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A Long-Term Study of Navenibart in Participants With Hereditary Angioedema
Sponsor: Astria Therapeutics, Inc.
Summary
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.
Official title: A Phase 3 Trial to Evaluate the Long-Term Safety and Efficacy of Navenibart in Participants With Hereditary Angioedema - ORBIT-EXPANSE
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
145
Start Date
2025-10-01
Completion Date
2031-12
Last Updated
2026-05-18
Healthy Volunteers
No
Conditions
Interventions
navenibart
Navenibart will be administered as a subcutaneous injection.
Locations (10)
Site 2
Scottsdale, Arizona, United States
Site 3
Little Rock, Arkansas, United States
Site 7
San Diego, California, United States
Site 4
Santa Monica, California, United States
Site 1
Walnut Creek, California, United States
Site 5
Centennial, Colorado, United States
Site 6
Cincinnati, Ohio, United States
Site 9
Hershey, Pennsylvania, United States
Site 10
Hong Kong, Hong Kong
Site 8
Cambridge, United Kingdom