Long-Term Phase 3 Study of Daily Oral Deucrictibant Extended-Release Tablet to Prevent Angioedema Attacks in Adolescents and Adults with Hereditary Angioedema

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a once-daily oral extended-release tablet called deucrictibant to prevent angioedema attacks in people aged 12 years and older who have Hereditary Angioedema HAE. This Phase 3, multicenter, long-term, open-label study aims to understand how well deucrictibant works and its safety over an extended period. Participants will take deucrictibant once daily for about 130 weeks during the Treatment Period after an initial Screening Period to confirm eligibility. Those who joined previous deucrictibant prophylactic studies and rolled over within 28 days may skip screening. After treatment, participants will have an End of Study visit within 4 weeks. Throughout the study, participants will complete daily electronic diaries and questionnaires at set times to monitor their condition and treatment effects. During the study, researchers will perform regular safety checks including laboratory tests, heart rate, blood pressure, body temperature, and ECGs. They will track any adverse events and collect blood and urine samples to measure drug levels. The main outcomes include monitoring treatment-emergent adverse events and changes in vital signs and lab results over 130 weeks. Effectiveness will be assessed by counting angioedema attacks, quality of life questionnaires, and patient-reported outcomes. The study runs until December 2028.

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