Clinical Trial

Phase 2 Study of EDG-5506 in Children and Adolescents With Duchenne Muscular Dystrophy Previously Treated With Gene Therapy

Study acronym: FOX
Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
The FOX study is a 2-part, multicenter, Phase 2 study of safety, pharmacokinetics, and biomarkers in children and adolescents with Duchenne muscular dystrophy previously treated with gene therapy including a randomized, double-blind, placebo-controlled Part A, followed by an open-label part B.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2023-10-20; most recent amendment 2025-11-05.
Status change: Recruiting → Active, Not Recruiting 2025-05-05
Status change: Not Yet Recruiting → Recruiting 2024-03-14
Trial Details
NCT Number NCT06100887
Lead Sponsor Edgewise Therapeutics, Inc.
Conditions Duchenne Muscular Dystrophy
Enrollment 43 participants
Start Date 2024-03-22
Primary Completion 2027-03 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2025-11-06