NCT07204938

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

A Phase 3 Trial to Evaluate the Long-Term Safety and Efficacy of Navenibart in Participants With Hereditary Angioedema - ORBIT-EXPANSE

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 145 (estimated)
• Sponsor: Astria Therapeutics, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hereditary Angioedema (HAE)

Interventions

Type	Name	Description
DRUG	navenibart	Navenibart will be administered as a subcutaneous injection.

Timeline

• Start date: 2025-10-01
• Primary completion: 2031-06-01
• Completion: 2031-12-01
• First posted: 2025-10-03
• Last updated: 2025-11-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study