Last updated 2 months ago
Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) (MK-7240-007)
152 patients around the world
Available in Chile
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
8Research sites
152Patients around the world
This study is for people with
Interstitial Lung Disease
Rare diseases
Systemic sclerosis
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.Is a current smoker or smoking within 6 months of screening.Has any concomitant medical conditions that, in the opinion of the investigator, might place them in unacceptable risk for participation in the study.Meets the protocol criteria for important laboratory exclusion criteria.
Sites
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
Instituto Médico Río Cuarto
Recruiting
Consultorios Médicos Dr. Doreski
Recruiting
Clínica Privada Independencia - Buenos Aires
Clínica Dermacross S.A. - Vitacura - Santiago
Recruiting
BIOCINETIC SpA
Recruiting
Centro Internacional de Estudios Clínicos - CIEC
Recruiting
Centro Médico Vanguardia
Recruiting
StudyATHENA-SSc-ILD
SponsorPrometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Study typeInterventional
Conditions
Interstitial Lung DiseaseSystemic sclerosis
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05270668
