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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 52 and up to approximately 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 52 and up to approximately 4 years
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
+30 moreAwards & 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
2,696 Previous Clinical Trials
4,097,886 Total Patients Enrolled
3 Trials studying Idiopathic Pulmonary Fibrosis
361 Patients Enrolled for Idiopathic Pulmonary Fibrosis