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 States81 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 range12 Years
SexALL
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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.
✓. 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
What they're measuring
1
Time-normalized (per 4 weeks) number of Investigator-confirmed HAE attacks during the 24-week Treatment Period
. 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