Hereditary Angioedema
Conditions
Interventions
Deucrictibant 40mg extended-release tablet by mouth once daily for approximately 130 weeks.
Sponsors
Yu Ming
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent/assent. 2. Male or female, aged => 12 years and older at the time of providing written informed consent/assent. 3. Diagnosis of hereditary angioedema (HAE) 4.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 5.Reliable access and ability to use standard of care on-demand treatments to effectively manage acute HAE attacks. 6. Willing and able to adhere to all protocol requirements, including eDiary and ePRO data recording. 7. Female participants of childbearing must agree to the protocol specified pregnancy testing and contraception methods.
Exclusion criteria
Exclusion criteria: 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 ICF signature (whichever is longer) 3. Prior gene therapy for any indication at any time 4. 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 5. Exposure to ACE inhibitors or any estrogen-containing medications with systemic absorption within 4 weeks of Screening 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 enrollment 13. Known hypersensitivity to deucrictibant or any of the excipients of the study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), adverse events of special interest (AESIs), and TEAEs leading to study drug discontinuation [Time Frame: Up to 138 weeks] Change in heart rate [Time Frame: Up to 138 weeks] Change in blood pressure [Time Frame: Up to 138 weeks] Change in body temperature [Time Frame: Up to 138 weeks] Change in clinical laboratory tests from baseline [Time Frame: Up to 138 weeks] - Hematology, blood chemistry, and urinalysis. Descriptive in nature, no formal statistical hypothesis testing will be performed. Change in electrocardiograms (ECGs) from baseline [Time Frame: Up to 138 weeks] - Digital triplicate 12-lead ECG. Descriptive in nature, no formal statistical hypothesis testing will be performed. | — |
Countries
Argentina, Australia, Austria, Brazil, Bulgaria, Canada, China, Colombia, France, Germany, Hong Kong, Hungary, Ireland, Italy, Japan, New Zealand, Poland, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, UK, USA
Contacts
Public ContactAkane Maeno
A2 Healthcare Corporation
Outcome results
None listed