Study of Oral Deucrictibant XR Tablet for Prophylaxis and Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adults With Acquired Angioedema Due to C1 Inhibitor Deficiency
Condition(s) studied
Investigational drug(s) / intervention(s)
Deucrictibant: Part 1: Deucrictibant 40 mg extended-release tablet for once daily oral use
Placebo: Part 1: Placebo Comparator tablet for once daily oral use
Deucrictibant: Part 2: Deucrictibant 20 mg soft capsule oral use
Placebo: Part 2: Placebo Comparator soft capsule oral use
Deucrictibant: Part 3: Deucrictibant 20 mg soft capsule oral use
Study summary
This is a Phase 3, multicenter, 3-part study, with 2 randomized, double-blind, placebo-controlled parts and an open-label extension part, to evaluate the efficacy and safety of orally administered deucrictibant XR tablet for prophylaxis, and deucrictibant soft capsule for on-demand treatment of angioedema attacks in adult participants aged ≥ 18 years with AAE-C1INH.
Eligibility
Primary outcome measure(s)
- Part 1: Time-normalized number of Investigator-confirmed AAE-C1INH attacks during Treatment Phase — 12 weeks
- Part 2: Time to symptom relief, Patient Global Impression of Change (PGI-C) rating of at least "better" — 12 hours post-treatment
- Part 3: Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent adverse events of special interest (AESIs), and serious adverse events (SAEs) — Through study termination, an average of 36 weeks
- Part 3: Number of participants with clinically significant changes from baseline in Hematology parameters — Through study termination, an average of 36 weeks
- Part 3: Number of participants with clinically significant changes from baseline in Urinalysis parameters — Through study termination, an average of 36 weeks
- Part 3: Number of participants with clinically significant changes from baseline in Biochemistry parameters — Through study termination, an average of 36 weeks
- Part 3: Number of participants with clinically significant changes from baseline in vital signs — Through study termination, an average of 36 weeks
- Part 3: Number of participants with clinically significant changes from baseline in physical examinations — Through study termination, an average of 36 weeks
- Part 3: Number of participants with clinically significant changes in electrocardiogram (ECG) — Through study termination, an average of 36 weeks
Trial sites (32)
| Facility | City | Region | Status |
|---|---|---|---|
| Study Site | San Diego | California | Recruiting |
| Study Site | Walnut Creek | California | Recruiting |
| Study Site | St Louis | Missouri | Recruiting |
| Study Site | Hershey | Pennsylvania | Recruiting |
| Study Site | Clayton | Australia | Recruiting |
| Study Site | Vienna | Austria | Recruiting |
| Study Site | Sofia | Bulgaria | Recruiting |
| Study Site | Edmonton | Canada | Recruiting |
| Study Site | Grenoble | France | Recruiting |
| Study Site | Lille | France | Recruiting |
| Study Site | Paris | France | Recruiting |
| Study Site | Berlin | Germany | Recruiting |
| Study Site | Frankfurt am Main | Germany | Recruiting |
| Study Site | Munich | Germany | Recruiting |
| Study Site | Budapest | Hungary | Recruiting |
| Study Site 1 | Milan | Italy | Recruiting |
| Study Site 2 | Milan | Italy | Recruiting |
| Study Site 3 | Milan | Italy | Recruiting |
| Study Site | Padova | Italy | Recruiting |
| Study Site | Roma | Italy | Recruiting |
| Study Site | Amsterdam | Netherlands | Recruiting |
| Study Site | Auckland | New Zealand | Recruiting |
| Study Site | Krakow | Poland | Recruiting |
| Study Site | Madrid | Spain | Recruiting |
| Study Site | Basel | Switzerland | Recruiting |
| Study Site | Ankara | Turkey (Türkiye) | Recruiting |
| Study Site | Bristol | United Kingdom | Recruiting |
| Study Site | Cambridge | United Kingdom | Recruiting |
| Study Site | Leicester | United Kingdom | Recruiting |
| Study Site | London | United Kingdom | Recruiting |
| Study Site | Newcastle upon Tyne | United Kingdom | Recruiting |
| Study Site | Plymouth | United Kingdom | Recruiting |
More Pharvaris Netherlands B.V. trials in Poland
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 NCT07266805 on ClinicalTrials.gov ↗ ← All trials in Poland