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NCT05139810 · ClinicalTrials.gov registry record · Phase 3
OASIS-HAE: A Study to Evaluate the Safety and Efficacy of Donidalorsen (ISIS 721744 or IONIS-PKK-LRx) in Participants With Hereditary Angioedema (HAE)
A Phase 3 study of Hereditary Angioedema, sponsored by Ionis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 91
- Enrollment target
- 20
- Study locations
NCT05139810: Completed Phase 3 study of Hereditary Angioedema, sponsored by Ionis Pharmaceuticals.
NCT05139810 is a Phase 3 study of Hereditary Angioedema that has completed, run by Ionis Pharmaceuticals. The registered enrollment target is 91 participants, above the 69-participant average among 14 other Hereditary Angioedema trials with a reported enrollment target (32% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05139810, a Phase 3 study of Hereditary Angioedema, has completed, sponsored by Ionis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 91 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study was to evaluate the safety and efficacy of donidalorsen in participants with HAE and effect of donidalorsen on the quality and pattern of HAE attacks and their impact on quality of life (QoL).
Primary Outcome
The time-adjusted HAE attack rate was calculated as number of IC HAE attacks occurring from Week 1 to Week 25, divided by the number of days the participant contributed to the period multiplied by 28 days. An HAE attack was defined as an event with signs or symptoms consistent with an attack in at least 1 of the locations: peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without ab
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Donidalorsen
Study Locations (20)
Other
- Ionis Investigative Site - Brussels
- Ionis Investigative Site - Brussels
- Ionis Investigative Site - Edegem
- Ionis Investigative Site - Sofia
- Ionis Investigative Site - Sofia
California
- Ionis Investigative Site - San Diego
- Ionis Investigative Site - Santa Monica
- Ionis Investigative Site - Walnut Creek
Ohio
- Ionis Investigative Site - Columbus
- Ionis Investigative Site - Toledo
Arizona
- Ionis Investigative Site - Scottsdale
Colorado
- Ionis Investigative Site - Colorado Springs
Florida
- Ionis Investigative Site - Tampa
Kansas
- Ionis Investigative Site - Kansas City
Massachusetts
- Ionis Investigative Site - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2021-12-03 |
| Est. Completion | 2023-11-09 |
| Phase | Phase 3 |
What the finished NCT05139810 record still lists
NCT05139810 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, above the 69-participant average among 14 other Hereditary Angioedema trials with a reported enrollment target (32% higher).
The record links to 1 condition, with Hereditary Angioedema appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05139810 names 20 study sites across 13 states, led by Other, California, Ohio.
Frequently Asked Questions
What is clinical trial NCT05139810 about?
NCT05139810 is a clinical study titled "OASIS-HAE: A Study to Evaluate the Safety and Efficacy of Donidalorsen (ISIS 721744 or IONIS-PKK-LRx) in Participants With Hereditary Angioedema (HAE)". The purpose of this study was to evaluate the safety and efficacy of donidalorsen in participants with HAE and effect of donidalorsen on the quality and pattern of HAE attacks and their impact on quality of life (QoL).
What is the current status of trial NCT05139810?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 91 participants. The study started on 2021-12-03. Estimated completion is 2023-11-09.
What conditions does trial NCT05139810 study?
This clinical trial studies the following conditions: Hereditary Angioedema.
What interventions are being tested in trial NCT05139810?
The interventions under investigation include: Placebo (DRUG), Donidalorsen (DRUG).
Who is sponsoring clinical trial NCT05139810?
This trial is sponsored by Ionis Pharmaceuticals, which has 76 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05139810 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT05139810's enrollment target sits among peer trials
91 4th of 14 higher than 11 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
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