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ACTIVE NOT RECRUITING

NCT05976243

PHASE3

A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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

Official title: A 52-week Multi-center, Randomized, Double-blind, Placebo Controlled, Basket Study With an Open-label Extension to Investigate the Efficacy, Safety, and Tolerability of Remibrutinib (LOU064) in Chronic Inducible Urticaria (CINDU) in Adults Inadequately Controlled by H1-antihistamines

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

362

Start Date

2023-12-07

Completion Date

2029-06-15

Last Updated

2026-10-15

Healthy Volunteers

Conditions

Chronic Inducible Urticaria

Interventions

DRUG

Remibrutinib

Remibrutinib treated groups and arms

OTHER

Placebo

Placebo treated groups and arms

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

Locations (130)

AllerVie Clinical Research-Homewood

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

Sugarland, 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

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

CABA, Argentina

Novartis Investigative Site

Greenslopes, 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

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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

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

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Toulouse, France

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Göttingen, Lower Saxony, Germany

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Stade, Lower Saxony, Germany

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Dresden, Saxony, Germany

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Berlin, Germany

Novartis Investigative Site

Mainz, Germany

Novartis Investigative Site

Münster, Germany

Novartis Investigative Site

Tübingen, Germany

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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

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Mysore, Karnataka, India

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Haifa, Israel

Novartis Investigative Site

Jerusalem, Israel

Novartis Investigative Site

Ramat Gan, Israel

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Tel Aviv, Israel

Novartis Investigative Site

Ancona, AN, Italy

Novartis Investigative Site

Milan, MI, Italy

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Rozzano, MI, Italy

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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

Ōtsu, Shiga, Japan

Novartis Investigative Site

Izumo, Shimane, 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

And 30 more locations on ClinicalTrials.gov

Clinical Research Directory

A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (130)