Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE
NCT ID: NCT06679881
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
130 participants
INTERVENTIONAL
2025-02-01
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Deucrictibant
Deucrictibant
Deucrictibant
Deucrictibant extended-release tablet for once daily oral use
Interventions
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Deucrictibant
Deucrictibant extended-release tablet for once daily oral use
Eligibility Criteria
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Inclusion Criteria
2. Male or female, aged ≥12 years at the time of providing written informed consent/assent.
3. Diagnosis of hereditary angioedema (HAE)
4. For participants that did not participate in a previous deucrictibant prophylactic study: history of at least 1 attack in the last 3 consecutive months prior to Screening
5. Reliable access and ability to use standard of care on-demand treatments to effectively manage acute HAE attacks.
6. Willing and able to adhere to all protocol requirements, including eDiary and ePRO data recording.
7. Female participants of childbearing must agree to the protocol specified pregnancy testing and contraception methods.
Exclusion Criteria
2. Participation in a clinical study with any other investigational drug within the last 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 prophylactic and/or on-demand treatment due to safety reasons or compliance issues that, in the opinion of the Investigator, would interfere with the participant's safety or compliance to participate in the study
5. Exposure to ACE inhibitors or any estrogen-containing medications with systemic absorption within 4 weeks of Screening
6. Use of prophylactic treatment for HAE within 2 weeks of Screening for C1INH, oral kallikrein inhibitors, or anti-fibrinolytics; within 4 weeks of Screening for attenuated androgens; within 5 half-lives of Screening for monoclonal antibodies, or within 7 days of Screening for short-term prophylaxis
7. Any females who are pregnant, plan to become pregnant, or are currently breast-feeding
8. Abnormal hepatic function
9. Moderate or severe renal impairment
10. Any clinically significant comorbidity or systemic dysfunction that would interfere with 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 of substance dependence or abuse
12. Use of medications that are moderate and strong inhibitors or strong inducers of CYP3A4 within the last 30 days or within 5 half-lives (whichever is longer) of the time of randomization
13. Known hypersensitivity to deucrictibant or any of the excipients of the study drug
12 Years
ALL
No
Sponsors
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Pharvaris Netherlands B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director, Pharvaris
Role: STUDY_DIRECTOR
Pharvaris Netherlands B.V.
Locations
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Study Site
Santa Monica, California, United States
Study Site
Walnut Creek, California, United States
Study Site
St Louis, Missouri, United States
Study Site
Melbourne, , Australia
Study Site
Melbourne, , Australia
Study Site
Perth, , Australia
Study Site
Vienna, , Austria
Study Site
Sofia, , Bulgaria
Study Site
Montreal, , Canada
Study Site
Berlin, , Germany
Study Site
Frankfurt, , Germany
Study Site
Hong Kong, , Hong Kong
Study Site
Dublin, , Ireland
Study Site
Padua, , Italy
Study Site
Krakow, , Poland
Study Site
Cape Town, , South Africa
Study Site
Daegu, , South Korea
Study Site
Seoul, , South Korea
Study Site
Barcelona, , Spain
Study Site
Brighton, , United Kingdom
Study Site
Bristol, , United Kingdom
Study Site
Cambridge, , United Kingdom
Study Site
London, , United Kingdom
Study Site
Plymouth, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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PHA022121-C307
Identifier Type: -
Identifier Source: org_study_id
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