M5049 low dose for Lupus Erythematosus, Systemic

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA
Lupus Erythematosus, Systemic+1 More
M5049 low dose - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

1 of 3

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

2 of 3
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: Drug
Treatment
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
Photo of california 1Photo of california 2Photo of california 3
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 preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

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.