Remibrutinib in Real-world Clinical Practice - a Germany Sub-study (REASSERT) (NCT07642557) | Clinical Trial Compass
RecruitingNot Applicable
Remibrutinib in Real-world Clinical Practice - a Germany Sub-study (REASSERT)
Germany470 participantsStarted 2026-08-04
Plain-language summary
Prospective, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
.2.1 Inclusion criteria Patients must meet all the following criteria to be eligible for inclusion in this study.
. Patients with a confirmed diagnosis of primary CSU by the treating physician.
. Aged at least 18 years on the date of enrollment.
. Written informed consent of the patient to participate in the study and willingness to complete full follow-up period of 24 months.
. 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 enrollment) to switch to remibrutinib treatment as per local label.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Achievement of well-controlled disease (UCT7 ≥ 12)
Timeframe: 12 weeks after initiating remibrutinib treatment
. Cohort3: Any other treatment received in addition to H1-AH, any time during patients' CSU treatment history, with decision (independent of study enrollment) 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 3 weeks during treatment history, they will be included in cohort 3.
Exclusion criteria
. Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with remibrutinib.
. Patients within the safety follow-up phase of a previous interventional or non-interventional study.
. Patients who received remibrutinib 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.