Hereditary Angioedema
Conditions
Interventions
Deucrictibant 20 mg will be administered orally during HAE attacks.
Sponsors
Sun Justin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent. If the participant is a minor(i.e., =12 to <18 years or age of adulthood as defined locally) from these studies is with consideration of local age requirements. 3. Female participants of childbearing potential (or who become of childbearing potential during the study) must agree to the protocol-specified pregnancy testing and to be abstinent from heterosexual intercourse or to use an acceptable contraception method as defined in the protocol and as available locally from enrollment until 30 days after the last study drug administration. 4. In the opinion of the Investigator, the participant (and parent/caregiver for adolescent participants) is willing and able to comply with the protocol.
Exclusion criteria
Exclusion criteria: 1. Any female who is pregnant, plans to become pregnant, or is breast-feeding. 2. Any other systemic disease (e.g., cardiovascular, gastrointestinal, renal, respiratory, neurological) or significant disease or disorder that, in the opinion of the Investigator, would interfere with the participant's safety or ability to participate in the study. 3. Participants who have recently used short or long-term HAE prophylaxis or ondemand HAE treatment will not be excluded from the study provided the following washout period is observed (i.e., study screening or enrollment/rollover should be delayed allowing for washout): - For Part B: - If a participant is receiving long-term prophylactic therapy with one of the following medications indicated for HAE: plasma-derived C1-INH, danazol at less than or equal to 200 mg/day, anti-fibrinolytics, berotralstat, or lanadelumab, they must be on a stable dose and regimen for at least 3 months before screening and intends to remain on the same dose for the duration of the study. 4. History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse. 5. Participation in any other investigational drug study (except with deucrictibant) currently, within the last 30 days prior to the first deucrictibant dose or within 5 half-lives of study drug at enrollment, whichever is longer. 6. Discontinued from parent study after enrollment for any study drug-related safety reason or non-compliance including significant protocol deviation. 7. Use of concomitant medications with systemic absorption that are strong CYP3A4 inhibitors (e.g., clarithromycin, erythromycin, itraconazole, ketoconazole, ritonavir) or strong CYP3A4 inducers (e.g., carbamazepine and phenytoin).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Treatment-emergent adverse events (TEAEs), treatment-related TEAEs, treatment-emergent serious adverse events (TESAEs), treatment-related TESAEs, and TEAEs leading to deucrictibant discontinuation - Heart Rate - Blood pressure - Body temperature - Clinical laboratory tests - Electrocardiograms - Physical examination | — |
Countries
Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Colombia, Czech Republic, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Netherlands, North Macedonia, Poland, Puerto Rico, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Turkey, United Kingdom, United States
Contacts
Public ContactNobuhiko Osawa
Medpace Japan K.K.
Outcome results
None listed