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Purpose

The purpose of this study is to provide an initial evaluation of the effectiveness of BMS-986278 in participants with lung fibrosis, to demonstrate the safety of BMS-986278, and provide information on the drug levels of BMS-986278 in these participants.

Condition

Eligibility

Eligible Ages
Over 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

For the idiopathic pulmonary fibrosis (IPF) Cohort - Diagnosis of IPF within 7 years of screening - Female and males ≥ 40 years of age For the progressive fibrotic interstitial lung disease (PF-ILD) Cohort - Evidence of progressive ILD within the 24 months before screening - Female and male ≥ 21 years of age.

Exclusion Criteria

  • Women of childbearing potential (WOCBP) - Active Smokers - Current malignancy or previous malignancy up to 5 years prior to screening - History of allergy to BMS-986278 or related compounds Other protocol-defined inclusion/exclusion criteria apply

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
IPF Dose 1 + Post Treatment Follow-up or OTE 		IPF (Idiopathic Pulmonary Fibrosis) OTE (Optional Treatment Extension)
  • Drug: BMS-986278
    Specified Dose on Specified Days
Experimental
IPF Dose 2 + Post Treatment Follow-up or OTE
  • Drug: BMS-986278
    Specified Dose on Specified Days
Placebo Comparator
IPF Placebo + Post Treatment Follow-up or OTE
  • Other: BMS-986278 Placebo
    Specified Dose on Specified Days
Experimental
PF-ILD Dose 1 + Post Treatment Follow-up or OTE 		PF-ILD (Progressive Fibrotic Interstitial Lung Disease)
  • Drug: BMS-986278
    Specified Dose on Specified Days
Experimental
PF-ILD Dose 2 + Post Treatment Follow-up or OTE
  • Drug: BMS-986278
    Specified Dose on Specified Days
Placebo Comparator
PF-ILD Placebo + Post Treatment Follow-up or OTE
  • Other: BMS-986278 Placebo
    Specified Dose on Specified Days

Recruiting Locations

More Details

NCT ID
NCT04308681
Status
Completed
Sponsor
Bristol-Myers Squibb

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center