BMS-986278 in Participants With 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.

• Study Sponsor: Bristol-Myers Squibb
  
  
• Start Date: October 2023
  
  
• Estimated Primary Completion Date: December 2027
  
  
• Phase 3, multicenter, randomized, double-blind, placebo-controlled, study to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with progressive pulmonary fibrosis

Primary Outcome Measure:

• Cohort 1: Number of participants that experience spontaneous syncopal events [Timeframe: at approximately 4 weeks]
• Cohort 2: Absolute change from baseline in forced vital capacity (FVC) measured in mL [Timeframe: at Week 52]

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 or a previous malignancy in the past 5 years prior to screening, except for those who have a documented history of cured nonmetastatic squamous cell skin carcinoma, basal cell skin carcinoma, or cervical carcinoma in situ.
• 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.