A Phase 2 interventional study of Sevasemten in Becker Muscular Dystrophy, sponsored by Edgewise Therapeutics, Inc.. Enrolling by invitation at 48 sites in 12 countries. Open to male participants. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Edgewise Therapeutics, Inc. · Phase 2, Interventional, and Treatment
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 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.
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:
Key Exclusion Criteria:
Drug: Sevasemten
Drug: Sevasemten
Sevasemten is administered orally once per day
Number of adverse events in those treated with sevasemten
Time frame: 55 Months
Severity of adverse events in those treated with sevasemten
Time frame: 55 Months
Incidence of treatment-emergent abnormal clinical chemistry laboratory test results
Time frame: 54 Months
Incidence of treatment-emergent abnormal hematology laboratory test results
Time frame: 54 Months
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Edgewise Therapeutics, Inc.