Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorPharvaris Netherlands B.V.

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Deucrictibant

Treatment groups

170 Participants
are divided into 1 treatment group

Sponsors and collaborators