Phase
Condition
Hives (Urticaria)
Allergy
Allergies & Asthma
Treatment
Deucrictibant
Placebo
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)
History of at least 3 HAE attacks within the 3 consecutive months prior to ScreeningVisit
Predefined number of attacks during the Screening Period
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 potential must agree to the protocol specifiedpregnancy testing 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 Screening (whichever is longer)
Has received prior prophylactic treatment with deucrictibant
Exposure to ACE inhibitors or any estrogen-containing medications with systemicabsorption within 4 weeks of Screening
Prior gene therapy for any indication at any time
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, 1431
BulgariaActive - Recruiting
Study Site
Edmonton,
CanadaActive - Recruiting
Study Site
Ottawa,
CanadaActive - Recruiting
Study Site
Grenoble,
FranceActive - Recruiting
Study Site
Hongkong,
Hong KongActive - Recruiting
Study Site
Dublin,
IrelandActive - Recruiting
Study Site
Tokyo,
JapanActive - Recruiting
Study Site
Seoul,
Korea, Republic ofActive - Recruiting
Study Site
San Juan,
Puerto RicoActive - Recruiting
Study Site
Sangeorgiu de Mures,
RomaniaActive - Recruiting
Study Site
Singapore,
SingaporeActive - Recruiting
Study Site
Martin,
SlovakiaActive - Recruiting
Study site
London, England E1 1FR
United KingdomActive - Recruiting
Study Site
Birmingham,
United KingdomActive - Recruiting
Study site
Plymouth, PL6 5FP
United KingdomActive - Recruiting
Study Site
Little Rock, Arkansas 72205
United StatesActive - Recruiting
Study site
Santa Monica, California 90404
United StatesActive - Recruiting
Study site
Walnut Creek, California 94598
United StatesActive - Recruiting
Study Site
Wheaton, Maryland 20902
United StatesActive - Recruiting
Study Site
Saint Louis, Missouri 63141
United StatesActive - Recruiting
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