Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE
Condition(s) studied
Investigational drug(s) / intervention(s)
Deucrictibant: Deucrictibant extended-release tablet for once daily oral use
Study summary
This is a Phase 3, multicenter, long-term, open-label study to evaluate the safety and efficacy of once-daily orally administered deucrictibant extended-release tablet for prophylaxis to prevent angioedema attacks in participants aged ≥12 years with Hereditary Angioedema
Eligibility
Primary outcome measure(s)
- Number of participants with treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), adverse events of special interest (AESIs), and TEAEs leading to study drug discontinuation — Up to Week 240
- Change in heart rate — Up to Week 240
- Change in blood pressure — Up to Week 240
- Change in body temperature — Up to Week 240
- Number of participants with clinically significant changes in Hematology — Up to Week 240
Blood samples will be collected for the analysis of hematology parameters. - Number of participants with clinically significant changes in Clinical Chemistry — Up to Week 240
Blood samples will be collected for the analysis of clinical chemistry parameters. - Number of participants with clinically significant changes in Urinalysis — Up to Week 240
Urine samples will be collected for the analysis of urinalysis parameters. - Change from Baseline electrocardiograms (ECGs) — Up to Week 240
Digital triplicate 12-lead ECG. Descriptive in nature, no formal statistical hypothesis testing will be performed.
Trial sites (67)
| Facility | City | Region | Status |
|---|---|---|---|
| Study Site | Birmingham | Alabama | |
| Study Site | Scottsdale | Arizona | |
| Study Site | Little Rock | Arkansas | |
| Study Site | San Diego | California | |
| Study Site | Santa Monica | California | |
| Study Site | Walnut Creek | California | |
| Study Site | Colorado Springs | Colorado | |
| Study Site | Wheaton | Illinois | |
| Study Site | St Louis | Missouri | |
| Study Site | Las Vegas | Nevada | |
| Study Site | Hershey | Pennsylvania | |
| Study Site | Dallas | Texas | |
| Study Site | Milwaukee | Wisconsin | |
| Study Site | Corrientes | Argentina | |
| Study Site | Pilar | Argentina | |
| Study Site | Salta | Argentina | |
| Study Site | Box Hill | Australia | |
| Study Site | Parkville | Australia | |
| Study Site | Perth | Australia | |
| Study Site | Sydney | Australia | |
| Study Site | Vienna | Austria | |
| Study Site | Ribeirão Preto | Brazil | |
| Study Site | Salvador | Brazil | |
| Study Site | Santo André | Brazil | |
| Study Site | São Paulo | Brazil | |
| Study Site | São Paulo | Brazil | |
| Study Site | Sofia | Bulgaria | |
| Study Site | Edmonton | Canada | |
| Study Site | Montreal | Canada | |
| Study Site | Beijing | China | |
| Study Site | Grenoble | France | |
| Study Site | Berlin | Germany | |
| Study Site | Frankfurt | Germany | |
| Study Site | Munich | Germany | |
| Study Site | Hong Kong | Hong Kong | |
| Study Site | Budapest | Hungary | |
| Study Site | Dublin | Ireland | |
| Study Site | Milan | Italy | |
| Study Site | Padova | Italy | |
| Study Site | Palermo | Italy |
+ 27 more sites — see the full list on the official registry below.
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06679881 on ClinicalTrials.gov ↗ ← All trials in China