A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis

a study on Fibrosis Idiopathic Pulmonary Fibrosis

Summary

Eligibility
for people ages 40 years and up (full criteria)
Location
at UC Davis UC Irvine UCLA UCSD UCSF
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.
  • Participants who exhibit symptoms of heart failure at rest.
  • 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.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Locations

  • University of California San Diego not yet accepting patients
    La Jolla California 92093 United States
  • David Geffen School of Medicine at UCLA not yet accepting patients
    Los Angeles California 90095-3075 United States
  • UC Irvine Medical Center accepting new patients
    Orange California 92868-3201 United States
  • University of California UC Davis Medical Center not yet accepting patients
    Sacramento California 95817 United States
  • University of California, San Francisco Medical Center- Pulmonary Practice not yet accepting patients
    San Francisco California 94143-2202 United States
  • Scripps Clinic Torrey Pines not yet accepting patients
    La Jolla California 92037-1027 United States
  • University of Southern California (USC) - Keck School of Medicine (KSOM) - Transplant Clinic not yet accepting patients
    Los Angeles California 90033-5313 United States
  • Stanford Hospital And Clinics not yet accepting patients
    Stanford California 94305 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
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