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

Elegibilidad

Edad mínima: 21 YearsSexo: ALL

Criterios de inclusión

Diagnosis of interstitial lung disease (ILD) with features consistent with progressive ILD within 24 months prior to screening, and ≥ 10% extent of fibrosis 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) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on traditional DMARD, participants must not have taken these medications within 28 days prior to screening.
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. If not currently on Biologic DMARD or JAK inhibitor, participants must not have taken 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

Idiopathic pulmonary fibrosis with usual interstitial pneumonia (UIP) verification at screening.
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; a previous malignancy with less than 2 years free of recurrence; and a biopsy that is suspicious for malignancy and the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations.
Use of systemic corticosteroids equivalent to prednisone \> 15 mg/day is not allowed within 4 weeks prior to screening and during the study.

Ubicaciones

Local Institution - 0020

Mar del Plata, Buenos Aires, Argentina

Local Institution - 0446

San Juan Bautista, Buenos Aires, Argentina

Local Institution - 0025

Buenos Aires, B, Argentina

Local Institution - 0039

Caba, B, Argentina

Local Institution - 0003

Florida, B, Argentina

Local Institution - 0182

Mar del Plata, B, Argentina

Local Institution - 0501

Quilmes, Provincia de Buenos Aires, B, Argentina

Local Institution - 0162

Ciudad Autónoma Buenos Aires, C, Argentina

Local Institution - 0032

Córdoba, Córdoba Province, Argentina

Local Institution - 0288

Godoy Cruz, M, Argentina

Local Institution - 0401

Mendoza, M, Argentina

Local Institution - 0400

Rosario, S, Argentina

Local Institution - 0005

San Miguel de Tucuman, Tucumán, T, Argentina

Local Institution - 0165

Buenos Aires, Argentina

Local Institution - 0450

Santa Fe, Argentina

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis

Resumen