A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
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)
Proportion of participants with complete response in Total Fric Score; symptomatic dermographism — Week 12 Total Fric score (a scale from 0-4 where a positive response with all of the four pins is TFS = 4, while a positive response with only one pin - the largest pin is TFS = 1)
Proportion of participants with complete response in critical temperature threshold; cold urticaria — Week 12 The Temptest is used to induce itch and hives in participants with cold urticaria. Critical temperature threshold (CTT), as measured by the Temptest, determines the highest temperature that induces symptoms.
Proportion of participants with itch numerical rating scale =0; cholinergic urticaria — Week 12 Itch numerical rating scale, a scale from 0 to 10
Patients are asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst itch imaginable")
Trial sites (130)
Facility
City
Region
Status
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.
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.
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