Phase
Condition
Urticaria
Treatment
Placebo
Remibrutinib
Clinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria for core period:
Male and female participants ≥18 years of age at the time of signing of the ICFs
Confirmed CINDU diagnosis (as per guidelines) for symptomatic dermographism, cold urticaria or cholinergic urticaria for ≥ 4 months (defined as onset of CINDU with supporting documentation (e.g medical record, clinical history, photographs)) and inadequate control with H1-AH at local label approved doses at the time of randomization
The following response to the provocation test for each subtype is required at the randomization visit :
Symptomatic Dermographism: A Total Fric Score of ≥3 using the FricTest® 4.0 and a numerical rating scale score of ≥5 for itch after the provocation test.
Cold Urticaria: A Critical Threshold Temperature of ≥15°C using the TempTest® 4.0 and a numerical rating scale score of ≥5 for itch after the provocation test.
Cholinergic Urticaria: A physician global assessment of severity of hives ≥ 2 using the Pulse-controlled ergometry test and a numerical rating scale score of ≥5 for itch after the provocation test.
Cold Urticaria: Positive ice-cube test resulting in hives at the provocation site for participants at Screening.
Cholinergic urticaria: Participants must show sweating in performing the pulse-controlled ergometry test on day of randomization. Participants with anhidrosis must not be included.
Inclusion criteria for the OLE:
- Participants who have completed the Core period up to Week 52 and are willing to enter the OLE period
Exclusion Criteria for core period:
Previous use of remibrutinib or other BTK inhibitors.
Participants who have concomitant CSU at screening. Participants with resolved CSU at the time of screening can be included in the study.
Participants who have a familial form (e.g familial cold autoinflammatory syndrome, familial cold urticaria) of the target CINDU that is being considered for the participant's inclusion in this study.
Participants having a more defined other form of inducible urticaria than the target CINDU that is being considered for the participant's inclusion in this study.
Diseases, other than chronic inducible urticaria, with urticaria or angioedema symptoms including but not limited to urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema
Any other skin disease associated with chronic itching that might influence, in the investigator's opinion, the study evaluations and results (e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases associated with only wheals and no itch e.g asymptomatic dermographism
There are no exclusion criteria for OLE
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Caba, Buenos Aires C1181ACH
ArgentinaActive - Recruiting
Novartis Investigative Site
Rosario, Santa Fe 2000
ArgentinaActive - Recruiting
Novartis Investigative Site
Buenos Aires, C1125ABE
ArgentinaActive - Recruiting
Novartis Investigative Site
Woolloongabba, Queensland 4102
AustraliaActive - Recruiting
Novartis Investigative Site
Carlton, Victoria 3053
AustraliaActive - Recruiting
Novartis Investigative Site
Melbourne, Victoria 3004
AustraliaActive - Recruiting
Novartis Investigative Site
Santo Andre, SP 09060 650
BrazilActive - Recruiting
Novartis Investigative Site
Sorocaba, SP 18040-425
BrazilActive - Recruiting
Novartis Investigative Site
Alphaville Barueri, Sao Paulo 06454010
BrazilActive - Recruiting
Novartis Investigative Site
Winnipeg, Manitoba R3J 0S9
CanadaActive - Recruiting
Novartis Investigative Site
Hamilton, Ontario L8L 3C3
CanadaActive - Recruiting
Novartis Investigative Site
Trois Rivieres, Quebec G8T 7A1
CanadaSite Not Available
Novartis Investigative Site
Fuzhou, Fujian 350025
ChinaCompleted
Novartis Investigative Site
Guangzhou, Guangdong 510630
ChinaSite Not Available
Novartis Investigative Site
Guangdong, Guangzhou 510091
ChinaSite Not Available
Novartis Investigative Site
Changsha, Hunan 410008
ChinaSite Not Available
Novartis Investigative Site
Wuxi, Jiangsu 214002
ChinaSite Not Available
Novartis Investigative Site
Chang Chun, Jilin 130021
ChinaSite Not Available
Novartis Investigative Site
Jinan, Shandong 250022
ChinaActive - Recruiting
Novartis Investigative Site
Chengdu, Sichuan 610072
ChinaSite Not Available
Novartis Investigative Site
Urumqi, Xinjiang 830001
ChinaSite Not Available
Novartis Investigative Site
Hangzhou, Zhejiang 310001
ChinaSite Not Available
Novartis Investigative Site
Yi Wu, Zhejiang 322000
ChinaActive - Recruiting
Novartis Investigative Site
Beijing, 100730
ChinaSite Not Available
Novartis Investigative Site
Chongqing, 400038
ChinaActive - Recruiting
Novartis Investigative Site
Nanjing, 210042
ChinaActive - Recruiting
Novartis Investigative Site
Shanghai, 200025
ChinaSite Not Available
Novartis Investigative Site
Tianjin, 300052
ChinaSite Not Available
Novartis Investigative Site
Barranquilla, 080020
ColombiaActive - Recruiting
Novartis Investigative Site
Clermont Ferrand, 63003
FranceActive - Recruiting
Novartis Investigative Site
Grenoble, 38043
FranceActive - Recruiting
Novartis Investigative Site
Montpellier, 34295
FranceActive - Recruiting
Novartis Investigative Site
Nantes Cedex 1, 44093
FranceActive - Recruiting
Novartis Investigative Site
Paris, 75970
FranceActive - Recruiting
Novartis Investigative Site
Pierre Benite, 69495
FranceActive - Recruiting
Novartis Investigative Site
Rouen, 76031
FranceActive - Recruiting
Novartis Investigative Site
Toulouse, 31400
FranceActive - Recruiting
Novartis Investigative Site
Goettingen, Niedersachsen 37075
GermanyActive - Recruiting
Novartis Investigative Site
Berlin, 13353
GermanyActive - Recruiting
Novartis Investigative Site
Dresden, 01307
GermanyActive - Recruiting
Novartis Investigative Site
Gottingen, 37075
GermanySite Not Available
Novartis Investigative Site
Luebeck, 23538
GermanyActive - Recruiting
Novartis Investigative Site
Mainz, 55131
GermanyActive - Recruiting
Novartis Investigative Site
Muenster, 48149
GermanyActive - Recruiting
Novartis Investigative Site
Stade, 21682
GermanyActive - Recruiting
Novartis Investigative Site
Tuebingen, 72076
GermanyActive - Recruiting
Novartis Investigative Site
Hong Kong,
Hong KongActive - Recruiting
Novartis Investigative Site
Debrecen, Hajdu Bihar 4026
HungarySite Not Available
Novartis Investigative Site
Szolnok, 5000
HungaryActive - Recruiting
Novartis Investigative Site
Bangalore, Karnataka 560004
IndiaActive - Recruiting
Novartis Investigative Site
Mysore, Karnataka 570001
IndiaActive - Recruiting
Novartis Investigative Site
Nagpur, Maharashtra 440015
IndiaActive - Recruiting
Novartis Investigative Site
New Delhi, 110029
IndiaActive - Recruiting
Novartis Investigative Site
Haifa, 3339419
IsraelActive - Recruiting
Novartis Investigative Site
Jerusalem, 9112001
IsraelActive - Recruiting
Novartis Investigative Site
Kfar Saba, 44281
IsraelActive - Recruiting
Novartis Investigative Site
Ramat Gan, 52621
IsraelActive - Recruiting
Novartis Investigative Site
Tel Aviv, 6423906
IsraelActive - Recruiting
Novartis Investigative Site
Ancona, AN 60126
ItalyActive - Recruiting
Novartis Investigative Site
Catania, CT 95123
ItalyActive - Recruiting
Novartis Investigative Site
Milano, MI 20122
ItalyActive - Recruiting
Novartis Investigative Site
Rozzano, MI 20089
ItalyActive - Recruiting
Novartis Investigative Site
Roma, RM 00133
ItalyActive - Recruiting
Novartis Investigative Site
Kitakyushu, Fukuoka 807-8556
JapanActive - Recruiting
Novartis Investigative Site
Kitakyushu-city, Fukuoka 807-8556
JapanSite Not Available
Novartis Investigative Site
Sapporo, Hokkaido 060-8543
JapanActive - Recruiting
Novartis Investigative Site
Kamimashi-gun, Kumamoto 861-3106
JapanActive - Recruiting
Novartis Investigative Site
Habikino city, Osaka 583 8588
JapanActive - Recruiting
Novartis Investigative Site
Takatsuki, Osaka 569-8686
JapanActive - Recruiting
Novartis Investigative Site
Takatsuki-city, Osaka 569-8686
JapanSite Not Available
Novartis Investigative Site
Izumo-city, Shimane 693 8501
JapanActive - Recruiting
Novartis Investigative Site
Shimotsuga Gun, Tochigi 321-0293
JapanActive - Recruiting
Novartis Investigative Site
Bunkyo-ku, Tokyo 113-8519
JapanActive - Recruiting
Novartis Investigative Site
Itabashi-ku, Tokyo 173-8610
JapanActive - Recruiting
Novartis Investigative Site
Shinjuku Ku, Tokyo 160-0023
JapanActive - Recruiting
Novartis Investigative Site
Tachikawa, Tokyo 190-0023
JapanActive - Recruiting
Novartis Investigative Site
Hiroshima, 730-8518
JapanActive - Recruiting
Novartis Investigative Site
Kyoto, 606 8507
JapanActive - Recruiting
Novartis Investigative Site
Suwon si, Gyeonggi Do 16499
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
Kuala Lumpur, Wilayah Persekutuan 50586
MalaysiaActive - Recruiting
Novartis Investigative Site
Penang, 10990
MalaysiaSite Not Available
Novartis Investigative Site
Pulau Pinang, 10990
MalaysiaActive - Recruiting
Novartis Investigative Site
Groningen, 9725 CH
NetherlandsActive - Recruiting
Novartis Investigative Site
Utrecht, 3584
NetherlandsActive - Recruiting
Novartis Investigative Site
Bydgoszcz, 85-094
PolandActive - Recruiting
Novartis Investigative Site
Olsztyn, 10-045
PolandActive - Recruiting
Novartis Investigative Site
Rzeszow, 35 055
PolandActive - Recruiting
Novartis Investigative Site
Warszawa, 02-962
PolandActive - Recruiting
Novartis Investigative Site
Coimbra, 3000 075
PortugalActive - Recruiting
Novartis Investigative Site
Lisboa, 1649 035
PortugalActive - Recruiting
Novartis Investigative Site
Vila Nova De Gaia, 4434 502
PortugalActive - Recruiting
Novartis Investigative Site
Bucharest, District 2 020762
RomaniaActive - Recruiting
Novartis Investigative Site
Timisoara, Timis 300566
RomaniaActive - Recruiting
Novartis Investigative Site
Brasov, 500283
RomaniaActive - Recruiting
Novartis Investigative Site
Cluj Napoca, 400162
RomaniaActive - Recruiting
Novartis Investigative Site
Singapore, 308205
SingaporeActive - Recruiting
Novartis Investigative Site
Bratislava, 84102
SlovakiaActive - Recruiting
Novartis Investigative Site
Kezmarok, 060 01
SlovakiaActive - Recruiting
Novartis Investigative Site
Trnava, 91702
SlovakiaSite Not Available
Novartis Investigative Site
Zilina, 01207
SlovakiaSite Not Available
Novartis Investigative Site
Santiago de Compostela, A Coruna 15702
SpainActive - Recruiting
Novartis Investigative Site
Cordoba, Andalucia 14004
SpainActive - Recruiting
Novartis Investigative Site
Granada, Andalucia 18014
SpainActive - Recruiting
Novartis Investigative Site
Barcelona, Catalunya 08003
SpainActive - Recruiting
Novartis Investigative Site
Alicante, Comunidad Valenciana 03010
SpainActive - Recruiting
Novartis Investigative Site
Valencia, Comunidad Valenciana 46015
SpainActive - Recruiting
Novartis Investigative Site
Mostoles, Madrid Communidad De 28933
SpainActive - Recruiting
Novartis Investigative Site
Madrid, 280796
SpainActive - Recruiting
Novartis Investigative Site
Bangkoknoi, Bangkok 10700
ThailandSite Not Available
Novartis Investigative Site
Bangkok, 10700
ThailandActive - Recruiting
Novartis Investigative Site
Chiang Mai, 50200
ThailandActive - Recruiting
Novartis Investigative Site
Istanbul, 34662
TurkeyActive - Recruiting
Novartis Investigative Site
Sakarya, 54290
TurkeyActive - Recruiting
Novartis Investigative Site
Talas / Kayseri, 38039
TurkeySite Not Available
Novartis Investigative Site
Talas Kayseri, 38039
TurkeyActive - Recruiting
Novartis Investigative Site
Glasgow, G51 4TF
United KingdomActive - Recruiting
Novartis Investigative Site
Oxford, OX3 7LE
United KingdomActive - Recruiting
Allervie Clinical Research
Birmingham, Alabama 35209
United StatesActive - Recruiting
Acuro Research Inc
Little Rock, Arkansas 72205
United StatesSite Not Available
Little Rock Allergy and Asthma Clnc
Little Rock, Arkansas 72205
United StatesActive - Recruiting
Kern Research
Bakersfield, California 93301
United StatesActive - Recruiting
Allergy and Asthma Specialists Medical Group and Research Ct
Huntington Beach, California 92647
United StatesActive - Recruiting
OC Allergy and Asthma Specialists
Huntington Beach, California 92647
United StatesCompleted
Antelope Valley Clinical Trials
Lancaster, California 93534
United StatesSite Not Available
Asthma and Allergy Associates P C
Colorado Springs, Colorado 80907
United StatesActive - Recruiting
Florida Ctr Allergy Asthma Research
Aventura, Florida 33180
United StatesActive - Recruiting
Florida Ctr Allergy Asthma Research .
Aventura, Florida 33180
United StatesActive - Recruiting
Finlay Medical Research
Greenacres City, Florida 33467
United StatesActive - Recruiting
Sarasota Clinical Research
Sarasota, Florida 34233
United StatesSite Not Available
Sarasota Clinical Research .
Sarasota, Florida 34233
United StatesActive - Recruiting
Univ of South Florida Asthma Allergy and Immunology CRU
Tampa, Florida 33613
United StatesSite Not Available
AeroAllergy Research Laboratories of Savannah Inc
Savannah, Georgia 31406
United StatesActive - Recruiting
AeroAllergy Research Laboratories of Savannah, Inc.
Savannah, Georgia 31406
United StatesActive - Recruiting
Treasure Valley Medical Research
Boise, Idaho 83706
United StatesActive - Recruiting
Endeavor Health
Glenview, Illinois 60077
United StatesSite Not Available
Northshore University Health System Division of Dermatology
Glenview, Illinois 60077
United StatesActive - Recruiting
Asthma and Allergy Center of Chicago S C
River Forest, Illinois 60305
United StatesActive - Recruiting
The Indiana Clinical Trials Center
Plainfield, Indiana 46168
United StatesActive - Recruiting
Allergy and Asthma Specialist P S C
Owensboro, Kentucky 42301
United StatesActive - Recruiting
Allergy and Asthma Specialist P S C Main Center
Owensboro, Kentucky 42301
United StatesActive - Recruiting
Allergy and Asthma Specialist, P.S.C. Main Center
Owensboro, Kentucky 42301
United StatesActive - Recruiting
John Hopkins University
Baltimore, Maryland 21204
United StatesActive - Recruiting
John Hopkins University .
Baltimore, Maryland 21204
United StatesActive - Recruiting
Somnos Clinical Research
Lincoln, Nebraska 68510
United StatesActive - Recruiting
Somnos Clinical Research Allergy Asthma and Immunology
Lincoln, Nebraska 68510
United StatesActive - Recruiting
Toledo Institute of Clinical Research
Toledo, Ohio 43617
United StatesActive - Recruiting
Allergy Asthma and Clinical Research
Oklahoma City, Oklahoma 73120
United StatesSite Not Available
Allergy and Clinical Immunology Ass
Pittsburgh, Pennsylvania 15241
United StatesActive - Recruiting
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania 15241
United StatesSite Not Available
National Allergy and Asthma Research LLS
North Charleston, South Carolina 29420
United StatesSite Not Available
PanAmerican Clinical Research
Brownsville, Texas 78520
United StatesActive - Recruiting
PanAmerican Clinical Research Research
Brownsville, Texas 78520
United StatesActive - Recruiting
Asthma and Allergy Research Assoc
Dallas, Texas 75231
United StatesSite Not Available
Asthma and Allergy Research Assoc .
Dallas, Texas 75231
United StatesActive - Recruiting
Western Sky Medical Research
El Paso, Texas 79924
United StatesActive - Recruiting
Western Sky Medical Research Research
El Paso, Texas 79924
United StatesActive - Recruiting
RFSA Dermatology
San Antonio, Texas 78213
United StatesActive - Recruiting
STAAMP Research LLC
San Antonio, Texas 78229
United StatesActive - Recruiting
Complete Dermatology
Sugar Land, Texas 77479
United StatesActive - Recruiting
Allergy Associates of Utah
Murray, Utah 84107
United StatesSite Not Available
Allergy Associates of Utah
Sandy, Utah 84093
United StatesSite Not Available
Novartis Investigative Site
Hanoi, 100000
VietnamActive - Recruiting
Novartis Investigative Site
Ho Chi Minh, 7000
VietnamActive - Recruiting
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