A Long-term trial to learn about a study drug (STAR-0215) in adults with hereditary angioedema

You may be able to join if

• At least 18 years of age at the time of Screening.
• STAR-0215-201 status was 1 of the following: a. Completed all visits through 6 months after their last dose in STAR-0215-201 b. Eligible for participation in STAR-0215-201 (met all inclusion criteria [with the exception of the criterion for the minimum number of HAE attacks during the Run-In Period] and met none of the exclusion criteria) and entered the Run-In-Period, but did not qualify for the Treatment Period because they did not meet the criterion for the minimum number of HAE attacks. c. Eligible for participation in STAR-0215-201 and entered the Run-In Period but did not complete it for reasons other than not meeting the criterion for the minimum number of HAE attacks – eligibility requires consultation with the Medical Monitor; or d. Discontinued participation in STAR-0215-201 (for personal or social reasons) after having completed at least 84 days of trial follow-up since their last dose of STAR-0215. Eligibility requires consultation with the Medical Monitor. Participants who discontinued for safety reasons are not eligible.
• For participants who are STAR-0215-naïve and were not enrolled in STAR-0215-201: Documented diagnosis of HAE (Type 1 or Type 2). All of the following must be met: a. Documented clinical history consistent with HAE (e.g. subcutaneous [SC] or mucosal, nonpruritic swelling episodes without accompanying urticaria). b. Age at reported onset of first angioedema symptoms 30 years of age or younger, or a family history consistent with HAE Type 1 or Type 2. c. C1-esterase inhibitor protein (C1-INH) antigen or functional level less than 40% of the normal level. Participants with antigen or functional C1-INH level 40% to 50% of the normal level may be eligible if they also have a C4 level below the normal range and a family history consistent with HAE Type 1 or Type 2. Testing for C1-INH and C4 will be performed at Screening. Historical test results for C1-INH may be used to confirm eligibility if the screening C1-INH antigen test or functional level or C4 level laboratory values are inconclusive, after discussion with the Medical Monitor. If the C1-INH functional level by enzyme immunoassay (EIA) does not qualify a participant with known or clinically suspected Type 2 HAE for study eligibility, a chromogenic assay may be obtained after discussion with the Sponsor's Medical Monitor. Functional level via chromogenic assay is inclusionary if the C1-INH functional level is < 74%. In this situation, the chromogenic assay should be ordered by the site per their usual process for ordering the test.
• For participants who are STAR-0215-naïve and were not enrolled in STAR-0215-201: At least 2 HAE attacks during the Run-In Period, as confirmed by an investigator based on protocol-specified definition of an HAE attack.