Език: EN EN
← Назад към резултатите
Активно (без набиране) Фаза 2 NCT05540327

The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Systemic Lupus Erythematosus

Спонсор: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Налично на: БГ
Обобщение
The purpose of the study is to evaluate the long term safety and efficacy of orally administered M5049 in participants with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE) and/or systemic lupus erythematosus (SLE) who have completed the 24 week treatment period of Willow study (MS200569\_0003 \[NCT05162586\]).
Кой може да участва
Inclusion Criteria: * Are SCLE, DLE and/or SLE that have completed the 24 week Treatment of the Willow Study * Have a Body Mass Index (BMI) within the less than or equal to (\<=) 40 kilograms per meter square (inclusive) at Screening * Participants who had successfully completed Week 48 of the Part 1 will have the opportunity to participate in the LTE Part 2. In exceptional cases and after Sponsor review, participants who have completed the Week 48 visit of the Part 1 within the previous 4-weeks may be considered for Part 2 participation based on eligibility review. Previous 4-weeks will be calculated from the Week 48 visit of Part 1 * Other protocol defined inclusion criteria could apply Exclusion Criteria: * Participants who experienced serious event(s) related to the study intervention during the WILLOW study * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with Long Term Extension (LTE) study participation * Ongoing or active clinically significant viral (including Severe acute respiratory syndrome coronavirus 2 \[(SARS-CoV-2)\], bacterial or fungal infection, or any major episode of infection requiring hospitalization * Received LTE prohibited medication during the WILLOW study or after the WILLOW study Week 24 * Participation in any other investigational drug study after the WILLOW study Week 24 * Other protocol defined exclusion criteria could apply
Места на провеждане 22
Argentina (1)
Centro de Investigaciones Medicas Mar del Plata - CIM
Buenos Aires
Австралия (1)
Monash Medical Centre Clayton
Clayton
Бразилия (1)
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte
България (1)
DCC 'Sveti Georgi' EOOD - Cardiology Office
Haskovo
Chile (1)
Clinica Alemana de Osorno - Corporacion de Beneficencia Osorno
Los Lagos
Китай (1)
The First Affiliated Hospital of Baotou Medical College
Baotou
Colombia (1)
Centro de Investigacion Medico Asistencial S.A.S
Barranquilla
Гърция (1)
General Hospital of Athens Laiko
Athens
Израел (1)
Chaim Sheba Medical Center - pt
Ramat Gan
Япония (1)
NHO Asahikawa Medical Center - Dept of Gastroenterology
Asahikawa-shi
Mauritius (1)
CAP Research Ltd
Quatre Bornes
Mexico (1)
Consultorio Privado Dr. Miguel Cortes Hernandez
Cuernavaca
Moldova (1)
ICS ARENSIA Exploratory Medicine SRL - Republican Clinical Hospital "Timofei Mosneaga"
Chisinau
Philippines (1)
Davao Doctors Hospital - Medicine
Davao City
Полша (1)
Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Bialystok
Румъния (1)
Centrul Medical Monza SRL - Arensia Exploratory Medicine
Bucharest
Сърбия (1)
Institute of Rheumatology - Rheumatology
Belgrade
South Africa (1)
Arthritis Clinical Research Trial Unit - Dr CE Spargo and Dr RB Bhorat
Cape Town
Южна Корея (1)
Gachon University Gil Medical Center
Incheon
Испания (1)
Hospital General de Castellon - Servicio de Reumatologia
Castelló
Taiwan (1)
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
САЩ (1)
The Lundquist Institute at Harbor-UCLA Medical Center
Torrance , California
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
76 Years
Здрави доброволци
Не
Начална дата
16.09.2022
Крайна дата
12.08.2028
Регистрационен номер
NCT05540327
Източник
anzctr
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.