Actively Recruiting
Remibrutinib in Real-world Clinical Practice
Led by Novartis Pharmaceuticals · Updated on 2026-04-16
3280
Participants Needed
1
Research Sites
299 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prospective, multi-country, 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
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 to participate and willingness to complete the 24-month follow-up.
- Cohort 1: Inadequate control of CSU despite licensed dose of sgH1-AH with decision to escalate sgH1-AH treatment.
- Cohort 2: Inadequate control of CSU despite licensed or escalated sgH1-AH(s) with decision to switch to remibrutinib.
- Cohort 3: Any other treatment added to H1-AH during CSU history with decision to switch to remibrutinib; continuous steroids for at least 3 weeks during history included.
- Patients must not have started the next treatment step before enrolment to capture baseline status.
You will not qualify if you...
- Currently enrolled in a clinical trial or receiving experimental treatment.
- In safety follow-up phase of a previous study.
- Previously received remibrutinib as an investigational product.
- Unable or unwilling to provide continuous electronic patient-reported data.
- Treated with remibrutinib outside of 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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