An Open-Label Extension Study to Assess the Long-Term Effect of Edg-5506 on Safety, Biomarkers, and Functional Measures in Adults and Adolescents with Becker Muscular Dystrophy

Study on Long-Term Effects of Investigational Medication in Becker Muscular Dystrophy

C
Cynthia Bodkin, MD

Primary Investigator

Enrolling By Invitation
100 years or below
Male
Phase N/A
1 participants needed
1 Location

Brief description of study

EDG-5506-203 MESA is an open-label extension study to assess the long-term effect of sevasemten (EDG-5506) on safety, biomarkers, and functional measures in adults and adolescents with Becker muscular dystrophy
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - This is an open-label, treatment extension study to evaluate the safety, tolerability, and durability of effect in long-term dosing of sevasemten. EDG-5506-203 MESA will provide continued access to sevasemten treatment to participants with Becker muscular dystrophy who were previously enrolled in EDG-5506-002 ARCH, completed EDG-5506-201 CANYON and GRAND CANYON, or completed EDG-5506-202 DUNE.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Becker Muscular Dystrophy
  • Age: 100 years or below
  • Gender: Male

Key Inclusion Criteria:

1. Males with a diagnosis of BMD and participation in EDG-5506-002 ARCH, EDG-5506-201 CANYON and GRAND CANYON, or EDG-5506-202 DUNE. Participants are eligible if they complete the respective prior study visits as follows:

  • EDG-5506-002 ARCH: Complete the final study Visit 27 [Month 24]; or, completion of the ET visit prior to Visit 27 [Month 24]
  • EDG-5506-201 CANYON and GRAND CANYON: Complete the final study visit (Cohorts 1, 2, 4, and 5: Visit 12 [Month 12]; Cohort 6: Visit 11 [Month 18])
  • EDG-5506-202 DUNE: Complete at least 36 weeks of open-label treatment (Visit 14 [Week 52])

Key Exclusion Criteria:

  1. Any clinically significant changes during or following participation in EDG-5506-002, EDG-5506-201, or EDG-5506-202 that would affect the potential safety of the participant to receive sevasemten.
  2. Receiving moderate or strong cytochrome P450 CYP3A4 inhibitors or inducers.
  3. Receipt of an investigational drug other than sevasemten within 30 days or 5 half-lives (whichever is longer) of dosing in the present study.

3. Receipt of oral corticosteroids for the treatment of BMD in the previous 6 months.

This study investigates the long-term effects of an investigational medication on people with Becker muscular dystrophy, a condition that causes muscle weakness and wasting. The purpose is to observe the safety, biomarkers, and functional measures over an extended period.

Participants will continue receiving the investigational medication and undergo regular assessments to monitor their health and the effects of the treatment. This study is open-label, meaning both the participants and researchers know what treatment is being given.

  • Who can participate: Males with Becker muscular dystrophy who completed certain previous studies on this treatment are eligible. Participants must not have major health changes that could affect safety and should avoid certain other medications.
  • Study details: Participants will continue receiving the investigational medication and attend regular health assessments. This study does not use a placebo, meaning all participants receive the active treatment.
Updated on 06 Jul 2026. Study ID: NEUR-EDGEWISE-MESA, 27997
Please visit our main page to search for other studies you may be interested in. If you need help finding a study or have any questions, please contact us at inhealth@iu.edu

Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only