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

June 5, 2026 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
362

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Argentina
      • CABA, Argentina, C1181ACH
        • Novartis Investigative Site
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1414AIF
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1121ABE
        • Novartis Investigative Site
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Novartis Investigative Site
  • Australia
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Novartis Investigative Site
    • Victoria
      • Carlton, Victoria, Australia, 3053
        • Novartis Investigative Site
      • Melbourne, Victoria, Australia, 3004
        • Novartis Investigative Site
  • Brazil
    • São Paulo
      • Alphaville Barueri, São Paulo, Brazil, 06454-010
        • Novartis Investigative Site
      • Santo André, São Paulo, Brazil, 09060-870
        • Novartis Investigative Site
      • Sorocaba, São Paulo, Brazil, 18040-425
        • Novartis Investigative Site
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3J 0S9
        • Novartis Investigative Site
    • Ontario
      • Hamilton, Ontario, Canada, L8L 3C3
        • Novartis Investigative Site
    • Quebec
      • Trois-Rivières, Quebec, Canada, G8T 7A1
        • Novartis Investigative Site
  • China
      • Beijing, China, 100730
        • Novartis Investigative Site
      • Beijing, China, 100050
        • Novartis Investigative Site
      • Jinan, China, 250012
        • Novartis Investigative Site
      • Shanghai, China, 200040
        • Novartis Investigative Site
      • Tianjin, China, 300052
        • Novartis Investigative Site
    • Fujian
      • Fuzhou, Fujian, China, 350025
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Novartis Investigative Site
      • Guangzhou, Guangdong, China, 510091
        • Novartis Investigative Site
    • Hunan
      • Changsha, Hunan, China, 410008
        • Novartis Investigative Site
    • Jiangsu
      • Wuxi, Jiangsu, China, 214002
        • Novartis Investigative Site
    • Jilin
      • Changchun, Jilin, China, 130021
        • Novartis Investigative Site
    • Shandong
      • Jinan, Shandong, China, 250022
        • Novartis Investigative Site
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Novartis Investigative Site
      • Chengdu, Sichuan, China, 610072
        • Novartis Investigative Site
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830001
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310001
        • Novartis Investigative Site
      • Yiwu, Zhejiang, China, 322000
        • Novartis Investigative Site
  • Colombia
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 080002
        • Novartis Investigative Site
      • Barranquilla, Atlántico, Colombia, 080020
        • Novartis Investigative Site
  • France
      • Clermont-Ferrand, France, 63003
        • Novartis Investigative Site
      • Grenoble, France, 38043
        • Novartis Investigative Site
      • Montpellier, France, 34295
        • Novartis Investigative Site
      • Nantes, France, 44093
        • Novartis Investigative Site
      • Paris, France, 75970
        • Novartis Investigative Site
      • Pierre-Bénite, France, 69495
        • Novartis Investigative Site
      • Rouen, France, 76031
        • Novartis Investigative Site
      • Toulouse, France, 31400
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 13353
        • Novartis Investigative Site
      • Mainz, Germany, 55131
        • Novartis Investigative Site
      • Münster, Germany, 48149
        • Novartis Investigative Site
      • Tübingen, Germany, 72076
        • Novartis Investigative Site
    • Lower Saxony
      • Göttingen, Lower Saxony, Germany, 37075
        • Novartis Investigative Site
      • Stade, Lower Saxony, Germany, 21682
        • Novartis Investigative Site
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Novartis Investigative Site
  • Hong Kong
      • Hong Kong, Hong Kong, 999077
        • Novartis Investigative Site
  • Hungary
    • Hajdu Bihar Megye
      • Debrecen, Hajdu Bihar Megye, Hungary, 4032
        • Novartis Investigative Site
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4031
        • Novartis Investigative Site
    • Jász-Nagykun-Szolnok
      • Szolnok, Jász-Nagykun-Szolnok, Hungary, 5000
        • Novartis Investigative Site
  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560004
        • Novartis Investigative Site
      • Mysore, Karnataka, India, 570001
        • Novartis Investigative Site
  • Israel
      • Haifa, Israel, 3104802
        • Novartis Investigative Site
      • Jerusalem, Israel, 9112001
        • Novartis Investigative Site
      • Ramat Gan, Israel, 5265601
        • Novartis Investigative Site
      • Tel Aviv, Israel, 6423906
        • Novartis Investigative Site
  • Italy
    • AN
      • Ancona, AN, Italy, 60126
        • Novartis Investigative Site
    • MI
      • Milan, MI, Italy, 20122
        • Novartis Investigative Site
      • Rozzano, MI, Italy, 20089
        • Novartis Investigative Site
  • Japan
      • Hiroshima, Japan, 7308518
        • Novartis Investigative Site
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 8078556
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 0608543
        • Novartis Investigative Site
    • Kumamoto
      • Kamimashi-gun, Kumamoto, Japan, 861-3106
        • Novartis Investigative Site
    • Osaka
      • Habikino, Osaka, Japan, 5838588
        • Novartis Investigative Site
      • Takatsuki, Osaka, Japan, 5698686
        • Novartis Investigative Site
    • Shiga
      • Ohtsu, Shiga, Japan, 5202192
        • Novartis Investigative Site
    • Shimane
      • Izumo, Shimane, Japan, 6938501
        • Novartis Investigative Site
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 1138519
        • Novartis Investigative Site
      • Itabashi-ku, Tokyo, Japan, 1738610
        • Novartis Investigative Site
      • Shinjuku Ku, Tokyo, Japan, 160-0023
        • Novartis Investigative Site
      • Tachikawa, Tokyo, Japan, 1900023
        • Novartis Investigative Site
  • Malaysia
    • Johor
      • Muar town, Johor, Malaysia, 84000
        • Novartis Investigative Site
    • Perak
      • Ipoh, Perak, Malaysia, 30450
        • Novartis Investigative Site
    • Pulau Pinang
      • George Town, Pulau Pinang, Malaysia, 10450
        • Novartis Investigative Site
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • Novartis Investigative Site
  • Poland
      • Bydgoszcz, Poland, 85-094
        • Novartis Investigative Site
      • Warsaw, Poland, 02-962
        • Novartis Investigative Site
  • Portugal
      • Coimbra, Portugal, 3004-561
        • Novartis Investigative Site
      • Lisbon, Portugal, 1649-035
        • Novartis Investigative Site
      • Vila Nova de Gaia, Portugal, 4434 502
        • Novartis Investigative Site
  • Romania
    • District 2
      • Bucharest, District 2, Romania, 020762
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 308205
        • Novartis Investigative Site
  • Slovakia
      • Kežmarok, Slovakia, 060 01
        • Novartis Investigative Site
      • Trnava, Slovakia, 917 02
        • Novartis Investigative Site
      • Žilina, Slovakia, 012 07
        • Novartis Investigative Site
  • South Korea
      • Seoul, South Korea, 03722
        • Novartis Investigative Site
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, South Korea, 16499
        • Novartis Investigative Site
  • Spain
      • Alicante, Spain, 03010
        • Novartis Investigative Site
      • Barcelona, Spain, 08035
        • Novartis Investigative Site
      • Madrid, Spain, 28041
        • Novartis Investigative Site
      • Madrid, Spain, 280796
        • Novartis Investigative Site
      • Valencia, Spain, 46015
        • Novartis Investigative Site
    • A Coruna
      • Santiago, A Coruna, Spain, 15702
        • Novartis Investigative Site
    • Andalusia
      • Granada, Andalusia, Spain, 18014
        • Novartis Investigative Site
    • Catalonia
      • Barcelona, Catalonia, Spain, 08003
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand, 10700
        • Novartis Investigative Site
      • Bangkok, Thailand, 10400
        • Novartis Investigative Site
      • Chiang Mai, Thailand, 50200
        • Novartis Investigative Site
  • Turkey (Türkiye)
    • Adapazari
      • Sakarya, Adapazari, Turkey (Türkiye), 54290
        • Novartis Investigative Site
    • Basaksehir
      • Istanbul, Basaksehir, Turkey (Türkiye), 34480
        • Novartis Investigative Site
    • Fatih
      • Istanbul, Fatih, Turkey (Türkiye), 34093
        • Novartis Investigative Site
    • Melikgazi
      • Kayseri, Melikgazi, Turkey (Türkiye), 38039
        • Novartis Investigative Site
    • Uskudar
      • Istanbul, Uskudar, Turkey (Türkiye), 34662
        • Novartis Investigative Site
  • United Kingdom
      • Oxford, United Kingdom, OX3 7LE
        • Novartis Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Allervie Clinical Research
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Acuro Research Inc
    • California
      • Bakersfield, California, United States, 93301
        • Kern Research
      • Huntington Beach, California, United States, 92647
        • Allergy and Asthma Specialists Group
      • Lancaster, California, United States, 93534
        • Antelope Valley Clinical Trials
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Asthma and Allergy Associates P C
    • Florida
      • Aventura, Florida, United States, 33180
        • Florida Ctr Allergy Asthma Research
      • Sarasota, Florida, United States, 34233
        • Sarasota Clinical Research
      • Tampa, Florida, United States, 33613
        • Univ of South Florida Asthma Allergy and Immunology CRU
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Aeroallergy Research Laboratories
    • Idaho
      • Boise, Idaho, United States, 83706
        • Treasure Valley Medical Research
    • Illinois
      • Glenview, Illinois, United States, 60077
        • Endeavor Health
      • River Forest, Illinois, United States, 60305
        • Asthma and Allergy Center of Chicago S C
    • Indiana
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center
    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Allergy and Asthma Specialist P S C
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • John Hopkins University
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Allergy Asthma and Clinical Research
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15241
        • Allergy and Clinical Immunology Associates
    • South Carolina
      • North Charleston, South Carolina, United States, 29420
        • National Allergy and Asthma Research LLS
    • Texas
      • Brownsville, Texas, United States, 78520
        • PanAmerican Clinical Research
      • El Paso, Texas, United States, 79924
        • Western Sky Medical Research
      • San Antonio, Texas, United States, 78229
        • STAAMP Research LLC
      • San Antonio, Texas, United States, 78213
        • RFSA Dermatology
      • Sugar Land, Texas, United States, 77479
        • Complete Dermatology
    • Utah
      • Sandy City, Utah, United States, 84093
        • Allergy Associates of Utah
  • Vietnam
      • Hanoi, Vietnam, 100000
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Remibrutinib, symptomatic dermographism group
Remibrutinib oral twice daily in participants with symptomatic dermographism
Drug: Remibrutinib
Remibrutinib treated groups and arms
Placebo Comparator: Placebo, symptomatic dermographism group
Placebo oral twice daily, symptomatic dermographism
Other: Placebo
Placebo treated groups and arms
Experimental: Remibrutinib, cold urticaria group
Remibrutinib oral twice daily, cold urticaria
Drug: Remibrutinib
Remibrutinib treated groups and arms
Placebo Comparator: Placebo, cold urticaria group
Placebo oral twice daily, cold urticaria
Other: Placebo
Placebo treated groups and arms
Experimental: Remibrutinib, cholinergic urticaria group
Remibrutinib oral twice daily, cholinergic urticaria
Drug: Remibrutinib
Remibrutinib treated groups and arms
Placebo Comparator: Placebo, cholinergic urticaria
Placebo oral twice daily, cholinergic urticaria
Other: Placebo
Placebo treated groups and arms

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of participants with complete response in Total Fric Score; symptomatic dermographism
Time Frame: 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)
Week 12
Proportion of participants with complete response in critical temperature threshold; cold urticaria
Time Frame: 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.
Week 12
Proportion of participants with itch numerical rating scale =0; cholinergic urticaria
Time Frame: 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")
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in Total Fric score; symptomatic dermographism
Time Frame: Week 12
Total Fric score, a scale from 0-4 where a positive response with all four pins is TFS=4, while a positive only 1 pin - the largest pin is TFS=1
Week 12
Change from baseline in criticial temperature threshold following Temptest; cold urticaria
Time Frame: Week 12
Critical temperature threshold, as measured by the Temptest, determines the highest temperature that induces symptoms
Week 12
Change from baseline in itch numerical rating scale; cholinergic urticaria
Time Frame: Week 12
Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").
Week 12
proportion of participants with Physician Global Assessment (PGA) severity of hives =0; cholinergic urticaria
Time Frame: Week 12
Physician global assessment of severity of hives. This assessment is scored 0 to 4 with 0=no hives, 1=mild hives, 2=moderate hives, 3=severe hives and 4=very severe hives
Week 12
Proportion of participants with complete response in TFS; symptomatic dermographism
Time Frame: Week 24
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)
Week 24
Proportion of participants with complete response in Critical Temperature threshold; cold urticaria
Time Frame: Week 24
Critical Temperature Threshold, as measured by the Temptest, is the highest temperature that induces symptoms
Week 24
Proportion of participants with complete response in itch numerical rating scale; cholinergic urticaria
Time Frame: Week 24
Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").
Week 24
Change from baseline in itch numerical rating scale in participants with symptomatic dermographism
Time Frame: Week 12
Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").
Week 12
Change from baseline in itch numerical rating scale in participants with cold urticaria
Time Frame: Week 12
Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").
Week 12
Proportion of participants with complete response in Total Fric score; symptomatic dermographism
Time Frame: Week 2
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)
Week 2
Proportion of participants with complete response in Critical Temperature Threshold; cold urticaria
Time Frame: Week 2
Critical temperature threshold (CTT), as measured by the Temptest, determines the highest temperature that induces symptoms.
Week 2
Proportion of participants with itch NRS=0; cholinergic urticaria
Time Frame: Week 2
Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").
Week 2
Change from baseline in TFS in participants with symptomatic dermographism
Time Frame: Week 2
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)
Week 2
Change from baseline in Critical Temperature Threshold in participants with cold urticaria
Time Frame: Week 2
Critical temperature threshold (CTT), as measured by the Temptest, determines the highest temperature that induces symptoms.
Week 2
Change from baseline in itch NRS in participants with cholinergic urticaria
Time Frame: Week 2
Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").
Week 2
Change from baseline in itch NRS in participants with symptomatic dermographism
Time Frame: Week 2
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)
Week 2
Change from baseline in itch NRS in participants with cold urticaria
Time Frame: Week 2
Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").
Week 2
Proportion of participants with cholinergic urticaria with PGA=0
Time Frame: Week 2
Physician global assessment of severity of hives is a 4-point scale (0 = no active disease, 1 = mild disease, 2 = moderate disease, 3 = severe disease).
Week 2
Change from baseline in weekly most bothersome symptom NRS score on the USDD
Time Frame: Week 12
Urtricara symptom daily diary (USDD). This daily diary records if the participant experiences any symptoms or avoided the triggers
Week 12
Proportion of participants with DLQI=0-1
Time Frame: Week 12
The Dermatology Life Quality Index (DLQI) is a 10-item dermatology-specific quality of life (QoL) measure. Subjects rate their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives thinking about the previous 7 days. An overall score is calculated and ranges from 0 to 30 (higher score meaning worse disease-related QoL). A DLQI score of 0 or 1 means that there is no impact of a skin disease on the patient's life.
Week 12
Occurrence of treatment emergent adverse events and serious adverse events during the study
Time Frame: Week 52
Treatment emergent adverse events and serious adverse events are those that occur at any time only after treatment has started
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 7, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 11, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLOU064M12301
  • 2023-505739-12-00 (Registry Identifier: EU CT NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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