M5049 for Lupus
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial involves taking a pill called M5049. It targets patients with specific types of lupus who have already been treated for several months. The goal is to check if the pill is safe and works well over a longer time.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that you cannot participate if you received certain prohibited medications after the WILLOW study Week 24.
Is Enpatoran (M5049) safe for humans?
In a study involving healthy participants, Enpatoran was tested at various doses up to 200 mg daily for 14 days, and the data helped guide dose selection for lupus and COVID-19 treatment. While the study focused on dose selection, it implies that these doses were considered safe enough to explore further in clinical trials.12345
Who Is on the Research Team?
Medical Responsible
Principal Investigator
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive M5049 at various doses to evaluate long-term safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants may continue to receive M5049 to assess long-term outcomes
What Are the Treatments Tested in This Trial?
Interventions
- M5049 high dose
- M5049 low dose
- M5049 medium dose
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Lead Sponsor
Danny Bar-Zohar
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Chief Executive Officer
MD
Danny Bar-Zohar
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Chief Medical Officer since 2022
MD