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Remibrutinib in Real-world Clinical Practice - a US Sub-study

Key facts

Who runs it
Novartis Pharmaceuticals
Where
Kirksville, United StatesSee the site
Trial code
Status
Recruiting
People taking part
505 people, planned
Started
2 Feb 2026
Expected to end
30 Sept 2029
Type of study
Observational, 3 groups
Record updated
13 February 2026

Who can take part

Age
18 years to 100 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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 who are treated with remibrutinib outside of the local label
  • Currently enrolled in a clinical trial or on any experimental treatment
  • Patients not capable or willing to continuously provide ePRO/eDiary data via electronic means throughout the duration of the study

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 100 years old?

Where in United States

  • Cleaver DermatologyKirksville, United StatesContact: Novartis PharmaceuticalsTaking people

About the trial

What the trial wants to find out

Prospective, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to either escalate current sgH1-AHs treatment or escalate/switch current treatment to remibrutinib. The primary aim of this study is to gather real-world effectiveness and safety data for remibrutinib, a new treatment option, covering a broader, real-world clinical practice population.

The 3 groups in the trial

  • Cohort 1

    Inadequate control of CSU despite licensed dose of sgH1-AH (no other pre-treatments permitted) and decision 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 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 to switch to remibrutinib treatment as per local label

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Remibrutinib in Real-world Clinical Practice: a Prospective, Multi-country, Non-interventional, Effectiveness and Safety Study - a US Sub-study
Fit questions
Built from NCT07358780, who can take part
Record updated
13 February 2026