Astria Therapeutics, Inc.
This is a Phase 3 multicenter trial in 2 parts to evaluate the long-term safety and efficacy of navenibart in adult and adolescent participants with hereditary angioedema (HAE) who participated in STAR-0215-301 (NCT06842823; ALPHA-ORBIT). Part 1 provides all participants with navenibart in a dose-controlled fashion; Part 2 introduces a personalized dosing option (PDO) for participants based on individual needs.
Inclusion Criteria: 1\. Participants from STAR-0215-301 who met one of the following conditions: 1. Completed STAR-0215-301 through the Day 181 visit 2. Withdrew from STAR-0215-301 but met the following criteria: i. Received 2 doses of IP ii. completed ≥ 2 months of trial follow-up after the second dose of IP iii. Met other eligibility criteria as assessed by Investigator Exclusion Criteria: 1. Participation in an investigational clinical trial other than STAR-0215- 301 in the 30 days or any exposure to an investigational drug (other than navenibart in STAR-0215-301) within 5 half-lives b…
Navenibart will be administered as a subcutaneous injection.