A Phase II, Double-blind, Dose-Ranging, Parallel, Long-term Extension Study to Evaluate the Safety and Efficacy of Enpatoran in Participants With Subacute Cutaneous Lupus Erythematosus, Discoid Lupus Erythematosus and/or Systemic Lupus Erythematosus Having Completed the WILLOW (MS200569_0003) Study Treatment (WILLOW LTE)

  • STATUS
    Recruiting
  • End date
    Apr 15, 2025
  • participants needed
    440
  • sponsor
    Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Updated on 28 October 2022
body mass index
lupus
cutaneous lupus

Summary

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]).

Details
Condition Systemic Lupus Erythematosus
Treatment Placebo, M5049 low dose, M5049 medium dose, M5049 high dose
Clinical Study IdentifierNCT05540327
SponsorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Last Modified on28 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 range 18.5 to 35 kilograms per meter square (inclusive) at Screening
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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