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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06100887
The ClinicalTrials.gov registry entry for NCT06100887 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 411-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (90% lower). The listed sponsor is Edgewise Therapeutics, which has 15 total studies on file at ClinicalTrials.gov.
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 reports 7 study locations spanning 6 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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