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A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants With Lung Fibrosis

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	21 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04308681
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Bristol-Myers Squibb
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Bristol-Myers Squibb
Principal Investigator Affiliation	Bristol-Myers Squibb
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Australia, Belgium, Brazil, Canada, Chile, China, France, Germany, Israel, Italy, Japan, Korea, Republic of, Mexico, Spain, Taiwan, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Fibrosis
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: IPF Dose 1 + Post Treatment Follow-up or OTE

IPF (Idiopathic Pulmonary Fibrosis) OTE (Optional Treatment Extension)

Experimental: IPF Dose 2 + Post Treatment Follow-up or OTE

Placebo Comparator: IPF Placebo + Post Treatment Follow-up or OTE

Experimental: PF-ILD Dose 1 + Post Treatment Follow-up or OTE

PF-ILD (Progressive Fibrotic Interstitial Lung Disease)

Experimental: PF-ILD Dose 2 + Post Treatment Follow-up or OTE

Placebo Comparator: PF-ILD Placebo + Post Treatment Follow-up or OTE

Interventions

Other: - BMS-986278 Placebo

Specified Dose on Specified Days

Drug: - BMS-986278

Specified Dose on Specified Days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Birmingham, Alabama

Status

Recruiting

Address

University of Alabama at Birmingham-Division of Pulmonary, Allergy & Critical Care Med

Birmingham, Alabama, 35294

Site Contact

Tejaswini Kulkarni, Site 0032