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

About

Brief Summary

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

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 3

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
40 Years
Maximum Age
N/A

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.

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Study Stats
Protocol No.
24-5048
Category
Lung/Respiratory Disorders
Contact
Jennifer Perez
Location
  • UCLA Westwood
For Providers
NCT No.
NCT06003426
For detailed technical eligibility, visit ClinicalTrials.gov.