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Clinical Trials in the UK / NCT05976243
Active, not recruiting Phase 3

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

NCT05976243 · tracked via the Priya Life Science UK tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 3
Started
2023-12-07
Last updated
2026-08-20

Condition(s) studied

Chronic Inducible Urticaria

Investigational drug(s) / intervention(s)

RemibrutinibPlacebo

Remibrutinib: Remibrutinib treated groups and arms

Placebo: Placebo treated groups and arms

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (130)

FacilityCityRegionStatus
Allervie Clinical Research Birmingham Alabama
Acuro Research Inc Little Rock Arkansas
Kern Research Bakersfield California
Allergy and Asthma Specialists Group Huntington Beach California
Antelope Valley Clinical Trials Lancaster California
Asthma and Allergy Associates P C Colorado Springs Colorado
Florida Ctr Allergy Asthma Research Aventura Florida
Sarasota Clinical Research Sarasota Florida
Univ of South Florida Asthma Allergy and Immunology CRU Tampa Florida
Aeroallergy Research Laboratories Savannah Georgia
Treasure Valley Medical Research Boise Idaho
Endeavor Health Glenview Illinois
Asthma and Allergy Center of Chicago S C River Forest Illinois
The Indiana Clinical Trials Center Plainfield Indiana
Allergy and Asthma Specialist P S C Owensboro Kentucky
John Hopkins University Baltimore Maryland
Allergy Asthma and Clinical Research Oklahoma City Oklahoma
Allergy and Clinical Immunology Associates Pittsburgh Pennsylvania
National Allergy and Asthma Research LLS North Charleston South Carolina
PanAmerican Clinical Research Brownsville Texas
Western Sky Medical Research El Paso Texas
RFSA Dermatology San Antonio Texas
STAAMP Research LLC San Antonio Texas
Complete Dermatology Sugarland Texas
Allergy Associates of Utah Sandy City Utah
Novartis Investigative Site Caba Buenos Aires
Novartis Investigative Site CABA Buenos Aires
Novartis Investigative Site Rosario Santa Fe Province
Novartis Investigative Site CABA Argentina
Novartis Investigative Site Woolloongabba Queensland
Novartis Investigative Site Carlton Victoria
Novartis Investigative Site Melbourne Victoria
Novartis Investigative Site Alphaville Barueri São Paulo
Novartis Investigative Site Santo André São Paulo
Novartis Investigative Site Sorocaba São Paulo
Novartis Investigative Site Winnipeg Manitoba
Novartis Investigative Site Hamilton Ontario
Novartis Investigative Site Trois-Rivières Quebec
Novartis Investigative Site Fuzhou Fujian
Novartis Investigative Site Guangzhou Guangdong

+ 90 more sites — see the full list on the official registry below.

More Novartis Pharmaceuticals trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05976243 on ClinicalTrials.gov ↗ ← All trials in the UK