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NCT07236606 · ClinicalTrials.gov registry record · Phase 3
RGX-121-3102 Gene Therapy in Participants With MPS II (Hunter Syndrome)
A Phase 3 study, sponsored by REGENXBIO.
- Active
- Registry status
- Phase 3
- Development phase
- 2
- Enrollment target
NCT07236606: Active Phase 3 study, sponsored by REGENXBIO.
NCT07236606 is a Phase 3 study that is active but no longer recruiting, run by REGENXBIO. The registered enrollment target is 2 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07236606, a Phase 3 study, is active but no longer recruiting, sponsored by REGENXBIO.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 2 participants
- Enrollment target
Study Summary
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, efficacy, and pharmacodynamic dose ranging study to determine whether RGX-121 is safe, effective and well-tolerated by patients with MPS II (Hunter Syndrome)
Primary Outcome
To evaluate the effect of RGX-121 on the neurodevelopmental function as measured by the Bayley Scales of Infant and Toddler Development, 3rd Edition (BSID-III).
Interventions
- GENETIC RGX-121-3102
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2025-11-25 |
| Est. Completion | 2031-05-30 |
| Phase | Phase 3 |
What the registry record for NCT07236606 still lists
NCT07236606 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which RGX-121-3102 is the first listed.
NCT07236606 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07236606 about?
NCT07236606 is a clinical study titled "RGX-121-3102 Gene Therapy in Participants With MPS II (Hunter Syndrome)". 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, efficacy, and pharmacodynamic dose ranging study to determine whether RGX-121 is safe, effective and well-tolerated by patients with...
What is the current status of trial NCT07236606?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 2 participants. The study started on 2025-11-25. Estimated completion is 2031-05-30.
What interventions are being tested in trial NCT07236606?
The interventions under investigation include: RGX-121-3102 (GENETIC).
Who is sponsoring clinical trial NCT07236606?
This trial is sponsored by REGENXBIO, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07236606's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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