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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Oct 16, 2025

Status verified

May 2026

Primary completion

Jun 30, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

32 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1 - Arm 1 - Active
• Placebo Comparator: Part 1 - Arm 2 - Placebo
• Experimental: Part 2 - Arm 1
• Experimental: Part 2 - Arm 2
• Experimental: Part 3 - Open-label

Primary Outcome Measure

Part 1 (Prophylaxis, Double-blind Treatment Phase) [ Time Frame: 12 weeks ]

Central Contacts

• Pharvaris Clinical Team
  0031-712-036-410
  [email protected]

Locations (3)

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