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

NCT05540327

Active Not RecruitingPhase 2

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

Conditions: Systemic Lupus Erythematosus

Interventions: M5049 low dose, M5049 medium dose, M5049 high dose, Placebo

Countries: United States, Argentina, Australia, Brazil, Bulgaria, Chile, China, Colombia

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 \[NCT05162586\]).

Eligibility overview

Sex: ALL

Age: 18 Years to 76 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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 (122)
  • Torrance, California, United States
  • Brandon, Florida, United States
  • Miami, Florida, United States
  • Indianapolis, Indiana, United States
  • Grand Blanc, Michigan, United States
  • Minneapolis, Minnesota, United States
  • Columbus, Ohio, United States
  • Memphis, Tennessee, United States
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Ciudad Autonoma Buenos Aires, Argentina
  • Ciudad Autonoma Buenos Aires, Argentina
  • Mar del Plata, Argentina
  • Mendoza, Argentina
  • San Fernando, Argentina
  • San Juan, Argentina
  • San Miguel, Argentina
  • San Miguel, Argentina
  • San Miguel de Tucumán, Argentina
  • San Miguel de Tucumán, Argentina
  • Clayton, Australia
  • Woolloongabba, Australia
  • Belo Horizonte, Brazil
  • Cuiabá, Brazil
  • Graça, Brazil
  • Juiz de Fora, Brazil
  • Moinhos de Vento, Brazil
  • São José, Brazil
  • São Paulo, Brazil
  • Haskovo, Bulgaria
  • + 92 more on CT.gov