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

Recruiting at 224 trial locations

Overseen By BMS Study Connect Contact Center www.BMSStudyConnect.com

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bristol-Myers Squibb

Disqualifiers: Women of childbearing potential, active smokers, malignancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

403 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called BMS-986278 to help people with lung fibrosis. The goal is to see if it can reduce lung scarring and improve breathing. The study will also check if the drug is safe and how much of it stays in the body.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

Inclusion Criteria

Evidence of progressive ILD within the 24 months before screening

You are eligible for this study if you are female and male, 21 years of age or older.

For the idiopathic pulmonary fibrosis (IPF) Cohort: Diagnosis of IPF within 7 years of screening; Female and males ≥ 40 years of age

Exclusion Criteria

You are currently smoking cigarettes.

You have had an allergic reaction to BMS-986278 or similar compounds in the past.

Current malignancy or previous malignancy up to 5 years prior to screening

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986278 or placebo for the treatment of pulmonary fibrosis

26 weeks

Regular visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Optional Treatment Extension (OTE)

Participants may opt into continuation of treatment long-term

Treatment Details

Interventions

• BMS-986278
• BMS-986278 Placebo

Participant Groups

Group I: PF-ILD Dose 2 + Post Treatment Follow-up or OTE Experimental Treatment 1 Intervention

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

PF-ILD (Progressive Fibrotic Interstitial Lung Disease)

Group III: IPF Dose 2 + Post Treatment Follow-up or OTE Experimental Treatment 1 Intervention

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

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

Group V: PF-ILD Placebo + Post Treatment Follow-up or OTE Placebo Group 1 Intervention

Group VI: IPF Placebo + Post Treatment Follow-up or OTE Placebo Group 1 Intervention

BMS-986278 is already approved in United States for the following indications:

Approved in United States as BMS-986278 for:

• Progressive Pulmonary Fibrosis (Breakthrough Therapy Designation)

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania