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

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06003426Tipo: INTERVENTIONALInicio: 14 de sept de 2023Fin estimado: 26 de oct de 2026

Traducción no disponible, mostrando original

Resumen

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

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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 with less than 2 years free of recurrence or a biopsy that is suspicious for malignancy and the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations.

Intervenciones

drug

BMS-986278

Specified dose on specified days

drug

BMS-986278 Placebo

Specified dose on specified days

Ubicaciones

Local Institution - 0131

Mar del Plata, Buenos Aires, Argentina

Local Institution - 0019

Buenos Aires, B, Argentina

Local Institution - 0172

Caba, B, Argentina

Local Institution - 0170

Florida, B, Argentina

Local Institution - 0286

Mar del Plata, B, Argentina

Local Institution - 0485

Quilmes, Provincia de Buenos Aires, B, Argentina

Local Institution - 0290

San Juan Bautista, B, Argentina

Local Institution - 0288

Ciudad Autónoma Buenos Aires, C, Argentina

Local Institution - 0287

Godoy Cruz, M, Argentina

Local Institution - 0013

Mendoza, M, Argentina

Local Institution - 0356

Mendoza, M, Argentina

Local Institution - 0330

Rosario, S, Argentina

Local Institution - 0169

San Miguel de Tucumán, T, Argentina

Local Institution - 0218

Córdoba, X, Argentina

Local Institution - 0283

Buenos Aires, Argentina

Local Institution - 0173

Santa Fe, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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