- Study of Oral Deucrictibant XR Tablet for Prophylaxis and Deucrictibant IR Capsule for On-Demand Treatment of Angioedema Attacks in Adults With Acquired Angioedema Due to C1 Inhibitor Deficiency — Recruiting • Phase III • Cardiology / Cardiovascular • NCT07266805.
- What is being tested: Deucrictibant XR (extended-release) tablet for preventative treatment and deucrictibant IR (immediate-release) capsule for acute attack management in acquired angioedema due to C1 inhibitor deficiency, using a randomized controlled study design with long-term follow-up data.
- Patient eligibility overview: Adults diagnosed with acquired angioedema secondary to C1 inhibitor deficiency; this represents a distinct patient population requiring both prophylactic strategies to prevent attacks and rapid-acting treatments for breakthrough angioedema episodes.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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.
- : * Provision of written informed consent * Male or female (sex at birth) aged ≥18 years * Diagnosis of AAE-C1INH * History of AAE-C1INH attacks prior to the Screening Visit: * Participants enrolling in Part 1 must have stable underlying disease of AAE-C1INH * The underlying condition can reasonably be expected to remain stable for the duration * Reliable access and ability to use available therapy to effectively manage AAE- C1INH attacks. * Female participants of childbearing potential must agree to the protocol-specified pregnancy testing and to be abstinent from heterosexual intercourse or to use an acceptable contraception method. Females of non-childbearing potential (prepubertal, surgically sterile, or postmenopausal with ≥ 12 months amenorrhea and postmenopausal FSH confirmation) are not required to use contraception during the study. • Capable of recording, without assistance, eDiary and ePRO data using an electronic device, as evidenced by the eDiary and ePRO training.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.