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.
More Pharvaris Netherlands B.V. trials in Poland
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 Poland