REVEAL: A Phase 3 Study of ION582 in Angelman Syndrome

NCT06914609 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2026-05-15

No results posted yet for this study

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

Placebo

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06914609 on ClinicalTrials.gov