NCT06003426

A Study 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

Summary

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

Eligibility

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Disease(s) and\or Condition(s)

Idiopathic Pulmonary Fibrosis

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: BMS-986278
    • Description: Specified dose on specified days
    • Arm Group Labels: BMS-986278 Dose 1, BMS-986278 Dose 2
    • Type: DRUG
    • Name: BMS-986278 Placebo
    • Description: Specified dose on specified days
    • Arm Group Labels: BMS-986278 Placebo
Sponsor
  • Bristol-Myers Squibb