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Monoclonal Antibodies

BMS-986278 for Pulmonary Fibrosis

Phase 3
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of interstitial lung disease (ILD) with features consistent with progressive ILD within 24 months prior to screening, and ≥ 10% extent of disease on screening high-resolution computed tomography (HRCT)
Mycophenolate mofetil (MMF), mycophenolic acid (MA), azathioprine (AZA), and Tacrolimus are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on MMF, MA, AZA, or tacrolimus, participants must not have taken these medications within 28 days prior to screening
Must not have
Idiopathic pulmonary fibrosis with usual interstitial pneumonia (UIP) verification at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 52 and up to approximately 3 years
Awards & highlights
Pivotal Trial

Summary

This trial tests the effectiveness, safety and tolerability of a new drug for people with progressive pulmonary fibrosis.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, generally such trials may monitor for drug reactions like nausea, rash, liver issues, breathing difficulties or other symptoms that could indicate intolerance to the medication being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with a worsening lung condition in the last 2 years and it affects more than 10% of my lungs.
Select...
I have been on a stable dose of MMF, MA, AZA, or Tacrolimus for 90 days, or haven't taken them in the last 28 days.
Select...
I agree to use condoms during sex with women who can have children.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with a specific lung condition called idiopathic pulmonary fibrosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 52 and up to approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 52 and up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Absolute change from baseline in forced vital capacity (FVC) measured in mL
Number of participants that experience spontaneous syncopal events
Secondary study objectives
Change from baseline in EQ-5D-5L visual analog scale score
Change from baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) health utility index score
Change from baseline in L-PF dyspnea domain score
+29 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BMS-986278
2023
Completed Phase 2
~750

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,686 Previous Clinical Trials
4,128,735 Total Patients Enrolled
4 Trials studying Idiopathic Pulmonary Fibrosis
1,546 Patients Enrolled for Idiopathic Pulmonary Fibrosis
~728 spots leftby Dec 2027
Unbiased ResultsWe believe in providing patients with all the options.
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