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Monoclonal Antibodies

BMS-986278 for Idiopathic Pulmonary Fibrosis

Verified Trial
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 IPF within 7 years prior to screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained at screening and verification of usual interstitial pneumonia
Subjects with IPF aged ≥ 40 years at the time of signing the informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 52 and up to approximately 4 years
Awards & highlights
Pivotal Trial

Summary

This trial will test a drug to see if it's safe and effective to treat a lung disease called Idiopathic Pulmonary Fibrosis.

Who is the study for?
This trial is for adults over 40 with Idiopathic Pulmonary Fibrosis diagnosed within the last 7 years, confirmed by specific chest scans. Participants must use effective contraception if of childbearing potential and can't join if they've had a stroke or certain cancers recently, or significant heart disease as assessed by the investigator.
What is being tested?
The study tests BMS-986278's effectiveness and safety in treating Idiopathic Pulmonary Fibrosis compared to a placebo. Some participants will receive BMS-986278 while others will get a placebo, without knowing which one they're getting.
What are the potential side effects?
While not specified here, common side effects may include gastrointestinal issues, skin reactions, fatigue, headache, dizziness and potential risks associated with immune system changes due to drug intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was diagnosed with IPF within the last 7 years, confirmed by a chest HRCT scan.
Select...
I am 40 years or older with idiopathic pulmonary fibrosis.
Select...
I was diagnosed with IPF within the last 7 years, confirmed by a chest HRCT.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 52 and up to approximately 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 52 and up to approximately 4 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
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
+26 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
2,682 Previous Clinical Trials
4,128,336 Total Patients Enrolled
3 Trials studying Idiopathic Pulmonary Fibrosis
361 Patients Enrolled for Idiopathic Pulmonary Fibrosis
~737 spots leftby Oct 2026
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