Clinical Trial

A Study of Navenibart in Participants With Hereditary Angioedema

Study acronym: ALPHA-ORBIT
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This is a Phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of subcutaneous administration of navenibart in adult and adolescent participants with type 1 or type 2 hereditary angioedema (HAE). The goal of this clinical trial is to evaluate the efficacy and safety of navenibart compared to placebo in preventing HAE attacks in participants with HAE.
Protocol Amendment History 5 changes
critical Trial status changed: Enrolling by Invitation → Active, Not Recruiting 2026-07-01
notable Primary completion moved earlier: 2027-03 -> 2026-12 2026-07-01
minor Completion moved earlier: 2027-09 -> 2027-06 2026-07-01
critical Trial status changed: Recruiting → Enrolling by Invitation 2026-06-06
notable Trial sites expanded: 79 -> 85 locations 2026-04-10
Trial Details
NCT Number NCT06842823
Lead Sponsor Astria Therapeutics, Inc.
Conditions Hereditary Angioedema (HAE)
Enrollment 157 participants
Start Date 2025-03-20
Primary Completion 2026-12 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-06-30