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Активно (без набиране) Фаза 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)

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Diffuse Cutaneous Systemic Sclerosis Interstitial Lung Disease

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

Налично на: БГ
Обобщение
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.
Кой може да участва
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
Места на провеждане 20
Argentina (1)
Consultorios Médicos Dr. Doreski ( Site 4800)
CABA , Buenos Aires
Австралия (1)
Royal Adelaide Hospital ( Site 4050)
Adelaide , South Australia
Белгия (1)
UZ Gent ( Site 4401)
Ghent , Oost-Vlaanderen
Канада (1)
University Of Alberta Hospital ( Site 4702)
Edmonton , Alberta
Chile (1)
Centro de especialidades médicas Vanguardia ( Site 4850)
Temuco , Araucania
Франция (1)
CHU de Bordeaux. Hopital Pellegrin ( Site 4202)
Bordeaux , Nord
Германия (1)
Universitaetsklinikum Freiburg ( Site 4152)
Freiburg im Breisgau , Baden-Wurttemberg
Унгария (1)
Pecsi Tudomanyegyetem AOK ( Site 4250)
Pécs , Baranya
Израел (1)
Rambam Medical Center ( Site 4601)
Haifa
Италия (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
Нидерландия (1)
Radboud University Medical Center ( Site 4650)
Nijmegen , Gelderland
Норвегия (1)
Oslo Universitetssykehus HF. Rikshospitalet ( Site 4350)
Oslo
Peru (1)
Instituto de Ginecologia y Reproduccion ( Site 4952)
Lima
Полша (1)
Twoja Przychodnia Poznanskie Centrum Medyczne ( Site 4452)
Poznan , Greater Poland Voivodeship
Испания (1)
HOSPITAL CLÍNIC DE BARCELONA ( Site 4105)
Barcelona , Catalonia
Швейцария (1)
Inselspital Bern ( Site 4502)
Bern , Canton of Bern
Ukraine (1)
Kyiv City Clinical Hospital # 3 ( Site 4754)
Kyiv , Kyivska Oblast
Великобритания (1)
Royal Free Hospital ( Site 4550)
London , London, City of
САЩ (1)
Mayo Clinic - Scottsdale ( Site 4014)
Phoenix , Arizona
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
29.03.2022
Крайна дата
31.07.2029
Регистрационен номер
NCT05270668
Източник
anzctr
Запитване за медицински туризъм

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