Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05693142 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 21, 2026 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status changed: Recruiting → Active, Not Recruiting Trial sites expanded: 17 → 23 locations · Primary completion pushed from Aug 2026 to Sep 2026 · Completion moved earlier from Aug 2028 to Jun 2028 · 2 morev20 Show 5 more changesShow less
    • Trial sites expanded: 17 → 23 locations
    • Primary completion pushed from Aug 2026 to Sep 2026
    • Completion moved earlier from Aug 2028 to Jun 2028
    • Eligibility criteria expanded, about 53 words
    • Study description expanded, about 12 words

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Feb 2026 to Aug 2026v19
  3. Study sites: 16 to 17v18
  4. Re-verified, no change to tracked fieldsv17
  5. Site details revised at 1 of 16 sitesv16
Show 14 earlier versionsHide 14 earlier versions
  1. Study sites: 13 to 16v15
  2. Site details revised at 4 of 13 sitesv14
  3. Study sites: 8 to 13v13
  4. Study sites: 7 to 8v12
  5. Study sites: 6 to 7 Eligibility criteria shortened, about 12 words · Secondary endpoints: details revised at 9 of 14 entriesv11 Show 2 more changesShow less
    • Eligibility criteria shortened, about 12 words
    • Secondary endpoints: details revised at 9 of 14 entries

    See this version in full on ClinicalTrials.gov ↗

  6. Study sites: 5 to 6v10
  7. Phase: Phase 1/2 to Phase 2/3 Enrollment target: 15 to 65 · Primary endpoints: 1 to 2 · Primary completion date: Dec 2025 to Feb 2026 · 5 morev9 Show 8 more changesShow less
    • Enrollment target: 15 to 65
    • Primary endpoints: 1 to 2
    • Primary completion date: Dec 2025 to Feb 2026
    • Completion date: Dec 2025 to Aug 2028
    • Eligibility criteria expanded, about 550 words
    • Secondary endpoints: 5 to 14
    • Study description shortened, about 57 words
    • Site contacts updated at 5 of 5 sites

    See this version in full on ClinicalTrials.gov ↗

  8. Enrollment target: 18 to 15 Eligibility criteria expanded, about 211 words · Secondary endpoints: 4 to 5 · Study description expanded, about 88 wordsv8 Show 3 more changesShow less
    • Eligibility criteria expanded, about 211 words
    • Secondary endpoints: 4 to 5
    • Study description expanded, about 88 words

    See this version in full on ClinicalTrials.gov ↗

  9. Study sites: 3 to 5v7
  10. Site details revised at 2 of 3 sitesv6
  11. Study sites: 2 to 3v5
  12. Eligibility criteria expanded, about 26 words Study description shortened, about 1 wordv4 Show 1 more changeShow less
    • Study description shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  13. Site contacts updated at 2 of 2 sitesv3
  14. Study sites: 1 to 2 Start date changed from estimate of Jan 2023 to Jan 4, 2023v2 Show 1 more changeShow less
    • Start date changed from estimate of Jan 2023 to Jan 4, 2023
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05693142
Lead Sponsor REGENXBIO Inc.
Conditions Duchenne Muscular Dystrophy
Enrollment 65 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov