A Phase 3 Trial to Evaluate the Long-Term Safety and Efficacy of Navenibart in Participants with Hereditary Angioedema – ORBIT-EXPANSE
Hereditary angioedema
Adult participants will receive one of three dosing regimens: Regimen 1: Participants will receive 600 mg of navenibart (STAR-0215) via subcutaneous injection every 3 months. Regimen 2: Participants will receive 300 mg of navenibart (STAR-0215) via subcutaneous injection every 3 months. Regimen 3: Participants will receive 600 mg of navenibart (STAR-0215) via subcutaneous injection every 6 months. Adolescent participants will receive 300 mg of navenibart (STAR-0215) via subcutaneous injection every 3 months.
1. Participants from STAR-0215-301 who met one of the following conditions: a. Completed STAR-0215-301 through the Day 181 visit b. Withdrew from STAR-0215-301 and met all of 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
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 before informed consent/assent 2. Any exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy [HRT]) within 30 days before informed consent/assent. 3. Known sensitivity to the ingredients in the formulation of IP