BMS-986278 for Pulmonary Fibrosis

Recruiting at 873 trial locations

Overseen By Peter Bercz, Site 0452

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bristol-Myers Squibb

Must not be taking: Systemic corticosteroids

Disqualifiers: Idiopathic pulmonary fibrosis, Stroke, Heart failure, Current malignancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

1092 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis.

Will I have to stop taking my current medications?

You may need to stop certain medications before joining the trial. If you are not currently on medications like pirfenidone, nintedanib, MMF, MA, AZA, tacrolimus, traditional DMARDs, biologic DMARDs, or JAK inhibitors, you should not have taken them within 28 days before screening. If you are on these medications, you must be on a stable dose for at least 90 days before screening.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for people with progressive pulmonary fibrosis who've been on a stable dose of certain lung disease medications for at least 90 days, or haven't taken them in the last 28 days. They should not have had a stroke, significant heart disease recently, or any cancer (except some skin/cervical cancers) in the past 5 years. Women must use effective birth control and provide a negative pregnancy test; men must agree to use barrier contraception.

Inclusion Criteria

Women who are of childbearing potential must have a highly effective form of contraception and must provide a negative urine/serum pregnancy test

I have been diagnosed with a worsening lung condition in the last 2 years and it affects more than 10% of my lungs.

I have been on a stable dose of pirfenidone or nintedanib for 90 days, or I haven't taken them in the last 28 days.

Exclusion Criteria

I have not had a stroke or mini-stroke in the last 3 months.

I have been diagnosed with a specific lung condition called idiopathic pulmonary fibrosis.

I haven't had cancer in the last 5 years, except for certain skin cancers or cervical cancer that were cured.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986278 or placebo to evaluate efficacy, safety, and tolerability

52 weeks

Regular visits throughout the treatment period

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 28 days after last dose

Long-term Follow-up

Participants are monitored for disease progression and other outcomes

Up to approximately 3 years

Treatment Details

Interventions

• BMS-986278

Trial Overview The study tests BMS-986278's effectiveness and safety compared to a placebo in treating progressive pulmonary fibrosis. Participants will either receive BMS-986278 or an inactive substance without knowing which one they're getting.

Participant Groups

Group I: BMS-986278 Dose 2 Experimental Treatment 1 Intervention

Group II: BMS-986278 Dose 1 Experimental Treatment 1 Intervention

Group III: BMS-986278 Placebo 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