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M5049 for Lupus

Phase 2
Recruiting
Research Sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (willow study), weeks 0, 2, 4, 12, 24, 36 and 48
Awards & highlights

Study Summary

This trial is testing the long-term safety and effectiveness of a drug called M5049 in people with lupus.

Who is the study for?
This trial is for people with certain types of lupus (SCLE, DLE, or SLE) who finished a previous 24-week Willow study. Participants should have a BMI between 18.5 and 35 and must not have serious infections, recent use of prohibited meds, other investigational drug studies post-Willow study Week 24, or severe health conditions that increase risk.Check my eligibility
What is being tested?
The Willow LTE Study tests the long-term safety and effectiveness of M5049 at various doses in treating lupus. It's an oral medication given to those who've completed the initial Willow study treatment period.See study design
What are the potential side effects?
While specific side effects are not listed here, participants from the original Willow study experiencing serious events related to M5049 were excluded, suggesting potential continuation of similar side effects such as infection risks or reactions related to immune system changes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (willow study), weeks 0, 2, 4, 12, 24, 36 and 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (willow study), weeks 0, 2, 4, 12, 24, 36 and 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs)
Secondary outcome measures
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
Number of Participants With Based Composite Lupus Assessment (BICLA) Response
Number of Participants With Systemic lupus Erythematosus Responder Index-4 (SRI-4) Response
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: M5049 very high dose + PlaceboExperimental Treatment2 Interventions
Participants with CLE (active SCLE and/or DLE) or SLE who received M5049 matched placebo or very high dose of M5049 in WILLOW study will receive M5049 very high dose.
Group II: M5049 medium dose+ PlaceboExperimental Treatment2 Interventions
Participants with CLE (active SCLE and/or DLE) or SLE who received medium dose of M5049 in WILLOW study will continue to receive M5049 medium dose and matching placebo.
Group III: M5049 low dose + PlaceboExperimental Treatment2 Interventions
Participants with CLE (active SCLE and/or DLE) or SLE who received low dose of M5049 in WILLOW study will continue to receive M5049 low dose and matching placebo.
Group IV: M5049 high dose + PlaceboExperimental Treatment2 Interventions
Participants with CLE (active SCLE and/or DLE) or SLE who received M5049 matched placebo or high dose of M5049 in WILLOW study will receive M5049 high dose .
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyLead Sponsor
51 Previous Clinical Trials
6,329 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
288 Previous Clinical Trials
68,443 Total Patients Enrolled

Media Library

M5049 low dose Clinical Trial Eligibility Overview. Trial Name: NCT05540327 — Phase 2
Lupus Research Study Groups: M5049 high dose + Placebo, M5049 very high dose + Placebo, M5049 low dose + Placebo, M5049 medium dose+ Placebo
Lupus Clinical Trial 2023: M5049 low dose Highlights & Side Effects. Trial Name: NCT05540327 — Phase 2
M5049 low dose 2023 Treatment Timeline for Medical Study. Trial Name: NCT05540327 — Phase 2
Lupus Patient Testimony for trial: Trial Name: NCT05540327 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the criteria for this clinical trial incorporate a maximum age limit?

"This medical trial has set its eligibility requirements as patients aged between 18 to 76. For participants younger than 18, there are an additional 18 studies available and 106 for those older than 65 years of age."

Answered by AI

Is there still availability for participants in this trial?

"Affirmative. According to information on clinicaltrials.gov, this research project is still open to applicants. Initially posted in September 16th 2022 and last updated in October 6th 2022, the study seeks 440 participants across 22 sites."

Answered by AI

What risks, if any, accompany the use of M5049 at a low dosage?

"By our internal estimation, M5049 low dose has achieved a score of 2 in terms of safety as it is currently completing Phase 2 testing with some evidence supporting its security profile but no data indicating efficacy."

Answered by AI

How many volunteers are contributing to this experiment?

"Affirmative, the information at clinicaltrials.gov shows this trial is actively enrolling patients. Initially posted on September 16th 2022, 440 participants are being recruited from 22 locations across the country."

Answered by AI

Who qualifies for participation in this investigation?

"This medical trial is recruiting 440 persons suffering from lupus erythematosus, systemic between 18 and 76 years old. The main criteria for inclusion are having a BMI of 18.5 to 35 kilograms per meter square at screening; other prerequisites may apply as well as being an active sufferer of SCLE, DLE or SLE that completed the 24 week Treatment of the Willow Study."

Answered by AI

What is the geographic scope of this experiment?

"Clinicial trial sites offering this medication include CenExel ForCare Clinical Research in Tampa, Dawes Fretzin Dermatology Group, LLC in Indianapolis, and Massachusetts General Hospital - Dermatology Clinic in Boston. There are 22 total locations available for participation."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
What site did they apply to?
HMD Research, LLC

Why did patients apply to this trial?

I've had SLE FOR OVER 20+ YEARS. INTERESTING IN ME.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)
2022. "The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05540327.
All > Systemic Lupus Erythematosus
~195 spots leftby Apr 2025
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