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Recruiting

A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis - IM027-1015

Oppdatert: 13 juni, 2024   |   ClinicalTrials.gov

Utskriftsvennlig Sammendrag

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Vis detaljer

  • Phase 3

    Fase

  • Kjønn

  • 21+

    Aldersgruppe

  • 260

    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: - Diagnosis of interstitial lung disease (ILD) with features consistent with progressive ILD within 24 months prior to screening, and ≥ 10% extent of disease on screening high-resolution computed tomography (HRCT).. - 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. - Mycophenolate mofetil (MMF), mycophenolic acid (MA), azathioprine (AZA), and Tacrolimus are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on MMF, MA, AZA, or tacrolimus, participants must not have taken these medications within 28 days prior to screening. - Traditional disease-modifying antirheumatic drug (DMARDs) (eg. Methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine), Biologic DMARDs (eg. TNF blockers and IL-1 inhibitors) and Janus kinase inhibitors (JAK inhibitors) (eg. tofacitinib, upadacitinib) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. - Systemic corticosteroids are permitted provided that the participant is on prednisone ≤ 15 mg/day or equivalent for at least 70 days prior to Day 1. - 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: - Idiopathic pulmonary fibrosis with usual interstitial pneumonia (UIP) verification at screening - 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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For å rapportere bivirkninger (uønskede hendelser) eller reklamere på et legemiddel: Medisinsk informasjon

MLTNO2000046