A Study of STAR-0215 in Participants With Hereditary Angioedema
Hereditary Angioedema
About this trial
This is an interventional treatment trial for Hereditary Angioedema focused on measuring HAE, Angioedema
Eligibility Criteria
Inclusion Criteria: Documented diagnosis of HAE (type I or II). The following must be met: a. Documented clinical history consistent with HAE (for example, subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria). Experienced at least 2 HAE attacks during the Run-In period, as confirmed by an investigator based on meeting the protocol-specified definition of an HAE attack. Exclusion Criteria: Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH (also known as HAE type III), idiopathic angioedema, or angioedema associated with urticaria. Use of therapies prescribed for the prevention of HAE attacks prior to Screening: lanadelumab within 90 days berotralstat within 21 days all other prophylactic therapies, within 7 days Any exposure to angiotensin-converting enzyme inhibitors or any estrogen containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy) within 28 days prior to Screening. Any exposure to androgens (for example, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 7 days prior to Screening.
Sites / Locations
- Allervie Clinical ResearchRecruiting
- Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD.Recruiting
- Allergy & Asthma Clinic of Northwest ArkansasRecruiting
- Little Rock Allergy & Asthma Clinical Research CenterRecruiting
- Raffi Tachdjian MD, IncRecruiting
- Allergy & Asthma Clinical ResearchRecruiting
- Institute for Asthma and Allergy, PCRecruiting
- Massachusetts General HospitalRecruiting
- Washington University School of MedicineRecruiting
- Optimed ResearchRecruiting
- Penn State Health Milton S. Hershey Medical CenterRecruiting
- AARA Research CenterRecruiting
- University of AlbertaRecruiting
- Ottawa Allergy Research CorporationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Cohort 1 - Single Dose
Cohort 2 - Multiple Dose
Cohort 3 - Multiple Dose
Participants will receive 1 dose of STAR-0215.
Participants will receive 2 doses of STAR-0215 administered 3 months apart.
Participants will receive 2 doses of STAR-0215 administered 1 month apart.