Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in… (NCT06669754) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE
United States, Argentina, Brazil81 participantsStarted 2024-12-01
Plain-language summary
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of once-daily orally administered deucrictibant extended-release tablet compared to placebo for prophylaxis to prevent angioedema attacks in participants aged ≥ 12 years with hereditary angioedema.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provision of written informed consent/assent.
. Male or female, aged ≥12 years at the time of providing written informed consent/assent.
. Diagnosis of hereditary angioedema (HAE)
. History of at least 3 HAE attacks within the 3 consecutive months prior to Screening Visit
. Predefined number of attacks during the Screening Period
. Reliable access and ability to use standard of care on-demand treatments to effectively manage acute HAE attacks.
. Willing and able to adhere to all protocol requirements, including eDiary and ePRO data recording.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time-normalized (per 4 weeks) number of Investigator-confirmed HAE attacks during the 24-week Treatment Period
. Female participants of childbearing potential must agree to the protocol specified pregnancy testing and contraception methods.
Exclusion criteria
. Any diagnosis of angioedema other than HAE
. 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 Screening (whichever is longer)
. Has received prior prophylactic treatment with deucrictibant
. Exposure to ACE inhibitors or any estrogen-containing medications with systemic absorption within 4 weeks of Screening
. Prior gene therapy for any indication at any time
. Use of prophylactic treatment for HAE within 2 weeks of Screening for C1INH, oral kallikrein inhibitors, or anti-fibrinolytics; within 4 weeks of Screening for attenuated androgens; within 5 half-lives of Screening for monoclonal antibodies, or within 7 days of Screening for short-term prophylaxis
. Any females who are pregnant, plan to become pregnant, or are currently breast-feeding