STOP-HAE: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema
Status: Recruiting
Location: See all (49) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This study will evaluate the efficacy and safety of ADX-324 in participants with Type 1 or Type 2 hereditary angioedema. The study will also evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD), and health-related quality of life measures.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18 years at the time of signing informed consent.
• Have a documented diagnosis of HAE-1/HAE-2 (Type I or II)
• Experience ≥1 Investigator-confirmed HAE attack in the first 4 weeks of Screening or ≥2 Investigator-confirmed HAE attacks in 8 weeks of Screening
• Able to use at least one acute therapy to treat HAE attacks (such as a plasma-derived or recombinant C1-INH concentrate or a BK2-receptor antagonist)
Locations
United States
Arkansas
ADARx Clinical Site
RECRUITING
Little Rock
Arizona
ADARx Clinical Site
RECRUITING
Litchfield Park
California
ADARx Clinical Site
RECRUITING
San Diego
ADARx Clinical Site
RECRUITING
Walnut Creek
Florida
ADARx Clinical Site
RECRUITING
Orlando
Maryland
ADARx Clinical Site
RECRUITING
Chevy Chase
ADARx Clinical Site
RECRUITING
Wheaton
Michigan
ADARx Clinical Site
RECRUITING
Detroit
Missouri
ADARx Clinical Site
RECRUITING
St Louis
Nevada
ADARx Clinical Site
RECRUITING
Las Vegas
New York
ADARx Clinical Site
RECRUITING
New York
Ohio
ADARx Clinical Site
RECRUITING
Cincinnati
ADARx Clinical Site
RECRUITING
Columbus
ADARx Clinical Site
RECRUITING
Toledo
Pennsylvania
ADARx Clinical Site
RECRUITING
Hershey
Other Locations
Argentina
ADARx Clinical Site
RECRUITING
Buenos Aires
ADARx Clinical Site
NOT_YET_RECRUITING
Capital Federal
Australia
ADARx Clinical Site
RECRUITING
Adelaide
Austria
ADARx Clinical Site
RECRUITING
Vienna
Belgium
ADARx Clinical Site
NOT_YET_RECRUITING
Edegem
Bulgaria
ADARx Clinical Site
RECRUITING
Sofia
Canada
ADARx Clinical Site
NOT_YET_RECRUITING
Edmonton
ADARx Clinical Site
NOT_YET_RECRUITING
Montreal
ADARx Clinical Site
RECRUITING
Ottawa
China
ADARx Clinical Site
RECRUITING
Beijing
ADARx Clinical Site
NOT_YET_RECRUITING
Harbin
ADARx Clinical Site
NOT_YET_RECRUITING
Zhengzhou
Croatia
ADARx Clinical Site
RECRUITING
Split
ADARx Clinical Site
RECRUITING
Zagreb
France
ADARx Clinical Site
NOT_YET_RECRUITING
Montpellier
ADARx Clinical Site
NOT_YET_RECRUITING
Nice
ADARx Clinical Site
RECRUITING
Paris
ADARx Clinical Site
RECRUITING
Tours
Germany
ADARx Clinical Site
RECRUITING
Tübingen
Hong Kong Special Administrative Region
ADARx Clinical Site
NOT_YET_RECRUITING
Hong Kong
Hungary
ADARx Clinical Site
RECRUITING
Budapest
Israel
ADARx Clinical Site
NOT_YET_RECRUITING
Ashkelon
ADARx Clinical Site
NOT_YET_RECRUITING
Ramat Gan
ADARx Clinical Site
NOT_YET_RECRUITING
Tel Aviv
Poland
ADARx Clinical Site
RECRUITING
Krakow
ADARx Clinical Site
RECRUITING
Lodz
ADARx Clinical Site
RECRUITING
Wroclaw
Spain
ADARx Clinical Site
RECRUITING
Barcelona
ADARx Clinical Site
RECRUITING
Madrid
Taiwan
ADARx Clinical Site
RECRUITING
Taichung
United Kingdom
ADARx Clinical Site
RECRUITING
Cambridge
ADARx Clinical Site
RECRUITING
Cardiff
ADARx Clinical Site
RECRUITING
London
ADARx Clinical Site
RECRUITING
Southampton
Contact Information
Primary
Lupe Gallegos
info@adarx.com
877-232-7974
Time Frame
Start Date: 2025-08-28
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 90
Treatments
Experimental: ADX-324 Dose Level 1
Experimental: ADX-324 Dose Level 2
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: ADARx Pharmaceuticals, Inc.