Long-term study of sevasemten in Becker muscular dystrophy
Tests sevasemten over time in teens and adults with Becker muscular dystrophy.
Plain-language title generated from the registry record
Registry title: Open-Label Extension of EDG-5506 in Participants With Becker Muscular Dystrophy
Key facts
- Where
- Leiden, NetherlandsSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for males with Becker muscular dystrophy who took part in an earlier sevasemten (EDG-5506) study and finished its required visits.
- Sex
- Males only.
- Disease stage
- Becker muscular dystrophy (BMD).
- Earlier treatment
- Must have taken part in EDG-5506-002 ARCH, EDG-5506-201 CANYON and GRAND CANYON, or EDG-5506-202 DUNE, and completed the required visits. No oral corticosteroids for BMD in the previous 6 months.
Main reasons for not taking part
- Clinically significant changes in an earlier study that could affect safety with sevasemten
- Taking moderate or strong CYP3A4 inhibitors or inducers
- Another investigational drug within 30 days or 5 half-lives, whichever is longer
- Oral corticosteroids for BMD in the previous 6 months
Read by machine on 9 November 2026.
Where in Netherlands
- Leids Universitair Medisch CentrumLeiden, NetherlandsNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Edgewise Therapeutics, Inc.
- Trial code
- NCT06066580
- Record updated
- 17 September 2026
- Original description
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 dystrophyRead full original descriptionShow less
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
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
Inclusion: 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]).
Exclusion: 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; Receipt of oral corticosteroids for the treatment of BMD in the previous 6 months; 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.