Phase
Condition
Allergies & Asthma
Allergy
Hives (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
Melbourne 2158177,
AustraliaActive - Recruiting
Study Site
Perth 2063523,
AustraliaActive - Recruiting
Study Site
Vienna,
AustriaSite Not Available
Study Site
Vienna 2761369,
AustriaActive - Recruiting
Study Site
Sofia,
BulgariaSite Not Available
Study Site
Sofia 727011,
BulgariaActive - Recruiting
Study Site
Montreal 6077243,
CanadaActive - Recruiting
Study Site
Montréal,
CanadaSite Not Available
Study Site
Berlin,
GermanySite Not Available
Study Site
Berlin 2950159,
GermanyActive - Recruiting
Study Site
Frankfurt,
GermanySite Not Available
Study Site
Frankfurt 2925536,
GermanyActive - Recruiting
Study Site
Hong Kong,
Hong KongSite Not Available
Study Site
Hong Kong 1819729,
Hong KongActive - Recruiting
Study Site
Dublin,
IrelandSite Not Available
Study Site
Dublin 2964574,
IrelandActive - Recruiting
Study Site
Padova,
ItalySite Not Available
Study Site
Padua 3171728,
ItalyActive - Recruiting
Study Site
Krakow 3094802,
PolandActive - Recruiting
Study Site
Kraków,
PolandSite Not Available
Study Site
Cape Town 3369157,
South AfricaActive - Recruiting
Study Site
Daegu 1835329,
South KoreaActive - Recruiting
Study Site
Seoul 1835848,
South KoreaActive - Recruiting
Study Site
Barcelona, 08907
SpainSite Not Available
Study Site
Barcelona 3128760, 08907
SpainActive - Recruiting
Study Site
Brighton,
United KingdomSite Not Available
Study Site
Brighton 2654710,
United KingdomActive - Recruiting
Study Site
Bristol,
United KingdomSite Not Available
Study Site
Bristol 2654675,
United KingdomActive - Recruiting
Study Site
Cambridge,
United KingdomSite Not Available
Study Site
Cambridge 2653941,
United KingdomActive - Recruiting
Study Site
London,
United KingdomSite Not Available
Study Site
London 2643743,
United KingdomActive - Recruiting
Study Site
Plymouth 2640194,
United KingdomActive - Recruiting
Study Site
Santa Monica, California 90404
United StatesSite Not Available
Study Site
Walnut Creek, California 94598
United StatesSite Not Available
Study Site
Santa Monica 5393212, California 5332921 90404
United StatesActive - Recruiting
Study Site
Walnut Creek 5406990, California 5332921 94598
United StatesActive - Recruiting
Study Site
Saint Louis, Missouri 63141
United StatesSite Not Available
Study Site
St Louis 4407066, Missouri 4398678 63141
United StatesActive - Recruiting

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