Remibrutinib use in everyday US care for chronic spontaneous urticaria
Remibrutinib in Real-world Clinical Practice: a Prospective, Multi-country, Non-interventional, Effectiveness and Safety Study - a US Sub-study
This US sub-study will test remibrutinib's real-world safety and effectiveness for adults with chronic spontaneous urticaria who are escalating or switching from second-generation H1 antihistamines.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 505 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Drugs / interventions | remibrutinib |
| Locations | 1 site (Kirksville, Missouri) |
| Trial ID | NCT07358780 on ClinicalTrials.gov |
What this trial studies
This prospective, non-interventional US sub-study will collect 24 months of real-world effectiveness and safety data on remibrutinib in adults with chronic spontaneous urticaria as part of the global REASSERT program. Patients are enrolled only after a treating physician has independently decided to either escalate second-generation H1 antihistamine therapy or switch/escalate treatment to remibrutinib; the study does not assign treatments. Three observational cohorts capture patients escalating sgH1-AHs, switching to remibrutinib per local label, or receiving other adjunctive therapies, with routine clinical visits and data collection on symptoms, medication use, and adverse events. The aim is to extend controlled-trial findings into broader clinical practice by documenting outcomes across a more heterogeneous patient population in usual-care settings.
Who should consider this trial
Good fit: Adults (≥18) with physician-confirmed primary chronic spontaneous urticaria who have inadequate control on licensed doses of second-generation H1 antihistamines and whose clinicians plan to escalate therapy or switch to remibrutinib are the intended participants.
Not a fit: Patients whose CSU is well controlled on current treatment, children under 18, or those with urticaria due to identified alternative causes are unlikely to benefit from switching to remibrutinib in this observational setting.
Why it matters
Potential benefit: If successful, the data could support remibrutinib as an additional safe and effective option for adults with CSU who do not respond adequately to or need escalation beyond second-generation H1 antihistamines.
How similar studies have performed: Randomized clinical trials of remibrutinib and other BTK inhibitors have shown promising efficacy in CSU, but systematically collected real-world safety and effectiveness data remain limited.
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: +41613241111
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.