NCT06679881

Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE

A Long-term, Open-label Study to Evaluate the Safety and Efficacy of Orally Administered Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Pharvaris Netherlands B.V. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3, multicenter, long-term, open-label study to evaluate the safety and efficacy of once-daily orally administered deucrictibant extended-release tablet for prophylaxis to prevent angioedema attacks in participants aged ≥12 years with Hereditary Angioedema

Detailed description

The study consists of a Screening Period during which eligibility is confirmed (only for participants not rolling over within 28 days from a previous deucrictibant prophylactic study), a Treatment Period in which participants will receive open-label deucrictibant extended-release tablet once daily for approximately 130 weeks, followed by an End of Study visit after maximum 4 weeks. Participants will undergo regular safety (e.g. lab draws) and efficacy assessments, will complete an electronic diary daily, and also complete questionnaires at predefined timepoints during the study.

Conditions

• Hereditary Angioedema (HAE)

Interventions

Type	Name	Description
DRUG	Deucrictibant	Deucrictibant extended-release tablet for once daily oral use

Timeline

• Start date: 2025-02-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2024-11-08
• Last updated: 2026-03-16

Locations

24 sites across 14 countries: United States, Australia, Austria, Bulgaria, Canada, Germany, Hong Kong, Ireland, Italy, Poland, South Africa, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study