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

Last updated: May 6, 2026
Sponsor: Pharvaris Netherlands B.V.
Overall Status: Active - Recruiting

Phase

3

Condition

Allergies & Asthma

Urticaria

Hives (Urticaria)

Treatment

Placebo

Deucrictibant

Clinical Study ID

NCT07266805
PHA022121-C308
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 theduration

  • Reliable access and ability to use available therapy to effectively manage AAE-C1INH attacks.

  • Female participants of childbearing potential must agree to the protocol-specifiedpregnancy testing and to be abstinent from heterosexual intercourse or to use anacceptable 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.

Exclusion

Exclusion Criteria:

  • Participation in a clinical study with any other investigational drug within thelast 30 days or within 5 half-lives of the investigational drug at the ScreeningVisit (whichever is longer).

  • Participants who have previously received prophylactic therapy but have stopped canparticipate in this study provided the last dose of the treatment was received priorto the timepoint before the Screening Visit

  • Any females who are pregnant, plan to become pregnant, or are currentlybreast-feeding

  • Abnormal hepatic function

  • Moderate or severe renal impairment

  • Any clinically significant comorbidity or systemic dysfunction that would interferewith 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 mayimpact 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-containingmedications

Study Design

Total Participants: 32
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
October 16, 2025
Estimated Completion Date:
June 30, 2027

Study 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.

Connect with a study center

  • Study Site

    Sofia,
    Bulgaria

    Active - Recruiting

  • Study Site

    Edmonton,
    Canada

    Active - Recruiting

  • Study Site

    Edmonton 5946768,
    Canada

    Site Not Available

  • Study Site

    Paris,
    France

    Active - Recruiting

  • Study Site

    Berlin,
    Germany

    Active - Recruiting

  • Study Site

    Frankfurt am Main,
    Germany

    Active - Recruiting

  • Study Site

    Munich,
    Germany

    Active - Recruiting

  • Study Site

    Budapest,
    Hungary

    Active - Recruiting

  • Study List

    Milan,
    Italy

    Active - Recruiting

  • Study Site

    Basel,
    Switzerland

    Active - Recruiting

  • Study Site

    Cambridge,
    United Kingdom

    Active - Recruiting

  • Study Site

    Cambridge 2653941,
    United Kingdom

    Site Not Available

  • Study Site

    Leicester,
    United Kingdom

    Active - Recruiting

  • Study Site

    Leicester 2644668,
    United Kingdom

    Site Not Available

  • Study Site

    London,
    United Kingdom

    Active - Recruiting

  • Study Site

    London 2643743,
    United Kingdom

    Site Not Available

  • Study Site

    Newcastle upon Tyne,
    United Kingdom

    Active - Recruiting

  • Study Site

    Plymouth,
    United Kingdom

    Active - Recruiting

  • Study Site

    Plymouth 2640194,
    United Kingdom

    Site Not Available

  • Study Site

    Walnut Creek, California 94598
    United States

    Active - Recruiting

  • Study Site

    Walnut Creek 5406990, California 5332921 94598,
    United States

    Site Not Available

  • Study Site

    St Louis, Missouri 63130
    United States

    Active - Recruiting

  • Study Site

    St Louis 4407066, Missouri 4398678 63130
    United States

    Site Not Available

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