Clinical Trial

A Study to Assess the Long-Term Safety and Efficacy of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE)

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The purpose of this study is to evaluate the long-term safety and efficacy of donidalorsen in people with HAE and the effects of donidalorsen on the number of HAE attacks and their impact on quality of life (QoL).
Protocol Amendment History 39 amendments
This ClinicalTrials.gov record has been amended 39 times since 2022-05-23; most recent amendment 2025-12-05.
Status change: Recruiting → Active, Not Recruiting 2025-06-18
Status change: Not Yet Recruiting → Recruiting 2022-08-01
Trial Details
NCT Number NCT05392114
Lead Sponsor Ionis Pharmaceuticals, Inc.
Conditions Hereditary Angioedema
Enrollment 154 participants
Start Date 2022-07-13
Primary Completion 2026-12 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2025-12-12