Trial intelligence / Profile preview

ALPHA-ORBIT: Phase 3 Trial of Navenibart in Hereditary Angioedema

2025-521660-35-00Phase 3Authorised

Sponsor
Astria Therapeutics
Start
Aug 2025
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Countries
23
01

Overview

Phase 3, randomised, double-blind trial in hereditary angioedema (HAE) comparing Navenibart with Placebo (2 arms). Primary endpoint: Number of time-normalized investigator-confirmed HAE attacks during the 6-month Treatment Period. Planned start Aug 2025; status: authorised.

02

Drugs

navenibart
03

Conditions

hereditary angioedema (HAE)

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