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

Condition studied

Hereditary Angioedema

Investigational medicinal product(s)

Eligibility

Primary endpoint

Incidence of treatment-emergent adverse events

Endpoint detail

Number of time-normalized investigator-confirmed HAE attacks, Number of moderate or severe investigator-confirmed HAE attacks, Number of investigator-confirmed HAE attacks that require on-demand treatment, Percent reduction in monthly investigator-confirmed HAE attacks, Time to first investigator-confirmed HAE attack after first dose, The number of participants responding to treatment, defined as a ≥ 50%, ≥ 70%, or ≥ 90% reduction in investigator-confirmed HAE attack rate, Number of participants with no investigator-confirmed HAE attacks, Angioedema Quality of Life (AE-QoL) questionnaire total score