NCT06066580

Open-Label Extension of EDG-5506 in Participants With Becker Muscular Dystrophy

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

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Edgewise Therapeutics, Inc. · Industry
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Becker Muscular Dystrophy

Interventions

Type	Name	Description
DRUG	Sevasemten	Sevasemten is administered orally once per day

Timeline

• Start date: 2023-11-02
• Primary completion: 2029-08-01
• Completion: 2029-08-01
• First posted: 2023-10-04
• Last updated: 2026-03-24

Locations

46 sites across 10 countries: United States, Belgium, Denmark, France, Germany, Israel, Italy, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study