Oral Deucrictibant for Prophylactic and Acute Treatment in Hereditary Angioedema Patients (NCT07046806) | Clinical Trial Compass
RecruitingPhase 1/2
Oral Deucrictibant for Prophylactic and Acute Treatment in Hereditary Angioedema Patients
United States10 participantsStarted 2025-03-10
Plain-language summary
To assess the efficacy of prophylactic treatment with deucrictibant extended release (XR) tablet versus placebo in preventing angioedema attacks, and to also assess the efficacy of deucrictibant soft capsules as on-demand treatment versus placebo in achieving angioedema symptom relief during acute attacks.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Provision of written informed consent.
✓. Male or female, aged ≥18 at the time of provision of informed consent.
✓. Diagnosis of bradykinin-mediated angioedema based upon all of the following:
✓. Documented history of at least 2 angioedema attacks in the previous 2 months.
✓. Reliable access and experience to use standard of care medication to effectively manage acute angioedema attacks.
Exclusion criteria
✕. Any diagnosis of angioedema other than BK-AE-nC1INH.
✕. Participation in a clinical study with any other investigational drug within the previous 30 days or within 5 half-lives of the investigational drug at Screening (whichever was longer).
✕. Exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption (such as oral contraceptives or hormonal replacement therapy) within 4 weeks of Screening.
✕. Receiving prophylactic treatment for BK-AE-nC1INH. Participants who have previously received prophylactic therapy but have stopped can participate in this study provided a sufficiently long washout period (≥5 half-life) is observed before the participant is screened. Exclusion includes use of:
✕. Any females who are pregnant, plan to become pregnant, or are currently breast-feeding.
✕. Abnormal hepatic function (aspartate aminotransferase \>2× upper limit of normal, alanine aminotransferase \>2× ULN, or total bilirubin \>1.5× upper limit of normal). Participants with Gilbert's syndrome, defined as isolated increase of total bilirubin ≤3× upper limit of normal and aspartate aminotransferase and alanine aminotransferase within the normal range, are not excluded.
What they're measuring
1
Part-1: Incidence and quality of HAE attacks comparing active versus placebo arms.
Timeframe: 24 weeks
2
Part-2: Efficacy of active on-demand treatment versus placebo in achieving angioedema symptom relief during acute attacks
✕. Any clinically significant history of angina, myocardial infarction, syncope, stroke, left ventricular hypertrophy or cardiomyopathy, uncontrolled hypertension, bradycardia, or any other clinically significant cardiovascular abnormality within the previous year that, in the opinion of the Investigator, would interfere with the participant's safety or ability to participate in the study.