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:
Provision of written informed consent. If the participant is a minor (i.e., <18years of age or as determined by local law), consent will be obtained from theparticipant's parent/legally designated representative/guardian and written assentwill be obtained from the participant, per country regulations.
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. Enrollment of adolescents (≥12 to <18 years or age of adulthood as defined locally)from these studies is with consideration of local age requirements.
Female participants of childbearing potential (or who become of childbearingpotential during the study) must agree to the protocol-specified pregnancy testingand to be abstinent from heterosexual intercourse or to use an acceptablecontraception method as defined in the protocol and as available locally fromenrollment until 30 days after the last study drug administration.
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:
Any female who is pregnant, plans to become pregnant, or is breast-feeding.
Any other systemic disease (e.g., cardiovascular, gastrointestinal, renal,respiratory, neurological) or significant disease or disorder that, in the opinionof the Investigator, would interfere with the participant's safety or ability toparticipate 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 or non-compliance including significant protocol deviation.
Use of concomitant medications that are strong CYP3A4 inhibitors (e.g.,clarithromycin, erythromycin, itraconazole, ketoconazole, ritonavir) or strongCYP3A4 inducers (e.g., carbamazepine and phenytoin).
Study Design
Study Description
Connect with a study center
Study site
Buenos Aires, B1629AHJ
ArgentinaSite Not Available
Study site
Campbelltown, New South Wales 2560
AustraliaSite Not Available
Study site
Graz, 8036
AustriaSite Not Available
Study site
Wien, 1090
AustriaSite Not Available
Study site
Sofia, 1680
BulgariaSite Not Available
Study site
Edmonton, Alberta T6G 1Z1
CanadaSite Not Available
Study site
Montréal, Quebec
CanadaSite Not Available
Study site
Brno, 602 00
CzechiaSite Not Available
Study site
Grenoble, 38043
FranceSite Not Available
Study site
La Tronche, 38700
FranceSite Not Available
Study site
Paris, 75571
FranceSite Not Available
Study site
Berlin, 12203
GermanySite Not Available
Study site
Frankfurt am Main, 60590
GermanySite Not Available
Study site
Lubeck, 23538
GermanySite Not Available
Study site
Hong Kong,
Hong KongSite Not Available
Study site
Budapest, 1088
HungarySite Not Available
Study site
Ashkelon, 78278
IsraelSite Not Available
Study site
Catania, 95124
ItalySite Not Available
Study site
Milano, 20097
ItalySite Not Available
Study site
Napoli, 80131
ItalySite Not Available
Study site
Padova, 35128
ItalySite Not Available
Study site
Palermo, 90146
ItalySite Not Available
Study site
Roma, 00133
ItalySite Not Available
Study site
Hiroshima, 730-8518
JapanSite Not Available
Study site
Kanagawa, 216-8511
JapanSite Not Available
Study site
Osaka, 569-8686
JapanSite Not Available
Study site
Tokyo, 133-8431
JapanSite Not Available
Study site
Daegu, 41944
Korea, Republic ofSite Not Available
Study site
Seoul, 03080
Korea, Republic ofSite Not Available
Study site
Amsterdam, 1005 AZ
NetherlandsSite Not Available
Study site
Kraków, 31-503
PolandSite Not Available
Study site
San Juan, 918
Puerto RicoSite Not Available
Study site
Cape Town, 7700
South AfricaSite Not Available
Study site
Barcelona, 08035
SpainSite Not Available
Study site
Madrid, 28007
SpainSite Not Available
Study site
Lund, 22185
SwedenSite Not Available
Study site
Ankara, 06230
TurkeySite Not Available
Study site
Istanbul, 34093
TurkeySite Not Available
Study site
Birmingham, Alabama 35209
United StatesSite Not Available
Study site
Scottsdale, Arizona 85258
United StatesSite Not Available
Study site
Little Rock, Arkansas 72205
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
Study site
Detroit, Michigan 48202
United StatesSite Not Available
Study site
St. Louis, Missouri 63141
United StatesSite Not Available
Study site
Hershey, Pennsylvania 17033
United StatesSite Not Available
Study site
Dallas, Texas 75231
United StatesSite Not Available
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