Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against… (NCT06679881) | Clinical Trial Compass
RecruitingPhase 3
Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE
United States170 participantsStarted 2025-02-01
Plain-language summary
This is a Phase 3, multicenter, long-term, open-label study to evaluate the safety and efficacy of once-daily orally administered deucrictibant extended-release tablet 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 the signed ICF by the participant and/or legally designated representative.
✓. Male or female, aged ≥12 years at the time of providing written informed consent/assent.
✓. Diagnosis of hereditary angioedema (HAE)
✓. For participants that did not participate in a previous deucrictibant prophylactic study: history of at least 1 attack in the last 3 consecutive months prior to Screening
✓. 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 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 ICF signature (whichever is longer)
✕. Prior gene therapy for any indication at any time
✕. Participants who discontinued from previous studies with deucrictibant prophylactic and/or on-demand treatment due to safety reasons or compliance issues that, in the opinion of the Investigator, would interfere with the participant's safety or compliance to participate in the study
What they're measuring
1
Treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), adverse events of special interest (AESIs), and TEAEs leading to study drug discontinuation
✕. Exposure to ACE inhibitors or any estrogen-containing medications with systemic absorption within 4 weeks of Screening
✕. 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