Testing Deucrictibant for hereditary angioedema (HAE)

Exclusion

• −Known hypersensitivity to deucrictibant or any of the excipients of the study drug
• −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 ICFInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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 InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, would interfere with the participant's safety or compliance to participate in the study
• −Exposure to ACE inhibitors or any estrogen-containing medications with systemic absorption within 4 weeks of ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →
• −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
• −Abnormal hepatic function
• −Moderate or severe renal impairment
• −Any clinically significant comorbidity or systemic dysfunction that would interfere with the participant's safety or ability to participate in the study.
• −History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse
• −Use of medications that are moderate and strong inhibitors or strong inducers of CYP3A4 within the last 30 days or within 5 half-lives (whichever is longer) of the time of randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
• −Any females who are pregnant, plan to become pregnant, or are currently breast-feeding