New hope for teens with stubborn hives: drug trial launches

NCT ID NCT05677451

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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