BMS-986278 for Pulmonary Fibrosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called BMS-986278 to determine its effectiveness for progressive pulmonary fibrosis, a lung condition that causes scarring and difficulty breathing. Researchers aim to assess the treatment's safety and efficacy. Participants will receive either one of two doses of the treatment or a placebo, which contains no active drug. Individuals diagnosed with progressive interstitial lung disease (a type of lung scarring) in the last two years and who meet other criteria might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment.
Will I have to stop taking my current medications?
You may need to stop certain medications before joining the trial. If you are not currently on medications like pirfenidone, nintedanib, MMF, MA, AZA, tacrolimus, traditional DMARDs, biologic DMARDs, or JAK inhibitors, you should not have taken them within 28 days before screening. If you are on these medications, you must be on a stable dose for at least 90 days before screening.
Is there any evidence suggesting that BMS-986278 is likely to be safe for humans?
Research has shown that BMS-986278 has been tested in people with idiopathic pulmonary fibrosis. In those studies, participants found the treatment safe and well-tolerated, with no serious side effects reported. The studies also suggested that the treatment did not cause major problems and helped slow the decline in lung function.
Since this trial is in an advanced phase, earlier studies have demonstrated the treatment's reasonable safety for people. This is a promising sign for those considering joining the trial for progressive pulmonary fibrosis.12345Why do researchers think this study treatment might be promising?
Researchers are excited about BMS-986278 for pulmonary fibrosis because it represents a new approach to tackling this challenging condition. Unlike current treatments like pirfenidone and nintedanib, which primarily slow disease progression, BMS-986278 may offer a distinct mechanism of action. It targets a specific molecular pathway involved in fibrosis, potentially leading to better outcomes for patients. This novel targeting could mean not only improved effectiveness but also a different side effect profile, which is crucial for enhancing patient quality of life.
What evidence suggests that BMS-986278 might be an effective treatment for pulmonary fibrosis?
Research has shown that BMS-986278, a type of medication, offers promising results in slowing the decline of lung function. In one study with patients who have idiopathic pulmonary fibrosis, taking 60 mg of this medication twice a day for 26 weeks reduced the rate of lung capacity decrease. This was measured by percent predicted forced vital capacity (ppFVC), a key indicator of lung health. These findings suggest that BMS-986278 could effectively treat progressive pulmonary fibrosis by slowing the worsening of lung function. Participants in this trial will receive either BMS-986278 at different dosages or a placebo to further evaluate its effectiveness.12567
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
This trial is for people with progressive pulmonary fibrosis who've been on a stable dose of certain lung disease medications for at least 90 days, or haven't taken them in the last 28 days. They should not have had a stroke, significant heart disease recently, or any cancer (except some skin/cervical cancers) in the past 5 years. Women must use effective birth control and provide a negative pregnancy test; men must agree to use barrier contraception.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 to evaluate efficacy, safety, and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are monitored for disease progression and other outcomes
What Are the Treatments Tested in This Trial?
Interventions
- BMS-986278
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