Actively Recruiting

Phase 3
Age: 18Years +
All Genders
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

Led by Pharvaris Netherlands B.V. · Updated on 2026-05-07

32

Participants Needed

17

Research Sites

84 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provision of written informed consent

  • Male or female (sex at birth) aged ≥18 years

  • Diagnosis of AAE-C1INH

  • History of AAE-C1INH attacks prior to the Screening Visit:

  • Participants enrolling in Part 1 must have stable underlying disease of AAE-C1INH

    • The underlying condition can reasonably be expected to remain stable for the duration
  • Reliable access and ability to use available therapy to effectively manage AAE- C1INH attacks.

  • Female participants of childbearing potential must agree to the protocol-specified pregnancy testing and to be abstinent from heterosexual intercourse or to use an acceptable contraception method.

Females of non-childbearing potential (prepubertal, surgically sterile, or postmenopausal with ≥ 12 months amenorrhea and postmenopausal FSH confirmation) are not required to use contraception during the study.

• Capable of recording, without assistance, eDiary and ePRO data using an electronic device, as evidenced by the eDiary and ePRO training.

Not Eligible

You will not qualify if you...

  • Participation in a clinical study with any other investigational drug within the last 30 days or within 5 half-lives of the investigational drug at the Screening Visit (whichever is longer).
  • Participants who have previously received prophylactic therapy but have stopped can participate in this study provided the last dose of the treatment was received prior to the timepoint before the Screening Visit
  • Any females who are pregnant, plan to become pregnant, or are currently breast-feeding
  • Abnormal hepatic function
  • Moderate or severe renal impairment
  • Any clinically significant comorbidity or systemic dysfunction that would interfere with the participant's safety or ability to participate in the study.
  • History of epilepsy and/or other significant neurological diseases
  • Any clinically significant and uncontrolled gastrointestinal dysfunction that may impact study drug absorption
  • Evidence of current alcohol or drug abuse
  • Use of medications that are moderate and strong inhibitors of cytochrome P450 (CYP) 3A4, or strong inducers of CYP3A4 within the last 30 days or within 5 half-lives (whichever is longer) at the time of the Screening Visit
  • Known hypersensitivity to deucrictibant or any of the excipients of the study drug
  • Use of angiotensin-converting enzyme inhibitors or any estrogen-containing medications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 17 locations

1

Study Site

Walnut Creek, California, United States, 94598,

Actively Recruiting

2

Study Site

Walnut Creek, California, United States, 94598

Actively Recruiting

3

Study Site

St Louis, Missouri, United States, 63130

Actively Recruiting

4

Study Site

Sofia, Bulgaria

Actively Recruiting

5

Study Site

Edmonton, Canada

Actively Recruiting

6

Study Site

Paris, France

Actively Recruiting

7

Study Site

Berlin, Germany

Actively Recruiting

8

Study Site

Frankfurt am Main, Germany

Actively Recruiting

9

Study Site

Munich, Germany

Actively Recruiting

10

Study Site

Budapest, Hungary

Actively Recruiting

11

Study List

Milan, Italy

Actively Recruiting

12

Study Site

Basel, Switzerland

Actively Recruiting

13

Study Site

Cambridge, United Kingdom

Actively Recruiting

14

Study Site

Leicester, United Kingdom

Actively Recruiting

15

Study Site

London, United Kingdom

Actively Recruiting

16

Study Site

Newcastle upon Tyne, United Kingdom

Actively Recruiting

17

Study Site

Plymouth, United Kingdom

Actively Recruiting

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Research Team

P

Pharvaris Clinical Team

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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