Lupus
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Lupus
MS200569_0048 Enrolling

Research Trial for Systemic and Cutaneous Lupus (33 Weeks)


Treatment: Oral Age: 18 Years

Adults between 18 and 75 years of age with systemic or cutaneous lupus, may qualifiy to participate.  Individuals must have either:

      • a diagnosis of CLE (subacute: SCLE or discoid: DLE) documented in medical history, with a disease duration of ≥ 6 months from time of diagnosis OR
      • a diagnosis of SLE and fulfil additional classification criteria, with a disease duration of ≥ 6 months from when they met classification criteria.

Participants will receive investigational oral medication (active study drug) or placebo.  Study medication and study-related assessments will be provided at no cost.  Reimbursement for study-related expenses will also be provided.

Study participation will last about 33 weeks and involve about 10 visits to the study centre, plus a safety follow-up phone call.


The following information is from ClinicalTrials.gov

Last Update Posted: March 19, 2023

Official Title

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)

ClinicalTrials.gov ID

NCT05540327

Sponsor

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

Study Description

  • Brief 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]).

  • Condition or Disease:

    Systemic Lupus Erythematosus

  • Intervention/Treatment:

    Drug: M5049 low dose
    Drug: M5049 medium dose
    Drug: M5049 high dose
  • Phase:

    Phase 2

  • Ages Eligible for Study:

    18 Years and 76 Years (Adult)

  • Sexes Eligible for Study:

    All

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


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.


Participating Locations

COUNTRY
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Chile
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Australia

Participating Experts

Dr. Fernando Valenzuela

Dermatologist

Dr. Lynda Spelman

Dermatologist

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