RecruitingPhase 3NCT07266805

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


Sponsor

Pharvaris Netherlands B.V.

Enrollment

32 participants

Start Date

Oct 16, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Deucrictibant, a drug called Deucrictibant, and others for people with acquired angioedema due to c1-inhibitor deficiency (aae-c1-inh). The study is currently recruiting participants at 17 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDeucrictibant

Part 1: Deucrictibant 40 mg extended-release tablet for once daily oral use

DRUGPlacebo

Part 1: Placebo Comparator tablet for once daily oral use

DRUGDeucrictibant

Part 2: Deucrictibant 20 mg soft capsule oral use

DRUGPlacebo

Part 2: Placebo Comparator soft capsule oral use

DRUGDeucrictibant

Part 3: Deucrictibant 20 mg soft capsule oral use


Locations(32)

Study Site

San Diego, California, United States

Study Site

Walnut Creek, California, United States

Study Site

St Louis, Missouri, United States

Study Site

Hershey, Pennsylvania, United States

Study Site

Clayton, Australia

Study Site

Vienna, Austria

Study Site

Sofia, Bulgaria

Study Site

Edmonton, Canada

Study Site

Grenoble, France

Study Site

Lille, France

Study Site

Paris, France

Study Site

Berlin, Germany

Study Site

Frankfurt am Main, Germany

Study Site

Munich, Germany

Study Site

Budapest, Hungary

Study Site 1

Milan, Italy

Study Site 2

Milan, Italy

Study Site 3

Milan, Italy

Study Site

Padova, Italy

Study Site

Roma, Italy

Study Site

Amsterdam, Netherlands

Study Site

Auckland, New Zealand

Study Site

Krakow, Poland

Study Site

Madrid, Spain

Study Site

Basel, Switzerland

Study Site

Ankara, Turkey (Türkiye)

Study Site

Bristol, United Kingdom

Study Site

Cambridge, United Kingdom

Study Site

Leicester, United Kingdom

Study Site

London, United Kingdom

Study Site

Newcastle upon Tyne, United Kingdom

Study Site

Plymouth, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07266805