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NCT06100887

A Phase 2 Study to Evaluate the Effect of EDG-5506 on Safety, Pharmacokinetics, and Biomarkers in Children and Adolescents With Duchenne Muscular Dystrophy Previously Treated With Gene Therapy

Study 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.

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Interventions

Sevasemten Dose 1DRUG
Sevasemten is administered orally once per day
Sevasemten Dose 2DRUG
Sevasemten is administered orally once per day
Sevasemten Dose 3DRUG
Sevasemten is administered orally once per day
PlaceboDRUG
Placebo is administered orally once per day

Study Locations

FacilityCityStateCountry
UCLA Medical CenterLos AngelesCaliforniaUnited States
UC Davis Medical CenterSacramentoCaliforniaUnited States
University of FloridaGainesvilleFloridaUnited States
University of Massachusetts Memorial Medical CenterWorcesterMassachusettsUnited States
Washington University School of MedicineSt LouisMissouriUnited States
Rare Disease ResearchHillsboroughNorth CarolinaUnited States
Nationwide Children's HospitalColumbusOhioUnited States

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026