A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Orally Administered Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema

Status: Recruiting
Location: See all (55) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of once-daily orally administered deucrictibant extended-release tablet compared to placebo 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)

• History of at least 3 HAE attacks within the 3 consecutive months prior to Screening Visit

• Predefined number of attacks during the Screening Period

• 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 potential must agree to the protocol specified pregnancy testing and contraception methods.

Locations
United States
Arkansas
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Little Rock
California
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San Diego
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Santa Monica
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Walnut Creek
Maryland
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Chevy Chase
Missouri
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St Louis
Other Locations
Argentina
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Corrientes
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San Martín
Brazil
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Santo André
Bulgaria
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Sofia
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Sofia
Canada
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Edmonton
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Ottawa
France
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Grenoble
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Lille
Germany
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Berlin
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Frankfurt
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Hanover
Hong Kong Special Administrative Region
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Hong Kong
Hungary
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Budapest
Ireland
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Dublin
Italy
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Milan
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Padua
Japan
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Kawasaki
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Tokyo
New Zealand
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Auckland
Poland
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Krakow
Puerto Rico
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San Juan
Republic of Korea
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Daegu
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Seoul
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Seoul
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Suwon
Romania
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Sângeorgiu De Mureş
Singapore
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Singapore
Slovakia
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Martin
South Africa
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Cape Town
Spain
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Barcelona
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Barcelona
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Seville
Switzerland
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Basel
Turkey
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Ankara
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Istanbul
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Izmir
United Kingdom
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Birmingham
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Birmingham
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Bristol
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Cambridge
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Frimley
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Leeds
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London
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London
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Oxford
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Plymouth
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Southampton
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Stoke
Contact Information
Primary
Pharvaris Clinical Team
clinicaltrials@pharvaris.com
0031-712-036-410
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2026-08
Participants
Target number of participants: 81
Treatments
Experimental: Active
Deucrictibant 40mg extended-release tablet by mouth once daily
Experimental: Placebo
Placebo 1 tablet by mouth once daily
Related Therapeutic Areas
Sponsors
Leads: Pharvaris Netherlands B.V.

This content was sourced from clinicaltrials.gov