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Clinical Trials in the UK / NCT06066580
Enrolling by invitation Phase 2

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

NCT06066580 · tracked via the Priya Life Science UK tracker
Sponsor
Edgewise Therapeutics, Inc.
Phase
Phase 2
Started
2023-11-02
Last updated
2026-09-17

Condition(s) studied

Becker Muscular Dystrophy

Investigational drug(s) / intervention(s)

Sevasemten

Sevasemten: Sevasemten is administered orally once per day

Study 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

Eligibility

Sex
MALE
Min age
Max age
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.

Primary outcome measure(s)

Trial sites (48)

FacilityCityRegionStatus
Arkansas Children's Hospital Little Rock Arkansas
UC San Diego La Jolla California
UCLA Medical Center Los Angeles California
UC Irvine Medical Center Orange California
Stanford Neuroscience Health Center Palo Alto California
UC Davis Medical Center Sacramento California
UC Denver Aurora Colorado
University of Florida Gainesville Florida
Rare Disease Research Atlanta Georgia
Northwestern University Chicago Illinois
Indiana University School of Medicine Indianapolis Indiana
University of Iowa Iowa City Iowa
University of Kansas Medical Center Kansas City Kansas
Kennedy Krieger Institute Baltimore Maryland
University of Massachusetts Memorial Medical Center Worcester Massachusetts
Washington University School of Medicine St Louis Missouri
University of Rochester Medical Center Rochester New York
Rare Disease Research, LLC NC Hillsborough North Carolina
University of Cincinnati Gardner Neuroscience Institute Cincinnati Ohio
Nationwide Children's Hospital Columbus Ohio
University of Pennsylvania Philadelphia Pennsylvania
National Neuromuscular Research Institute Austin Texas
Neurology Rare Disease Center Denton Texas
Virginia Commonwealth University Health Richmond Virginia
St Vincent's Hospital Melbourne Victoria
University Hospital Gent Ghent Belgium
Universitaire Ziekenhuizen Leuven Leuven Belgium
Centre Hospitalier Régional de la Citadelle Liége Belgium
Rigshospitalet Copenhagen Denmark
Centre de Reference des Maladies Neuromusculaires et de la SLA - AP-HM Hopital de La Timone Marseille France
CHU de Nantes Nantes France
CHU de Nice - Hopital Pasteur 2 - Centre de reference des Maladies Neuromusculaires Nice France
AP-HP Hopital Pitie-Salpetriere Paris France
Klinikum der Ludwig-Maximilians-Universitaet Muenchen Munich Germany
Hadassah University Hospital Jerusalem Israel
Fondazione IRCCS Ca'Granda Ospedale Maggiore Milan Italy
Azienda Ospedale - Università Padova Padova Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore Rome Italy
Leids Universitair Medisch Centrum Leiden Netherlands
Optimal Clinical Trials Auckland New Zealand

+ 8 more sites — see the full list on the official registry below.

More Edgewise Therapeutics, Inc. trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06066580 on ClinicalTrials.gov ↗ ← All trials in the UK