BMS-986278 for Pulmonary Fibrosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of a new drug, BMS-986278, for individuals with lung fibrosis, a condition characterized by scarring and stiffening of the lungs. The study will assess the drug's safety and participant tolerance. It includes several groups, with some receiving the actual drug and others a placebo (a harmless pill without the active drug). Eligible participants have been diagnosed with idiopathic pulmonary fibrosis (IPF) within the last seven years or have shown signs of progressive fibrotic interstitial lung disease (PF-ILD) within the last two years. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that BMS-986278 is likely to be safe for humans?
Research shows that BMS-986278 may help treat lung conditions like Idiopathic Pulmonary Fibrosis (IPF) and Progressive Fibrotic Interstitial Lung Disease (PF-ILD). Previous studies found that participants generally tolerated this treatment well. For example, admilparant, a similar drug with a comparable mechanism, was safe and helped slow the decline in lung function. This suggests that treatments like BMS-986278 could be safe for people.
The study is currently in a phase that evaluates both the treatment's efficacy and safety, indicating that earlier safety results were positive enough to proceed. Participants in earlier trials did not report major safety concerns, which is encouraging for those considering joining the trial.12345Why do researchers think this study treatment might be promising for lung fibrosis?
Most treatments for lung fibrosis focus on slowing the progression of the disease by targeting inflammation or fibrosis pathways. However, BMS-986278 works differently by specifically targeting the LPA1 receptor, which plays a key role in the fibrotic process. This unique mechanism of action could potentially offer a more direct approach to slowing or even reversing fibrosis. Researchers are excited about BMS-986278 because it represents a promising new avenue for treating lung fibrosis, with the potential to improve outcomes for patients who have limited options today.
What evidence suggests that BMS-986278 might be an effective treatment for lung fibrosis?
Research has shown that BMS-986278 could be helpful in treating lung fibrosis. In this trial, participants will receive either BMS-986278 or a placebo. Studies found that a 60 mg dose taken twice daily reduced the rate of lung function decline by 69% over 26 weeks in patients with Idiopathic Pulmonary Fibrosis (IPF). Slowing the loss of lung function is crucial in treating these conditions. Additionally, the treatment was well tolerated, with most participants not experiencing serious side effects. BMS-986278 works by blocking a receptor involved in fibrosis, the thickening and scarring of lung tissue. Early results suggest it might help manage Progressive Fibrotic Interstitial Lung Disease (PF-ILD) by slowing the disease's progression.24678
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BMS-986278 or placebo for the treatment of pulmonary fibrosis
Follow-up
Participants are monitored for safety and effectiveness after treatment
Optional Treatment Extension (OTE)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- BMS-986278
- BMS-986278 Placebo
BMS-986278 is already approved in United States for the following indications:
- Progressive Pulmonary Fibrosis (Breakthrough Therapy Designation)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania