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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: Recruiting Phase 2 study of Duchenne Muscular Dystrophy, sponsored by REGENXBIO.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Evaluate incidences of AEs and SAEs
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 |
What NCT05693142 shows while recruiting
NCT05693142 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 411-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (84% lower).
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 lists 17 locations in 15 states (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.
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 NCT05693142's enrollment target sits among peer trials
65 20th of 48 higher than 29 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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