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

NCT05047185 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-07-30

No results posted yet for this study

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

  • 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 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

Sponsors & Collaborators

  • Pharvaris Netherlands B.V.

    lead INDUSTRY

Principal Investigators

  • Marc Riedl, MD · UC San Diego, La Jolla, California, United States

  • Emel Aygören-Pürsün, MD · University Hospital Frankfurt - Goethe University, Frankfurt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-04-19
Primary Completion
2025-06-30
Completion
2025-06-30
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Bulgaria
  • Canada
  • Germany
  • Ireland
  • Italy
  • Poland
  • 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 NCT05047185 on ClinicalTrials.gov