← Back to Search

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

Study 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.Check my eligibility

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.See study design

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 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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Absolute change from baseline in forced vital capacity (FVC) measured in mL

Secondary outcome measures

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

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,641 Previous Clinical Trials

4,128,879 Total Patients Enrolled

3 Trials studying Idiopathic Pulmonary Fibrosis

361 Patients Enrolled for Idiopathic Pulmonary Fibrosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please detail the safety profile of BMS-986278 Dose 1?

"Based on the available data, our team at Power has assessed BMS-986278 Dose 1's safety to be 3 out of a possible score range from 1 to 3. This score is due to multiple rounds of clinical testing demonstrating efficacy and supporting evidence for its security profile."

Answered by AI

How many centers are overseeing this clinical trial?

"At the moment, this medical trial is being conducted in 443 sites across the United States. These include Jasper, Phoenix and La Jolla, with a variety of other locations available to choose from. Choosing an institution close to you can help reduce any associated travelling costs that may be incurred when enrolling in the study."

Answered by AI

Are there still openings available for the trial participants?

"Per information hosted on clinicaltrials.gov, this experiment is not presently enrolling participants. The trial was first published on August 16th 2023 and last edited a day later; however, there are currently 434 alternative trials actively seeking volunteers."

Answered by AI

Who else is applying?

What site did they apply to?

University of California UC Davis Medical Center

National Jewish Health

Southeastern Research Center

Other

What portion of applicants met pre-screening criteria?

Met criteria

Did not meet criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

Want to try to obtain a longer life. Currently stable and wish to stay that way.

PatientReceived no prior treatments

I am currently taking Ofev and using a Stilicho inhaler. i have covid fibrosis with significantly compromised lung function. covid onset was 11/20 and my ku pulmonologist is mark hamblin.

PatientReceived no prior treatments

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis

2023. "A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06003426.

All > Pulmonary Fibrosis > Vancouver