NCT06343779

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

A Phase 3, Randomized, Double-blind, Placebo-controlled, Cross-over Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Attacks in Adolescents and Adults With Hereditary Angioedema

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Pharvaris Netherlands B.V. · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study consists of a Screening Phase during which eligibility is confirmed, a Treatment Phase in which participants will be randomized and receive double blinded study drug to treat 2 qualifying HAE attacks (i.e., 2 Treatment Periods within the Treatment Phase), and an End-of-Study Follow-up Phase after the second attack treated with study drug. In addition, for adolescent participants (age ≥12 to \<18 years), PK samples are collected after administration of deucrictibant at Day 1 in a non-attack state.

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

Type	Name	Description
DRUG	Deucrictibant, Placebo	Deucrictibant Soft Capsules for Oral Use

Timeline

• Start date: 2024-02-26
• Primary completion: 2025-10-17
• Completion: 2025-10-17
• First posted: 2024-04-03
• Last updated: 2025-11-21

Locations

76 sites across 29 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

Regulatory

• FDA-regulated drug study