STOP-HAE: A Phase 3 Study of ADX-324 in HAE
Trial Parameters
Brief 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 Criteria
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 known as HAE Type III), idiopathic angioedema, or recurrent angioedema associated with urticaria). * Any clinically significant renal disease * Any clinically significant hepatic disease * Have used any of the following for long-term prevention of HAE attacks: 1. C1-INH agent (CINRYZE, HAEGARDA, RUCONEST) within 2 weeks prior to Screening. 2. Berotralstat (ORLADEYO) within 3 weeks prior to Screening. 3.