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.
- Diseases
- Duchenne muscular dystrophy
- 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
Sites (48)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St Vincent's Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| University Hospital Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| Universitaire Ziekenhuizen Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Centre Hospitalier Regional de la Citadelle Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| Klinikum der Ludwig-Maximilians-Universitaet Muenchen Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Hospital Universitario Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario de Bellvitge Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Donostia Coordinator of this site? Confirm its status | Donostia / San Sebastian | Spain | Unknown status |
| Hospital Universitari i Politécnic La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Centre de Reference des Maladies Neuromusculaires et de la SLA - AP-HM Hopital de La Timone Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| CHU de Nantes Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| CHU de Nice - Hopital Pasteur 2 - Centre de reference des Maladies Neuromusculaires Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| AP-HP Hopital Pitie-Salpetriere Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| University College London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| St. George's University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Newcastle Freeman Hospital Coordinator of this site? Confirm its status | Newcastle | United Kingdom | Unknown status |
| Salford Royal Hospital Coordinator of this site? Confirm its status | Salford | United Kingdom | Unknown status |
| Hadassah University Hospital Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Azienda Ospedale Universita Padova Coordinator of this site? Confirm its status | Padova | Italy | Unknown status |
| Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Leids Universitair Medisch Centrum Coordinator of this site? Confirm its status | Leiden | Netherlands | Unknown status |
| Optimal Clinical Trials Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Rare Disease Research Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| UC Denver Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| National Neuromuscular Research Institute Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Kennedy Krieger Institute Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University of Cincinnati Gardner Neuroscience Institute Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Nationwide Children's Hospital Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Neurology Rare Disease Center Coordinator of this site? Confirm its status | Denton | United States | Unknown status |
| University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Rare Disease Research, LLC NC Coordinator of this site? Confirm its status | Hillsborough | United States | Unknown status |
| Indiana University School of Medicine Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| University of Iowa Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| UC San Diego Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Arkansas Children's Hospital Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| UCLA Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| UC Irvine Medical Center Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Stanford Neuroscience Health Center Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Virginia Commonwealth University Health Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| University of Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| UC Davis Medical Center Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| University of Massachusetts Memorial Medical Center Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.