Study Description
This is a Phase 3, parallel group, placebo-controlled, double-blind, confirmatory study
in patients with CINDU, with an optional Open-label Extension (OLE).
The purpose of the core period (52 weeks of treatment) of this study is to evaluate the
efficacy, safety, and tolerability of remibrutinib (LOU064) vs. placebo in adults
suffering from CINDU inadequately controlled by H1-antihistamines (H1-AHs).
The purpose of the OLE period is to collect long-term efficacy, safety, and tolerability
data on remibrutinib in participants after having completed the Core period This study consists of a core and extension periods.
The Core period (6 arms) has a total duration of up to 60 weeks including a double-blind
placebo-controlled treatment period until Week 24 followed by open-label treatment with
remibrutinib up to Week 52. The primary endpoint for all CINDU subtypes is assessed at
Week 12.
The Core period consists of:
- Screening period (up to 4 weeks): During the screening period, participants who have
provided informed consent will be assessed for study eligibility.
- Double-blind, placebo-controlled treatment period (24 weeks): 24 weeks of
double-blind treatment with remibrutinib or placebo.
- Open-label treatment period (28 weeks): 28 weeks of open-label treatment with
remibrutinib.
- Follow-up period: 4 weeks of treatment free follow-up. The open-label extension
period consists of observation and treatment period. At the end of the core period
of the study, if participants continue to experience symptoms, they will transition
to the treatment period in OLE. If they do not experience symtpoms they will
transition to the observation period in the OLE.
The duration of the Open-label Extension period will be approximately 3 years where
participants can switch from observation to treatment depending on if they start
developing symptoms. Only those participants participating in the Open-label Extension
Treatment period will receive remibrutinib. The participants in the Open-label Extension
Observation period will not receive remibrutinib
Interventions
Placebo
Remibrutinib
Eligibility Criteria
Inclusion Criteria for core period:
1. Male and female participants ≥18 years of age at the time of signing of the ICFs
2. 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
3. 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.
4. Cold Urticaria: Positive ice-cube test resulting in hives at the provocation site
for participants at Screening.
5. 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:
1. Participants who have completed the Core period up to Week 52 and are willing to
enter the OLE period
Exclusion Criteria for core period:
-
1. Previous use of remibrutinib or other BTK inhibitors.
2. Participants who have concomitant CSU at screening. Participants with resolved CSU
at the time of screening can be included in the study.
3. 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.
4. 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.
5. 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
6. 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 Location
Novartis Investigative Site
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Rosario,Santa Fe,2000,Argentina
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Buenos Aires,C1125abe,Argentina
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Caba,Buenos Aires,C1181ach,Argentina
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Caba,Buenos Aires,C1414aif,Argentina
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Woolloongabba,Queensland,4102,Australia
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Melbourne,Victoria,3004,Australia
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Carlton,Victoria,3053,Australia
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Sorocaba,SP,18040-425,Brazil
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Santo Andre,SP,09060 650,Brazil
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Alphaville Barueri,Sao Paulo,06454010,Brazil
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Winnipeg,Manitoba,R3j 0s9,Canada
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Hamilton,Ontario,L8l 3c3,Canada
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Trois Rivieres,Quebec,G8t 7a1,Canada
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Beijing,100191,China
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Shanghai,200025,China
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Tianjin,300052,China
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Chang Chun,Jilin,130021,China
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Jinan,250012,China
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Beijing,100730,China
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Shanghai,200040,China
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Changsha,Hunan,410008,China
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Jinan,Shandong,250022,China
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Nanjing,210042,China
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Wuxi,Jiangsu,214002,China
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Chengdu,Sichuan,610041,China
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Hangzhou,Zhejiang,310001,China
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Yi Wu,Zhejiang,322000,China
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Fuzhou,Fujian,350025,China
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Urumqi,Xinjiang,830001,China
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Chengdu,Sichuan,610072,China
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Guangdong,Guangzhou,510091,China
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Guangzhou,Guangdong,510630,China
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Beijing,100050,China
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Chongqing,400038,China
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Barranquilla,Atlantico,080002,Colombia
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Barranquilla,080020,Colombia
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Rouen,76031,France
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Nantes Cedex 1,44093,France
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Paris,75970,France
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Montpellier,34295,France
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Pierre Benite,69495,France
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Hong Kong,Hong Kong
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Debrecen,Hajdu Bihar,4026,Hungary
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Mysore,Karnataka,570001,India
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Bangalore,Karnataka,560004,India
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Nagpur,Maharashtra,440015,India
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Jerusalem,9112001,Israel
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Haifa,3339419,Israel
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Ramat Gan,52621,Israel
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Kfar Saba,44281,Israel
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Tel Aviv,6423906,Israel
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Ancona,AN,60126,Italy
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Shimotsuga Gun,Tochigi,321-0293,Japan
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Kamimashi-gun,Kumamoto,861-3106,Japan
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Tachikawa,Tokyo,190-0023,Japan
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Shinjuku Ku,Tokyo,160-0023,Japan
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Takatsuki,Osaka,569-8686,Japan
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Itabashi-ku,Tokyo,173-8610,Japan
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Hiroshima,730-8518,Japan
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Izumo-city,Shimane,693 8501,Japan
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Kitakyushu,Fukuoka,807-8556,Japan
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Habikino city,Osaka,583 8588,Japan
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Suwon si,Gyeonggi Do,16499,Korea, Republic of
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Seoul,03722,Korea, Republic of
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Ipoh,Perak,30450,Malaysia
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Kuala Lumpur,Wilayah Persekutuan,50586,Malaysia
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Muar,Johor,84000,Malaysia
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Pulau Pinang,10990,Malaysia
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Utrecht,3584 cx,Netherlands
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Coimbra,3000 075,Portugal
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Lisboa,1649 035,Portugal
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Singapore,308205,Singapore
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Singapore,119074,Singapore
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Trnava,91702,Slovakia
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Kezmarok,060 01,Slovakia
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Zilina,01207,Slovakia
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Cordoba,Andalucia,14004,Spain
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Madrid,28041,Spain
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Alicante,Comunidad Valenciana,03010,Spain
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Valencia,Comunidad Valenciana,46015,Spain
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Bangkoknoi,Bangkok,10700,Thailand
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Bangkok,10400,Thailand
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Chiang Mai,50200,Thailand
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Istanbul,34093,Turkey
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Istanbul,34480,Turkey
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Istanbul,34662,Turkey
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Sakarya,54290,Turkey
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Talas Kayseri,38039,Turkey
Asthma and Allergy Research Assoc .
Recruiting
Dallas,Texas,75231,United States
William R Lumry
Treasure Valley Medical Research
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Boise,Idaho,83706,United States
Stephanie Gil
Neetu Talreja
AeroAllergy Research Laboratories of Savannah Inc
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Savannah,Georgia,31406,United States
Bruce Finkel
John Hopkins University .
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Baltimore,Maryland,21204,United States
Sarbjit S Saini
STAAMP Research LLC
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San Antonio,Texas,78229,United States
Erika Gonzalez
Antelope Valley Clinical Trials
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Lancaster,California,93534,United States
Ricardo Tan
Florida Ctr Allergy Asthma Research
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Aventura,Florida,33180,United States
Jaime Landman
Ileana Rodicio
RFSA Dermatology
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San Antonio,Texas,78213,United States
Lindsey Finklea
Allergy Associates of Utah
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Sandy,Utah,84093,United States
Andrew Smith
National Allergy and Asthma Research LLS
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North Charleston,South Carolina,29420,United States
Patricia Gerber
Univ of South Florida Asthma Allergy and Immunology CRU
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Tampa,Florida,33613,United States
Amber N Pepper
Allergy and Asthma Specialist P S C Main Center
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Owensboro,Kentucky,42301,United States
Lee Clore
The Indiana Clinical Trials Center
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Plainfield,Indiana,46168,United States
Mitchell William Smith
Northshore University Health System Division of Dermatology
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Glenview,Illinois,60077,United States
Giselle Mosnaim
Madeline Snedden
Sarasota Clinical Research .
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Sarasota,Florida,34233,United States
Hugh Harmon Windom
Complete Dermatology
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Sugar Land,Texas,77479,United States
Bartley Joseph Gill
Kern Research
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Bakersfield,California,93301,United States
Eric Boren
Asthma and Allergy Associates P C
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Colorado Springs,Colorado,80907,United States
Daniel Soteres
Allergy Asthma and Clinical Research
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Oklahoma City,Oklahoma,73120,United States
Martha Tarpay
Western Sky Medical Research Research
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El Paso,Texas,79924,United States
Todd Funkhouser
Finlay Medical Research
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Greenacres City,Florida,33467,United States
Jorge Calle Medina
Allergy and Asthma Specialists Medical Group and Research Ct
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Huntington Beach,California,92647,United States
Steven F Weinstein
Toledo Institute of Clinical Research
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Toledo,Ohio,43617,United States
Syed Rehman
Somnos Clinical Research Allergy Asthma and Immunology
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Lincoln,Nebraska,68510,United States
Robert J Szalewski
Little Rock Allergy and Asthma Clnc
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Little Rock,Arkansas,72205,United States
Karl Sitz
Asthma and Allergy Center of Chicago S C
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River Forest,Illinois,60305,United States
Rachna Shah
Allervie Clinical Research
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Birmingham,Alabama,35209,United States
John Anderson
Allergy and Clinical Immunology Associates
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Pittsburgh,Pennsylvania,15241,United States
Michael Palumbo
PanAmerican Clinical Research Research
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Brownsville,Texas,78520,United States
Cynthia Aguirre
James Charles Campbell
Novartis Investigative Site
Recruiting
Hanoi,100000,Vietnam
Worldwide Contacts
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