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

Last updated: September 18, 2025
Sponsor: Pharvaris Netherlands B.V.
Overall Status: Active - Enrolling

Phase

2/3

Condition

Hives (Urticaria)

Allergies & Asthma

Hereditary Angioedema

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. 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. Provision of written informed consent. If the participant is a minor (i.e., <18years of age or as determined by local law), consent will be obtained from theparticipant's parent/legally designated representative/guardian and written assentwill be obtained from the participant, per country regulations.

  2. 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. Enrollment of adolescents (≥12 to <18 years or age of adulthood as defined locally)from these studies is with consideration of local age requirements.

  3. Female participants of childbearing potential (or who become of childbearingpotential during the study) must agree to the protocol-specified pregnancy testingand to be abstinent from heterosexual intercourse or to use an acceptablecontraception method as defined in the protocol and as available locally fromenrollment until 30 days after the last study drug administration.

  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. Any female who is pregnant, plans to become pregnant, or is breast-feeding.

  2. Any other systemic disease (e.g., cardiovascular, gastrointestinal, renal,respiratory, neurological) or significant disease or disorder that, in the opinionof the Investigator, would interfere with the participant's safety or ability toparticipate 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 or non-compliance including significant protocol deviation.

  8. Use of concomitant medications that are strong CYP3A4 inhibitors (e.g.,clarithromycin, erythromycin, itraconazole, ketoconazole, ritonavir) or strongCYP3A4 inducers (e.g., carbamazepine and phenytoin).

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

    Buenos Aires, B1629AHJ
    Argentina

    Site Not Available

  • Study site

    Buenos Aires 3435910, B1629AHJ
    Argentina

    Site Not Available

  • Study site

    Salta 3838233, 4400
    Argentina

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  • Study site

    Campbelltown, New South Wales 2560
    Australia

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  • Study site

    Campbelltown 2172586, New South Wales 2155400 2560
    Australia

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  • Study site

    Graz, 8036
    Austria

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  • Study site

    Graz 2778067, 8036
    Austria

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    Vienna 2761369, 1090
    Austria

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    Wien, 1090
    Austria

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  • Study site

    Salvador 3450554, Estado de Bahia 3471168 41950-640
    Brazil

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  • Study site

    Ribeirão Preto 3451328, 14048-900
    Brazil

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    Santo André 3449701, 09060-870
    Brazil

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    São Paulo 3448439, 05403-000
    Brazil

    Site Not Available

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    Sofia, 1431
    Bulgaria

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  • Study site

    Sofia 727011, 1680
    Bulgaria

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    Edmonton, Alberta T6G 1Z1
    Canada

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  • Study site

    Edmonton 5946768, Alberta 5883102 T6G 1Z1
    Canada

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    Montréal, Quebec
    Canada

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    Montreal 6077243, Quebec 6115047
    Canada

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    Brno, 602 00
    Czechia

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    Brno 3078610, 602 00
    Czechia

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    Grenoble, 38043
    France

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    Grenoble 3014728, 38043
    France

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    La Tronche, 38700
    France

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    Paris, 75571
    France

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  • Study site

    Paris 2988507, 75571
    France

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    Berlin, 12203
    Germany

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    Berlin 2950159, 12203
    Germany

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    Frankfurt am Main, 60590
    Germany

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    Frankfurt am Main 2925533, 60590
    Germany

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    Lubeck, 23538
    Germany

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  • Study site

    Lübeck 2875601, 23538
    Germany

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    Hong Kong,
    Hong Kong

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    Hong Kong 1819729,
    Hong Kong

    Site Not Available

  • Study site

    Budapest, 1088
    Hungary

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    Budapest 3054643, 1088
    Hungary

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    Ashkelon, 78278
    Israel

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    Ashkelon 295620, 78278
    Israel

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    Catania, 95124
    Italy

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  • Study site

    Catania 2525068, 95124
    Italy

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    Milan 6951411, 20138
    Italy

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    Milano, 20138
    Italy

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    Napoli, 80131
    Italy

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    Napoli 9031661, 80131
    Italy

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    Padova, 35128
    Italy

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    Padua 3171728, 35128
    Italy

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    Palermo, 90146
    Italy

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    Palermo 2523920, 90146
    Italy

    Site Not Available

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    Roma, 00133
    Italy

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    Roma 8957247, 00133
    Italy

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    Hiroshima, 730-8518
    Japan

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    Hiroshima 1862415, 730-8518
    Japan

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    Kanagawa, 216-8511
    Japan

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    Kanagawa 1860292, 216-8511
    Japan

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    Osaka, 569-8686
    Japan

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    Osaka 1853909, 569-8686
    Japan

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    Tokyo, 133-8431
    Japan

    Site Not Available

  • Study site

    Tokyo 1850147, 133-8431
    Japan

    Site Not Available

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    Daegu, 41944
    Korea, Republic of

    Site Not Available

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    Seoul, 03080
    Korea, Republic of

    Site Not Available

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    Amsterdam, 1005 AZ
    Netherlands

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  • Study site

    Amsterdam 2759794, 1005 AZ
    Netherlands

    Site Not Available

  • Study site

    Krakow 3094802, 31-503
    Poland

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    Kraków, 31-503
    Poland

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  • Study site

    San Juan, 918
    Puerto Rico

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    San Juan 4568127, 927
    Puerto Rico

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    Riyadh 108410, 11471
    Saudi Arabia

    Site Not Available

  • Study site

    Cape Town, 7700
    South Africa

    Site Not Available

  • Study site

    Cape Town 3369157, 7700
    South Africa

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  • Study site

    Daegu 1835329, 41944
    South Korea

    Site Not Available

  • Study site

    Seoul 1835848, 03080
    South Korea

    Site Not Available

  • Study site

    Barcelona, 08035
    Spain

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  • Study site

    Barcelona 3128760, 08907
    Spain

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    Madrid, 28007
    Spain

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  • Study site

    Madrid 3117735, 28007
    Spain

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  • Study site

    Lund, 22185
    Sweden

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  • Study site

    Lund 2693678, 22185
    Sweden

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  • Study site

    Ankara, 06230
    Turkey

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    Istanbul, 34093
    Turkey

    Site Not Available

  • Study site

    Ankara 323786, 06230
    Turkey (Türkiye)

    Site Not Available

  • Study site

    Istanbul 745044, 34093
    Turkey (Türkiye)

    Site Not Available

  • Study site

    London 2643743, E1 2ES
    United Kingdom

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    Birmingham, Alabama 35209
    United States

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  • Study site

    Birmingham 4049979, Alabama 4829764 35209
    United States

    Site Not Available

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    Scottsdale, Arizona 85258
    United States

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    Scottsdale 5313457, Arizona 5551752 85258
    United States

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    Little Rock, Arkansas 72205
    United States

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  • Study site

    Little Rock 4119403, Arkansas 4099753 72205
    United States

    Site Not Available

  • Study site

    Santa Monica, California 90404
    United States

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    Walnut Creek, California 94598
    United States

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    San Diego 5391811, California 5332921 92122
    United States

    Site Not Available

  • Study site

    Santa Monica 5393212, California 5332921 90404
    United States

    Site Not Available

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    Walnut Creek 5406990, California 5332921 94598
    United States

    Site Not Available

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    Colorado Springs, Colorado 80907
    United States

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  • Study site

    Colorado Springs 5417598, Colorado 5417618 80907
    United States

    Site Not Available

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    Chevy Chase, Maryland 20815
    United States

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  • Study site

    Chevy Chase 4351335, Maryland 4361885 20815
    United States

    Site Not Available

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    Boston 4930956, Massachusetts 6254926 02115
    United States

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    Detroit, Michigan 48202
    United States

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  • Study site

    Detroit 4990729, Michigan 5001836 48202
    United States

    Site Not Available

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    St. Louis, Missouri 63141
    United States

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  • Study site

    St Louis 4407066, Missouri 4398678 63141
    United States

    Site Not Available

  • Study site

    Hershey, Pennsylvania 17033
    United States

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  • Study site

    Hershey 5193342, Pennsylvania 6254927 17033
    United States

    Site Not Available

  • Study site

    Dallas, Texas 75231
    United States

    Site Not Available

  • Study site

    Dallas 4684888, Texas 4736286 75231
    United States

    Site Not Available

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