REVEAL: A Phase 3 Study of ION582 in Angelman Syndrome
NCT06914609 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 158
Last updated 2026-05-15
Summary
The purpose of this study is to evaluate the efficacy and safety of ION582 in children and adults with Angelman syndrome caused by a deletion or mutation of the UBE3A gene.
Conditions
Interventions
- DRUG
-
ION582
ION582 will be administered by IT injection.
- DRUG
-
ION582 matching placebo will be administered by IT injection.
Sponsors & Collaborators
-
Ionis Pharmaceuticals, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 2 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-10
- Primary Completion
- 2027-08-31
- Completion
- 2030-04-30
- FDA Drug
- Yes
Countries
- United States
- Australia
- Canada
- Germany
- Israel
- Italy
- Japan
- Poland
- Singapore
- South Korea
- Spain
- United Kingdom
Study Locations
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