Status:
ENROLLING_BY_INVITATION
Open-Label Extension of EDG-5506 in Participants With Becker Muscular Dystrophy
Lead Sponsor:
Edgewise Therapeutics, Inc.
Collaborating Sponsors:
Medpace, Inc.
Conditions:
Becker Muscular Dystrophy
Eligibility:
MALE
Phase:
PHASE2
Brief 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...
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 se...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
- Receiving moderate or strong cytochrome P450 CYP3A4 inhibitors or inducers.
- 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.
Key Trial Info
Start Date :
November 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT06066580
Start Date
November 2 2023
End Date
August 1 2029
Last Update
December 1 2025
Active Locations (46)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
2
UC San Diego
La Jolla, California, United States, 92037
3
UCLA Medical Center
Los Angeles, California, United States, 90095
4
UC Irvine Medical Center
Orange, California, United States, 92868