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

Status: Recruiting
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• Provision of written informed consent/assent.

• 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 eDiary and ePRO data recording.

• Female participants of childbearing must agree to the protocol specified pregnancy testing and contraception methods.

Locations
United States
California
Study Site
RECRUITING
Santa Monica
Study Site
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Walnut Creek
Missouri
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St Louis
Other Locations
Australia
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Melbourne
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Melbourne
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Perth
Austria
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Vienna
Bulgaria
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Sofia
Canada
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Montreal
Germany
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Berlin
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Frankfurt
Hong Kong Special Administrative Region
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Hong Kong
Ireland
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Dublin
Italy
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Padua
Poland
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Krakow
Republic of Korea
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Daegu
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Seoul
South Africa
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Cape Town
Spain
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Barcelona
United Kingdom
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Brighton
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Bristol
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Cambridge
Study Site
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London
Study Site
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Plymouth
Contact Information
Primary
Pharvaris Clinical Team
clinicaltrials@pharvaris.com
0031 712-036-410
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2028-12
Participants
Target number of participants: 130
Treatments
Experimental: Deucrictibant
Deucrictibant
Related Therapeutic Areas
Sponsors
Leads: Pharvaris Netherlands B.V.

This content was sourced from clinicaltrials.gov