Trials / Completed

CompletedNCT05047185

Dose-ranging Study of Oral PHA-022121 for Prophylaxis Against Angioedema Attacks in Patients With Hereditary Angioedema Type I or Type II

A Phase II, Double-blind, Placebo-controlled, Randomized, Dose-ranging, Parallel Group Study to Evaluate the Safety and Efficacy of PHA-022121 Administered Orally for Prophylaxis Against Angioedema Attacks in Patients With Hereditary Angioedema Due to C1-Inhibitor Deficiency (Type I or Type II)

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: 34 (actual)

Sponsor: Pharvaris Netherlands B.V. · Industry
Sex: All
Age: 18 Years – 75 Years
Healthy volunteers: Not accepted

Summary

This study evaluates the safety and efficacy of PHA-022121 administered orally for prophylaxis against angioedema attacks in patients with hereditary angioedema (HAE). The study consists of 2 parts, with patients completing participation in Part 1 prior to initiation of treatment in Part 2. Part 1 of the study has 3 parallel arms and approximately 30 patients will be equally randomized to one of two dose regimens of PHA-022121 or matching placebo. Patients will continue to the single open-label arm in Part 2 of the study after completion of Part 1. The screening period is up to 8 weeks and the treatment periods are 12 weeks (Part 1) and 30 months (Part 2) in duration.

Conditions

Interventions

Type	Name	Description
DRUG	Deucrictibant low dose	Deucrictibant softgel capsules for oral use (PHVS416)
DRUG	Deucrictibant high dose	Deucrictibant softgel capsules for oral use (PHVS416)
DRUG	Placebo	Matching placebo capsules for oral use

Timeline

Start date: 2022-04-19
Primary completion: 2025-06-30
Completion: 2025-06-30
First posted: 2021-09-17
Last updated: 2025-07-30

Locations

19 sites across 9 countries: United States, Austria, Bulgaria, Canada, Germany, Ireland, Italy, Poland, United Kingdom

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT05047185. Inclusion in this directory is not an endorsement.