Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE
Start Date
2/1/2025
Completion Date
12/1/2028
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
Detailed Description
The study consists of a Screening Period during which eligibility is confirmed (only for participants not rolling over within 28 days from a previous deucrictibant prophylactic study), a Treatment Period in which participants will receive open-label deucrictibant extended-release tablet once daily for approximately 130 weeks, followed by an End of Study visit after maximum 4 weeks. Participants will undergo regular safety (e.g. lab draws) and efficacy assessments, will complete an electronic diary daily, and also complete questionnaires at predefined timepoints during the study.
Eligibility Criteria
Age Range: 12 years to No maximum
Interventions
Deucrictibant
Conditions
Locations
Study Site
Birmingham, Alabama 35209
United States
Study Site
Scottsdale, Arizona 85251
United States
Study Site
Little Rock, Arkansas 72205
United States
Study Site
San Diego, California 92122
United States
Study Site
Santa Monica, California 90404
United States
Study Site
Walnut Creek, California 94598
United States
Study Site
Wheaton, Maryland 20902
United States
Study Site
St Louis, Missouri 63141
United States
Study Site
Las Vegas, Nevada 89128-0450
United States
Study Site
Hershey, Pennsylvania 17033
United States
Study Site
Dallas, Texas 75231
United States
Study Site
Milwaukee, Wisconsin 53226-3067
United States
Study Site
Corrientes,
Argentina
Study Site
Pilar,
Argentina
Study Site
Salta,
Argentina
Study Site
Melbourne, 3052
Australia
Study Site
Melbourne,
Australia
Study Site
Perth,
Australia
Study Site
Sydney,
Australia
Study Site
Vienna,
Austria
Study Site
Ribeirão Preto,
Brazil
Study Site
Salvador,
Brazil
Study Site
Santo André,
Brazil
Study Site
São Paulo, 01454010
Brazil
Study Site
São Paulo, 14051-140
Brazil
Study Site
Sofia,
Bulgaria
Study Site
Edmonton,
Canada
Study Site
Montreal,
Canada
Study Site
Beijing,
China
Study Site
Grenoble,
France
Study Site
Berlin,
Germany
Study Site
Frankfurt,
Germany
Study Site
Munich,
Germany
Study Site
Hong Kong,
Hong Kong
Study Site
Budapest,
Hungary
Study Site
Dublin,
Ireland
Study Site
Padova,
Italy
Study Site
Palermo,
Italy
Study Site
Roma,
Italy
Study Site
Hiroshima,
Japan
Study Site
Kanagawa,
Japan
Study Site
Osaka,
Japan
Study Site
Tokyo,
Japan
Study Site
Krakow,
Poland
Study Site
Martin,
Slovakia
Study Site
Cape Town,
South Africa
Study Site
Daegu,
South Korea
Study Site
Seoul,
South Korea
Study Site
Barcelona, 08907
Spain
Study Site
Ankara,
Turkey (Türkiye)
Study Site
Istanbul,
Turkey (Türkiye)
Study Site
Izmir,
Turkey (Türkiye)
Study Site
Birmingham, B18 7QH
United Kingdom
Study Site
Birmingham, B9 5SS
United Kingdom
Study Site
Brighton,
United Kingdom
Study Site
Bristol,
United Kingdom
Study Site
Cambridge,
United Kingdom
Study Site
London, E1 1FR
United Kingdom
Study Site
London,
United Kingdom
Study Site
Oxford,
United Kingdom
Study Site
Plymouth,
United Kingdom
Study Site
Southampton,
United Kingdom