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Active (not recruiting) Phase 2 NCT05540327

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

Phase 2 – studying effectiveness and dosage
Conditions: Systemic Lupus Erythematosus

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

trial.available_in: БГ
Overview
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 \[NCT05162586\]).
Who can participate
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
Locations 22
Argentina (1)
Centro de Investigaciones Medicas Mar del Plata - CIM
Buenos Aires
Australia (1)
Monash Medical Centre Clayton
Clayton
Brazil (1)
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte
Bulgaria (1)
DCC 'Sveti Georgi' EOOD - Cardiology Office
Haskovo
Chile (1)
Clinica Alemana de Osorno - Corporacion de Beneficencia Osorno
Los Lagos
China (1)
The First Affiliated Hospital of Baotou Medical College
Baotou
Colombia (1)
Centro de Investigacion Medico Asistencial S.A.S
Barranquilla
Greece (1)
General Hospital of Athens Laiko
Athens
Israel (1)
Chaim Sheba Medical Center - pt
Ramat Gan
Japan (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
Poland (1)
Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Bialystok
Romania (1)
Centrul Medical Monza SRL - Arensia Exploratory Medicine
Bucharest
Serbia (1)
Institute of Rheumatology - Rheumatology
Belgrade
South Africa (1)
Arthritis Clinical Research Trial Unit - Dr CE Spargo and Dr RB Bhorat
Cape Town
South Korea (1)
Gachon University Gil Medical Center
Incheon
Spain (1)
Hospital General de Castellon - Servicio de Reumatologia
Castelló
Taiwan (1)
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
United States (1)
The Lundquist Institute at Harbor-UCLA Medical Center
Torrance , California
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
76 Years
Healthy volunteers
No
Start date
16.09.2022
Completion date
12.08.2028
Registry ID
NCT05540327
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.