Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE

Eligibility Criteria

• 1. Provision of written informed consent/assent.
• 2. Male or female, aged ≥12 years at the time of providing written informed consent/assent.
• 3. Diagnosis of hereditary angioedema (HAE)
• 4. History of at least 3 HAE attacks within the 3 consecutive months prior to Screening Visit
• 5. Predefined number of attacks during the Screening Period
• 6. Reliable access and ability to use standard of care on-demand treatments to effectively manage acute HAE attacks.
• 7. Willing and able to adhere to all protocol requirements, including eDiary and ePRO data recording.
• 8. Female participants of childbearing potential must agree to the protocol specified pregnancy testing and contraception methods.
• 1. Any diagnosis of angioedema other than HAE
• 2. 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)
• 3. Has received prior prophylactic treatment with deucrictibant
• 4. Exposure to ACE inhibitors or any estrogen-containing medications with systemic absorption within 4 weeks of Screening
• 5. Prior gene therapy for any indication at any time
• 6. 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
• 7. Any females who are pregnant, plan to become pregnant, or are currently breast-feeding
• 8. Abnormal hepatic function
• 9. Moderate or severe renal impairment
• 10. Any clinically significant comorbidity or systemic dysfunction that would interfere with the participant's safety or ability to participate in the study.
• 11. History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse
• 12. 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 randomization
• 13. Known hypersensitivity to deucrictibant or any of the excipients of the study drug