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NCT05693142 · ClinicalTrials.gov registry record · Phase 2
AFFINITY DUCHENNE: RGX-202 Gene Therapy in Participants With Duchenne Muscular Dystrophy (DMD)
A Phase 2 study of Duchenne Muscular Dystrophy, sponsored by REGENXBIO.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
- 17
- Study locations
NCT05693142 is a Phase 2 study of Duchenne Muscular Dystrophy that is actively recruiting participants, run by REGENXBIO. The registered enrollment target is 65 participants, below the 411-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (84% lower). The trial reports 17 study locations across 15 states.
The verdict
NCT05693142, a Phase 2 study of Duchenne Muscular Dystrophy, is actively recruiting participants, sponsored by REGENXBIO.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
- 17
- Study locations
Study Summary
RGX-202 is a gene therapy designed to deliver a transgene for a novel microdystrophin that includes functional elements of naturally-occurring dystrophin including the C-Terminal (CT) domain. This is a multicenter, open-label dose evaluation clinical study to assess the safety, tolerability, and clinical efficacy of a one-time intravenous (IV) dose of RGX-202 in participants with Duchenne. For additional information on how to participate (or be considered for the study), please follow this link: https://mytomorro.ws/affinity-ct-gov
Conditions Studied
Interventions
- GENETIC RGX-202
Study Locations (17)
Virginia
- Children's Hospital of the King's Daughters - Norfolk
- Children's Hospital of Richmond at Virginia Commonwealth University - Richmond
Ontario
- Children's Hospital London Health Science Centre - London
- Children's Hospital of Eastern Ontario - Ottawa
Arkansas
- Arkansas Children's Hospital - Little Rock
California
- Stanford School of Medicine /Division of Neuromuscular Medicine - Palo Alto
Colorado
- Children's Hospital Colorado - Aurora
Florida
- University of Florida - Gainesville
Georgia
- Rare Disease Research - Atlanta
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2023-01-04 |
| Est. Completion | 2028-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05693142
The ClinicalTrials.gov registry entry for NCT05693142 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 65 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 (84% lower). The listed sponsor is REGENXBIO, which has 9 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 1 intervention - of which RGX-202 is the first listed.
NCT05693142 reports 17 study locations spanning 15 distinct geographic areas - top geographies include Virginia, Ontario, Arkansas.
Frequently Asked Questions
What is clinical trial NCT05693142 about?
NCT05693142 is a clinical study titled "AFFINITY DUCHENNE: RGX-202 Gene Therapy in Participants With Duchenne Muscular Dystrophy (DMD)". RGX-202 is a gene therapy designed to deliver a transgene for a novel microdystrophin that includes functional elements of naturally-occurring dystrophin including the C-Terminal (CT) domain. This is a multicenter, open-label dose evaluation clinical study to assess the safety, tolerability, and cl...
What is the current status of trial NCT05693142?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2023-01-04. Estimated completion is 2028-08.
What conditions does trial NCT05693142 study?
This clinical trial studies the following conditions: Duchenne Muscular Dystrophy.
What interventions are being tested in trial NCT05693142?
The interventions under investigation include: RGX-202 (GENETIC).
Who is sponsoring clinical trial NCT05693142?
This trial is sponsored by REGENXBIO, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05693142 being conducted?
This trial has 17 study locations across Arkansas, California, Colorado, Florida, Georgia. 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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