Overview
The goal of this clinical trial is to test the drug STAR-0215 in participants with hereditary angioedema (HAE). One group of participants will get 1 dose of STAR-0215, and two other groups will get 2 doses of STAR-0215. Researchers will study the effects of STAR-0215 in participants with HAE as this is the first time that the drug has been given to participants with HAE.
Description
This is a Phase 1b/2 single and multiple dose trial evaluating the safety, tolerability, clinical activity, pharmacokinetics, pharmacodynamics, and immunogenicity of subcutaneous administration of STAR-0215 in participants with type I or type II HAE in 3 dose cohorts. The first cohort will receive 1 dose of STAR-0215; the second and third cohorts will receive 2 sequential doses. This is the first trial of STAR-0215 in participants with HAE and the first evaluation of a multiple-dose regimen. After the required follow up period, participants who are willing and eligible to consent can begin participation in the long-term open label extension study (STAR-0215-202, ALPHA-SOLAR).
Eligibility
Inclusion Criteria:
- Documented diagnosis of HAE (type I or II). The following must be met:
- 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.