A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-7240/PRA023 in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD)

Activo, no reclutaFase 2ClinicalTrials.gov

ID: NCT05270668Tipo: INTERVENTIONALInicio: 29 de mar de 2022Fin estimado: 31 de jul de 2029

Neumología

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Has confirmed diagnosis of systemic sclerosis with onset of disease ≤ 5 years ago.
Has diffuse cutaneous scleroderma
Has systemic sclerosis related interstitial lung disease confirmed by HRCT
FVC ≥ 45% of predicted normal
Diffusing capacity of lung for carbon monoxide (DLCO)≥ 45% of predicted normal
If on background therapy, meets stable dosing requirements for nintedanib, mycophenolate mofetil (MMF), methotrexate (MTX) OR azathioprine, and corticosteroids
Women of childbearing potential are eligible to participate if not pregnant or breastfeeding and either willing to use an acceptable contraceptive method or sexually abstinent
Able to provide written informed consent and understand and comply with the requirements of the study

Criterios de exclusión

Is a current smoker or smoking within 6 months of screening
Has an airway obstruction per pulmonary function test (PFT) or clinically significant pulmonary arterial hypertension
Has current clinical diagnosis of another inflammatory connective tissue disease
Has any active infections, a serious infection within the past 3 months, or chronic bacterial infection
Has any concomitant medical conditions that, in the opinion of the investigator, might place them in unacceptable risk for participation in the study

Intervenciones

drug

Tulisokibart

Tulisokibart administered at timepoints as directed by the protocol

diagnostic_test

Companion diagnostic ( CDx)

CDx+ or CDx-

drug

Placebo

Ubicaciones

Consultorios Médicos Dr. Doreski ( Site 4800)

CABA, Buenos Aires, Argentina

Clínica Privada Independencia ( Site 4802)

Munro, Buenos Aires, Argentina

Centro de Investigación Instituto Médico Río Cuarto ( Site 4801)

Río Cuarto, Córdoba Province, Argentina

Instituto Medico de la Fundacion Estudios Clinicos ( Site 4803)

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalPrometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

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