For Healthcare Professionals

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

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About the study

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 \[NCT05162586\]).
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Are SCLE, DLE and/or SLE that have completed the 24 week Treatment of the Willow Study
  2. Have a Body Mass Index (BMI) within the less than or equal to (<=) 40 kilograms per meter square (inclusive) at Screening
  3. 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
  4. * Other protocol defined inclusion criteria could apply


EXCLUSION CRITERIA

Exclusion Criteria:


  1. Participants who experienced serious event(s) related to the study intervention during the WILLOW study
  2. 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
  3. 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
  4. Received LTE prohibited medication during the WILLOW study or after the WILLOW study Week 24
  5. Participation in any other investigational drug study after the WILLOW study Week 24
  6. * Other protocol defined exclusion criteria could apply


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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Systemic Lupus Erythematosus

Age (in years)

18 - 76

Phase

PHASE2

Participants needed

379

Est. Completion Date

Aug 12, 2028

Treatment type

INTERVENTIONAL


Sponsor

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

ClinicalTrials.gov identifier

NCT05540327

Study number

MS200569_0048

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