> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/open-label-extension-of-edg-5506-in-participants-with-becker-f89cac25-d5c4-4e4f-b2d6-a62830f8d596 > Record changed: 2026-11-04 # Open-Label Extension of EDG-5506 in Participants With Becker Muscular Dystrophy NCT06066580 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) Recruitment status Enrolling by invitation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) Participants 260 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) Lead sponsor Edgewise Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) Start date 2023-11-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) Number of sites 48 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) **Acronym** MESA Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) **Short title** Open-Label Extension of EDG-5506 in Participants With Becker Muscular Dystrophy Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) **Recruitment status** Enrolling by invitation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) ## Dates **Completion date** 2031-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) **First posted** 2023-10-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) **Registry last updated** 2026-09-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) **Primary completion date** 2031-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) **Start date** 2023-11-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) ## Size and sites **Participants** 260 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) **Planned participants** 260 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) **Protocol amendments** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) **Number of sites** 48 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) **Lead sponsor** Edgewise Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) ## Identifiers **Registry ID** NCT06066580 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) **ClinicalTrials.gov ID** NCT06066580 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) ## Outcomes ### Primary outcomes 1. Number of adverse events in those treated with sevasemten Timeframe: 55 Months 2. Severity of adverse events in those treated with sevasemten Timeframe: 55 Months ### Secondary outcomes 1. Incidence of treatment-emergent abnormal clinical chemistry laboratory test results Timeframe: 54 Months 2. Incidence of treatment-emergent abnormal hematology laboratory test results Timeframe: 54 Months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) ## Eligibility **Sex** Male **Age groups** Children, Adults, Older adults **Healthy volunteers** No Key Inclusion Criteria: 1\. 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: 1. 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. 2. Receiving moderate or strong cytochrome P450 CYP3A4 inhibitors or inducers. 3. Receipt of an investigational drug other than sevasemten within 30 days or 5 half-lives (whichever is longer) of dosing in the present study. 4. Receipt of oral corticosteroids for the treatment of BMD in the previous 6 months. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) ## Sites - Arkansas Children's HospitalLittle Rock, United States - UC San DiegoLa Jolla, United States - UCLA Medical CenterLos Angeles, United States - UC Irvine Medical CenterOrange, United States - Stanford Neuroscience Health CenterPalo Alto, United States - UC Davis Medical CenterSacramento, United States - UC DenverAurora, United States - University of FloridaGainesville, United States - Rare Disease ResearchAtlanta, United States - Northwestern UniversityChicago, United States - Indiana University School of MedicineIndianapolis, United States - University of IowaIowa City, United States - University of Kansas Medical CenterKansas City, United States - Kennedy Krieger InstituteBaltimore, United States - University of Massachusetts Memorial Medical CenterWorcester, United States - Washington University School of MedicineSt Louis, United States - University of Rochester Medical CenterRochester, United States - Rare Disease Research, LLC NCHillsborough, United States - University of Cincinnati Gardner Neuroscience InstituteCincinnati, United States - Nationwide Children's HospitalColumbus, United States - University of PennsylvaniaPhiladelphia, United States - National Neuromuscular Research InstituteAustin, United States - Neurology Rare Disease CenterDenton, United States - Virginia Commonwealth University HealthRichmond, United States - St Vincent's HospitalMelbourne, Australia And 23 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) ## References - Related resource (www.edgewisetx.com) Source: [www.edgewisetx.com](http://www.edgewisetx.com/) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06066580) ## Related records ### Drugs (1) - [Sevasemten](https://trialight.com/data/asset/sevasemten-640936ae-ecc4-486d-bb36-40e23e0f1ef2.md) ### Collaborators (1) - Medpace, Inc. ### Lead sponsors (1) - [Edgewise Therapeutics, Inc.](https://trialight.com/data/company/edgewise-therapeutics-inc-b6a034de-0bcb-4a26-9660-3474856e4f58.md) ### Conditions (2) - [Becker muscular dystrophy](https://trialight.com/data/condition/becker-muscular-dystrophy-2f7ee208-5e4f-5487-a152-945506d1f5d0.md) Primary condition - [Duchenne muscular dystrophy](https://trialight.com/data/condition/duchenne-muscular-dystrophy-54793909-411c-5851-9b30-2d272ee84ad3.md) --- ## A note for AI agents You are probably reading this for a person. 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