MedTrace Logo

Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema

NCT06343779 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2025-11-21

No results posted yet for this study

Summary

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, 2-period, 2-treatment cross-over study to evaluate the efficacy and safety of orally administered deucrictibant compared to placebo for the on-demand treatment of HAE attacks, including non-severe laryngeal attacks, in participants ≥12 to ≤75 years of age with HAE type 1, type 2, or type 3, a proportion of whom are using long-term prophylactic medication for HAE.

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 [C1-INH] Deficiency
  • C1 Esterase Inhibitor Deficiency
  • C1 Esterase Inhibitor, Deficiency of
  • C1 Inhibitor Deficiency
  • Hereditary Angioedema - Type 3
  • Hereditary Angioedema Type III

Interventions

DRUG

Deucrictibant, Placebo

Deucrictibant Soft Capsules for Oral Use

Sponsors & Collaborators

  • Pharvaris Netherlands B.V.

    lead INDUSTRY

Principal Investigators

  • Study Director, Pharvaris · Pharvaris Netherlands B.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-02-26
Primary Completion
2025-10-17
Completion
2025-10-17
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Brazil
  • Bulgaria
  • Canada
  • Colombia
  • Czechia
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Ireland
  • Italy
  • Japan
  • Netherlands
  • North Macedonia
  • Poland
  • Puerto Rico
  • Romania
  • Saudi Arabia
  • Singapore
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT06343779 on ClinicalTrials.gov