A Real-world Study of Remibrutinib in Chronic Spontaneous Urticaria Patients

Last updated: March 3, 2026
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urticaria

Hives (Urticaria)

Treatment

N/A

Clinical Study ID

NCT07408219
CLOU064AUS05
  • Ages 18-100
  • All Genders

Study Summary

This is a United States (US) based, prospective, non-interventional, provider-referral study to evaluate the real-world effectiveness and patient-centered outcomes of remibrutinib in chronic spontaneous urticaria (CSU) patients using validated patient reported outcome (PRO) tools.

Eligibility Criteria

Inclusion

Inclusion criteria:

Healthcare provider (HCP) participants eligible to refer patients for inclusion in this study must meet all the following criteria:

  1. Have an active medical license and be board certified/board eligible allergist ordermatologist in the US. Nurse practitioners and physician assistant practicing inallergy and dermatology are eligible.

  2. Manage CSU patients within their practice.

  3. Enrolled in the research network or are referred HCPs who agree to participate.

  4. Have the requisite patient population based on study inclusion/exclusion criteria. Patients eligible for inclusion in this study must meet all of the followingcriteria:

  5. ≥ 18 years of age.

  6. Diagnosed with CSU by an HCP.

  7. Have received a prescription for remibrutinib or dupilumab and are expected toinitiate treatment.

  8. Have access to an electronic device with internet capabilities.

  9. Able to read and understand English.

  10. Willing and able to provide consent for study participation.

Exclusion

Exclusion criteria:

Patients will be excluded if they meet any of the following criteria:

  1. Unable to procure remibrutinib or dupilumab (through samples, commercially orpatient assistance program).

  2. Exposure to oral corticosteroid treatment in 14 days prior to consent.

  3. Exposure to oral corticosteroid treatment in 14 days prior to initiating treatmentwith remibrutinib or dupilumab.

  4. Prior participation in a remibrutinib or dupilumab clinical trial.

  5. Cognitive impairment that impacts the patient's ability to participate.

Study Design

Total Participants: 350
Study Start date:
January 17, 2026
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Novartis

    East Hanover, New Jersey 07936
    United States

    Active - Recruiting

  • Novartis

    East Hanover 5097421, New Jersey 5101760 07936
    United States

    Site Not Available

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