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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Duchenne Muscular Dystrophy

In brief

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.

Key facts

Study ID

NCT06100887

Run by

Edgewise Therapeutics, Inc.

People needed

43

Starts

2024-03-22

Expected to finish

2027-03-01

Last updated by the study team

2025-11-06

Who can join

Age: 6 and older, up to 17. Sex: male. Healthy volunteers: not accepted.

Where it is running

• UCLA Medical Center — Los Angeles, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• University of Florida — Gainesville, Florida, United States
• University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Rare Disease Research — Hillsborough, North Carolina, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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