Phase
Condition
Allergy
Hives (Urticaria)
Urticaria
Treatment
deucrictibant selected dose
deucrictibant low dose
deucrictibant medium dose
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Signed and dated informed consent form
Diagnosis of HAE type I or II
For participants from Study C201, received at least one dose of study drug (including the non-attack visit) in Study C201. For participants from Study C306,participant was randomized (and for adolescent participants 12 to <18 years receiveda dose of study drug in a non-attack state at Visit 1) and completed Study C306,with 2 attacks treated, or after closure of that study by the Sponsor.
In the opinion of the Investigator, the participant (and parent/caregiver foradolescent participants) is willing and able to comply with the protocol.
Exclusion
Key Exclusion Criteria:
Pregnancy or breast-feeding
Any other systemic disease or significant disease or disorder that would interferewith the patient's safety or ability to participate in the study
Use of lanadelumab for long-term HAE prophylactic therapy within 12 weeks prior toenrollment in Part A.
For Part A: Use of C1-esterase inhibitor, oral kallikrein inhibitors, attenuatedandrogens, anti-fibrinolytics, or monoclonal HAE therapy within a defined periodprior to enrolment. For Part B: If a participant is receiving long-term prophylactic therapy with one ofthe following medications indicated for HAE: plasma-derived C1-INH, danazol at lessthan or equal to 200 mg/day, anti-fibrinolytics, berotralstat, or lanadelumab, theymust be on a stable dose and regimen for at least 3 months before screening andintends to remain on the same dose for the duration of the study.
History of alcohol or drug abuse within defined period, or current evidence ofsubstance dependence or abuse
Participation in any other investigational drug study within defined period
Discontinued from parent study after enrollment for any study drug-related safetyreason.
Use of concomitant medications that are potent CYP3A4 inhibitors (e.g.,clarithromycin, erythromycin, itraconazole, ketoconazole, ritonavir, grapefruit) orpotent CYP3A4 inducers (e.g., phenytoin, rifampicin, St. John's Wort).
Study Design
Study Description
Connect with a study center
Study site
Sofia, 1680
BulgariaSite Not Available
Study site
Montréal, Quebec
CanadaSite Not Available
Study site
Brno, 65691
CzechiaSite Not Available
Study site
Grenoble, 38043
FranceSite Not Available
Study site
La Tronche, 38700
FranceSite Not Available
Study site
Paris, 75010
FranceSite Not Available
Study site
Berlin, 10114
GermanySite Not Available
Study site
Frankfurt am Main, 60596
GermanySite Not Available
Study site
Budapest, 1088
HungarySite Not Available
Study site
Ashkelon, 78278
IsraelSite Not Available
Study site
Napoli, 80131
ItalySite Not Available
Study site
Kraków, 31-503
PolandSite Not Available
Study site
Barcelona, 08035
SpainSite Not Available
Study site
Madrid, 28007
SpainSite Not Available
Study site
Birmingham, Alabama 35209
United StatesSite Not Available
Study site
Scottsdale, Arizona 85258
United StatesSite Not Available
Study site
Santa Monica, California 90404
United StatesSite Not Available
Study site
Walnut Creek, California 94598
United StatesSite Not Available
Study site
Colorado Springs, Colorado 80907
United StatesSite Not Available
Study site
Chevy Chase, Maryland 20815
United StatesSite Not Available
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