Hereditary Angioedema
Conditions
Interventions
Navenibart(STAR-0215) 600 mg SC every 3 months every 3 months (Q3M), 300 mg SC Q3M or 600 mg SC every 6 months (Q6M).
Sponsors
Dyson Rie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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
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 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) within 30 days before Screening. 3. Known sensitivity to the ingredients in the formulation of IP
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | — |
Countries
Australia, Austria, Brazil, Bulgaria, Canada, Czech Republic, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Macedonia, Netherlands, New Zealand, Poland, Portugal, South Africa, South Korea, Spain, United Kingdom, United States
Contacts
Public ContactRie Dyson
Fortrea Japan K.K.
Outcome results
None listed