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Active (not recruiting) Phase 2 NCT05270668

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)

Phase 2 – studying effectiveness and dosage
Conditions: Diffuse Cutaneous Systemic Sclerosis Interstitial Lung Disease

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

trial.available_in: БГ
Overview
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.
Who can participate
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Locations 20
Argentina (1)
Consultorios Médicos Dr. Doreski ( Site 4800)
CABA , Buenos Aires
Australia (1)
Royal Adelaide Hospital ( Site 4050)
Adelaide , South Australia
Belgium (1)
UZ Gent ( Site 4401)
Ghent , Oost-Vlaanderen
Canada (1)
University Of Alberta Hospital ( Site 4702)
Edmonton , Alberta
Chile (1)
Centro de especialidades médicas Vanguardia ( Site 4850)
Temuco , Araucania
France (1)
CHU de Bordeaux. Hopital Pellegrin ( Site 4202)
Bordeaux , Nord
Germany (1)
Universitaetsklinikum Freiburg ( Site 4152)
Freiburg im Breisgau , Baden-Wurttemberg
Hungary (1)
Pecsi Tudomanyegyetem AOK ( Site 4250)
Pécs , Baranya
Israel (1)
Rambam Medical Center ( Site 4601)
Haifa
Italy (1)
A.O.U. Citta della Salute e della Scienza di Torino ( Site 4304)
Turin , Piedmont
Mexico (1)
PanAmerican Clinical Research - Guadalajara ( Site 4900)
Guadalajara , Jalisco
Netherlands (1)
Radboud University Medical Center ( Site 4650)
Nijmegen , Gelderland
Norway (1)
Oslo Universitetssykehus HF. Rikshospitalet ( Site 4350)
Oslo
Peru (1)
Instituto de Ginecologia y Reproduccion ( Site 4952)
Lima
Poland (1)
Twoja Przychodnia Poznanskie Centrum Medyczne ( Site 4452)
Poznan , Greater Poland Voivodeship
Spain (1)
HOSPITAL CLÍNIC DE BARCELONA ( Site 4105)
Barcelona , Catalonia
Switzerland (1)
Inselspital Bern ( Site 4502)
Bern , Canton of Bern
Ukraine (1)
Kyiv City Clinical Hospital # 3 ( Site 4754)
Kyiv , Kyivska Oblast
United Kingdom (1)
Royal Free Hospital ( Site 4550)
London , London, City of
United States (1)
Mayo Clinic - Scottsdale ( Site 4014)
Phoenix , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
29.03.2022
Completion date
31.07.2029
Registry ID
NCT05270668
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.