Summary

Eligibility
for males (full criteria)
Location
at La Jolla, California and other locations
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. 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:
  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 (Visit 14 [Week 52])

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

Locations

  • UC San Diego
    La Jolla California 92037 United States
  • UC Irvine Medical Center
    Orange California 92868 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 260 study participants
Last Updated