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A Safety and Efficacy Study of GTX-102 in Subjects With Deletion- or Nondeletion-type Angelman Syndrome (AS)

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NCT07157254 · readout ≤ 1,261 d

Sponsored by Ultragenyx Pharmaceutical Inc (industry) · RARE — their whole pipeline →.

Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
60estimated
Sites
21
Countries
Argentina, Brazil, France +5

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
DateFiledBasisWhat it is
Start2025-10-13actualWhen the study began enrolling
Primary completionJan 2030estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completionJan 2030estimatedThe whole study's end, after follow-up
First posted2025-09-05actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-08-07actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Angelman Syndrome

Interventions

  • Other: No intervention
  • Drug: GTX-102 — also filed as apazunersen

Primary outcomes

what the primary-completion date above is the date OF
Subprotocol A/B/C/D: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), Severe Events, and Events Related to Investigational Product, Procedure, and Premedication
measured Up to Day 506
Subprotocol A Only: Bayley-4 Cognitive Without Caregiver Input Raw Score Change from Baseline at Day 338
measured Baseline, Day 338
Subprotocol B/D Only: Multidomain Responder Index (MDRI) Net Response at Day 338
measured Baseline, Day 338
Subprotocol C Only: MDRI Net Response at Day 338
measured Baseline, Day 338

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