This is a Phase 3, multicenter, long-term, open-label study to evaluate the safety and efficacy of once-daily orally administered deucrictibant extended-release tablet for prophylaxis to prevent angioedema attacks in participants aged ≥12 years with Hereditary Angioedema
Provision of the signed ICF by the participant and/or legally designated representative.
Male or female, aged ≥12 years at the time of providing written informed consent/assent.
Diagnosis of hereditary angioedema (HAE)
For participants that did not participate in a previous deucrictibant prophylactic study: history of at least 1 attack in the last 3 consecutive months prior to Screening
Any diagnosis of angioedema other than HAE
Participation in a clinical study with any other investigational drug within the last 30 days or within 5 half-lives of the investigational drug at ICF signature (whichever is longer)
Prior gene therapy for any indication at any time
Participants who discontinued from previous studies with deucrictibant prophylactic and/or on-demand treatment due to safety reasons or compliance issues that, in the opinion of the Investigator, would interfere with the participant's safety or compliance to participate in the study
Single group
Deucrictibant
DrugDeucrictibant extended-release tablet for once daily oral use
Treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), adverse events of special interest (AESIs), and TEAEs leading to study drug discontinuation
Change in heart rate
Change in blood pressure
Change in body temperature
Time-normalized number of Investigator-confirmed HAE attacks during the Treatment Period
Time-normalized number of Investigator-confirmed HAE attacks treated with on-demand medication during the Treatment Period
Time-normalized number of Investigator-confirmed moderate or severe HAE attacks during Treatment Period
Time-normalized number of Investigator-confirmed severe HAE attacks during the Treatment Period
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