Extension Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients with Hereditary Angioedema

Last updated: September 30, 2024
Sponsor: Pharvaris Netherlands B.V.
Overall Status: Active - Enrolling

Phase

2/3

Condition

Allergy

Hives (Urticaria)

Urticaria

Treatment

deucrictibant selected dose

deucrictibant low dose

deucrictibant medium dose

Clinical Study ID

NCT05396105
PHA022121-C303
2023-505766-28-00
  • Ages > 12
  • All Genders

Study Summary

This study evaluates the safety and efficacy of long-term on-demand treatment with orally administered deucrictibant for acute hereditary angioedema (HAE) attacks, including laryngeal attacks, in participants with HAE type 1 or type 2 (HAE-1/2). The study will enroll patients from Study PHA022121-C201 (NCT04618211) and Study PHA022121-C306 (NCT06343779) who elect to participate in this extension study and meet the eligibility requirements.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Signed and dated informed consent form

  2. Diagnosis of HAE type I or II

  3. For participants from Study C201, received at least one dose of study drug (including the non-attack visit) in Study C201. For participants from Study C306,participant was randomized (and for adolescent participants 12 to <18 years receiveda dose of study drug in a non-attack state at Visit 1) and completed Study C306,with 2 attacks treated, or after closure of that study by the Sponsor.

  4. In the opinion of the Investigator, the participant (and parent/caregiver foradolescent participants) is willing and able to comply with the protocol.

Exclusion

Key Exclusion Criteria:

  1. Pregnancy or breast-feeding

  2. Any other systemic disease or significant disease or disorder that would interferewith the patient's safety or ability to participate in the study

  3. Use of lanadelumab for long-term HAE prophylactic therapy within 12 weeks prior toenrollment in Part A.

  4. For Part A: Use of C1-esterase inhibitor, oral kallikrein inhibitors, attenuatedandrogens, anti-fibrinolytics, or monoclonal HAE therapy within a defined periodprior to enrolment. For Part B: If a participant is receiving long-term prophylactic therapy with one ofthe following medications indicated for HAE: plasma-derived C1-INH, danazol at lessthan or equal to 200 mg/day, anti-fibrinolytics, berotralstat, or lanadelumab, theymust be on a stable dose and regimen for at least 3 months before screening andintends to remain on the same dose for the duration of the study.

  5. History of alcohol or drug abuse within defined period, or current evidence ofsubstance dependence or abuse

  6. Participation in any other investigational drug study within defined period

  7. Discontinued from parent study after enrollment for any study drug-related safetyreason.

  8. Use of concomitant medications that are potent CYP3A4 inhibitors (e.g.,clarithromycin, erythromycin, itraconazole, ketoconazole, ritonavir, grapefruit) orpotent CYP3A4 inducers (e.g., phenytoin, rifampicin, St. John's Wort).

Study Design

Total Participants: 140
Treatment Group(s): 4
Primary Treatment: deucrictibant selected dose
Phase: 2/3
Study Start date:
December 28, 2022
Estimated Completion Date:
June 30, 2027

Study Description

Part A of the study will enroll adult participants from Study PHA022121-C201. The double-blind treatment assignment from Study PHA022121-C201 will be maintained.

Part B will include participants rolling over from Part A and additionally enroll participants from Study PHA022121-C201 who did not participate in Part A, and participants from Study PHA022121-C306 who elect to participate in this extension study and meet the eligibility requirements.

Connect with a study center

  • Study site

    Sofia, 1680
    Bulgaria

    Site Not Available

  • Study site

    Montréal, Quebec
    Canada

    Site Not Available

  • Study site

    Brno, 65691
    Czechia

    Site Not Available

  • Study site

    Grenoble, 38043
    France

    Site Not Available

  • Study site

    La Tronche, 38700
    France

    Site Not Available

  • Study site

    Paris, 75010
    France

    Site Not Available

  • Study site

    Berlin, 10114
    Germany

    Site Not Available

  • Study site

    Frankfurt am Main, 60596
    Germany

    Site Not Available

  • Study site

    Budapest, 1088
    Hungary

    Site Not Available

  • Study site

    Ashkelon, 78278
    Israel

    Site Not Available

  • Study site

    Napoli, 80131
    Italy

    Site Not Available

  • Study site

    Kraków, 31-503
    Poland

    Site Not Available

  • Study site

    Barcelona, 08035
    Spain

    Site Not Available

  • Study site

    Madrid, 28007
    Spain

    Site Not Available

  • Study site

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Study site

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • Study site

    Santa Monica, California 90404
    United States

    Site Not Available

  • Study site

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Study site

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Study site

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

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