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
- Milan, Padova, and Rome, ItalySee the 3 sites
- Phase
- Phase 2
Where in Italy
- Fondazione IRCCS Ca' Granda Ospedale MaggioreMilan, ItalyNo longer taking part
- Azienda Ospedale Universita PadovaPadova, ItalyNo longer taking part
- Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro CuoreRome, ItalyNo 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.