Clinical Trial

AFFINITY DUCHENNE: RGX-202 Gene Therapy in Participants With Duchenne Muscular Dystrophy (DMD)

Active, Not Recruiting Phase 2/3
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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.
Protocol Amendment History 4 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-07-22
notable Trial sites expanded: 17 -> 23 locations 2026-07-22
notable Primary completion pushed: 2026-08 -> 2026-09 2026-07-22
minor Completion moved earlier: 2028-08 -> 2028-06 2026-07-22
Trial Details
NCT Number NCT05693142
Lead Sponsor REGENXBIO Inc.
Conditions Duchenne Muscular Dystrophy
Enrollment 65 participants
Start Date 2023-01-04
Primary Completion 2026-09 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-21