Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE

Last updated: August 26, 2025
Sponsor: Pharvaris Netherlands B.V.
Overall Status: Active - Recruiting

Phase

3

Condition

Allergies & Asthma

Allergy

Urticaria

Treatment

Deucrictibant

Placebo

Clinical Study ID

NCT06669754
PHA022121-C305
  • Ages > 12
  • All Genders

Study Summary

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of once-daily orally administered deucrictibant extended-release tablet compared to placebo for prophylaxis to prevent angioedema attacks in participants aged ≥ 12 years with hereditary angioedema.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Provision of written informed consent/assent.

  2. Male or female, aged ≥12 years at the time of providing written informedconsent/assent.

  3. Diagnosis of hereditary angioedema (HAE)

  4. History of at least 3 HAE attacks within the 3 consecutive months prior to ScreeningVisit

  5. Predefined number of attacks during the Screening Period

  6. Reliable access and ability to use standard of care on-demand treatments toeffectively manage acute HAE attacks.

  7. Willing and able to adhere to all protocol requirements, including eDiary and ePROdata recording.

  8. Female participants of childbearing potential must agree to the protocol specifiedpregnancy testing and contraception methods.

Exclusion

Exclusion Criteria:

  1. Any diagnosis of angioedema other than HAE

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

  3. Has received prior prophylactic treatment with deucrictibant

  4. Exposure to ACE inhibitors or any estrogen-containing medications with systemicabsorption within 4 weeks of Screening

  5. Prior gene therapy for any indication at any time

  6. Use of prophylactic treatment for HAE within 2 weeks of Screening for C1INH, oralkallikrein inhibitors, or anti-fibrinolytics; within 4 weeks of Screening forattenuated androgens; within 5 half-lives of Screening for monoclonal antibodies, orwithin 7 days of Screening for short-term prophylaxis

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

  8. Abnormal hepatic function

  9. Moderate or severe renal impairment

  10. Any clinically significant comorbidity or systemic dysfunction that would interferewith the participant's safety or ability to participate in the study.

  11. History of alcohol or drug abuse within the previous year, or current evidence ofsubstance dependence or abuse

  12. Use of medications that are moderate and strong inhibitors or strong inducers ofCYP3A4 within the last 30 days or within 5 half-lives (whichever is longer) of thetime of randomization

  13. Known hypersensitivity to deucrictibant or any of the excipients of the study drug

Study Design

Total Participants: 81
Treatment Group(s): 2
Primary Treatment: Deucrictibant
Phase: 3
Study Start date:
December 01, 2024
Estimated Completion Date:
August 31, 2026

Study Description

The study consists of a Screening Period during which eligibility is confirmed, a Treatment Period of 24 weeks, and a Follow-up Period of maximum 4 weeks or subjects may roll over into the open-label study PHA022121-C307 (CHAPTER-4). During the Treatment period participants will receive blinded study drug (deucrictibant or placebo randomized in a 2:1 ratio). Participants will undergo regular efficacy and safety assessments, complete an electronic diary daily, and also complete questionnaires at predefined timepoints during the study.

Connect with a study center

  • Study Site

    Corrientes,
    Argentina

    Site Not Available

  • Study Site

    Corrientes 3435217,
    Argentina

    Active - Recruiting

  • Study Site

    San Martín 3836992,
    Argentina

    Active - Recruiting

  • Study Site

    Santo André 3449701,
    Brazil

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    Sofia, 1680
    Bulgaria

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  • Study Site

    Sofia 727011, 1680
    Bulgaria

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    Edmonton,
    Canada

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  • Study Site

    Edmonton 5946768,
    Canada

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    Ottawa,
    Canada

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  • Study Site

    Ottawa 6094817,
    Canada

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    Grenoble,
    France

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  • Study Site

    Grenoble 3014728,
    France

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    Lille, 59037
    France

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  • Study Site

    Lille 2998324, 59037
    France

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    Berlin,
    Germany

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  • Study Site

    Berlin 2950159,
    Germany

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    Brandenburg,
    Germany

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    Frankfurt,
    Germany

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    Frankfurt 2925536,
    Germany

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    Hannover,
    Germany

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    Hanover 2910831,
    Germany

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    Hong Kong 1819729,
    Hong Kong

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    Hongkong,
    Hong Kong

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    Budapest,
    Hungary

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    Budapest 3054643,
    Hungary

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    Dublin,
    Ireland

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    Dublin 2964574,
    Ireland

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    Milan, 20062
    Italy

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    Milan 3173435, 20062
    Italy

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    Padova,
    Italy

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    Padua 3171728,
    Italy

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    Veneto,
    Italy

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    Kawasaki,
    Japan

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    Kawasaki 1859642,
    Japan

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    Tokyo, 1130033
    Japan

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  • Study Site

    Tokyo 1850147, 1130033
    Japan

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    Daegu,
    Korea, Republic of

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    Seoul, 06351
    Korea, Republic of

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    Suwon,
    Korea, Republic of

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    Auckland,
    New Zealand

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  • Study Site

    Auckland 2193733,
    New Zealand

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    Krakow 3094802,
    Poland

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    Kraków,
    Poland

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    San Juan,
    Puerto Rico

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    San Juan 4568127,
    Puerto Rico

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    Sangeorgiu de Mures,
    Romania

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    Sângeorgiu de Mureş 667034,
    Romania

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    Singapore,
    Singapore

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    Singapore 1880252,
    Singapore

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    Martin,
    Slovakia

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  • Study Site

    Martin 3058780,
    Slovakia

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    Cape Town,
    South Africa

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  • Study Site

    Cape Town 3369157,
    South Africa

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    Daegu 1835329,
    South Korea

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    Seoul 1835848, 06351
    South Korea

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  • Study Site

    Suwon 1835553,
    South Korea

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    Barcelona, 08013
    Spain

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  • Study Site

    Barcelona 3128760, 08907
    Spain

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    Seville,
    Spain

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  • Study Site

    Seville 2510911,
    Spain

    Active - Recruiting

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    Basel,
    Switzerland

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  • Study Site

    Basel 2661604,
    Switzerland

    Active - Recruiting

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    Ankara,
    Turkey

    Site Not Available

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    Istanbul,
    Turkey

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    İzmir,
    Turkey

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    Ankara 323786,
    Turkey (Türkiye)

    Active - Recruiting

  • Study Site

    Istanbul 745044,
    Turkey (Türkiye)

    Active - Recruiting

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    Izmir 311046,
    Turkey (Türkiye)

    Active - Recruiting

  • Study site

    London, England E1 1FR
    United Kingdom

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  • Study site

    London 2643743, England 6269131 E1 1FR
    United Kingdom

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    Birmingham, B9 5SS
    United Kingdom

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    Birmingham 2655603, B9 5SS
    United Kingdom

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  • Study Site

    Bristol, BS10 5NB
    United Kingdom

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  • Study Site

    Bristol 2654675, BS10 5NB
    United Kingdom

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    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • Study Site

    Cambridge 2653941, CB2 0QQ
    United Kingdom

    Active - Recruiting

  • Study Site

    Frimley, GU16 7UJ
    United Kingdom

    Site Not Available

  • Study Site

    Frimley 2649052, GU16 7UJ
    United Kingdom

    Active - Recruiting

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    Leeds, LS9 7TF
    United Kingdom

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    Leeds 2644688, LS9 7TF
    United Kingdom

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    London, NW3 2QG
    United Kingdom

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    London 2643743, NW3 2QG
    United Kingdom

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    Oxford,
    United Kingdom

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    Oxford 2640729,
    United Kingdom

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    Plymouth, PL6 5FP
    United Kingdom

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    Plymouth 2640194, PL6 5FP
    United Kingdom

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    Southampton,
    United Kingdom

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    Southampton 2637487,
    United Kingdom

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    Stoke 2636868,
    United Kingdom

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    Little Rock, Arkansas 72205
    United States

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    Little Rock 4119403, Arkansas 4099753 72205
    United States

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    Santa Monica, California 90404
    United States

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    Walnut Creek, California 94598
    United States

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    Santa Monica 5393212, California 5332921 90404
    United States

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  • Study site

    Walnut Creek 5406990, California 5332921 94598
    United States

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    Wheaton, Maryland 20902
    United States

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  • Study Site

    Wheaton 4373349, Maryland 4361885 20902
    United States

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  • Study Site

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Study Site

    St Louis 4407066, Missouri 4398678 63141
    United States

    Active - Recruiting

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