M5049 low dose for Lupus Erythematosus, Systemic
Phase-Based Progress Estimates
Effectiveness
Safety
The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA
Lupus Erythematosus, Systemic+1 More
M5049 low dose - DrugEligibility
18+
All Sexes
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Eligibility
18+
All Sexes
What conditions do you have?
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Study 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]).
Eligible Conditions
- Lupus Erythematosus, Systemic
Treatment Effectiveness
Effectiveness Progress
Other trials for Lupus Erythematosus, Systemic
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: Baseline (WILLOW study), Weeks 0, 2, 4, 12, 24, 36 and 48
Week 24
Number of Participants With Based Composite Lupus Assessment (BICLA) Response
Number of Participants With Systemic lupus Erythematosus Responder Index-4 (SRI-4) Response
Week 0
Change from WILLOW Study Baseline in Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) at Weeks 0, 2, 4, 12, 24, 36 and 48
Percent Change from WILLOW Study Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A) at Weeks 0, 2, 4, 12, 24, 36 and 48
Week 50
Number of Participants with Abnormalities in Laboratory Parameters and QT Interval Corrected
Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs)
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Other trials for Lupus Erythematosus, Systemic
Trial Design
3 Treatment Groups
M5049 low dose + Placebo
1 of 3
M5049 medium dose+ Placebo
1 of 3
M5049 high dose
1 of 3
Experimental Treatment
440 Total Participants · 3 Treatment Groups
Primary Treatment: M5049 low dose · Has Placebo Group · Phase 2
M5049 low dose + PlaceboExperimental Group · 2 Interventions: M5049 low dose, Placebo · Intervention Types: Drug, Drug
M5049 medium dose+ PlaceboExperimental Group · 2 Interventions: M5049 medium dose, Placebo · Intervention Types: Drug, Drug
M5049 high dose
Drug
Experimental Group · 1 Intervention: M5049 high dose · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (willow study), weeks 0, 2, 4, 12, 24, 36 and 48
Closest Location: The Lundquist Institute at Harbor-UCLA Medical Center · Torrance, CA
2021First Recorded Clinical Trial
4 TrialsResearching Lupus Erythematosus, Systemic
2 CompletedClinical Trials
Who is running the clinical trial?
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyLead Sponsor
40 Previous Clinical Trials
5,016 Total Patients Enrolled
1 Trials studying Lupus Erythematosus, Systemic
44 Patients Enrolled for Lupus Erythematosus, Systemic
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
276 Previous Clinical Trials
66,804 Total Patients Enrolled
7 Trials studying Lupus Erythematosus, Systemic
1,997 Patients Enrolled for Lupus Erythematosus, Systemic
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are active SCLE, DLE or SLE and have completed the 24-week Treatment of the Willow Study.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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