RGX-121-3102 Gene Therapy in Participants With MPS II (Hunter Syndrome)
← catalyst calendarNCT07236606 · readout in 620 d
Sponsored by REGENXBIO Inc. (industry) · RGNX — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
2estimated
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-11-25 | actual | When the study began enrolling |
| Primary completion | 2028-04-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2031-05-30 | estimated | The whole study's end, after follow-up |
| First posted | 2025-11-19 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- MPS II
- Hunter Syndrome (MPS II)
Intervention
- Genetic: RGX-121-3102
Primary outcomes
what the primary-completion date above is the date OFEfficacy of RGX-121 on Neurodevelopmental Function (as measured by the Bayley Scales of Infant and Toddler Development, 3rd Edition)
measured Month 24
Efficacy of RGX-121 on Neurodevelopmental Function (as measured by Kaufman Assessment Battery for Children, 2nd Edition)
measured Month 24
Long-term Safety of RGX-121
measured Year 5
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