Last updated 40 days ago
STOP-HAE: A Phase 3 Study of ADX-324 in HAE
90 patients around the world
Available in Argentina, United States
ADARx Pharmaceuticals, Inc.
5Research sites
90Patients around the world
This study is for people with
Angioedema
Angioedema hereditario
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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).
- 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.C1-INH agent (CINRYZE, HAEGARDA, RUCONEST) within 2 weeks prior to Screening.Berotralstat (ORLADEYO) within 3 weeks prior to Screening.Lanadelumab (TAKHZYRO) within 8 weeks prior to the Screening.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.
Sites
InAER - Investigaciones en Alergia y Enfermedades Respiratorias - CABA, Buenos Aires
Recruiting
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Unidad de Alergia, Asma e Inmunología Clínica
Recruiting
Centro Respiratorio Infantil S.A. - Rosario
Recruiting
Consultorios Médicos Dr. Doreski
Recruiting
StudySTOP-HAE
SponsorADARx Pharmaceuticals, Inc.
Study typeInterventional
Conditions
Angioedema hereditario
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06960213
