Health Trials

About this trial

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

Qualifiers

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)

Disqualifiers

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

C1-INH agent (CINRYZE, HAEGARDA, RUCONEST) within 2 weeks prior to Screening.

Trial design

Treatments tested in this trial

  • ADX-324
  • Placebo

Treatment groups

90 Participants
are divided into 3 treatment groups

Locations

51
Argentina
ADARx Clinical SiteC1425BEN, Capital FederalBuenos Aires, Argentina
ADARx Clinical SiteC1035AAT, Buenos AiresBuenos Aires F.D., Argentina
Australia
ADARx Clinical Site5000, AdelaideSouth Australia, Australia
Austria
ADARx Clinical Site1090, Vienna Austria

Sponsors and collaborators

ADARx Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov