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drugset / Trial / NCT07204938

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

NCT07204938 ↗

Phase 3 Enrolling by invitation 145 enrolled Astria Therapeutics, Inc.
Non-randomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2025-10-01
Primary completion
2031-06
Completion
2031-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Navenibart Monoclonal antibody 300 mg Subcutaneous
Subject Navenibart Monoclonal antibody 600 mg Subcutaneous

Indications

hereditary angioedema