Phase
Condition
Allergies & Asthma
Allergy
Urticaria
Treatment
Deucrictibant
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provision of written informed consent/assent.
Male or female, aged ≥12 years at the time of providing written informedconsent/assent.
Diagnosis of hereditary angioedema (HAE)
For participants that did not participate in a previous deucrictibant prophylacticstudy: history of at least 1 attack in the last 3 consecutive months prior toScreening
Reliable access and ability to use standard of care on-demand treatments toeffectively manage acute HAE attacks.
Willing and able to adhere to all protocol requirements, including eDiary and ePROdata recording.
Female participants of childbearing must agree to the protocol specified pregnancytesting and contraception methods.
Exclusion
Exclusion Criteria:
Any diagnosis of angioedema other than HAE
Participation in a clinical study with any other investigational drug within thelast 30 days or within 5 half-lives of the investigational drug at ICF signature (whichever is longer)
Prior gene therapy for any indication at any time
Participants who discontinued from previous studies with deucrictibant prophylacticand/or on-demand treatment due to safety reasons or compliance issues that, in theopinion of the Investigator, would interfere with the participant's safety orcompliance to participate in the study
Exposure to ACE inhibitors or any estrogen-containing medications with systemicabsorption within 4 weeks of Screening
Use of prophylactic treatment for HAE within 2 weeks of Screening for C1INH, oralkallikrein inhibitors, or anti-fibrinolytics; within 4 weeks of Screening forattenuated androgens; within 5 half-lives of Screening for monoclonal antibodies, orwithin 7 days of Screening for short-term prophylaxis
Any females who are pregnant, plan to become pregnant, or are currentlybreast-feeding
Abnormal hepatic function
Moderate or severe renal impairment
Any clinically significant comorbidity or systemic dysfunction that would interferewith the participant's safety or ability to participate in the study.
History of alcohol or drug abuse within the previous year, or current evidence ofsubstance dependence or abuse
Use of medications that are moderate and strong inhibitors or strong inducers ofCYP3A4 within the last 30 days or within 5 half-lives (whichever is longer) of thetime of randomization
Known hypersensitivity to deucrictibant or any of the excipients of the study drug
Study Design
Study Description
Connect with a study center
Study Site
Sofia,
BulgariaActive - Recruiting
Study Site
Hong Kong,
Hong KongActive - Recruiting
Study Site
Dublin,
IrelandActive - Recruiting
Study Site
Kraków,
PolandActive - Recruiting
Study Site
Brighton,
United KingdomActive - Recruiting
Study Site
Bristol,
United KingdomActive - Recruiting
Study Site
Cambridge,
United KingdomActive - Recruiting
Study Site
London,
United KingdomActive - Recruiting
Study Site
Saint Louis, Missouri 63141
United StatesActive - Recruiting
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