STOP-HAE: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema
ADARx Pharmaceuticals, Inc.
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * 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) Key Exclusion Criteria: * Concurrent diagnosis of another form of recurrent angioedema (such as acquired angioedema, HAE with normal C1-INH (previously kno…
Interventions
- DrugADX-324
siRNA duplex oligonucleotide
- DrugPlacebo
saline
Locations (50)
- ADARx Clinical SiteLitchfield Park, Arizona
- ADARx Clinical SiteLittle Rock, Arkansas
- ADARx Clinical SiteSan Diego, California
- ADARx Clinical SiteWalnut Creek, California
- ADARx Clinical SiteOrlando, Florida
- ADARx Clinical SiteChevy Chase, Maryland