Clinical Trials Directory

Trials / Completed

CompletedNCT04618211

Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema

A Phase II, Double-blind, Placebo-controlled, Randomized, Cross-over, Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema Due to C1-inhibitor Deficiency Type I and II

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
74 (actual)
Sponsor
Pharvaris Netherlands B.V. · Industry
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

This study evaluates the efficacy of orally administered deucrictibant for the acute treatment of attacks in patients with hereditary angioedema (HAE). Eligible subjects are randomized to one of three single doses of deucrictibant and placebo. The study will compare symptom relief (skin pain, skin swelling, abdominal pain) during HAE attacks and safety of each dose of deucrictibant with placebo.

Detailed description

In Part I of the study, patients in non-attack state receive the assigned active single dose of deucrictibant at the study center to assess pharmacokinetics (the way the body absorbs, distributes, and gets rid of the drug) and safety. In Part II of the study, patients self-administer blinded study drug at home to treat three HAE attacks with deucrictibant or placebo (cross-over).

Conditions

Interventions

TypeNameDescription
DRUGDeucrictibantdeucrictibant soft capsules for oral use
DRUGPlaceboMatching placebo capsules for oral use

Timeline

Start date
2021-02-03
Primary completion
2022-09-23
Completion
2023-03-01
First posted
2020-11-05
Last updated
2025-12-17
Results posted
2025-12-17

Locations

36 sites across 13 countries: United States, Bulgaria, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Spain, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT04618211. Inclusion in this directory is not an endorsement.