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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05392114
The ClinicalTrials.gov registry entry for NCT05392114 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 154 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 65-participant average among 14 other Hereditary Angioedema trials with a reported enrollment target (137% higher). The listed sponsor is Ionis Pharmaceuticals, which has 76 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.