Actively Recruiting
Remibrutinib in Real-world Clinical Practice - a US Sub-study
Led by Novartis Pharmaceuticals · Updated on 2026-02-13
505
Participants Needed
1
Research Sites
190 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Remibrutinib in Real-world Clinical Practice - a US Sub-study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 and willingness to complete full follow-up period of 24 months.
- 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 except 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 during CSU treatment history, with decision to switch to remibrutinib as per local label; continuous steroids for at least three weeks during treatment history qualifies for cohort 3.
- Candidate patients must not have started the next escalated treatment prior to enrolment to capture baseline clinical status before treatment escalation.
You will not qualify if you...
- 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 in a prior remibrutinib interventional study or MAP/PSDS.
- Patients not capable or willing to continuously provide electronic patient-reported outcome or diary data during the study.
- Patients treated with remibrutinib outside of the local label.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cleaver Dermatology
Kirksville, Missouri, United States, 63501
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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