Phase
Condition
Allergies & Asthma
Urticaria
Hives (Urticaria)
Treatment
Placebo
Deucrictibant
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provision of written informed consent
Male or female (sex at birth) aged ≥18 years
Diagnosis of AAE-C1INH
History of AAE-C1INH attacks prior to the Screening Visit:
Participants enrolling in Part 1 must have stable underlying disease of AAE-C1INH
The underlying condition can reasonably be expected to remain stable for theduration
Reliable access and ability to use available therapy to effectively manage AAE-C1INH attacks.
Female participants of childbearing potential must agree to the protocol-specifiedpregnancy testing and to be abstinent from heterosexual intercourse or to use anacceptable contraception method.
Females of non-childbearing potential (prepubertal, surgically sterile, or postmenopausal with ≥ 12 months amenorrhea and postmenopausal FSH confirmation) are not required to use contraception during the study.
• Capable of recording, without assistance, eDiary and ePRO data using an electronic device, as evidenced by the eDiary and ePRO training.
Exclusion
Exclusion Criteria:
Participation in a clinical study with any other investigational drug within thelast 30 days or within 5 half-lives of the investigational drug at the ScreeningVisit (whichever is longer).
Participants who have previously received prophylactic therapy but have stopped canparticipate in this study provided the last dose of the treatment was received priorto the timepoint before the Screening Visit
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 epilepsy and/or other significant neurological diseases
Any clinically significant and uncontrolled gastrointestinal dysfunction that mayimpact study drug absorption
Evidence of current alcohol or drug abuse
Use of medications that are moderate and strong inhibitors of cytochrome P450 (CYP) 3A4, or strong inducers of CYP3A4 within the last 30 days or within 5 half-lives (whichever is longer) at the time of the Screening Visit
Known hypersensitivity to deucrictibant or any of the excipients of the study drug
Use of angiotensin-converting enzyme inhibitors or any estrogen-containingmedications
Study Design
Study Description
Connect with a study center
Study Site
Sofia,
BulgariaActive - Recruiting
Study Site
Edmonton,
CanadaActive - Recruiting
Study Site
Edmonton 5946768,
CanadaSite Not Available
Study Site
Paris,
FranceActive - Recruiting
Study Site
Berlin,
GermanyActive - Recruiting
Study Site
Frankfurt am Main,
GermanyActive - Recruiting
Study Site
Munich,
GermanyActive - Recruiting
Study Site
Budapest,
HungaryActive - Recruiting
Study List
Milan,
ItalyActive - Recruiting
Study Site
Basel,
SwitzerlandActive - Recruiting
Study Site
Cambridge,
United KingdomActive - Recruiting
Study Site
Cambridge 2653941,
United KingdomSite Not Available
Study Site
Leicester,
United KingdomActive - Recruiting
Study Site
Leicester 2644668,
United KingdomSite Not Available
Study Site
London,
United KingdomActive - Recruiting
Study Site
London 2643743,
United KingdomSite Not Available
Study Site
Newcastle upon Tyne,
United KingdomActive - Recruiting
Study Site
Plymouth,
United KingdomActive - Recruiting
Study Site
Plymouth 2640194,
United KingdomSite Not Available
Study Site
Walnut Creek, California 94598
United StatesActive - Recruiting
Study Site
Walnut Creek 5406990, California 5332921 94598,
United StatesSite Not Available
Study Site
St Louis, Missouri 63130
United StatesActive - Recruiting
Study Site
St Louis 4407066, Missouri 4398678 63130
United StatesSite Not Available

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