Study of Oral Deucrictibant XR Tablet for Prophylaxis and Deucrictibant IR Capsule for On-Demand … (NCT07266805) | Clinical Trial Compass
RecruitingPhase 3
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
United States, Bulgaria, Canada32 participantsStarted 2025-10-16
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 pregna…
What they're measuring
1
Part 1 (Prophylaxis, Double-blind Treatment Phase)
Timeframe: 12 weeks
2
Part 2 (On-demand, Double-blind Treatment Phase)
Timeframe: 12 hours post-treatment
3
Part 3 (On-demand, Open-label Extension Treatment Phase)
Timeframe: Through study completion, an average of 36 weeks