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

NCT04618211 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2025-12-17

Study results available
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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.

Conditions

  • Hereditary Angioedema
  • Hereditary Angioedema Type I
  • Hereditary Angioedema Type II
  • Hereditary Angioedema Types I and II
  • Hereditary Angioedema Attack
  • Hereditary Angioedema With C1 Esterase Inhibitor Deficiency
  • Hereditary Angioedema - Type 1
  • Hereditary Angioedema - Type 2
  • C1 Esterase Inhibitor Deficiency
  • C1 Inhibitor Deficiency

Interventions

DRUG

Deucrictibant

deucrictibant soft capsules for oral use

DRUG

Placebo

Matching placebo capsules for oral use

Sponsors & Collaborators

  • Pharvaris Netherlands B.V.

    lead INDUSTRY

Principal Investigators

  • Marcus Maurer, Prof MD · Charite University, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-03
Primary Completion
2022-09-23
Completion
2023-03-01
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04618211 on ClinicalTrials.gov