The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Systemic Lupus Erythematosus
In brief
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 \[NCT05162586\]).
Key facts
- Study ID
- NCT05540327
- Run by
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- People needed
- 379
- Starts
- 2022-09-16
- Expected to finish
- 2028-08-12
- Last updated by the study team
- 2026-07-20
Who can join
Age: 18 and older, up to 76. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The Lundquist Institute at Harbor-UCLA Medical Center — Torrance, California, United States
- Bay Area Arthritis and Osteoporosis — Brandon, Florida, United States
- Advance Medical Research Center — Miami, Florida, United States
- Dawes Fretzin Dermatology Group, LLC — Indianapolis, Indiana, United States
- AA MRC LLC Ahmed Arif Medical Research Center — Grand Blanc, Michigan, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- Ohio State University - CTMO Parent — Columbus, Ohio, United States
- Ramesh C Gupta, MD — Memphis, Tennessee, United States
- Centro de Investigaciones Medicas Mar del Plata - CIM — Buenos Aires, Argentina
- CINME - Centro De Investigaciones Metabolicas — Buenos Aires, Argentina
- Buenos Aires Skin — Ciudad Autonoma Buenos Aires, Argentina
- Hospital Militar Central Dr. Cosme Argerich — Ciudad Autonoma Buenos Aires, Argentina
- Centro de Investigaciones Medicas Mar del Plata - CIM — Mar del Plata, Argentina
- Instituto de Reumatologia — Mendoza, Argentina
- Instituto Medico de alta Complejidad San Isidro S.A (IMAC) — San Fernando, Argentina
- CER San Juan Centro Polivalente de Asistencia e Inv. Clinica — San Juan, Argentina
- Centro Dermatologico Schejtman — San Miguel, Argentina
- PSORIAHUE-Medicina Interdisciplinar — San Miguel, Argentina
- Centro de Investigaciones Medicas Tucuman — San Miguel de Tucumán, Argentina
- Investigaciones Clinicas Tucuman — San Miguel de Tucumán, Argentina
- Monash Medical Centre Clayton — Clayton, Australia
- Veracity Clinical Research — Woolloongabba, Australia
- Santa Casa de Misericórdia de Belo Horizonte — Belo Horizonte, Brazil
- Oncovida - Centro de Onco-Hematologia de Mato Grosso — Cuiabá, Brazil
- Huashan Hospital, Fudan University - Neurology — Shanghai, China
Full record on ClinicalTrials.gov
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