Summary

Eligibility
for people ages 40 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
completion around

Description

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis.

Official Title

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary Fibrosis, BMS-986278, LPA1 antagonist, IPF, Pulmonary fibrosis, Fibrosis

Eligibility

You can join if…

Open to people ages 40 years and up

  • Subjects with IPF aged ≥ 40 years at the time of signing the informed consent
  • 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.
  • If on pirfenidone or nintedanib, participants must have been on a stable dose for at least 90 days prior to screening
  • If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within 28 days prior to screening.
  • Women who are of childbearing potential must have a highly effective form of contraception and must provide a negative urine/serum pregnancy test
  • Men who are sexually active with women of childbearing potential agree to use male barrier contraception

You CAN'T join if...

  • History of stroke or transient ischemic attack within 3 months prior to screening
  • Significant cardiac disease within 6 months prior to screening per the investigator's discretion
  • Participants who have a current malignancy or a previous malignancy in the past 5 years prior to screening, except for those who have a documented history of cured nonmetastatic squamous cell skin carcinoma, basal cell skin carcinoma, or cervical carcinoma in situ.

    Note: Other protocol-defined inclusion/exclusion criteria apply

Locations

  • University of California San Diego not yet accepting patients
    La Jolla California 92093 United States
  • Scripps Clinic Torrey Pines not yet accepting patients
    La Jolla California 92037-1027 United States
  • University of Colorado Anschutz Medical Campus - Department of Family Medicine accepting new patients
    Aurora Colorado 80045 United States
  • Western Washington Medical Group (WWMG) - Everett - Silver Lake Medical Center Location accepting new patients
    Everett Washington 98208-6526 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT06003426
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 1185 study participants
Last Updated