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Enrolling by Invitation

NCT Number: NCT06066580

Open-Label Extension of EDG-5506 in Participants 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

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Key information

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Gent, Ghent, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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 Criteria:

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

Treatment and study plan

sevasemten

Drug

Sevasemten is administered orally once per day

Primary outcomes

  1. Number of adverse events in those treated with sevasemten

    Time frame: 55 Months

  2. Severity of adverse events in those treated with sevasemten

    Time frame: 55 Months

Secondary outcomes

  1. Incidence of treatment-emergent abnormal clinical chemistry laboratory test results

    Time frame: 54 Months

  2. Incidence of treatment-emergent abnormal hematology laboratory test results

    Time frame: 54 Months

Sponsors and collaborators

Lead sponsor

Edgewise Therapeutics, Inc.

Industry

Collaborators

  • Medpace, Inc.

Registry information

Official study 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

Acronym: MESA

Important dates

Study start
2023
Primary completion
2031
Study completion
2031
First posted
Oct 4, 2023
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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