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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05047185
Other study ID # PHA022121-C301
Secondary ID 2021-000227-13
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date April 19, 2022
Est. completion date December 2026

Study information

Verified date February 2024
Source Pharvaris Netherlands B.V.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the safety and efficacy of PHA-022121 administered orally for prophylaxis against angioedema attacks in patients with hereditary angioedema (HAE). The study consists of 2 parts, with patients completing participation in Part 1 prior to initiation of treatment in Part 2. Part 1 of the study has 3 parallel arms and approximately 30 patients will be equally randomized to one of two dose regimens of PHA-022121 or matching placebo. Patients will continue to the single open-label arm in Part 2 of the study after completion of Part 1. The screening period is up to 8 weeks and the treatment periods are 12 weeks (Part 1) and 30 months (Part 2) in duration.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 34
Est. completion date December 2026
Est. primary completion date October 2, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Signed and dated informed consent form - Diagnosis of HAE type I or II - Documented history of at least 3 HAE attacks within the last 3 consecutive months prior to screening, or a minimum of 2 HAE attacks during the screening period - Reliable access and experience to use standard of care acute attack medications Exclusion Criteria: - Pregnancy or breast-feeding - Clinically significant abnormal electrocardiogram - Any other systemic disease or significant disease or disorder that would interfere with the patient's safety or ability to participate in the study - Use of C1-esterase inhibitor, oral kallikrein inhibitors, attenuated androgens, anti-fibrinolytics, or monoclonal HAE therapy within a defined period prior to enrolment - Abnormal hepatic function - Abnormal renal function - History of alcohol or drug abuse within defined period, or current evidence of substance dependence or abuse - Participation in any other investigational drug study within defined period

Study Design


Intervention

Drug:
Deucrictibant low dose
Deucrictibant softgel capsules for oral use (PHVS416)
Deucrictibant high dose
Deucrictibant softgel capsules for oral use (PHVS416)
Placebo
Matching placebo capsules for oral use

Locations

Country Name City State
Austria Study Site Wien
Bulgaria Study site Sofia
Canada Study site Montréal Quebec
Canada Study site Ottawa Ontario
Germany Study site Berlin
Germany Study site Frankfurt
Ireland Study site Dublin
Italy Study site Milan
Italy Study site Padua PD
Italy Study site Palermo
Poland Study site Kraków
United Kingdom Study site Brighton England
United Kingdom Study site Bristol England
United Kingdom Study site Cambridge England
United Kingdom Study site London England
United Kingdom Study site Southampton England
United States Study site Birmingham Alabama
United States Study site Paradise Valley Arizona
United States Study site Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Pharvaris Netherlands B.V.

Countries where clinical trial is conducted

United States,  Austria,  Bulgaria,  Canada,  Germany,  Ireland,  Italy,  Poland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of investigator-confirmed HAE attacks Day 0 to Day 84
Secondary Number of investigator-confirmed moderate or severe HAE attacks during the treatment period Day 0 to Day 84
Secondary Number of investigator-confirmed HAE attacks requiring acute treatment during the treatment period Day 0 to Day 84
Secondary Number of patients achieving reduction in attack rate during the treatment period relative to baseline Day 0 to Day 84
Secondary Number of patients that are attack-free during the treatment period Day 0 to Day 84
Secondary Number and proportion of days with angioedema symptoms during the treatment period Day 0 to Day 84
Secondary Time to first investigator-confirmed HAE attack in the treatment period Day 0 to Day 84
Secondary Number of investigator-confirmed HAE attacks resulting in a visit to the emergency department or an admission to hospital Day 0 to Day 84
Secondary Number of investigator-confirmed angioedema attacks during the treatment period in Part 2. Day 84 to Day 938
Secondary Number of investigator-confirmed moderate or severe angioedema attacks during the treatment period in Part 2. Day 84 to Day 938
Secondary Number of investigator-confirmed angioedema attacks requiring acute treatment during the treatment period in Part 2. Day 84 to Day 938
Secondary Incidence of HAE attacks during the treatment period in Part 2 (attack rate trend over time). Day 84 to Day 938
Secondary Number and proportion of days with angioedema symptoms during the treatment period in Part 2. Day 84 to Day 938
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Active, not recruiting NCT04739059 - Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks Phase 3
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