A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
NCT ID: NCT05976243
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
364 participants
INTERVENTIONAL
2023-12-07
2028-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Remibrutinib, symptomatic dermographism group
Remibrutinib oral twice daily in participants with symptomatic dermographism
Remibrutinib
Remibrutinib treated groups and arms
Placebo, symptomatic dermographism group
Placebo oral twice daily, symptomatic dermographism
Placebo
Placebo treated groups and arms
Remibrutinib, cold urticaria group
Remibrutinib oral twice daily, cold urticaria
Remibrutinib
Remibrutinib treated groups and arms
Placebo, cold urticaria group
Placebo oral twice daily, cold urticaria
Placebo
Placebo treated groups and arms
Remibrutinib, cholinergic urticaria group
Remibrutinib oral twice daily, cholinergic urticaria
Remibrutinib
Remibrutinib treated groups and arms
Placebo, cholinergic urticaria
Placebo oral twice daily, cholinergic urticaria
Placebo
Placebo treated groups and arms
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
Placebo treated groups and arms
Remibrutinib
Remibrutinib treated groups and arms
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
1. Participants who have completed the Core period up to Week 52 and are willing to enter the OLE period
Exclusion Criteria
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
18 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
Istanbul, Basaksehir, Turkey (Türkiye)
Novartis Investigative Site
Istanbul, Fatih, Turkey (Türkiye)
Novartis Investigative Site
Kayseri, Melikgazi, Turkey (Türkiye)
Novartis Investigative Site
Istanbul, Uskudar, Turkey (Türkiye)
Novartis Investigative Site
Oxford, , United Kingdom
Novartis Investigative Site
Hanoi, , Vietnam
Novartis Investigative Site
Ho Chi Minh City, , Vietnam
Allervie Clinical Research
Birmingham, Alabama, United States
Acuro Research Inc
Little Rock, Arkansas, United States
Kern Research
Bakersfield, California, United States
Allergy and Asthma Specialists Group
Huntington Beach, California, United States
Antelope Valley Clinical Trials
Lancaster, California, United States
Asthma and Allergy Associates P C
Colorado Springs, Colorado, United States
Florida Ctr Allergy Asthma Research
Aventura, Florida, United States
Sarasota Clinical Research
Sarasota, Florida, United States
Univ of South Florida Asthma Allergy and Immunology CRU
Tampa, Florida, United States
Aeroallergy Research Laboratories
Savannah, Georgia, United States
Treasure Valley Medical Research
Boise, Idaho, United States
Endeavor Health
Glenview, Illinois, United States
Asthma and Allergy Center of Chicago S C
River Forest, Illinois, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
Allergy and Asthma Specialist P S C
Owensboro, Kentucky, United States
John Hopkins University
Baltimore, Maryland, United States
Allergy Asthma and Clinical Research
Oklahoma City, Oklahoma, United States
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, United States
National Allergy and Asthma Research LLS
North Charleston, South Carolina, United States
PanAmerican Clinical Research
Brownsville, Texas, United States
Western Sky Medical Research
El Paso, Texas, United States
RFSA Dermatology
San Antonio, Texas, United States
STAAMP Research LLC
San Antonio, Texas, United States
Complete Dermatology
Sugar Land, Texas, United States
Allergy Associates of Utah
Sandy City, Utah, United States
Novartis Investigative Site
Caba, Buenos Aires, Argentina
Novartis Investigative Site
CABA, Buenos Aires, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, Argentina
Novartis Investigative Site
CABA, , Argentina
Novartis Investigative Site
Woolloongabba, Queensland, Australia
Novartis Investigative Site
Carlton, Victoria, Australia
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Alphaville Barueri, São Paulo, Brazil
Novartis Investigative Site
Santo André, São Paulo, Brazil
Novartis Investigative Site
Sorocaba, São Paulo, Brazil
Novartis Investigative Site
Winnipeg, Manitoba, Canada
Novartis Investigative Site
Hamilton, Ontario, Canada
Novartis Investigative Site
Trois-Rivières, Quebec, Canada
Novartis Investigative Site
Fuzhou, Fujian, China
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Changsha, Hunan, China
Novartis Investigative Site
Wuxi, Jiangsu, China
Novartis Investigative Site
Changchun, Jilin, China
Novartis Investigative Site
Jinan, Shandong, China
Novartis Investigative Site
Chengdu, Sichuan, China
Novartis Investigative Site
Chengdu, Sichuan, China
Novartis Investigative Site
Ürümqi, Xinjiang, China
Novartis Investigative Site
Hangzhou, Zhejiang, China
Novartis Investigative Site
Yiwu, Zhejiang, China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Jinan, , China
Novartis Investigative Site
Shanghai, , China
Novartis Investigative Site
Tianjin, , China
Novartis Investigative Site
Barranquilla, Atlántico, Colombia
Novartis Investigative Site
Barranquilla, Atlántico, Colombia
Novartis Investigative Site
Clermont-Ferrand, , France
Novartis Investigative Site
Grenoble, , France
Novartis Investigative Site
Montpellier, , France
Novartis Investigative Site
Nantes, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Pierre-Bénite, , France
Novartis Investigative Site
Rouen, , France
Novartis Investigative Site
Toulouse, , France
Novartis Investigative Site
Göttingen, Lower Saxony, Germany
Novartis Investigative Site
Dresden, Saxony, Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Mainz, , Germany
Novartis Investigative Site
Münster, , Germany
Novartis Investigative Site
Stade, , Germany
Novartis Investigative Site
Tübingen, , Germany
Novartis Investigative Site
Hong Kong, , Hong Kong
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, Hungary
Novartis Investigative Site
Debrecen, Hajdú-Bihar, Hungary
Novartis Investigative Site
Szolnok, Jász-Nagykun-Szolnok, Hungary
Novartis Investigative Site
Bangalore, Karnataka, India
Novartis Investigative Site
Mysore, Karnataka, India
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, India
Novartis Investigative Site
Haifa, , Israel
Novartis Investigative Site
Jerusalem, , Israel
Novartis Investigative Site
Ramat Gan, , Israel
Novartis Investigative Site
Tel Aviv, , Israel
Novartis Investigative Site
Ancona, AN, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Rozzano, MI, Italy
Novartis Investigative Site
Kitakyushu, Fukuoka, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Kamimashi-gun, Kumamoto, Japan
Novartis Investigative Site
Habikino, Osaka, Japan
Novartis Investigative Site
Takatsuki, Osaka, Japan
Novartis Investigative Site
Ohtsu, Shiga, Japan
Novartis Investigative Site
Izumo, Shimane, Japan
Novartis Investigative Site
Shimotsuga Gun, Tochigi, Japan
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan
Novartis Investigative Site
Itabashi-ku, Tokyo, Japan
Novartis Investigative Site
Shinjuku Ku, Tokyo, Japan
Novartis Investigative Site
Tachikawa, Tokyo, Japan
Novartis Investigative Site
Hiroshima, , Japan
Novartis Investigative Site
Muar town, Johor, Malaysia
Novartis Investigative Site
Ipoh, Perak, Malaysia
Novartis Investigative Site
George Town, Pulau Pinang, Malaysia
Novartis Investigative Site
Utrecht, , Netherlands
Novartis Investigative Site
Bydgoszcz, , Poland
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
Coimbra, , Portugal
Novartis Investigative Site
Lisbon, , Portugal
Novartis Investigative Site
Vila Nova de Gaia, , Portugal
Novartis Investigative Site
Bucharest, District 2, Romania
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Kežmarok, , Slovakia
Novartis Investigative Site
Trnava, , Slovakia
Novartis Investigative Site
Žilina, , Slovakia
Novartis Investigative Site
Suwon, Gyeonggi-do, South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Santiago, A Coruna, Spain
Novartis Investigative Site
Granada, Andalusia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Alicante, , Spain
Novartis Investigative Site
Barcelona, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Valencia, , Spain
Novartis Investigative Site
Bangkok, , Thailand
Novartis Investigative Site
Bangkok, , Thailand
Novartis Investigative Site
Chiang Mai, , Thailand
Novartis Investigative Site
Sakarya, Adapazari, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-505739-12-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CLOU064M12301
Identifier Type: -
Identifier Source: org_study_id