Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06025578

A 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986278

Drug

Specified dose on specified days

BMS-986278 Placebo

Drug

Specified dose on specified days

Primary outcomes

  1. Number of participants that experience spontaneous syncopal events

    Time frame: At approximately 4 weeks

    Cohort 1

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

    Time frame: At Week 52

    Cohort 2

Secondary outcomes

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

    Time frame: Up to approximately 3 years

    Cohort 1

  2. Disease progression

    Time frame: Up to approximately 3 years

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

    Time frame: At Week 52 and up to approximately 3 years

    Cohort 2

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

    Time frame: At Week 52 and up to approximately 3 years

    Cohort 2

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

    Time frame: At Week 52

    Cohort 2

  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

    Time frame: Up to approximately 3 years

    Cohort 2

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

    Time frame: Up to approximately 3 years

    Cohort 2

  8. Time to first acute exacerbation of pulmonary fibrosis

    Time frame: Up to approximately 3 years

    Cohort 2

  9. Time to first respiratory-related hospitalization

    Time frame: Up to approximately 3 years

    Cohort 2

  10. Time to first pulmonary fibrosis-related hospitalization.

    Time frame: Up to approximately 3 years

    Cohort 2

  11. Time to all-cause mortality

    Time frame: Up to approximately 3 years

    Cohort 2

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

    Time frame: At Week 52 and up to approximately 3 years

    Cohort 2

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

    Time frame: At Week 52 and up to approximately 3 years

    Cohort 2

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

    Time frame: At Week 52 and up to approximately 3 years

    Cohort 2

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

    Time frame: At Week 52

    Cohort 2

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

    Time frame: At Week 52

    Cohort 2

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

    Time frame: At Week 52

    Cohort 2

  18. Rate of decline in ppFVC from baseline

    Time frame: At Week 52

    Cohort 2

  19. Change in ppFVC from baseline

    Time frame: At Week 52

    Cohort 2

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

    Time frame: At Week 52

    Cohort 2

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

    Time frame: At Week 52

    Cohort 2

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

    Time frame: At Week 52

    Cohort 2

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

    Time frame: At Week 52

    Cohort 2

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

    Time frame: At Week 52

    Cohort 2

  25. Number of participants with Adverse Events (AEs)

    Time frame: Up to 28 days after last dose

    Cohort 2

  26. Number of participants with Serious AEs (SAEs)

    Time frame: Up to 28 days after last dose

    Cohort 2

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

    Time frame: Up to 28 days after last dose

    Cohort 2

  28. Number of participants with AEs related to IMP

    Time frame: Up to 28 days after last dose

    Cohort 2

  29. Number of treatment-emergent deaths

    Time frame: Up to 28 days after last dose

    Cohort 2

  30. Number of participants with clinical laboratory abnormalities

    Time frame: Up to 28 days after last dose

    Cohort 2

  31. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to 28 days after last dose

    Cohort 2

  32. Number of participants with vital sign abnormalities

    Time frame: Up to 28 days after last dose

    Cohort 2

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 6, 2023
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.