Actively Recruiting
Remibrutinib in Real-world Clinical Practice: a Prospective, Multi-country, Non-interventional, Effectiveness and Safety Study
Led by Novartis Pharmaceuticals · Updated on 2026-04-16
3280
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating remibrutinib in patients with chronic spontaneous urticaria (CSU) in a prospective, multi-country, non-interventional study. The study focuses on patients where the treatment decision to escalate current second-generation H1-antihistamines (sgH1-AHs) or switch to remibrutinib was made before enrollment. The goal is to collect real-world data on the effectiveness and safety of remibrutinib across diverse clinical practices, reflecting a broader patient population than typical clinical trials. The study follows an umbrella design allowing adaptations to local treatment guidelines and evidence needs across countries. Patients are grouped into cohorts based on their treatment history and decisions: Cohort 1 includes those escalating sgH1-AH treatment due to inadequate control; Cohort 2 includes those switching to remibrutinib; Cohort 3 covers patients switching to remibrutinib with other prior treatments. Data are collected using tools like the Urticaria Control Test (UCT), Urticaria Activity Score over 7 days (UAS7), and Dermatology Life Quality Index (DLQI). Participants will be monitored for up to 24 months with regular assessments of disease control, quality of life, angioedema activity, treatment patterns, and adverse events. Data will be gathered via electronic patient-reported outcomes and diaries to track symptoms and treatment adherence. The primary outcomes measured are UCT7 and UAS7 scores at 12 weeks after starting remibrutinib, with additional long-term measures to understand treatment effects and patient experiences.
CONDITIONS
Brief 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 24 months of follow-up.
- Cohort 1: Inadequate control of CSU despite licensed dose of sgH1-AH with decision to escalate treatment.
- Cohort 2: Inadequate control of CSU despite licensed or escalated sgH1-AHs with decision to switch to remibrutinib.
- Cohort 3: Previous treatment with other CSU therapies plus H1-AH and decision to switch to remibrutinib; includes patients with continuous steroid use of at least three weeks.
- Patients must not have started the next treatment step before enrolment to capture baseline status.
You will not qualify if you...
- Currently enrolled in another 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 electronic patient-reported data continuously.
- Treated with remibrutinib outside of local label guidelines.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants who have decided to escalate or switch treatment in real-world clinical practice are observed to collect effectiveness and safety data on remibrutinib.
Regular visits as per local clinical practice
Trial Site Locations
Total: 1 location
1
Cleaver Dermatology
Kirksville, Missouri, United States, 63501
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
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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