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

Last updated: April 16, 2025
Sponsor: Pharvaris Netherlands B.V.
Overall Status: Active - Recruiting

Phase

3

Condition

Hives (Urticaria)

Allergy

Allergies & Asthma

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

    Sofia, 1431
    Bulgaria

    Active - Recruiting

  • Study Site

    Edmonton,
    Canada

    Active - Recruiting

  • Study Site

    Ottawa,
    Canada

    Active - Recruiting

  • Study Site

    Grenoble,
    France

    Active - Recruiting

  • Study Site

    Hongkong,
    Hong Kong

    Active - Recruiting

  • Study Site

    Dublin,
    Ireland

    Active - Recruiting

  • Study Site

    Tokyo,
    Japan

    Active - Recruiting

  • Study Site

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Study Site

    San Juan,
    Puerto Rico

    Active - Recruiting

  • Study Site

    Sangeorgiu de Mures,
    Romania

    Active - Recruiting

  • Study Site

    Singapore,
    Singapore

    Active - Recruiting

  • Study Site

    Martin,
    Slovakia

    Active - Recruiting

  • Study site

    London, England E1 1FR
    United Kingdom

    Active - Recruiting

  • Study Site

    Birmingham,
    United Kingdom

    Active - Recruiting

  • Study site

    Plymouth, PL6 5FP
    United Kingdom

    Active - Recruiting

  • Study Site

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • Study site

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Study site

    Walnut Creek, California 94598
    United States

    Active - Recruiting

  • Study Site

    Wheaton, Maryland 20902
    United States

    Active - Recruiting

  • Study Site

    Saint Louis, Missouri 63141
    United States

    Active - Recruiting

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