Only 699 spots left

~699 spots leftby Dec 2027

BMS-986278 for Pulmonary Fibrosis

Recruiting in Palo Alto (17 mi)

+847 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Bristol-Myers Squibb

Must not be taking: Systemic corticosteroids

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

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 1 Jurisdiction

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.

See 4 more

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.

See 1 more

Trial 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 (Monoclonal Antibodies)

Trial OverviewThe 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

3Treatment groups

Experimental Treatment

Placebo Group

Group I: BMS-986278 Dose 2Experimental Treatment1 Intervention

Group II: BMS-986278 Dose 1Experimental Treatment1 Intervention

Group III: BMS-986278 PlaceboPlacebo Group1 Intervention