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NCT06066580Enrolling by invitationPhase 2

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

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 · Last updated 17 Sept 2026

Brief summary (registry, in English)

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

Status (registry)
Enrolling by invitation
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
260 (estimated)
First submitted
27 Sept 2023
Start date
2 Nov 2023
Primary completion date
Feb 2031
Lead sponsor
Edgewise Therapeutics, Inc.
NCT number
NCT06066580

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 260
  • From 2 Nov 2023 to the primary completion date, Feb 2031
  • 48 sites in 12 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other

  • 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.

Who the study is looking for

  • 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 \[Week 52\])

Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (48)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
St Vincent's Hospital
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MelbourneAustraliaUnknown status
University Hospital Gent
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GhentBelgiumUnknown status
Universitaire Ziekenhuizen Leuven
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LeuvenBelgiumUnknown status
Centre Hospitalier Regional de la Citadelle
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LiègeBelgiumUnknown status
Klinikum der Ludwig-Maximilians-Universitaet Muenchen
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MunichGermanyUnknown status
Rigshospitalet
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CopenhagenDenmarkUnknown status
Hospital Universitario Vall d'Hebron
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BarcelonaSpainUnknown status
Hospital Universitario de Bellvitge
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BarcelonaSpainUnknown status
Hospital Universitario Donostia
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Donostia / San SebastianSpainUnknown status
Hospital Universitari i Politécnic La Fe
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ValenciaSpainUnknown status
Centre de Reference des Maladies Neuromusculaires et de la SLA - AP-HM Hopital de La Timone
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MarseilleFranceUnknown status
CHU de Nantes
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NantesFranceUnknown status
CHU de Nice - Hopital Pasteur 2 - Centre de reference des Maladies Neuromusculaires
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NiceFranceUnknown status
AP-HP Hopital Pitie-Salpetriere
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ParisFranceUnknown status
University College London Hospital
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LondonUnited KingdomUnknown status
St. George's University Hospitals NHS Foundation Trust
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LondonUnited KingdomUnknown status
Newcastle Freeman Hospital
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NewcastleUnited KingdomUnknown status
Salford Royal Hospital
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SalfordUnited KingdomUnknown status
Hadassah University Hospital
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JerusalemIsraelUnknown status
Fondazione IRCCS Ca' Granda Ospedale Maggiore
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MilanItalyUnknown status
Azienda Ospedale Universita Padova
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PadovaItalyUnknown status
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
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RomeItalyUnknown status
Leids Universitair Medisch Centrum
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LeidenNetherlandsUnknown status
Optimal Clinical Trials
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AucklandNew ZealandUnknown status
Rare Disease Research
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AtlantaUnited StatesUnknown status
UC Denver
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AuroraUnited StatesUnknown status
National Neuromuscular Research Institute
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AustinUnited StatesUnknown status
Kennedy Krieger Institute
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BaltimoreUnited StatesUnknown status
Northwestern University
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ChicagoUnited StatesUnknown status
University of Cincinnati Gardner Neuroscience Institute
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CincinnatiUnited StatesUnknown status
Nationwide Children's Hospital
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ColumbusUnited StatesUnknown status
Neurology Rare Disease Center
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DentonUnited StatesUnknown status
University of Florida
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GainesvilleUnited StatesUnknown status
Rare Disease Research, LLC NC
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HillsboroughUnited StatesUnknown status
Indiana University School of Medicine
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IndianapolisUnited StatesUnknown status
University of Iowa
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Iowa CityUnited StatesUnknown status
University of Kansas Medical Center
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Kansas CityUnited StatesUnknown status
UC San Diego
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La JollaUnited StatesUnknown status
Arkansas Children's Hospital
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Little RockUnited StatesUnknown status
UCLA Medical Center
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Los AngelesUnited StatesUnknown status
UC Irvine Medical Center
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OrangeUnited StatesUnknown status
Stanford Neuroscience Health Center
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Palo AltoUnited StatesUnknown status
University of Pennsylvania
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PhiladelphiaUnited StatesUnknown status
Virginia Commonwealth University Health
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RichmondUnited StatesUnknown status
University of Rochester Medical Center
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RochesterUnited StatesUnknown status
UC Davis Medical Center
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SacramentoUnited StatesUnknown status
Washington University School of Medicine
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St LouisUnited StatesUnknown status
University of Massachusetts Memorial Medical Center
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WorcesterUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.