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New hope for teens with stubborn hives: drug trial launches

NCT ID NCT05677451

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

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Updated 2 times

Summary

This study tests a drug called remibrutinib in teenagers aged 12 to 17 who have chronic spontaneous urticaria (hives that come and go for no clear reason) that isn't controlled by antihistamines. About 100 participants will receive either the drug or a placebo for 24 weeks, with an option to continue treatment for up to 3 more years. The goal is to see if the drug reduces itching and hives better than a placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
remibrutinib (a drug that targets inflammation to reduce hives and itching)
What this could lead to
If it works, this could provide a new treatment option for teenagers with chronic hives that don't respond to standard antihistamines.
What could go wrong
This is a Phase 3 trial, but it's still early for this age group. The drug may not work better than placebo, and side effects are possible. Long-term safety is still being studied.

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

100 people

The number who actually took part.

Started

Jul 2023

Expected to finish

Mar 2032

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

12 to 17 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.

Key Inclusion Criteria: * Male and female adolescent participants aged \>= 12 to \< 18 years of age at the time of signing the informed consent * CSU duration for \>= 6 months prior to screening (defined as the onset of CSU determined by the investigator based on all available supporting documentation) * Diagnosis of CSU inadequately controlled by second-generation H1-AH at the time of randomization defined as: * The presence of itch and hives for ≥ 6 consecutive weeks prior to screening despite the use of second-generation H1-AH during this time period according to local treatment guidelines * UAS7 score (range 0 - 42) \>= 16, ISS7 score (range 0 - 21) \>= 6 and HSS7 score (range 0 - 21) \>= 6 during the 7 days prior to randomization (Day 1) * Documentation of hives within three months before randomization (either at screening and/or at randomization; or documented in the participants' medical history) Key Exclusion criteria: * Previous use of remibrutinib or other BTK inhibitors * Significant bleeding risk or coagulation disorders * History of gastrointestinal bleeding * Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited * History or current hepatic disease * Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant * History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes * Participants having a clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria) including urticaria factitia (symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticaria * Other diseases with symptoms of urticaria or angioedema, including but not limited to urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary angioedema, or drug-induced urticaria * 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 or psoriasis Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

chronic idiopathic urticaria Chronic Urticaria

As listed by the trial registrant

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

Chronic spontaneous urticaria

Contacts and locations

Locations

  • Allergy Associates of Utah

    Sandy City, Utah, 84093, United States

  • Allergy Asthma and Clinical Research

    Oklahoma City, Oklahoma, 73120, United States

  • Allergy and Asthma Medical Group and Research Center

    San Diego, California, 92123, United States

  • Allergy and Asthma Specialist P S C

    Owensboro, Kentucky, 42301, United States

  • Allergy and Clinical Immunology Associates

    Pittsburgh, Pennsylvania, 15241, United States

  • Endeavor Health

    Glenview, Illinois, 60077, United States

  • Kern Research

    Bakersfield, California, 93301, United States

  • 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

    San Miguel de Tucumán, T4000AXL, Argentina

  • Novartis Investigative Site

    Montreal, Quebec, H4A 3J1, Canada

  • Novartis Investigative Site

    Santiago, Santiago Metropolitan, 8420383, Chile

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510091, China

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041, China

  • Novartis Investigative Site

    Beijing, 100050, China

  • Novartis Investigative Site

    Beijing, 100069, China

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60590, Germany

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Tübingen, 72076, Germany

  • Novartis Investigative Site

    Hong Kong, Hong Kong, 999077, Hong Kong

  • Novartis Investigative Site

    Hong Kong, 999077, Hong Kong

  • Novartis Investigative Site

    Florence, FI, 50139, Italy

  • Novartis Investigative Site

    Pavia, PV, 27100, Italy

  • Novartis Investigative Site

    Siena, SI, 53100, Italy

  • Novartis Investigative Site

    Kitakyushu, Fukuoka, 8078556, Japan

  • Novartis Investigative Site

    Kamimashi-gun, Kumamoto, 861-3106, Japan

  • Novartis Investigative Site

    Sakai, Osaka, 5938324, Japan

  • Novartis Investigative Site

    Izumo, Shimane, 6938501, Japan

  • Novartis Investigative Site

    Itabashi-ku, Tokyo, 1738610, Japan

  • Novartis Investigative Site

    Kuching, Sarawak, 93586, Malaysia

  • Novartis Investigative Site

    Utrecht, 3584 CX, Netherlands

  • Novartis Investigative Site

    Lodz, 90-436, Poland

  • Novartis Investigative Site

    Pretoria, Gauteng, 0181, South Africa

  • Novartis Investigative Site

    Cape Town, 7925, South Africa

  • Novartis Investigative Site

    Esplugues, Barcelona, 08950, Spain

  • Novartis Investigative Site

    Valencia, 46014, Spain

  • Novartis Investigative Site

    Songkhla, Hat Yai, 90110, Thailand

  • Novartis Investigative Site

    Bangkok, 10330, Thailand

  • Novartis Investigative Site

    Bangkok, 10700, Thailand

  • Novartis Investigative Site

    Istanbul, Fatih, 34093, Turkey (Türkiye)

  • Novartis Investigative Site

    Ankara, Sihhiye-Altindag, 06230, Turkey (Türkiye)

  • Novartis Investigative Site

    Adana, 01330, Turkey (Türkiye)

  • Novartis Investigative Site

    Peterborough, Cambridgeshire, PE3 9GZ, United Kingdom

  • Novartis Investigative Site

    Manchester, M13 9WL, United Kingdom

  • Novartis Investigative Site

    Southampton, SO16 6YD, United Kingdom

  • Pediatric Dermatology of Miami at the Pediatric CoE

    Miami, Florida, 33156, United States

  • RFSA Dermatology

    San Antonio, Texas, 78213, United States

  • Toledo Institute of Clinical Research

    Toledo, Ohio, 43617, United States

  • Treasure Valley Medical Research

    Boise, Idaho, 83706, United States

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