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

NCT05693142 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-12-17

No results posted yet for this 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

Interventions

GENETIC

RGX-202

RGX-202 is a recombinant AAV8 containing a transgene encoding a novel microdystrophin

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-04
Primary Completion
2026-02-28
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05693142 on ClinicalTrials.gov