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Recruiting

A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis - IM027-068

Oppdatert: 1 oktober, 2024   |   ClinicalTrials.gov

Utskriftsvennlig Sammendrag

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Vis detaljer

  • Phase 3

    Fase

  • Kjønn

  • 40+

    Aldersgruppe

  • 245

    Sted(er)

  • Recruiting

Behandlingsalternativer

Studiearmer
TILDELT INTERVENSJON
Experimental: BMS-986278 Dose 1
Drug: BMS-986278
Experimental: BMS-986278 Dose 2
Drug: BMS-986278
Placebo Comparator: BMS-986278 Placebo
Drug: BMS-986278 Placebo

Nøkkelkriterier for kvalifikasjon

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 - 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

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Bivirkninger (uønskede hendelser) og andre rapporterbare hendelser er definert her
For å rapportere bivirkninger (uønskede hendelser) eller reklamere på et legemiddel: Medisinsk informasjon

MLTNO2000046