STOP-HAE: A Phase 3 Study of ADX-324 in HAE

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  18 and up

Participation 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. Lanadelumab (TAKHZYRO) within 8 weeks prior to the Screening.
4. Androgen use within 12 weeks prior to Screening.
* Received prior treatment with any RNA/DNA-based therapy for HAE or intolerant to any prior RNA/DNA-based therapy for any condition, excluding vaccines.