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BMS-986278 for Idiopathic Pulmonary Fibrosis

Recruiting in Palo Alto (17 mi)

+819 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Bristol-Myers Squibb

Must be taking: Pirfenidone, Nintedanib

Disqualifiers: Stroke, Heart failure, 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 Idiopathic Pulmonary Fibrosis.

Will I have to stop taking my current medications?

If you are taking pirfenidone or nintedanib, you must have been on a stable dose for at least 90 days before joining the trial. If you are not taking these medications, you should not have taken them in the 28 days before the trial starts.

What data supports the effectiveness of the drug BMS-986278 for idiopathic pulmonary fibrosis?

The study on BMS-986020, a similar drug, showed that it slowed the decline in lung function compared to a placebo in patients with idiopathic pulmonary fibrosis, suggesting potential effectiveness for BMS-986278 as well.¹ ² ³ ⁴ ⁵

What is known about the safety of BMS-986278 for human use?

There is no specific safety data available for BMS-986278, but its predecessor, BMS-986020, was generally well-tolerated in a phase 2 trial for idiopathic pulmonary fibrosis, with treatment discontinuation due to adverse events being common in antifibrotic treatments.³ ⁶ ⁷ ⁸ ⁹

What makes the drug BMS-986278 unique for treating idiopathic pulmonary fibrosis?

BMS-986278 is a novel treatment for idiopathic pulmonary fibrosis, distinct from existing options like pirfenidone, as it is being evaluated for its unique mechanism of action and potential to improve upon the limitations of current anti-fibrotic treatments.¹ ² ³ ⁴ ⁵

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

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.

Inclusion Criteria

I was diagnosed with IPF within the last 7 years, confirmed by a chest HRCT scan.

I am 40 years or older with idiopathic pulmonary fibrosis.

I haven't taken pirfenidone or nintedanib in the last 28 days.

See 4 more

Exclusion Criteria

I haven't had cancer in the last 5 years, except for certain skin cancers or cervical cancer that were cured.

I have not had a stroke or mini-stroke in the last 3 months.

I haven't had serious heart problems in the last 6 months.

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

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days

Long-term Follow-up

Participants are monitored for long-term outcomes such as disease progression and mortality

Up to approximately 3 years

Treatment Details

Interventions

BMS-986278 (Monoclonal Antibodies)

Trial OverviewThe 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.

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

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:

Local Institution - 0094Evanston, IL

Local Institution - 0455Detroit, MI

UPMC - Dorothy P. and Richard P. Simmons Center for Interstitial Lung Diseases (ILD)Pittsburgh, PA

Local Institution - 0489Falls Church, VA

More Trial Locations

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Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2731

Patients Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal "Real-World" Outcomes of Pirfenidone in Idiopathic Pulmonary Fibrosis in Greece.Tzouvelekis, A., Karampitsakos, T., Ntolios, P., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1, randomized study to evaluate safety, tolerability, and pharmacokinetics of GDC-3280, a potential novel anti-fibrotic small molecule, in healthy subjects.Cheung, D., Fong, A., Ding, HT., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External Control Arms in Idiopathic Pulmonary Fibrosis Using Clinical Trial and Real-World Data Sources.Swaminathan, AC., Snyder, LD., Hong, H., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NO-releasing xanthine KMUP-1 bonded by simvastatin attenuates bleomycin-induced lung inflammation and delayed fibrosis.Liu, CP., Kuo, MS., Wu, BN., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plain language summary: Clinical study of BI 1015550 as a potential treatment for idiopathic pulmonary fibrosis.Richeldi, L., Azuma, A., Cottin, V., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 2 trial design of BMS-986278, a lysophosphatidic acid receptor 1 (LPA1) antagonist, in patients with idiopathic pulmonary fibrosis (IPF) or progressive fibrotic interstitial lung disease (PF-ILD).Corte, TJ., Lancaster, L., Swigris, JJ., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Phase 1 Evaluation of Deupirfenidone, a Novel Deuterium-Containing Drug Candidate for Interstitial Lung Disease and Other Inflammatory and Fibrotic Diseases.Chen, MC., Korth, CC., Harnett, MD., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LPA1 antagonist BMS-986020 changes collagen dynamics and exerts antifibrotic effects in vitro and in patients with idiopathic pulmonary fibrosis.Decato, BE., Leeming, DJ., Sand, JMB., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial of BMS-986020, a Lysophosphatidic Acid Receptor Antagonist for the Treatment of Idiopathic Pulmonary Fibrosis.Palmer, SM., Snyder, L., Todd, JL., et al.[2019]

References

1.Switzerlandpubmed.ncbi.nlm.nih.gov

Longitudinal "Real-World" Outcomes of Pirfenidone in Idiopathic Pulmonary Fibrosis in Greece. [2022]

2.Englandpubmed.ncbi.nlm.nih.gov

A phase 1, randomized study to evaluate safety, tolerability, and pharmacokinetics of GDC-3280, a potential novel anti-fibrotic small molecule, in healthy subjects. [2021]

3.United Statespubmed.ncbi.nlm.nih.gov

External Control Arms in Idiopathic Pulmonary Fibrosis Using Clinical Trial and Real-World Data Sources. [2023]

4.Englandpubmed.ncbi.nlm.nih.gov

NO-releasing xanthine KMUP-1 bonded by simvastatin attenuates bleomycin-induced lung inflammation and delayed fibrosis. [2022]

5.Englandpubmed.ncbi.nlm.nih.gov

Plain language summary: Clinical study of BI 1015550 as a potential treatment for idiopathic pulmonary fibrosis. [2023]

6.Englandpubmed.ncbi.nlm.nih.gov

7.United Statespubmed.ncbi.nlm.nih.gov

A Randomized Phase 1 Evaluation of Deupirfenidone, a Novel Deuterium-Containing Drug Candidate for Interstitial Lung Disease and Other Inflammatory and Fibrotic Diseases. [2022]

8.Englandpubmed.ncbi.nlm.nih.gov

LPA1 antagonist BMS-986020 changes collagen dynamics and exerts antifibrotic effects in vitro and in patients with idiopathic pulmonary fibrosis. [2022]

9.United Statespubmed.ncbi.nlm.nih.gov

Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial of BMS-986020, a Lysophosphatidic Acid Receptor Antagonist for the Treatment of Idiopathic Pulmonary Fibrosis. [2019]