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NCT05392114 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Long-Term Safety and Efficacy of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE)
A Phase 3 study of Hereditary Angioedema, sponsored by Ionis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 154
- Enrollment target
- 20
- Study locations
NCT05392114: Active Phase 3 study of Hereditary Angioedema, sponsored by Ionis Pharmaceuticals.
NCT05392114 is a Phase 3 study of Hereditary Angioedema that is active but no longer recruiting, run by Ionis Pharmaceuticals. The registered enrollment target is 154 participants, above the 65-participant average among 14 other Hereditary Angioedema trials with a reported enrollment target (137% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05392114, a Phase 3 study of Hereditary Angioedema, is active but no longer recruiting, sponsored by Ionis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 154 participants
- Enrollment target
- 20
- Study locations
Study 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).
Conditions Studied
Interventions
- DRUG Donidalorsen
Study Locations (20)
California
- Ionis Investigative Site - La Jolla
- Ionis Investigative Site - Santa Monica
- Ionis Investigative Site - Walnut Creek
Other
- Ionis Investigative Site - Edegem
- Ionis Investigative Site - Sofia
- Ionis Investigative Site - Sofia
Michigan
- Ionis Investigative Site - Ann Arbor
- Ionis Investigative Site - Detroit
Ohio
- Ionis Investigative Site - Cincinnati
- Ionis Investigative Site - Columbus
Arizona
- Ionis Investigative Site - Paradise Valley
Florida
- Ionis Investigative Site - Tampa
Kansas
- Ionis Investigative Site - Kansas City
Massachusetts
- Ionis Investigative Site - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2022-07-13 |
| Est. Completion | 2027-03 |
| Phase | Phase 3 |
What the registry record for NCT05392114 still lists
NCT05392114 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, above the 65-participant average among 14 other Hereditary Angioedema trials with a reported enrollment target (137% higher).
The record links to 1 condition, with Hereditary Angioedema appearing as the primary indexed condition, and to 1 intervention - of which Donidalorsen is the first listed.
NCT05392114 names 20 study sites across 14 states, led by California, Other, Michigan.
Frequently Asked Questions
What is clinical trial NCT05392114 about?
NCT05392114 is a clinical study titled "A Study to Assess the Long-Term Safety and Efficacy of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE)". 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).
What is the current status of trial NCT05392114?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 154 participants. The study started on 2022-07-13. Estimated completion is 2027-03.
What conditions does trial NCT05392114 study?
This clinical trial studies the following conditions: Hereditary Angioedema.
What interventions are being tested in trial NCT05392114?
The interventions under investigation include: Donidalorsen (DRUG).
Who is sponsoring clinical trial NCT05392114?
This trial is sponsored by Ionis Pharmaceuticals, which has 76 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05392114 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Kansas, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hereditary Angioedema
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05392114's enrollment target sits among peer trials
154 1st of 14 higher than 14 of 14 other Hereditary Angioedema trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hereditary Angioedema trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
STOP-HAE: A Phase 3 Study of ADX-324 in HAE
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HAELO: A Phase 3 Study to Evaluate NTLA-2002 in Participants With Hereditary Angioedema (HAE)
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COMPLETED · Phase 3
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