolina, United States

Local Institution - 0325

Winston-Salem, North Carolina, United States

Local Institution - 0419

Cincinnati, Ohio, United States

Local Institution - 0186

Cleveland, Ohio, United States

Local Institution - 0209

Columbus, Ohio, United States

Local Institution - 0343

Toledo, Ohio, United States

Local Institution - 0198

Oklahoma City, Oklahoma, United States

Local Institution - 0008

Tulsa, Oklahoma, United States

Local Institution - 0037

Portland, Oregon, United States

Local Institution - 0205

Hershey, Pennsylvania, United States

Local Institution - 0334

Philadelphia, Pennsylvania, United States

Local Institution - 0348

Philadelphia, Pennsylvania, United States

Local Institution - 0196

Philadelphia, Pennsylvania, United States

Local Institution - 0364

Wynnewood, Pennsylvania, United States

Local Institution - 0531

Anderson, South Carolina, United States

Local Institution - 0071

Charleston, South Carolina, United States

Local Institution - 0373

Greenville, South Carolina, United States

Local Institution - 0363

Nashville, Tennessee, United States

Local Institution - 0024

Dallas, Texas, United States

Local Institution - 0317

Dallas, Texas, United States

Local Institution - 0028

Houston, Texas, United States

Local Institution - 0041

Houston, Texas, United States

Local Institution - 0221

McKinney, Texas, United States

Local Institution - 0217

San Antonio, Texas, United States

Local Institution - 0014

Salt Lake City, Utah, United States

Local Institution - 0504

Burlington, Vermont, United States

Local Institution - 0414

Richmond, Virginia, United States

Local Institution - 0190

Everett, Washington, United States

Local Institution - 0043

Seattle, Washington, United States

Local Institution - 0020

Mar del Plata, Buenos Aires, Argentina

Local Institution - 0446

San Juan Bautista, Buenos Aires, Argentina

Local Institution - 0025

Buenos Aires, B, Argentina

Local Institution - 0039

Caba, B, Argentina

Local Institution - 0003

Florida, B, Argentina

Local Institution - 0182

Mar del Plata, B, Argentina

Local Institution - 0501

Quilmes, Provincia de Buenos Aires, B, Argentina

Local Institution - 0162

Ciudad Autónoma Buenos Aires, C, Argentina

Local Institution - 0032

Córdoba, Córdoba Province, Argentina

Local Institution - 0288

Godoy Cruz, M, Argentina

Local Institution - 0401

Mendoza, M, Argentina

Local Institution - 0400

Rosario, S, Argentina

Local Institution - 0005

San Miguel de Tucuman, Tucumán, T, Argentina

Local Institution - 0165

Buenos Aires, Argentina

Local Institution - 0450

Santa Fe, Argentina

Local Institution - 0065

Camperdown, New South Wales, Australia

Local Institution - 0089

Westmead, New South Wales, Australia

Local Institution - 0090

Brisbane, Queensland, Australia

Local Institution - 0091

Greenslopes, Queensland, Australia

And 359 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (459)