Last updated 3 days 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)

4Research sites

152Patients around the world

This study is for people with

Interstitial Lung Disease

Rare diseases

Systemic sclerosis

From 18 Years

All Gender

: 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.

Clínica Dermacross S.A. - Vitacura - Santiago

Recruiting

Av. Manquehue Norte 2051 C, Vitacura, Metropolitana, 7640881

Centro Médico Vanguardia

Recruiting

Dieciocho de Septiembre 525, Of 403, 4810345 Temuco, Araucanía, Chile

BIOCINETIC SpA

Recruiting

Serafín Zamora 190, Torre B, piso 4, Oficina 14. Clínica Vespucio, La Florida

Centro Internacional de Estudios Clínicos - CIEC

Recruiting

Calle Manzano 343, Oficina 410-411, Comuna de Recoleta, Región Metropolitana, 8420383

StudyATHENA-SSc-ILD

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

Conditions

Interstitial Lung DiseaseSystemic sclerosis

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT05270668