BMS-986278 Placebo: Specified dose on specified days
Study summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis.
Eligibility
Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Number of participants that experience spontaneous syncopal events — At approximately 4 weeks Cohort 1
Absolute change from baseline in forced vital capacity (FVC) measured in mL — At Week 52 Cohort 2
Trial sites (459)
Facility
City
Region
Status
Local Institution - 0046
Birmingham
Alabama
Local Institution - 0314
Phoenix
Arizona
Local Institution - 0336
La Jolla
California
Local Institution - 0212
Los Angeles
California
Local Institution - 0019
Los Angeles
California
Local Institution - 0535
Newport Beach
California
Local Institution - 0366
Orange
California
Local Institution - 0341
Sacramento
California
Local Institution - 0015
San Francisco
California
Local Institution - 0352
Stanford
California
Local Institution - 0321
Aurora
Colorado
Local Institution - 0376
Denver
Colorado
Local Institution - 0211
New Haven
Connecticut
Local Institution - 0418
Stamford
Connecticut
Local Institution - 0067
Newark
Delaware
Local Institution - 0354
Washington D.C.
District of Columbia
Local Institution - 0195
Brandon
Florida
Local Institution - 0380
Celebration
Florida
Local Institution - 0013
Clearwater
Florida
Local Institution - 0396
DeBary
Florida
Local Institution - 0036
Gainesville
Florida
Local Institution - 0193
Gainesville
Florida
Local Institution - 0073
Loxahatchee Groves
Florida
Local Institution - 0220
Ocala
Florida
Local Institution - 0452
Pensacola
Florida
Local Institution - 0389
St. Petersburg
Florida
Local Institution - 0316
Tampa
Florida
Local Institution - 0070
Atlanta
Georgia
Local Institution - 0368
Dublin
Georgia
Local Institution - 0435
Chicago
Illinois
Local Institution - 0023
Chicago
Illinois
Local Institution - 0040
Evanston
Illinois
Local Institution - 0082
Maywood
Illinois
Local Institution - 0080
Iowa City
Iowa
Local Institution - 0049
Kansas City
Kansas
Local Institution - 0045
Louisville
Kentucky
Local Institution - 0361
Louisville
Kentucky
Local Institution - 0305
Baltimore
Maryland
Local Institution - 0033
Towson
Maryland
Local Institution - 0404
Boston
Massachusetts
+ 419 more sites — see the full list on the official registry below.
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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