Pharvaris Netherlands B.V.
This study evaluates the safety and efficacy of long-term on-demand treatment with orally administered deucrictibant for acute hereditary angioedema (HAE) attacks, including laryngeal attacks. The study will enroll participants from Study PHA022121-C201 (NCT04618211), Study PHA022121-C306 (NCT06343779) and deucrictibant treatment naïve HAE-nC1INH adult participants who elect to participate in this extension study and meet the eligibility requirements.
Part A of the study will enroll adult participants from Study PHA022121-C201. The double-blind treatment assignment from Study PHA022121-C201 will be maintained. Part B is open-label treatment and includes participants rolling over from Part A, participants from Study PHA022121-C201 who did not participate in Part A, participants aged 12 years and older with HAE type I, type II, or HAE-nC1INH rolling over from Study PHA022121-C306, and deucrictibant treatment naïve adult participants with HAE-nC1INH who elect to participate in this extension study and meet the eligibility requirements.
Key Inclusion Criteria: 1. Provision of the signed informed consent form by the participant and/ or legally designated representative. If the participant is a minor (i.e., \<18 years of age or as determined by local law), consent will be obtained from the participant's parent/legally designated representative/guardian and signed assent will be obtained from the participant, per country regulations. 2. For participants from Study C201, received at least one dose of study drug (including the non-attack visit) in Study C201. For participants from Study C306, participant was randomized (and for a…
3 capsules of deucrictibant or matching placebo will be administered orally for each HAE attack
deucrictibant soft capsules will be administered orally for each HAE attack