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New hope for chronic hives sufferers: drug targets root cause

NCT ID NCT05976243

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This study tests a new medication, remibrutinib, for people with chronic hives caused by triggers like cold, heat, or scratching (chronic inducible urticaria). The drug aims to control symptoms better than standard antihistamines. About 362 adults will take the drug or a placebo for 52 weeks, with an option to continue treatment longer. The goal is to see if it reduces itching and hives effectively and safely.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

362 people

The number who actually took part.

Started

Dec 2023

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cholinergic urticaria chronic inducible urticaria cold urticaria familial dermatographia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic inducible urticaria

Contacts and locations

Locations

  • Acuro Research Inc

    Little Rock, Arkansas, 72205, United States

  • Aeroallergy Research Laboratories

    Savannah, Georgia, 31406, United States

  • Allergy Associates of Utah

    Sandy City, Utah, 84093, United States

  • Allergy Asthma and Clinical Research

    Oklahoma City, Oklahoma, 73120, United States

  • Allergy and Asthma Specialist P S C

    Owensboro, Kentucky, 42301, United States

  • Allergy and Asthma Specialists Group

    Huntington Beach, California, 92647, United States

  • Allergy and Clinical Immunology Associates

    Pittsburgh, Pennsylvania, 15241, United States

  • Allervie Clinical Research

    Birmingham, Alabama, 35209, United States

  • Antelope Valley Clinical Trials

    Lancaster, California, 93534, United States

  • Asthma and Allergy Associates P C

    Colorado Springs, Colorado, 80907, United States

  • Asthma and Allergy Center of Chicago S C

    River Forest, Illinois, 60305, United States

  • Complete Dermatology

    Sugarland, Texas, 77479, United States

  • Endeavor Health

    Glenview, Illinois, 60077, United States

  • Florida Ctr Allergy Asthma Research

    Aventura, Florida, 33180, United States

  • John Hopkins University

    Baltimore, Maryland, 21204, United States

  • Kern Research

    Bakersfield, California, 93301, United States

  • National Allergy and Asthma Research LLS

    North Charleston, South Carolina, 29420, United States

  • Novartis Investigative Site

    Caba, Buenos Aires, C1121ABE, Argentina

  • Novartis Investigative Site

    CABA, Buenos Aires, C1414AIF, Argentina

  • Novartis Investigative Site

    Rosario, Santa Fe Province, 2000, Argentina

  • Novartis Investigative Site

    CABA, C1181ACH, Argentina

  • Novartis Investigative Site

    Woolloongabba, Queensland, 4102, Australia

  • Novartis Investigative Site

    Carlton, Victoria, 3053, Australia

  • Novartis Investigative Site

    Melbourne, Victoria, 3004, Australia

  • Novartis Investigative Site

    Alphaville Barueri, São Paulo, 06454-010, Brazil

  • Novartis Investigative Site

    Santo André, São Paulo, 09060-870, Brazil

  • Novartis Investigative Site

    Sorocaba, São Paulo, 18040-425, Brazil

  • Novartis Investigative Site

    Winnipeg, Manitoba, R3J 0S9, Canada

  • Novartis Investigative Site

    Hamilton, Ontario, L8L 3C3, Canada

  • Novartis Investigative Site

    Trois-Rivières, Quebec, G8T 7A1, Canada

  • Novartis Investigative Site

    Fuzhou, Fujian, 350025, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510091, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510630, China

  • Novartis Investigative Site

    Changsha, Hunan, 410008, China

  • Novartis Investigative Site

    Wuxi, Jiangsu, 214002, China

  • Novartis Investigative Site

    Changchun, Jilin, 130021, China

  • Novartis Investigative Site

    Jinan, Shandong, 250022, China

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041, China

  • Novartis Investigative Site

    Chengdu, Sichuan, 610072, China

  • Novartis Investigative Site

    Ürümqi, Xinjiang, 830001, China

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310001, China

  • Novartis Investigative Site

    Yiwu, Zhejiang, 322000, China

  • Novartis Investigative Site

    Beijing, 100050, China

  • Novartis Investigative Site

    Beijing, 100730, China

  • Novartis Investigative Site

    Jinan, 250012, China

  • Novartis Investigative Site

    Shanghai, 200040, China

  • Novartis Investigative Site

    Tianjin, 300052, China

  • Novartis Investigative Site

    Barranquilla, Atlántico, 080002, Colombia

  • Novartis Investigative Site

    Barranquilla, Atlántico, 080020, Colombia

  • Novartis Investigative Site

    Grenoble, 38043, France

  • Novartis Investigative Site

    Montpellier, 34295, France

  • Novartis Investigative Site

    Nantes, 44093, France

  • Novartis Investigative Site

    Paris, 75970, France

  • Novartis Investigative Site

    Pierre-Bénite, 69495, France

  • Novartis Investigative Site

    Rouen, 76031, France

  • Novartis Investigative Site

    Toulouse, 31400, France

  • Novartis Investigative Site

    Göttingen, Lower Saxony, 37075, Germany

  • Novartis Investigative Site

    Stade, Lower Saxony, 21682, Germany

  • Novartis Investigative Site

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Mainz, 55131, Germany

  • Novartis Investigative Site

    Münster, 48149, Germany

  • Novartis Investigative Site

    Tübingen, 72076, Germany

  • Novartis Investigative Site

    Hong Kong, 999077, Hong Kong

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032, Hungary

  • Novartis Investigative Site

    Debrecen, Hajdú-Bihar, 4031, Hungary

  • Novartis Investigative Site

    Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary

  • Novartis Investigative Site

    Bangalore, Karnataka, 560004, India

  • Novartis Investigative Site

    Mysore, Karnataka, 570001, India

  • Novartis Investigative Site

    Haifa, 3104802, Israel

  • Novartis Investigative Site

    Jerusalem, 9112001, Israel

  • Novartis Investigative Site

    Ramat Gan, 5265601, Israel

  • Novartis Investigative Site

    Tel Aviv, 6423906, Israel

  • Novartis Investigative Site

    Ancona, AN, 60020, Italy

  • Novartis Investigative Site

    Milan, MI, 20122, Italy

  • Novartis Investigative Site

    Rozzano, MI, 20089, Italy

  • Novartis Investigative Site

    Kitakyushu, Fukuoka, 8078556, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 0608543, Japan

  • Novartis Investigative Site

    Kamimashi-gun, Kumamoto, 861-3106, Japan

  • Novartis Investigative Site

    Habikino, Osaka, 5838588, Japan

  • Novartis Investigative Site

    Takatsuki, Osaka, 5698686, Japan

  • Novartis Investigative Site

    Ohtsu, Shiga, 5202192, Japan

  • Novartis Investigative Site

    Izumo, Shimane, 6938501, Japan

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo, 1138519, Japan

  • Novartis Investigative Site

    Itabashi-ku, Tokyo, 1738610, Japan

  • Novartis Investigative Site

    Shinjuku Ku, Tokyo, 160-0023, Japan

  • Novartis Investigative Site

    Tachikawa, Tokyo, 1900023, Japan

  • Novartis Investigative Site

    Hiroshima, 7308518, Japan

  • Novartis Investigative Site

    Muar town, Johor, 84000, Malaysia

  • Novartis Investigative Site

    Ipoh, Perak, 30450, Malaysia

  • Novartis Investigative Site

    George Town, Pulau Pinang, 10450, Malaysia

  • Novartis Investigative Site

    Utrecht, 3584 CX, Netherlands

  • Novartis Investigative Site

    Bydgoszcz, 85-094, Poland

  • Novartis Investigative Site

    Warsaw, 02-962, Poland

  • Novartis Investigative Site

    Coimbra, 3004-561, Portugal

  • Novartis Investigative Site

    Lisbon, 1649-035, Portugal

  • Novartis Investigative Site

    Vila Nova de Gaia, 4434-502, Portugal

  • Novartis Investigative Site

    Bucharest, District 2, 020762, Romania

  • Novartis Investigative Site

    Singapore, 308205, Singapore

  • Novartis Investigative Site

    Trnava, Slovakia, 917 02, Slovakia

  • Novartis Investigative Site

    Kežmarok, 060 01, Slovakia

  • Novartis Investigative Site

    Žilina, 012 07, Slovakia

  • Novartis Investigative Site

    Suwon, Gyeonggi-do, 16499, South Korea

  • Novartis Investigative Site

    Seoul, 03722, South Korea

  • Novartis Investigative Site

    Santiago, A Coruna, 15702, Spain

  • Novartis Investigative Site

    Granada, Andalusia, 18014, Spain

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003, Spain

  • Novartis Investigative Site

    Alicante, 03010, Spain

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Madrid, 28027, Spain

  • Novartis Investigative Site

    Madrid, 28041, Spain

  • Novartis Investigative Site

    Valencia, 46015, Spain

  • Novartis Investigative Site

    Bangkok, 10400, Thailand

  • Novartis Investigative Site

    Bangkok, 10700, Thailand

  • Novartis Investigative Site

    Chiang Mai, 50200, Thailand

  • Novartis Investigative Site

    Sakarya, Adapazari, 54290, Turkey (Türkiye)

  • Novartis Investigative Site

    Istanbul, Basaksehir, 34480, Turkey (Türkiye)

  • Novartis Investigative Site

    Istanbul, Fatih, 34093, Turkey (Türkiye)

  • Novartis Investigative Site

    Kayseri, Melikgazi, 38039, Turkey (Türkiye)

  • Novartis Investigative Site

    Istanbul, Uskudar, 34662, Turkey (Türkiye)

  • Novartis Investigative Site

    Oxford, Oxford, OX3 7LE, United Kingdom

  • Novartis Investigative Site

    Hanoi, Vietnam, 100000, Vietnam

  • PanAmerican Clinical Research

    Brownsville, Texas, 78520, United States

  • RFSA Dermatology

    San Antonio, Texas, 78213, United States

  • STAAMP Research LLC

    San Antonio, Texas, 78229, United States

  • Sarasota Clinical Research

    Sarasota, Florida, 34233, United States

  • The Indiana Clinical Trials Center

    Plainfield, Indiana, 46168, United States

  • Treasure Valley Medical Research

    Boise, Idaho, 83706, United States

  • Univ of South Florida Asthma Allergy and Immunology CRU

    Tampa, Florida, 33613, United States

  • Western Sky Medical Research

    El Paso, Texas, 79924, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.