What this study is
This is a Phase 3, multicenter, long-term, open-label study to evaluate the safety and efficacy of once-daily orally administered deucrictibant extended-release tablet for prophylaxis to prevent angioedema attacks in participants aged ≥12 years with Hereditary Angioedema
What's being tested
- Deucrictibant
Intervention · DRUG
Deucrictibant extended-release tablet for once daily oral use
Study details
- Official title
- A Long-term, Open-label Study to Evaluate the Safety and Efficacy of Orally Administered Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema
- Sponsor
- Pharvaris Netherlands B.V.
- Conditions
- Hereditary Angioedema (HAE)
- Enrolling
- 170 people
- Starts
- 2025-02-01
- Est. completion
- 2028-12
- Design
- Open-label, single group, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 12 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Provision of the signed ICF by the participant and/or legally designated representative.
- Male or female, aged ≥12 years at the time of providing written informed consent/assent.
- Diagnosis of hereditary angioedema (HAE)
- 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
- Reliable access and ability to use standard of care on-demand treatments to effectively manage acute HAE attacks.
- Willing and able to adhere to all protocol requirements, including the participant being capable of and compliant with data recording into an eDiary.
- Female participants of childbearing age must agree to the protocol specified pregnancy testing and contraception methods.
You can't join if
- Any diagnosis of angioedema other than HAE
- 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)
- Prior gene therapy for any indication at any time
- 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
- Exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption (such as oral contraceptives or hormonal replacement therapy) within 4 weeks of Screening
- 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
- Any females who are pregnant, plan to become pregnant, or are currently breast-feeding
- Abnormal hepatic function
- Moderate or severe renal impairment
- Any clinically significant comorbidity or systemic dysfunction that would interfere with the participant's safety or ability to participate in the study.
- History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse
- 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 enrollment.
- Known hypersensitivity to deucrictibant or any of the excipients of the study drug
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (67)
67 openStudy Site
Birmingham, Alabama, United States
Study Site
Scottsdale, Arizona, United States
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Little Rock, Arkansas, United States
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San Diego, California, United States
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Santa Monica, California, United States
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Walnut Creek, California, United States
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Colorado Springs, Colorado, United States
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Wheaton, Illinois, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Hershey, Pennsylvania, United States
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Dallas, Texas, United States
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Milwaukee, Wisconsin, United States
54 sites outside the US
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Corrientes, Argentina
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Pilar, Argentina
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Salta, Argentina
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Box Hill, Australia
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Parkville, Australia
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Perth, Australia
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Sydney, Australia
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Vienna, Austria
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Ribeirão Preto, Brazil
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Salvador, Brazil
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Santo André, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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Sofia, Bulgaria
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Edmonton, Canada
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Montreal, Canada
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Beijing, China
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Grenoble, France
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Berlin, Germany
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Frankfurt, Germany
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Munich, Germany
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Hong Kong, Hong Kong
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Budapest, Hungary
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Dublin, Ireland
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Milan, Italy
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Padova, Italy
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Palermo, Italy
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Roma, Italy
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Fukuoka, Japan
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Hiroshima, Japan
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Kanagawa, Japan
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Osaka, Japan
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Tokyo, Japan
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Auckland, New Zealand
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Krakow, Poland
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Martin, Slovakia
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Cape Town, South Africa
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Daegu, South Korea
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Seoul, South Korea
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Barcelona, Spain
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Ankara, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Birmingham, United Kingdom
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Birmingham, United Kingdom
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Brighton, United Kingdom
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Bristol, United Kingdom
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Cambridge, United Kingdom
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Frimley, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Oxford, United Kingdom
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Plymouth, United Kingdom
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Southampton, United Kingdom
Study team
Sponsor
Pharvaris Netherlands B.V.
Study ID PHA022121-C307
Study director
Study Director, Pharvaris
Pharvaris Netherlands B.V.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.