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NCT05259917 · ClinicalTrials.gov registry record · Phase 3
A Phase III, Crossover Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)
A Phase 3 study, sponsored by KalVista Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 136
- Enrollment target
NCT05259917: Completed Phase 3 study, sponsored by KalVista Pharmaceuticals.
NCT05259917 is a Phase 3 study that has completed, run by KalVista Pharmaceuticals. The registered enrollment target is 136 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05259917, a Phase 3 study, has completed, sponsored by KalVista Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 136 participants
- Enrollment target
Study Summary
This study is a randomized, double-blind, placebo-controlled, phase III, three-way crossover clinical trial evaluating the efficacy and safety of KVD900, in the treatment of hereditary angioedema attacks in adolescent and adult Patients
Primary Outcome
The analysis of time to the beginning of symptom relief defined as at least "a little better" (2 time points in a row) on the PGI-C within 12 hours of the first IMP administration using the Gehan score transformation test for Full Analysis Set (FAS). Attacks were treated as right-censored at 12 hours if they did not achieve beginning of symptom relief defined by PGI-C as at least "a little better" (2 time points in a row) or received conventional attack treatment prior to time-to-event within 1
Interventions
- DRUG Placebo
- DRUG KVD900 600 mg
- DRUG KVD900 300 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2022-02-22 |
| Est. Completion | 2023-12-31 |
| Phase | Phase 3 |
What the finished NCT05259917 record still lists
NCT05259917 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05259917 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05259917 about?
NCT05259917 is a clinical study titled "A Phase III, Crossover Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)". This study is a randomized, double-blind, placebo-controlled, phase III, three-way crossover clinical trial evaluating the efficacy and safety of KVD900, in the treatment of hereditary angioedema attacks in adolescent and adult Patients
What is the current status of trial NCT05259917?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 136 participants. The study started on 2022-02-22. Estimated completion is 2023-12-31.
What interventions are being tested in trial NCT05259917?
The interventions under investigation include: Placebo (DRUG), KVD900 600 mg (DRUG), KVD900 300 mg (DRUG).
Who is sponsoring clinical trial NCT05259917?
This trial is sponsored by KalVista Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05259917's enrollment target sits among peer trials
136 1580th of 2000 higher than 419 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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