By InvitationPhase 2

Open-Label Extension of EDG-5506 in Participants With Becker Muscular Dystrophy

United States260 participantsStarted 2023-11-02

Plain-language 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 dystrophy

Who can participate

SexMALE

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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.

What they're measuring

Number of adverse events in those treated with sevasemten

Timeframe: 55 Months

Severity of adverse events in those treated with sevasemten

Timeframe: 55 Months

Trial details

NCT IDNCT06066580

SponsorEdgewise Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2031-02

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