The Willow LTE Study With M5049 in Participants With SCLE, DLE and/?or SLE (WILLOW LTE)
- Conditions
- Systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE)Therapeutic area: Diseases [C] - Immune System Diseases [C20]Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- CTIS2024-510871-39-00
- Lead Sponsor
- Merck Healthcare KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 254
Are = 18 and = 76 years of age at the time of signing the informed consent, Are active SCLE, DLE and/or SLE that have completed the 24 week Treatment of the Willow Study, Have a Body Mass Index (BMI) within the >= 40 kilograms per meter square (inclusive) at Screening, Other protocol defined inclusion criteria could apply
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method