Clinical Trial

A Long-Term Study of Navenibart in Participants With Hereditary Angioedema

Enrolling by Invitation Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 changes
notable Trial sites expanded: 28 -> 40 locations 2026-07-31
notable Trial sites expanded: 10 -> 28 locations 2026-06-03
Trial Details
NCT Number NCT07204938
Lead Sponsor Astria Therapeutics, Inc.
Conditions Hereditary Angioedema (HAE)
Enrollment 145 participants
Start Date 2025-10-01
Primary Completion 2031-06 (estimated)
Study Completion 2031-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-30