deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT04571970

RGX-121 Gene Therapy in Children 5 Years of Age and Over With MPS II (Hunter Syndrome)

A Phase I/II Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of RGX-121 in Children 5 Years of Age and Older With MPS II (Hunter Syndrome)

Sponsor: REGENXBIO Inc.

Conditions Mucopolysaccharidosis Type II (MPS II)
Interventions RGX-121
Updated 16 times since 2020 Last updated: Jan 24, 2025 Started: Mar 11, 2021 Primary completion: May 9, 2023 Completion: May 23, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1/PHASE2 trial investigates Mucopolysaccharidosis Type II (MPS II) and is currently completed. REGENXBIO Inc. leads this study, which shows 16 recorded versions since 2021 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~Sep 2021 · 6 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~May 2022 · 7 months · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Oct 2022 · 4 months · monthly snapshot~Oct 2022 – ~Nov 2022 · 31 days · monthly snapshot~Nov 2022 – ~Mar 2023 · 4 months · monthly snapshot~Mar 2023 – ~Dec 2023 · 9 months · monthly snapshot~Dec 2023 – ~Jul 2024 · 7 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Feb 2025 · 5 months · monthly snapshot~Feb 2025 – ~Sep 2025 · 7 months · monthly snapshot~Sep 2025 – present · 8 months · monthly snapshot

Change History

16 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE1/PHASE2

  2. Feb 2025 — Sep 2025 [monthly]

    Completed PHASE1/PHASE2

    Status: Active Not Recruiting → Completed

  3. Sep 2024 — Feb 2025 [monthly]

    Active Not Recruiting PHASE1/PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  5. Dec 2023 — Jul 2024 [monthly]

    Active Not Recruiting PHASE1_PHASE2

▶ Show 11 earlier versions

  1. Mar 2023 — Dec 2023 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: Recruiting → Active Not Recruiting

  2. Nov 2022 — Mar 2023 [monthly]

    Recruiting PHASE1_PHASE2

  3. Oct 2022 — Nov 2022 [monthly]

    Recruiting PHASE1_PHASE2

  4. Jun 2022 — Oct 2022 [monthly]

    Recruiting PHASE1_PHASE2

  5. May 2022 — Jun 2022 [monthly]

    Recruiting PHASE1_PHASE2

  6. Oct 2021 — May 2022 [monthly]

    Recruiting PHASE1_PHASE2

  7. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE1_PHASE2

  8. Mar 2021 — Sep 2021 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Not Yet Recruiting → Recruiting

  9. Feb 2021 — Mar 2021 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

  10. Jan 2021 — Feb 2021 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

  11. Oct 2020 — Jan 2021 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • REGENXBIO Inc.
Data source: REGENXBIO Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations