Phase
Condition
Allergies & Asthma
Allergy
Urticaria
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
Corrientes,
ArgentinaSite Not Available
Study Site
Corrientes 3435217,
ArgentinaActive - Recruiting
Study Site
San Martín 3836992,
ArgentinaActive - Recruiting
Study Site
Santo André 3449701,
BrazilActive - Recruiting
Study Site
Sofia, 1680
BulgariaSite Not Available
Study Site
Sofia 727011, 1680
BulgariaActive - Recruiting
Study Site
Edmonton,
CanadaSite Not Available
Study Site
Edmonton 5946768,
CanadaActive - Recruiting
Study Site
Ottawa,
CanadaSite Not Available
Study Site
Ottawa 6094817,
CanadaActive - Recruiting
Study Site
Grenoble,
FranceSite Not Available
Study Site
Grenoble 3014728,
FranceActive - Recruiting
Study Site
Lille, 59037
FranceSite Not Available
Study Site
Lille 2998324, 59037
FranceActive - Recruiting
Study Site
Berlin,
GermanySite Not Available
Study Site
Berlin 2950159,
GermanyActive - Recruiting
Study Site
Brandenburg,
GermanySite Not Available
Study Site
Frankfurt,
GermanySite Not Available
Study Site
Frankfurt 2925536,
GermanyActive - Recruiting
Study Site
Hannover,
GermanySite Not Available
Study Site
Hanover 2910831,
GermanyActive - Recruiting
Study Site
Hong Kong 1819729,
Hong KongActive - Recruiting
Study Site
Hongkong,
Hong KongSite Not Available
Study Site
Budapest,
HungarySite Not Available
Study Site
Budapest 3054643,
HungaryActive - Recruiting
Study Site
Dublin,
IrelandSite Not Available
Study Site
Dublin 2964574,
IrelandActive - Recruiting
Study Site
Milan, 20062
ItalySite Not Available
Study Site
Milan 3173435, 20062
ItalyActive - Recruiting
Study Site
Padova,
ItalySite Not Available
Study Site
Padua 3171728,
ItalyActive - Recruiting
Study Site
Veneto,
ItalySite Not Available
Study Site
Kawasaki,
JapanSite Not Available
Study Site
Kawasaki 1859642,
JapanActive - Recruiting
Study Site
Tokyo, 1130033
JapanSite Not Available
Study Site
Tokyo 1850147, 1130033
JapanActive - Recruiting
Study Site
Daegu,
Korea, Republic ofSite Not Available
Study Site
Seoul, 06351
Korea, Republic ofSite Not Available
Study Site
Suwon,
Korea, Republic ofSite Not Available
Study Site
Auckland,
New ZealandSite Not Available
Study Site
Auckland 2193733,
New ZealandActive - Recruiting
Study Site
Krakow 3094802,
PolandActive - Recruiting
Study Site
Kraków,
PolandSite Not Available
Study Site
San Juan,
Puerto RicoSite Not Available
Study Site
San Juan 4568127,
Puerto RicoActive - Recruiting
Study Site
Sangeorgiu de Mures,
RomaniaSite Not Available
Study Site
Sângeorgiu de Mureş 667034,
RomaniaActive - Recruiting
Study Site
Singapore,
SingaporeSite Not Available
Study Site
Singapore 1880252,
SingaporeActive - Recruiting
Study Site
Martin,
SlovakiaSite Not Available
Study Site
Martin 3058780,
SlovakiaActive - Recruiting
Study Site
Cape Town,
South AfricaSite Not Available
Study Site
Cape Town 3369157,
South AfricaActive - Recruiting
Study Site
Daegu 1835329,
South KoreaActive - Recruiting
Study Site
Seoul 1835848, 06351
South KoreaActive - Recruiting
Study Site
Suwon 1835553,
South KoreaActive - Recruiting
Study Site
Barcelona, 08013
SpainSite Not Available
Study Site
Barcelona 3128760, 08907
SpainActive - Recruiting
Study Site
Seville,
SpainSite Not Available
Study Site
Seville 2510911,
SpainActive - Recruiting
Study Site
Basel,
SwitzerlandSite Not Available
Study Site
Basel 2661604,
SwitzerlandActive - Recruiting
Study Site
Ankara,
TurkeySite Not Available
Study Site
Istanbul,
TurkeySite Not Available
Study Site
İzmir,
TurkeySite Not Available
Study Site
Ankara 323786,
Turkey (Türkiye)Active - Recruiting
Study Site
Istanbul 745044,
Turkey (Türkiye)Active - Recruiting
Study Site
Izmir 311046,
Turkey (Türkiye)Active - Recruiting
Study site
London, England E1 1FR
United KingdomActive - Recruiting
Study site
London 2643743, England 6269131 E1 1FR
United KingdomActive - Recruiting
Study Site
Birmingham, B9 5SS
United KingdomSite Not Available
Study Site
Birmingham 2655603, B9 5SS
United KingdomActive - Recruiting
Study Site
Bristol, BS10 5NB
United KingdomSite Not Available
Study Site
Bristol 2654675, BS10 5NB
United KingdomActive - Recruiting
Study Site
Cambridge, CB2 0QQ
United KingdomSite Not Available
Study Site
Cambridge 2653941, CB2 0QQ
United KingdomActive - Recruiting
Study Site
Frimley, GU16 7UJ
United KingdomSite Not Available
Study Site
Frimley 2649052, GU16 7UJ
United KingdomActive - Recruiting
Study Site
Leeds, LS9 7TF
United KingdomSite Not Available
Study Site
Leeds 2644688, LS9 7TF
United KingdomActive - Recruiting
Study Site
London, NW3 2QG
United KingdomSite Not Available
Study Site
London 2643743, NW3 2QG
United KingdomActive - Recruiting
Study Site
Oxford,
United KingdomSite Not Available
Study Site
Oxford 2640729,
United KingdomActive - Recruiting
Study site
Plymouth, PL6 5FP
United KingdomSite Not Available
Study site
Plymouth 2640194, PL6 5FP
United KingdomActive - Recruiting
Study Site
Southampton,
United KingdomSite Not Available
Study Site
Southampton 2637487,
United KingdomActive - Recruiting
Study Site
Stoke 2636868,
United KingdomActive - Recruiting
Study Site
Little Rock, Arkansas 72205
United StatesSite Not Available
Study Site
Little Rock 4119403, Arkansas 4099753 72205
United StatesActive - 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
Wheaton, Maryland 20902
United StatesSite Not Available
Study Site
Wheaton 4373349, Maryland 4361885 20902
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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