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Enrolling by invitationPhase 2

Long-term study of sevasemten in Becker muscular dystrophy

Tests sevasemten over time in teens and adults with Becker muscular dystrophy.

Key facts

Who runs it
Edgewise Therapeutics, Inc.
Where
Marseille, Nantes, Nice, and Paris, FranceSee the 4 sitesAlso in 11 other countries, 44 sites
Trial code
Registry title
Open-Label Extension of EDG-5506 in Participants With Becker Muscular Dystrophy
Status
Enrolling by invitation
Phase
Phase 2
People taking part
260 people, planned
Started
2 Nov 2023
Expected to end
Feb 2031
Type of study
Interventional
Treatments tested
  • Sevasemten
Record updated
17 September 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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])

Who cannot take part

  • 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

Where in France

Also in 11 other countries, 44 sites

  • Centre de Reference des Maladies Neuromusculaires et de la SLA - AP-HM Hopital de La TimoneMarseille, FranceNo longer taking part
  • CHU de NantesNantes, FranceNo longer taking part
  • CHU de Nice - Hopital Pasteur 2 - Centre de reference des Maladies NeuromusculairesNice, FranceNo longer taking part
  • AP-HP Hopital Pitie-SalpetriereParis, FranceNo longer taking part

About the trial

What the trial wants to find out

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

The group in the trial

  • TreatmentTreatment being tested

    Drug: Sevasemten

    Treatment: Sevasemten

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Long-term study of sevasemten in Becker muscular dystrophyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
17 September 2026