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NCT06100887 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study of EDG-5506 in Children and Adolescents With Duchenne Muscular Dystrophy Previously Treated With Gene Therapy
A Phase 2 study of Duchenne Muscular Dystrophy, sponsored by Edgewise Therapeutics.
- Active
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
- 7
- Study locations
NCT06100887: Active Phase 2 study of Duchenne Muscular Dystrophy, sponsored by Edgewise Therapeutics.
NCT06100887 is a Phase 2 study of Duchenne Muscular Dystrophy that is active but no longer recruiting, run by Edgewise Therapeutics. The registered enrollment target is 43 participants, below the 411-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (90% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06100887, a Phase 2 study of Duchenne Muscular Dystrophy, is active but no longer recruiting, sponsored by Edgewise Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
- 7
- Study locations
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.
Primary Outcome
All participants
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Sevasemten Dose 1
- DRUG Sevasemten Dose 2
- DRUG Sevasemten Dose 3
Study Locations (7)
California
- UCLA Medical Center - Los Angeles
- UC Davis Medical Center - Sacramento
Florida
- University of Florida - Gainesville
Massachusetts
- University of Massachusetts Memorial Medical Center - Worcester
Missouri
- Washington University School of Medicine - St Louis
North Carolina
- Rare Disease Research - Hillsborough
Ohio
- Nationwide Children's Hospital - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2024-03-22 |
| Est. Completion | 2027-03 |
| Phase | Phase 2 |
What the registry record for NCT06100887 still lists
NCT06100887 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 411-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Duchenne Muscular Dystrophy appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT06100887 lists 7 locations in 6 states (California, Florida, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT06100887 about?
NCT06100887 is a clinical study titled "Phase 2 Study of EDG-5506 in Children and Adolescents With Duchenne Muscular Dystrophy Previously Treated With Gene Therapy". 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.
What is the current status of trial NCT06100887?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2024-03-22. Estimated completion is 2027-03.
What conditions does trial NCT06100887 study?
This clinical trial studies the following conditions: Duchenne Muscular Dystrophy.
What interventions are being tested in trial NCT06100887?
The interventions under investigation include: Placebo (DRUG), Sevasemten Dose 1 (DRUG), Sevasemten Dose 2 (DRUG), Sevasemten Dose 3 (DRUG).
Who is sponsoring clinical trial NCT06100887?
This trial is sponsored by Edgewise Therapeutics, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06100887 being conducted?
This trial has 7 study locations across California, Florida, Massachusetts, Missouri, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Duchenne Muscular Dystrophy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06100887's enrollment target sits among peer trials
43 28th of 48 higher than 21 of 48 other Duchenne Muscular Dystrophy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Duchenne Muscular Dystrophy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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