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

Last updated: March 28, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

Urticaria

Treatment

Placebo

Remibrutinib

Clinical Study ID

NCT05976243
CLOU064M12301
2023-505739-12
2023-505739-12-00
  • Ages 18-100
  • All Genders

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 Criteria

Inclusion

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.

  1. Cold Urticaria: Positive ice-cube test resulting in hives at the provocation site for participants at Screening.

  2. 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

Study Design

Total Participants: 348
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
December 07, 2023
Estimated Completion Date:
December 31, 2028

Study Description

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

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  • Novartis Investigative Site

    Caba, Buenos Aires C1181ACH
    Argentina

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    Rosario, Santa Fe 2000
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    Trois Rivieres, Quebec G8T 7A1
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    Fuzhou, Fujian 350025
    China

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    Guangzhou, Guangdong 510630
    China

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    Guangdong, Guangzhou 510091
    China

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    Wuxi, Jiangsu 214002
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    China

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  • Allervie Clinical Research

    Birmingham, Alabama 35209
    United States

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    Little Rock, Arkansas 72205
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    Little Rock, Arkansas 72205
    United States

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    Bakersfield, California 93301
    United States

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  • Allergy and Asthma Specialists Medical Group and Research Ct

    Huntington Beach, California 92647
    United States

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  • OC Allergy and Asthma Specialists

    Huntington Beach, California 92647
    United States

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  • Antelope Valley Clinical Trials

    Lancaster, California 93534
    United States

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    Colorado Springs, Colorado 80907
    United States

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  • Florida Ctr Allergy Asthma Research

    Aventura, Florida 33180
    United States

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  • Florida Ctr Allergy Asthma Research .

    Aventura, Florida 33180
    United States

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    Greenacres City, Florida 33467
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    Sarasota, Florida 34233
    United States

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    Sarasota, Florida 34233
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  • Univ of South Florida Asthma Allergy and Immunology CRU

    Tampa, Florida 33613
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    Savannah, Georgia 31406
    United States

    Active - Recruiting

  • AeroAllergy Research Laboratories of Savannah, Inc.

    Savannah, Georgia 31406
    United States

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    Boise, Idaho 83706
    United States

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    Glenview, Illinois 60077
    United States

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    Glenview, Illinois 60077
    United States

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  • Asthma and Allergy Center of Chicago S C

    River Forest, Illinois 60305
    United States

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  • The Indiana Clinical Trials Center

    Plainfield, Indiana 46168
    United States

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    Owensboro, Kentucky 42301
    United States

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    Owensboro, Kentucky 42301
    United States

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  • Allergy and Asthma Specialist, P.S.C. Main Center

    Owensboro, Kentucky 42301
    United States

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  • John Hopkins University

    Baltimore, Maryland 21204
    United States

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    Baltimore, Maryland 21204
    United States

    Active - Recruiting

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    Lincoln, Nebraska 68510
    United States

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    Lincoln, Nebraska 68510
    United States

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  • Toledo Institute of Clinical Research

    Toledo, Ohio 43617
    United States

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    Oklahoma City, Oklahoma 73120
    United States

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    Pittsburgh, Pennsylvania 15241
    United States

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    Pittsburgh, Pennsylvania 15241
    United States

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    North Charleston, South Carolina 29420
    United States

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  • PanAmerican Clinical Research

    Brownsville, Texas 78520
    United States

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  • PanAmerican Clinical Research Research

    Brownsville, Texas 78520
    United States

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    Dallas, Texas 75231
    United States

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    Dallas, Texas 75231
    United States

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    El Paso, Texas 79924
    United States

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    El Paso, Texas 79924
    United States

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    San Antonio, Texas 78213
    United States

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    San Antonio, Texas 78229
    United States

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    Sugar Land, Texas 77479
    United States

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    Murray, Utah 84107
    United States

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    Sandy, Utah 84093
    United States

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    Hanoi, 100000
    Vietnam

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    Ho Chi Minh, 7000
    Vietnam

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