NCT07266805

Study of Oral Deucrictibant XR Tablet for Prophylaxis and Deucrictibant IR Capsule for On-Demand Treatment of Angioedema Attacks in Adults With Acquired Angioedema Due to C1 Inhibitor Deficiency

A Phase 3, Randomized, Double-blind, Placebo-controlled, 3-Part Study to Evaluate the Efficacy and Safety of Orally Administered Deucrictibant Extended-release (XR) Tablet for Prophylaxis and Deucrictibant Immediate-release (IR) Capsule for On-demand Treatment of Angioedema Attacks in Adults With Acquired Angioedema Due to C1 Inhibitor Deficiency

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Pharvaris Netherlands B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3, multicenter, 3-part study, with 2 randomized, double-blind, placebo-controlled parts and an open-label extension part, to evaluate the efficacy and safety of orally administered deucrictibant XR tablet for prophylaxis, and deucrictibant IR capsule for on-demand treatment of angioedema attacks in adult participants aged ≥ 18 years with AAE-C1INH.

Detailed description

The study consists of a Screening Period, during which eligibility is confirmed, a Part 1 Prophylaxis Double-blind Treatment Phase, a Part 2 On-demand, Double-blind Treatment Phase, and a Part 3 On-demand Open-label Extension Phase. Approximately 24 participants will be randomized in Part 1 into 2 parallel arms for a treatment period of 12 weeks. During the prophylaxis treatment period participants will receive blinded study drug (deucrictibant 40 mg XR or placebo randomized in a 1:1 ratio). Upon completion of Part 1, participants will roll-over into Part 2. In addition to rollover participants completing Part 1, new deucrictibant treatment-naïve participants will be enrolled directly into Part 2 and this may occur while Part 1 is ongoing. During the on-demand period participants will receive blinded study drug (deucrictibant 20 mg IR capsule or matching placebo randomized in a 1:1 ratio, 2-period, 2-treatment crossover design) for 2 qualifying AAE-C1INH attacks. Participants completing Part 2 may roll over into Part 3 where all AAE-C1INH attacks will be treated with open-label deucrictibant 20 mg soft capsule.

Conditions

• Acquired Angioedema Due to C1-Inhibitor Deficiency (AAE-C1-INH)

Interventions

Type	Name	Description
DRUG	Deucrictibant	Part 1: Deucrictibant 40 mg extended-release tablet for once daily oral use
DRUG	Placebo	Part 1: Placebo Comparator tablet for once daily oral use
DRUG	Deucrictibant	Part 2: Deucrictibant 20 mg soft capsule oral use
DRUG	Placebo	Part 2: Placebo Comparator soft capsule oral use
DRUG	Deucrictibant	Part 3: Deucrictibant 20 mg soft capsule oral use

Timeline

• Start date: 2025-10-16
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2025-12-05
• Last updated: 2026-02-25

Locations

7 sites across 3 countries: United States, Canada, United Kingdom

Regulatory

• FDA-regulated drug study