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