Dose-ranging Study of Oral PHA-022121 for Prophylaxis Against Angioedema Attacks in Patients With Hereditary Angioedema Type I or Type II
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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 Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Hereditary Angioedema,Hereditary Angioedema Type I,Hereditary Angioedema Type II,Hereditary Angioedema Types I and II,Hereditary Angioedema Attack,Hereditary Angioedema With C1 Esterase Inhibitor Deficiency,Hereditary Angioedema - Type 1,Hereditary Angioedema - Type 2,C1 Esterase Inhibitor Deficiency,C1 Inhibitor Deficiency
Age (in years)
18 - 75
Phase
Phase 2
Participants needed
34
Est. Completion Date
Dec 31, 2026
Treatment type
Interventional
Sponsor
Pharvaris Netherlands B.V.
ClinicalTrials.gov identifier
NCT05047185
Study number
PHA022121-C301
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