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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
2026-07-30
Healthy Volunteers
No
Conditions
Interventions
navenibart
Navenibart will be administered as a subcutaneous injection.
Locations (40)
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 19
Colorado Springs, Colorado, United States
Site 21
Wheaton, Maryland, United States
Site 6
Cincinnati, Ohio, United States
Site 9
Hershey, Pennsylvania, United States
Site 22
Santo André, Brazil
Site 20
Sofia, Bulgaria
Site 23
Edmonton, Canada
Site 36
Prague, Czechia
Site 39
Paris, France
Site 25
Frankfurt, Germany
Site 10
Hong Kong, Hong Kong
Site 29
Ashkelon, Israel
Site 30
Haifa, Israel
Site 31
Petah Tikva, Israel
Site 24
Petah Tikva, Israel
Site 37
Milan, Italy
Site 38
Monserrato, Italy
Site 40
Kawagoe, Saitama, Japan
Site 27
Fukuoka, Japan
Site 33
Kawasaki, Japan
Site 17
Amsterdam, Netherlands
Site 18
Skopje, North Macedonia
Site 35
Krakow, Poland
Site 16
Rzeszów, Poland
Site 32
San Juan, Puerto Rico
Site 11
Cape Town, South Africa
Site 34
Madrid, Spain
Site 26
Valencia, Spain
Site 12
Bristol, United Kingdom
Site 8
Cambridge, United Kingdom
Site 28
Frimley, United Kingdom
Site 15
Hampstead, United Kingdom
Site 13
London, United Kingdom
Site 14
Plymouth, United Kingdom