drugset / Trial / NCT05291091
Phase 2 Study of EDG-5506 in Becker Muscular Dystrophy (GRAND CANYON)
Phase 2
Active not recruiting
244 enrolled
Edgewise Therapeutics, Inc.
ImagingNMD · collabMedpace, Inc. · collabSYSNAV · collab
RandomizedSequentialQuadruple-blindTreatment
Summary
A study of sevasemten (EDG-5506) in Becker muscular dystrophy (known as CANYON) and pivotal cohort (known as GRAND CANYON). The EDG-5506-201 CANYON study was expanded to include an additional 120 adult participants in a cohort called GRAND CANYON, that is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of sevasemten in adults with Becker. CANYON and GRAND CANYON are fully enrolled.
Timeline
- Start
- 2022-11-10
- Primary completion
- 2026-09
- Completion
- 2026-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sevasemten | Small molecule | 5 mg | Oral |
| Subject | Sevasemten | Small molecule | 10 mg | Oral |
| Subject | Sevasemten | Small molecule | 12.5 mg | Oral |