NCT07236606Phase 3Active not recruiting

RGX-121-3102 Gene Therapy in Participants With MPS II (Hunter Syndrome)

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2028-04-30Estimated

Enrollment · participants2Estimated

Source updated2026-06-04Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-06-04 · 1 field changed

Recruitment status changed

− Before

~~Suspended~~

+ After

Active not recruiting

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Posted 2026-02-27 · 1 field changed

Recruitment status changed

− Before

~~Recruiting~~

+ After

Suspended

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Posted 2025-11-26 · 1 field changed

Recruitment status changed

− Before

~~Not yet recruiting~~

+ After

Recruiting

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Study details

Conditions studied

MPS II; Hunter Syndrome (MPS II)

Treatments or interventions studied

Not recorded

Primary outcomes · main study measures

Read the study measures

measure: Efficacy of RGX-121 on Neurodevelopmental Function (as measured by the Bayley Scales of Infant and Toddler Development, 3rd Edition); description: 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).; timeFrame: Month 24; measure: Efficacy of RGX-121 on Neurodevelopmental Function (as measured by Kaufman Assessment Battery for Children, 2nd Edition); description: To evaluate the effect of RGX-121 on the neurodevelopmental function as measured by the Kaufman Assessment for Children, 2nd edition (KABC-II). The KABC-II is only given if the participant achieved the max ceiling on the BSID-III Cognitive scale at two consecutive administrations.; timeFrame: Month 24; measure: Long-term Safety of RGX-121; description: To evaluate the safety of RGX-121 for up to five years including serious and adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) (Version 5.0); timeFrame: Year 5

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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