At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
Sevasemtendrug
Likely dose
Sevasemten 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1b, Open-label Study of the Safety and Pharmacokinetics of EDG-5506 in Adults With Becker Muscular Dystrophy
In Brief
A Phase 1 clinical trial evaluating Sevasemten for Becker Muscular Dystrophy. Completed, enrolled 12 participants across 1 site.
Detailed Summary
The ARCH study was an open-label, single-center, Phase 1b study of sevasemtem (EDG-5506) to assess the safety and pharmacokinetics (PK) of sevasemten in adults with Becker muscular dystrophy (BMD). Sevasemten is an investigational product intended to protect and improve function of dystrophic muscle fibers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBecker Muscular Dystrophy
CountriesUnited States
CollaboratorsMedpace, Inc.
Timeline
Phase 1CompletedFinished
20222023202420252026
First PostedDec 2021
Enrollment StartDec 2021
Primary CompletionMar 2024
TodayJul 2026
First PostedDec 16, 2021
Enrollment StartDec 28, 2021
Primary CompletionMar 1, 2024
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 4.5 years ago
Interventions
Sevasemtendrug
Daily oral dose of 10 mg daily until Visit 8 (Day 57), followed by 15 mg daily until Visit 13 (Month 6), followed by 20 mg until Visit 21 (Month 15), followed by 10 mg daily to Visit 27 (Month 24).