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Trial ID IM027-068  |   NCT06003426

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

Summary

  • Phase 3
  • Male and Female Gender icon
  • 40+
    Age Range
  • 246
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

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

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • Subjects with IPF aged ≥ 40 years at the time of signing the informed consent.
    1. 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.
      1. If on pirfenidone or nintedanib, participants must have been on a stable dose for at least 90 days prior to screening.
        1. If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within 28 days prior to screening.
          1. Women who are of childbearing potential must have a highly effective form of contraception and must provide a negative urine/serum pregnancy test.
            1. Men who are sexually active with women of childbearing potential agree to use male barrier contraception.

              Exclusion Criteria

              Exclusion Criteria Icon
              • History of stroke or transient ischemic attack within 3 months prior to screening.
                1. Participants who exhibit symptoms of heart failure at rest.
                  1. 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.
                    Additional Information *
                    • Other protocol-defined Inclusion/Exclusion criteria apply.

                      Treatment Options

                      Study Arms

                      ASSIGNED INTERVENTION

                      Study Arms

                      Experimental: BMS-986278 Dose 1

                      ASSIGNED INTERVENTION
                      • Drug: BMS-986278

                      Study Arms

                      Experimental: BMS-986278 Dose 2

                      ASSIGNED INTERVENTION
                      • Drug: BMS-986278

                      Study Arms

                      Placebo Comparator: BMS-986278 Placebo

                      ASSIGNED INTERVENTION
                      • Drug: BMS-986278 Placebo
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