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 (13) 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
California
ADARx Clinical Site
RECRUITING
Walnut Creek
Maryland
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
Other Locations
Canada
ADARx Clinical Site
RECRUITING
Ottawa
Hungary
ADARx Clinical Site
RECRUITING
Budapest
Spain
ADARx Clinical Site
RECRUITING
Madrid
Contact Information
Primary
Lupe Gallegos
lgallegos@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.