Remibrutinib use in everyday US care for chronic spontaneous urticaria

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, non-interventional US sub-study will collect 24 months of real-world effectiveness and safety data on remibrutinib in adults with chronic spontaneous urticaria as part of the global REASSERT program. Patients are enrolled only after a treating physician has independently decided to either escalate second-generation H1 antihistamine therapy or switch/escalate treatment to remibrutinib; the study does not assign treatments. Three observational cohorts capture patients escalating sgH1-AHs, switching to remibrutinib per local label, or receiving other adjunctive therapies, with routine clinical visits and data collection on symptoms, medication use, and adverse events. The aim is to extend controlled-trial findings into broader clinical practice by documenting outcomes across a more heterogeneous patient population in usual-care settings.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with a confirmed diagnosis of primary CSU by the treating physician.
* Aged at least 18 years on the date of enrolment.
* Written informed consent of the patient to participate in the study (according to country specifications) and willingness to complete full follow-up period of 24 months.
* Cohort-specific observational inclusion criteria:

  * Cohort 1: Inadequate control of CSU despite licensed dose of sgH1-AH (no other pre-treatments permitted) and decision (independent of study enrolment) to escalate sgH1-AH treatment.
  * Cohort 2: Inadequate control of CSU despite licensed dose or escalated sgH1-AH(s) (no other pre-treatment with exception of first generation H1-AH permitted) with decision (independent of study enrolment) to switch to remibrutinib treatment as per local label.
  * Cohort 3: Any other treatment received in addition to H1-AH, any time during patients' CSU treatment history, with decision (independent of study enrolment) to switch to remibrutinib treatment as per local label. Note, occasional steroid rescue medication is out of scope for cohort definition. If a patient had been on continuous steroids for at least three weeks during treatment history, they will be included in cohort 3.

Note: Candidate patients must not have initiated the next escalated treatment step (i.e. up dosed AH for cohort 1, or remibrutinib for cohorts 2 and 3) prior to their enrolment to ensure the baseline visit captures their clinical status before treatment escalation.

Exclusion Criteria:

* Currently enrolled in a clinical trial or on any experimental treatment.
* Patients within the safety follow-up phase of a previous interventional or non-interventional study.
* Patients who received remibrutinib as an investigational medical product during a remibrutinib interventional study or MAP/PSDS at any time in the past.
* Patients not capable or willing to continuously provide ePRO/eDiary data via electronic means throughout the duration of the study.
* Patients who are treated with remibrutinib outside of the local label.

Where it's running

• Cleaver Dermatology
  Kirksville, Missouri, United States Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.