Phase
Condition
Urticaria
Hives (Urticaria)
Treatment
Placebo to remibrutinib
Placebo to omalizumab
Omalizumab
Clinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male and female adult participants ≥18 years of age at the time of signing theinformed consent.
CSU duration for ≥ 6 months prior to screening.
Diagnosis of CSU inadequately controlled by second generation H1-AH at the time ofrandomization, defined as:
The presence of itch and hives for ≥6 consecutive weeks prior to screening, despitethe use of second-generation H1-AH during this time period.
UAS7 score (range 0-42) ≥16, ISS7 score (range 0-21) ≥ 6 and HSS7 score (range 0-
- ≥ 6 during the 7 days prior to randomization (Day 1).
Documentation of hives within three months before randomization.
Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for theduration of the study and adhere to the study protocol.
Participants must not have had more than one missing UPDD entry (either morning orevening) in the 7 days prior to randomization (Day 1).
Exclusion
Exclusion Criteria:
Prior exposure to ligelizumab, omalizumab and other biologics with any effect inCSU, including anti-IgE therapies.
Significant bleeding risk or coagulation disorders.
History of gastrointestinal bleeding.
Requirement for anti-platelet or anti-coagulant medication.
History or current hepatic disease.
Evidence of clinically significant cardiovascular, neurological, psychiatric,pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders,gastrointestinal disease or immunodeficiency that, in the investigator's opinion,would compromise the safety of the participant, interfere with the interpretation ofthe study results or otherwise preclude participation or protocol adherence of theparticipant.
Evidence of helminthic parasitic infection as evidenced by stools being positive fora pathogenic organism according to local guidelines.
Documented history of anaphylaxis.
Pregnant or nursing (lactating) women.
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Rosario, Santa Fe S2000DBS
ArgentinaActive - Recruiting
Novartis Investigative Site
Bahia Blanca, B8000JRB
ArgentinaActive - Recruiting
Novartis Investigative Site
Caba, C1012AAY
ArgentinaActive - Recruiting
Novartis Investigative Site
Capital Federal, C1023AAB
ArgentinaActive - Recruiting
Novartis Investigative Site
Mendoza, 5500
ArgentinaActive - Recruiting
Novartis Investigative Site
Woolloongabba, Queensland 4102
AustraliaActive - Recruiting
Novartis Investigative Site
Melbourne, Victoria 3004
AustraliaActive - Recruiting
Novartis Investigative Site
Porto Alegre, RS 90560 030
BrazilActive - Recruiting
Novartis Investigative Site
Santo Andre, SP 09060-870
BrazilActive - Recruiting
Novartis Investigative Site
Sorocaba, SP 18040-425
BrazilActive - Recruiting
Novartis Investigative Site
Alphaville Barueri, Sao Paulo 06454010
BrazilActive - Recruiting
Novartis Investigative Site
Sofia, 1000
BulgariaActive - Recruiting
Novartis Investigative Site
Varna, 9000
BulgariaActive - Recruiting
Novartis Investigative Site
Edmonton, Alberta T6G 1C3
CanadaActive - Recruiting
Novartis Investigative Site
Hamilton, Ontario L8L 3C3
CanadaActive - Recruiting
Novartis Investigative Site
London, Ontario N6H 5L5
CanadaActive - Recruiting
Novartis Investigative Site
Niagara Falls, Ontario L2H 1H5
CanadaActive - Recruiting
Novartis Investigative Site
Verdun, Quebec H4G 3E7
CanadaActive - Recruiting
Novartis Investigative Site
Quebec, G1V 4W2
CanadaActive - Recruiting
Novartis Investigative Site
Brno, 60200
CzechiaActive - Recruiting
Novartis Investigative Site
Plzen Bolevec, 32300
CzechiaActive - Recruiting
Novartis Investigative Site
Prague 10, 100 34
CzechiaSite Not Available
Novartis Investigative Site
Praha 10, 100 34
CzechiaActive - Recruiting
Novartis Investigative Site
Toulon Cedex 9, Val De Marne 83800
FranceActive - Recruiting
Novartis Investigative Site
Bobigny Cedex, 93009
FranceActive - Recruiting
Novartis Investigative Site
Clermont Ferrand, 63003
FranceActive - Recruiting
Novartis Investigative Site
Grenoble, 38043
FranceActive - Recruiting
Novartis Investigative Site
La Rochelle, 17019
FranceActive - Recruiting
Novartis Investigative Site
La Tronche, 38700
FranceSite Not Available
Novartis Investigative Site
Nantes Cedex 1, 44093
FranceActive - Recruiting
Novartis Investigative Site
Nice, 06000
FranceActive - Recruiting
Novartis Investigative Site
Pierre Benite, 69495
FranceActive - Recruiting
Novartis Investigative Site
Rouen, 76031
FranceActive - Recruiting
Novartis Investigative Site
Frankfurt am Main, Hessen 60590
GermanyActive - Recruiting
Novartis Investigative Site
Goettingen, Niedersachsen 37075
GermanyActive - Recruiting
Novartis Investigative Site
Leipzig, Sachsen 04103
GermanyActive - Recruiting
Novartis Investigative Site
Halle Saale, Sachsen-Anhalt 06120
GermanyActive - Recruiting
Novartis Investigative Site
Bad Bentheim, 48455
GermanyActive - Recruiting
Novartis Investigative Site
Berlin, 13353
GermanyActive - Recruiting
Novartis Investigative Site
Bochum, 44791
GermanyActive - Recruiting
Novartis Investigative Site
Dresden, 01307
GermanyActive - Recruiting
Novartis Investigative Site
Frankfurt, 60590
GermanySite Not Available
Novartis Investigative Site
Freiburg, 79106
GermanyActive - Recruiting
Novartis Investigative Site
Gottingen, 37075
GermanySite Not Available
Novartis Investigative Site
Halle, 06120
GermanySite Not Available
Novartis Investigative Site
Halle S, 06120
GermanySite Not Available
Novartis Investigative Site
Hamburg, 22391
GermanyActive - Recruiting
Novartis Investigative Site
Heidelberg, 69120
GermanyActive - Recruiting
Novartis Investigative Site
Luebeck, 23538
GermanyActive - Recruiting
Novartis Investigative Site
Mainz, 55131
GermanyActive - Recruiting
Novartis Investigative Site
Muenchen, 81377
GermanyActive - Recruiting
Novartis Investigative Site
Muenster, 48149
GermanyActive - Recruiting
Novartis Investigative Site
Osnabrueck, 49074
GermanyActive - Recruiting
Novartis Investigative Site
Stade, 21682
GermanyActive - Recruiting
Novartis Investigative Site
Tuebingen, 72076
GermanyActive - Recruiting
Novartis Investigative Site
Debrecen, 4032
HungaryActive - Recruiting
Novartis Investigative Site
Kaposvar, 7400
HungaryActive - Recruiting
Novartis Investigative Site
Pecs, 7623
HungaryActive - Recruiting
Novartis Investigative Site
Ahmedabad, Gujarat 380016
IndiaSite Not Available
Novartis Investigative Site
Bangalore, Karnataka 560004
IndiaSite Not Available
Novartis Investigative Site
Belagavi, Karnataka 590010
IndiaSite Not Available
Novartis Investigative Site
Mysore, Karnataka 570001
IndiaSite Not Available
Novartis Investigative Site
Nagpur, Maharashtra 440015
IndiaSite Not Available
Novartis Investigative Site
Nashik, Maharashtra 422101
IndiaSite Not Available
Novartis Investigative Site
Bikaner, Rajasthan 334003
IndiaSite Not Available
Novartis Investigative Site
Hyderabad, Telangana 500004
IndiaSite Not Available
Novartis Investigative Site
Dehradun, Uttarakhand 248001
IndiaSite Not Available
Novartis Investigative Site
Belgavi, 590010
IndiaSite Not Available
Novartis Investigative Site
New Delhi, 110029
IndiaSite Not Available
Novartis Investigative Site
Milano, MI 20122
ItalyActive - Recruiting
Novartis Investigative Site
Rozzano, MI 20089
ItalyActive - Recruiting
Novartis Investigative Site
Modena, MO 41124
ItalyActive - Recruiting
Novartis Investigative Site
Roma, RM 00168
ItalyActive - Recruiting
Novartis Investigative Site
Siena, SI 53100
ItalyActive - Recruiting
Novartis Investigative Site
Ansan, Gyeonggi Do 425-801
Korea, Republic ofActive - Recruiting
Novartis Investigative Site
Busan, 49241
Korea, Republic ofActive - Recruiting
Novartis Investigative Site
Seoul, 03722
Korea, Republic ofActive - Recruiting
Novartis Investigative Site
Muar, Johor 84000
MalaysiaActive - Recruiting
Novartis Investigative Site
Ipoh, Perak 30450
MalaysiaActive - Recruiting
Novartis Investigative Site
Petaling Jaya, Selangor Darul Ehsan 46150
MalaysiaActive - Recruiting
Novartis Investigative Site
Kuala Lumpur, 59100
MalaysiaActive - Recruiting
Novartis Investigative Site
Penang, 10990
MalaysiaSite Not Available
Novartis Investigative Site
Pulau Pinang, 10990
MalaysiaActive - Recruiting
Novartis Investigative Site
Wilayah Persekutuan, 62502
MalaysiaActive - Recruiting
Novartis Investigative Site
Cuauhtemoc, Cdmx 06100
MexicoActive - Recruiting
Novartis Investigative Site
Zapopan, Jalisco 45190
MexicoActive - Recruiting
Novartis Investigative Site
Villahermosa, Tabasco 86035
MexicoActive - Recruiting
Novartis Investigative Site
Merida, Yucatan 97070
MexicoActive - Recruiting
Novartis Investigative Site
Amsterdam, 1105 AZ
NetherlandsActive - Recruiting
Novartis Investigative Site
Utrecht, 3584
NetherlandsActive - Recruiting
Novartis Investigative Site
Gdansk, 80-546
PolandActive - Recruiting
Novartis Investigative Site
Krosno, 38-400
PolandActive - Recruiting
Novartis Investigative Site
Poznan, 60-823
PolandActive - Recruiting
Novartis Investigative Site
Warszawa, 02-507
PolandActive - Recruiting
Novartis Investigative Site
Bardejov, 08501
SlovakiaActive - Recruiting
Novartis Investigative Site
Kezmarok, 060 01
SlovakiaActive - Recruiting
Novartis Investigative Site
Svidnik, 08901
SlovakiaActive - Recruiting
Novartis Investigative Site
Trnava, 91702
SlovakiaActive - Recruiting
Novartis Investigative Site
Cordoba, Andalucia 14004
SpainActive - Recruiting
Novartis Investigative Site
Granada, Andalucia 18014
SpainActive - Recruiting
Novartis Investigative Site
Barcelona, Catalunya 08035
SpainActive - Recruiting
Novartis Investigative Site
Valencia, Comunidad Valenciana 46015
SpainActive - Recruiting
Novartis Investigative Site
Pozuelo de Alarcon, Madrid 28223
SpainActive - Recruiting
Novartis Investigative Site
Las Palmas de Gran Canaria, 35010
SpainActive - Recruiting
Novartis Investigative Site
Madrid, 28046
SpainActive - Recruiting
Novartis Investigative Site
Geneve, 1205
SwitzerlandSite Not Available
Novartis Investigative Site
Geneve 14, 1211
SwitzerlandActive - Recruiting
Novartis Investigative Site
St Gallen, 9007
SwitzerlandSite Not Available
Novartis Investigative Site
Zuerich, 8091
SwitzerlandActive - Recruiting
Novartis Investigative Site
Taipei, 10002
TaiwanSite Not Available
Novartis Investigative Site
Taoyuan, 33305
TaiwanActive - Recruiting
Novartis Investigative Site
Bangkoknoi, Bangkok 10700
ThailandSite Not Available
Novartis Investigative Site
Songkhla, Hat Yai 90110
ThailandActive - Recruiting
Novartis Investigative Site
Khon Kaen, THA 40002
ThailandActive - Recruiting
Novartis Investigative Site
Bangkok, 10400
ThailandActive - Recruiting
Novartis Investigative Site
Chiang Mai, 50200
ThailandActive - Recruiting
Novartis Investigative Site
Istanbul, TUR 34098
TurkeyActive - Recruiting
Novartis Investigative Site
Aydin, 09100
TurkeyActive - Recruiting
Novartis Investigative Site
Denizli, 20070
TurkeyActive - Recruiting
Novartis Investigative Site
Fatih / Istanbul, 34093
TurkeySite Not Available
Novartis Investigative Site
Fatih-Istanbul, 34093
TurkeyActive - Recruiting
Novartis Investigative Site
Sakarya, 54290
TurkeyActive - Recruiting
Novartis Investigative Site
Westbruy On Trym, Bristol BS10 5NB
United KingdomActive - Recruiting
Novartis Investigative Site
Leeds, West Yorkshire LS9 7TF
United KingdomActive - Recruiting
Novartis Investigative Site
Birmingham, B9 5SS
United KingdomActive - Recruiting
Novartis Investigative Site
Oxford, OX3 7LE
United KingdomActive - Recruiting
Novartis Investigative Site
Hanoi, 100000
VietnamActive - Recruiting
Novartis Investigative Site
Ho Chi Minh, 7000
VietnamActive - Recruiting
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