403 Participants Needed

A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants With Lung Fibrosis

Recruiting at 224 trial locations
Rs
Fl
BS
Overseen ByBMS Study Connect Contact Center www.BMSStudyConnect.com
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Bristol-Myers Squibb
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called BMS-986278 to help people with lung fibrosis. The goal is to see if it can reduce lung scarring and improve breathing. The study will also check if the drug is safe and how much of it stays in the body.

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.

Research Team

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

Inclusion Criteria

Evidence of progressive ILD within the 24 months before screening
You are eligible for this study if you are female and male, 21 years of age or older.
For the idiopathic pulmonary fibrosis (IPF) Cohort: Diagnosis of IPF within 7 years of screening; Female and males ≥ 40 years of age
See 5 more

Exclusion Criteria

You are currently smoking cigarettes.
You have had an allergic reaction to BMS-986278 or similar compounds in the past.
Current malignancy or previous malignancy up to 5 years prior to screening
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986278 or placebo for the treatment of pulmonary fibrosis

26 weeks
Regular visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Optional Treatment Extension (OTE)

Participants may opt into continuation of treatment long-term

Treatment Details

Interventions

  • BMS-986278
  • BMS-986278 Placebo
Participant Groups
6Treatment groups
Experimental Treatment
Placebo Group
Group I: PF-ILD Dose 2 + Post Treatment Follow-up or OTEExperimental Treatment1 Intervention
Group II: PF-ILD Dose 1 + Post Treatment Follow-up or OTEExperimental Treatment1 Intervention
PF-ILD (Progressive Fibrotic Interstitial Lung Disease)
Group III: IPF Dose 2 + Post Treatment Follow-up or OTEExperimental Treatment1 Intervention
Group IV: IPF Dose 1 + Post Treatment Follow-up or OTEExperimental Treatment1 Intervention
IPF (Idiopathic Pulmonary Fibrosis) OTE (Optional Treatment Extension)
Group V: PF-ILD Placebo + Post Treatment Follow-up or OTEPlacebo Group1 Intervention
Group VI: IPF Placebo + Post Treatment Follow-up or OTEPlacebo Group1 Intervention

BMS-986278 is already approved in United States for the following indications:

🇺🇸
Approved in United States as BMS-986278 for:
  • Progressive Pulmonary Fibrosis (Breakthrough Therapy Designation)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

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 profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania