Long-Term, Open-label 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

Allergies & Asthma

Allergy

Urticaria

Treatment

Deucrictibant

Clinical Study ID

NCT06679881
PHA022121-C307
  • Ages > 12
  • All Genders

Study Summary

This is a Phase 3, multicenter, long-term, open-label study to evaluate the safety and efficacy of once-daily orally administered deucrictibant extended-release tablet 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. For participants that did not participate in a previous deucrictibant prophylacticstudy: history of at least 1 attack in the last 3 consecutive months prior toScreening

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

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

  7. Female participants of childbearing must agree to the protocol specified pregnancytesting 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 ICF signature (whichever is longer)

  3. Prior gene therapy for any indication at any time

  4. Participants who discontinued from previous studies with deucrictibant prophylacticand/or on-demand treatment due to safety reasons or compliance issues that, in theopinion of the Investigator, would interfere with the participant's safety orcompliance to participate in the study

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

  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: 130
Treatment Group(s): 1
Primary Treatment: Deucrictibant
Phase: 3
Study Start date:
February 01, 2025
Estimated Completion Date:
December 31, 2028

Study Description

The study consists of a Screening Period during which eligibility is confirmed (only for participants not rolling over within 28 days from a previous deucrictibant prophylactic study), a Treatment Period in which participants will receive open-label deucrictibant extended-release tablet once daily for approximately 130 weeks, followed by an End of Study visit after maximum 4 weeks. Participants will undergo regular safety (e.g. lab draws) and efficacy assessments, will complete an electronic diary daily, and also complete questionnaires at predefined timepoints during the study.

Connect with a study center

  • Study Site

    Sofia,
    Bulgaria

    Active - Recruiting

  • Study Site

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Study Site

    Dublin,
    Ireland

    Active - Recruiting

  • Study Site

    Kraków,
    Poland

    Active - Recruiting

  • Study Site

    Brighton,
    United Kingdom

    Active - Recruiting

  • Study Site

    Bristol,
    United Kingdom

    Active - Recruiting

  • Study Site

    Cambridge,
    United Kingdom

    Active - Recruiting

  • Study Site

    London,
    United Kingdom

    Active - Recruiting

  • Study Site

    Saint Louis, Missouri 63141
    United States

    Active - Recruiting

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