CAMPSIITE™ RGX-121 Gene Therapy in Subjects With MPS II (Hunter Syndrome)
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Phase
Phase 2/3
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
48estimated
Sites
5
Countries
Brazil, 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 | 2018-09-27 | actual | When the study began enrolling |
| Primary completion | 2023-11-27 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Aug 2025 | estimated | The whole study's end, after follow-up |
| First posted | 2018-06-21 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-01-28 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Mucopolysaccharidosis Type II (MPS II)
Intervention
- Genetic: RGX-121
Primary outcomes
what the primary-completion date above is the date OFPart 1 Safety
measured 24 Weeks
Part 2 Biomarkers
measured 52 Weeks
Part 2 Biomarkers
measured 104 weeks
Part 2 Neurodevelopmental parameters
measured 52 Weeks
Part 2 Neurodevelopmental parameters
measured 104 weeks
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