A Phase 3, Randomized, Double-blind, Placebo-controlled, Cross-over Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Attacks in Adolescents and Adults With Hereditary Angioedema
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, 2-period, 2-treatment cross-over study to evaluate the efficacy and safety of orally administered deucrictibant compared to placebo for the on-demand treatment of HAE attacks, including non-severe laryngeal attacks, in participants ≥12 to ≤75 years of age with HAE type 1, type 2, or type 3, a proportion of whom are using long-term prophylactic medication for HAE.
• Provision of written informed consent/assent.
• Male or female, aged ≥12 to ≤75 years at the time of providing written informed consent/assent.
• Diagnosis of HAE-1/2/3.
• History of at least 2 HAE attacks in the last 3 months before screening.
• Experience with using standard-of-care treatment to effectively manage on-demand treatment for HAE attacks.
• Participants on long-term prophylactic therapy with plasma-derived C1-INH (danazol, anti-fibrinolytics, berotralstat, or lanadelumab) must be on a stable dose and regimen and intend to remain on the same dose for 6 months before screening and the duration of the study. OR, Participant has stopped using plasma-derived C1-INH (danazol, anti-fibrinolytics, berotralstat) at least 2 weeks or lanadelumab at least 10 weeks before screening.
• Capable of recording, without assistance, electronic HAE diary and ePRO data using an electronic device.
• For adolescent participants aged ≥12 and \<18 years of age: body weight ≥40 kg.
• Female participants of childbearing potential must agree to the protocol specified pregnancy testing and contraception methods.