This study is accepting new patients by invitation only

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

a study on Duchenne Muscular Dystrophy

Summary

Eligibility
for males (full criteria)
Location
at UC Davis
Dates
study started
completion around

Description

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

Official Title

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

Details

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.

Keywords

Becker Muscular Dystrophy, Muscular Dystrophies, Duchenne Muscular Dystrophy, Sevasemten

Eligibility

You can join if…

Open to males

  1. 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:
  2. EDG-5506-002 ARCH: Complete the final study Visit 27 [Month 24]; or, completion of the ET visit prior to Visit 27 [Month 24]
  3. 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])
  4. EDG-5506-202 DUNE: Complete at least 36 weeks of open-label treatment

You CAN'T join if...

  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. 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.

Locations

  • UC Davis Medical Center
    Sacramento California 95817 United States
  • UC Denver
    Aurora Colorado 80045 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Edgewise Therapeutics, Inc.
Links
Sponsor Website
ID
NCT06066580
Phase
Phase 2 Duchenne Muscular Dystrophy Research Study
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated