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:
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:
1. 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 Location
Novartis Investigative Site
Recruiting
Melbourne,Victoria,3004,Australia
Novartis Investigative Site
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Woolloongabba,Queensland,4102,Australia
Novartis Investigative Site
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Carlton,Victoria,3053,Australia
Novartis Investigative Site
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Trois Rivieres,Quebec,G8T 7A1,Canada
Novartis Investigative Site
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Hamilton,Ontario,L8L 3C3,Canada
Novartis Investigative Site
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Winnipeg,Manitoba,R3J 0S9,Canada
Novartis Investigative Site
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Shanghai,200040,China
Novartis Investigative Site
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Chang Chun,Jilin,130021,China
Novartis Investigative Site
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Tianjin,300052,China
Novartis Investigative Site
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Chengdu,Sichuan,610072,China
Novartis Investigative Site
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Beijing,100050,China
Novartis Investigative Site
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Hangzhou,Zhejiang,310001,China
Novartis Investigative Site
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Fuzhou,Fujian,350025,China
Novartis Investigative Site
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Jinan,250012,China
Novartis Investigative Site
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Beijing,100191,China
Novartis Investigative Site
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Wuxi,Jiangsu,214002,China
Novartis Investigative Site
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Guangdong,Guangzhou,510091,China
Novartis Investigative Site
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Beijing,100730,China
Novartis Investigative Site
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Guangzhou,Guangdong,510630,China
Novartis Investigative Site
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Hong Kong,Hong Kong
Novartis Investigative Site
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Haifa,3339419,Israel
Novartis Investigative Site
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Jerusalem,9112001,Israel
Novartis Investigative Site
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Ramat Gan,52621,Israel
Novartis Investigative Site
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Kfar Saba,4428164,Israel
Novartis Investigative Site
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Tel Aviv,62439,Israel
Novartis Investigative Site
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Habikino city,Osaka,583 8588,Japan
Novartis Investigative Site
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Izumo-city,Shimane,693 8501,Japan
Novartis Investigative Site
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Tachikawa,Tokyo,190-0023,Japan
Novartis Investigative Site
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Suwon si,Gyeonggi Do,16499,Korea, Republic of
Novartis Investigative Site
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Seoul,03722,Korea, Republic of
Novartis Investigative Site
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Muar,Johor,84000,Malaysia
Novartis Investigative Site
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Penang,10990,Malaysia
Novartis Investigative Site
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Ipoh,Perak,30450,Malaysia
Novartis Investigative Site
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Kuala Lumpur,Wilayah Persekutuan,50586,Malaysia
Novartis Investigative Site
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Singapore,119074,Singapore
Novartis Investigative Site
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Singapore,308205,Singapore
Novartis Investigative Site
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Chiang Mai,50200,Thailand
Novartis Investigative Site
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Istanbul,34662,Turkey
Novartis Investigative Site
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Sakarya,54290,Turkey
Novartis Investigative Site
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Talas / Kayseri,38039,Turkey
Novartis Investigative Site
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Istanbul,34093,Turkey
Kern Research
Recruiting
Bakersfield,Melissa Reynoso (661-864-7710) email: [email protected] -- Eric Boren,93301 - California,United States
Antelope Valley Clinical Trials
Recruiting
Lancaster,Cinthia Sanchez (661-429-0100) email: [email protected] -- Ricardo Tan,93534 - California,United States
Treasure Valley Medical Research
Recruiting
Boise,Stephanie Gil email: [email protected] -- Neetu Talreja,83706 - Idaho,United States
AeroAllergy Research Laboratories of Savannah, Inc.
Recruiting
Savannah,Servon Jackson (912-356-3619) email: [email protected] -- Bruce Finkel,31406 - Georgia,United States
National Allergy and Asthma Research LLS
Recruiting
North Charleston,Theresa Heighsmith (843-820-1036) email: [email protected] -- Patricia Gerber,29420 - South Carolina,United States
Asthma and Allergy Center of Chicago S C
Recruiting
River Forest,(708-366-9300) -- Rachna Shah,60305 - Illinois,United States
Western Sky Medical Research Research
Recruiting
El Paso,Ruby Velasquez (915-544-2557) email: [email protected] -- Todd Funkhouser,79924 - Texas,United States
Allergy and Asthma Specialist P S C Main Center
Recruiting
Owensboro,Andrea Arthur (270-684-6144) email: [email protected] -- Lee Clore,42301 - Kentucky,United States
Northshore University Health System Division of Dermatology
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Glenview,Madeline Snedden email: [email protected] -- Giselle Mosnaim,60077 - Illinois,United States
Complete Dermatology
Recruiting
Sugar Land,Bartley Joseph Gill,77479 - Texas,United States
RFSA Dermatology
Recruiting
San Antonio,Lindsey Finklea,78213 - Texas,United States
Allergy and Asthma Specialists Medical Group and Research Ct
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Huntington Beach,Adilene Aguilar (714-848-8585) email: [email protected] -- Steven F Weinstein,92647 - California,United States
Finlay Medical Research
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Greenacres City,Danelis Sanchez Perez (561-766-2181) email: [email protected] -- Jorge Calle Medina,33467 - Florida,United States
Somnos Clinical Research Allergy Asthma and Immunology
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Lincoln,(402-464-6139) -- Robert J Szalewski,68510 - Nebraska,United States
Allergy Associates of Utah
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Murray,(801-263-8700) -- Andrew Smith,84107 - Utah,United States
Florida Ctr Allergy Asthma Research .
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Aventura,(305-273-2988) -- Ileana Rodicio,33180 - Florida,United States
STAAMP Research LLC
Recruiting
San Antonio,Daniela Alverdi (210-851-8682) email: [email protected] -- Erika Gonzalez,78229 - Texas,United States
Allergy Asthma and Clinical Research
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Oklahoma City,Gabriella Downs (405-752-0393) email: [email protected] -- Martha Tarpay,73120 - Oklahoma,United States
PanAmerican Clinical Research Research
Recruiting
Brownsville,Cynthia Aguirre email: [email protected] -- James Charles Campbell,78520 - Texas,United States
Allervie Clinical Research
Recruiting
Birmingham,Timothy Smith (205-871-9661) email: [email protected] -- John Anderson,35209 - Alabama,United States
The Indiana Clinical Trials Center
Recruiting
Plainfield,Haley Peterson (+1 317 837 6082) email: [email protected] -- Mitchell William Smith,46168 - Indiana,United States
Worldwide Contacts
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