EDG-5506 for Becker Muscular Dystrophy
(ARCH Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a new drug called sevasemten to see if it can help people with Becker muscular dystrophy, a disease that weakens muscles. The drug aims to protect and improve muscle function. Participants will take the drug for an extended period with frequent check-ups to monitor safety and effectiveness.
Will I have to stop taking my current medications?
The trial does not specify if you must stop all current medications, but you cannot take certain drugs like moderate or strong CYP3A4 inhibitors or inducers. If you're on oral corticosteroids, you must not have taken more than 5 mg per day for over 5 days in the past 6 months.
Who Is on the Research Team?
Sam Collins, MBBS, PhD
Principal Investigator
Edgewise Therapeutics, Inc.
Are You a Good Fit for This Trial?
This trial is for adult males aged 18-55 with Becker Muscular Dystrophy who can walk at least 100 meters. They must have completed a prior EDG-5506 study, weigh over 50 kg, and have a BMI of 20-34 kg/m2. Those on recent investigational drugs, with certain medical conditions or taking high doses of corticosteroids are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive sevasemten to assess safety and pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- EDG-5506
Find a Clinic Near You
Who Is Running the Clinical Trial?
Edgewise Therapeutics, Inc.
Lead Sponsor
Medpace, Inc.
Industry Sponsor
Dr. August J. Troendle
Medpace, Inc.
Chief Executive Officer since 1992
MD from the University of Maryland, School of Medicine; MBA from Boston University
Dr. Reinilde Heyrman
Medpace, Inc.
Chief Medical Officer since 2017
MD