About this trial
This is a Phase 3, multicenter, 3-part study, with 2 randomized, double-blind, placebo-controlled parts and an open-label extension part, to evaluate the efficacy and safety of orally administered deucrictibant XR tablet for prophylaxis, and deucrictibant IR capsule for on-demand treatment of angioedema attacks in adult participants aged ≥ 18 years with AAE-C1INH.
Eligibility criteria
Qualifiers
Provision of written informed consent
Male or female (sex at birth) aged ≥18 years
Diagnosis of AAE-C1INH
Participants enrolling in Part 1 must have stable underlying disease of AAE-C1INH
Disqualifiers
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 the Screening Visit (whichever is longer).
Participants who have previously received prophylactic therapy but have stopped can participate in this study provided the last dose of the treatment was received prior to the timepoint before the Screening Visit
Any females who are pregnant, plan to become pregnant, or are currently breast-feeding
Abnormal hepatic function
Trial design
Treatments tested in this trial
- Deucrictibant
- Placebo
- Deucrictibant
- Placebo
- Deucrictibant