Oral Deucrictibant for Preventing and Treating Angioedema Attacks in Adults with Bradykinin-Mediated Angioedema and Normal C1 Inhibitor

What this Trial Is About

Researchers are evaluating the effectiveness of deucrictibant, an oral bradykinin B2 receptor antagonist, for both preventing and treating acute angioedema attacks in adults with bradykinin-mediated angioedema with normal C1 inhibitor BK-AE-nC1INH. The study involves a randomized, double-blind, placebo-controlled crossover design to compare deucrictibant with placebo for long-term prophylaxis and on-demand treatment during attacks. This trial includes up to 10 participants and aims to assess both symptom prevention and relief. The study has two parts. Part 1 tests deucrictibant extended-release XR tablets at a dose of 40 mg once daily versus placebo for 12 weeks each, with participants crossing over after the first 12 weeks for a total of 24 weeks. Part 2 begins after Part 1 and evaluates deucrictibant 20 mg soft capsules versus placebo for on-demand treatment of two angioedema attacks over approximately 16 weeks. Participants self-administer the study drug or placebo during qualifying attacks and record treatment and symptoms in a diary. Participants will keep detailed diaries to track angioedema symptoms, treatments, and responses throughout the study. Researchers will assess the number and quality of angioedema attacks during prophylaxis and symptom relief during acute treatment. Safety will be monitored through adverse event tracking, lab tests, vital signs, physical exams, and ECGs. The total participation duration can be up to 40 weeks, including screening, treatment, and follow-up visits.

Oral Deucrictibant for Prophylactic and Acute Treatment in Hereditary Angioedema Patients