clinical trial · NCT07204938
A Long-Term Study of Navenibart in Participants With Hereditary Angioedema
Astria Therapeutics, Inc.·phase3·enrolling by invitation·n = 145
Hereditary Angioedema (HAE)navenibart
brief 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.
started
Oct 1, 2025
primary completion
Jun 1, 2031
completion
Dec 1, 2031
last updated
May 18, 2026
official title
A Phase 3 Trial to Evaluate the Long-Term Safety and Efficacy of Navenibart in Participants With Hereditary Angioedema - ORBIT-EXPANSE
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol