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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

NCT07266805 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-05-07

No results posted yet for this study

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.

Conditions

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

Interventions

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

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
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-16
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Canada
  • France
  • Germany
  • Hungary
  • Italy
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT07266805 on ClinicalTrials.gov