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A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines

Comparing two treatments for chronic spontaneous urticaria in a clinical trial.

Recruiting
18 years and older
All
Phase 3

This study is for adults with chronic spontaneous urticaria (CSU), a skin condition causing itchy hives, that is not controlled by second generation H1-antihistamines (sgH1-AH). It compares two treatments: remibrutinib, a pill taken twice daily, and dupilumab, an injection given every two weeks. The study lasts up to 24 weeks, starting with a screening period of up to 4 weeks to check eligibility, followed by a 12-week treatment period. After this, there is an optional open-label extension for 12 more weeks if remibrutinib is not available for sale yet.

  • The study involves several visits over 24 weeks, including possible safety follow-ups.
  • Participants will receive either remibrutinib or dupilumab as additional treatment.
  • Participants must not have serious health issues like heart disease or uncontrolled high blood pressure.

Participants must be willing to keep a daily diary and follow the study's rules. They should not have used similar medicines before. This study hopes to find out which treatment works better for CSU at earlier stages.

Study details
    Chronic Spontaneous Urticaria (CSU)

NCT06868212

Novartis Pharmaceuticals

7 March 2026

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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