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 - 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 - Patients with current malignancy - 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

University of Kansas Medical Center-Division of Pulmonary and Critical Care Medicine
Kansas City, Kansas 66103
Contact:
Mark Hamblin, Site 0031
504-905-7812

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

Recruiting sites have contact information. Please contact the sites directly. If there is no contact information
please email:
Clinical.Trials@bms.com

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.