Remibrutinib use in everyday clinical care for chronic spontaneous urticaria
Remibrutinib in Real-world Clinical Practice: a Prospective, Multi-country, Non-interventional, Effectiveness and Safety Study
This project sees if remibrutinib helps adults with chronic spontaneous urticaria who need higher‑dose second‑generation antihistamines or are switching to remibrutinib.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3280 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Drugs / interventions | remibrutinib |
| Locations | 1 site (Kirksville, Missouri) |
| Trial ID | NCT07358364 on ClinicalTrials.gov |
What this trial studies
This is a prospective, observational, multi-country umbrella program collecting real‑world effectiveness and safety data for remibrutinib in patients with chronic spontaneous urticaria (CSU). Patients are enrolled into cohorts based on treatment decisions made before enrolment: escalation of second‑generation H1 antihistamines, switching to remibrutinib, or other prior treatment histories. Core outcomes include symptom control measures (UCT or UAS7) and quality of life (DLQI) with planned 24‑month follow-up, and local sites may adapt the global protocol to meet country requirements. Data from participating countries will be pooled for global analysis to reflect broader routine clinical practice.
Who should consider this trial
Good fit: Adults (18+) with a physician‑confirmed diagnosis of primary chronic spontaneous urticaria who have inadequate control on licensed doses of second‑generation H1 antihistamines and whose clinician has independently decided to escalate treatment or switch to remibrutinib, and who can consent to 24 months of follow‑up.
Not a fit: Patients who are well controlled on current antihistamine therapy, are under 18, have contraindications to remibrutinib, or are in regions where specific cohorts (e.g., off‑label antihistamine escalation) are not permitted are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, remibrutinib could provide better symptom control and improved quality of life for people with CSU who do not respond adequately to standard second‑generation antihistamines.
How similar studies have performed: Early clinical trials of remibrutinib have shown promising efficacy and safety signals in CSU, but this observational program aims to confirm those findings in broader routine practice.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 during a remibrutinib interventional study or MAP/PSDS 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.
Where this trial is running
Kirksville, Missouri
- Cleaver Dermatology — Kirksville, Missouri, United States (Recruiting)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: 1-888-669-6682
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.