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CAMPSIITE™ RGX-121 Gene Therapy in Subjects With MPS II (Hunter Syndrome)

StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of May 2024 to Nov 27, 2023 Completion date: May 2025 to Aug 2025v22 Show 1 more changeShow less
    • Completion date: May 2025 to Aug 2025
  2. Trial status: Recruiting to Active, Not Recruiting Study sites: 6 to 5v21 Show 1 more changeShow less
    • Study sites: 6 to 5
  3. Study sites: 5 to 6v20
  4. Site details revised at 1 of 5 sitesv19
  5. Site details revised at 1 of 5 sitesv18
Show 16 earlier versionsHide 16 earlier versions
  1. Site details revised at 1 of 5 sitesv17
  2. Phase: Phase 1/2 to Phase 2/3 Enrollment target: 18 to 48 · Primary completion date: May 2022 to May 2024 · Primary endpoints: 1 to 5 · 7 morev16 Show 10 more changesShow less
    • Enrollment target: 18 to 48
    • Primary completion date: May 2022 to May 2024
    • Primary endpoints: 1 to 5
    • Study sites: 4 to 5
    • Completion date: May 2024 to May 2025
    • Eligibility criteria expanded, about 286 words
    • Secondary endpoints: 6 to 8
    • Study description expanded, about 96 words
    • Study arms: 5 to 6
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Site contacts updated at 1 of 4 sitesv15
  4. Re-verified, no change to tracked fieldsv14
  5. Enrollment target: 12 to 18 Primary completion date: Dec 2023 to May 2022 · Completion date: Dec 2023 to May 2024 · Study description revised · 2 morev13 Show 5 more changesShow less
    • Primary completion date: Dec 2023 to May 2022
    • Completion date: Dec 2023 to May 2024
    • Study description revised
    • Site contacts updated at 1 of 4 sites
    • Study arms: 4 to 5

    See this version in full on ClinicalTrials.gov ↗

  6. Site contacts updated at 1 of 4 sitesv12
  7. Primary completion date: May 2021 to Dec 2023v11
  8. Completion date: Dec 2022 to Dec 2023 Study arms: 3 to 4 · Study description shortened, about 3 wordsv10 Show 2 more changesShow less
    • Study arms: 3 to 4
    • Study description shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  9. Enrollment target: 6 to 12 Primary completion date: Dec 2020 to May 2021 · Secondary endpoints: details revised at 1 of 6 entries · Study description revised · 2 morev9 Show 5 more changesShow less
    • Primary completion date: Dec 2020 to May 2021
    • Secondary endpoints: details revised at 1 of 6 entries
    • Study description revised
    • Study arms: 2 to 3
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  10. Study sites: 3 to 4v8
  11. Study sites revised (3)v7 See this version in full on ClinicalTrials.gov ↗
  12. Study sites: 2 to 3v6
  13. Primary completion date: Aug 2019 to Dec 2020 Study sites: 1 to 2 · Completion date: Aug 2021 to Dec 2022 · Eligibility criteria shortened, about 24 wordsv5 Show 3 more changesShow less
    • Study sites: 1 to 2
    • Completion date: Aug 2021 to Dec 2022
    • Eligibility criteria shortened, about 24 words

    See this version in full on ClinicalTrials.gov ↗

  14. Start date changed from estimate of Jul 2018 to Sep 27, 2018 Eligibility criteria expanded, about 90 wordsv4 Show 1 more changeShow less
    • Eligibility criteria expanded, about 90 words

    See this version in full on ClinicalTrials.gov ↗

  15. Trial status: Not Yet Recruiting to Recruiting Start date: Jun 2018 to Jul 2018 · Eligibility criteria expanded, about 8 words · Site details revisedv3 Show 3 more changesShow less
    • Start date: Jun 2018 to Jul 2018
    • Eligibility criteria expanded, about 8 words
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  16. Study sites: 0 to 1v2
  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-121 is a gene therapy which is intended to deliver a functional copy of the iduronate-2-sulfatase gene (IDS) to the central nervous system. This study is a safety and efficacy, dose ranging study to determine whether RGX-121 is safe, effective and well-tolerated by patients with MPS II.
Trial Details
NCT Number NCT03566043
Lead Sponsor REGENXBIO Inc.
Conditions Mucopolysaccharidosis Type II (MPS II)
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov