Long-term safety of remibrutinib in patients with chronic spontaneous urticaria continuing from prior remibrutinib treatment trials

The primary objective is to evaluate long-term safety of remibrutinib in chronic spontaneous urticaria by assessing the occurrence of adverse events and serious adverse events, which is clinically relevant for characterizing tolerability during continued treatment. No secondary objectives were specified.

The trial population comprised 125 participants with chronic spontaneous urticaria. Both female and male participants were included, and the age range was not specified in the source beyond coded age categories. The population was selected from patients who had completed treatment per protocol in a prior Novartis study of remibrutinib in a dermatological or allergology indication, or who met specified exceptions related to parent study termination for non-safety and non-efficacy reasons. Participants were required to be deriving benefit from remibrutinib, with investigator judgment indicating that continued benefit outweighed risk, and to be unable to access the marketed remibrutinib formulation through local post-study supply, prescription, or reimbursement pathways. No information was provided on general health status beyond the disease population, and no lifestyle considerations such as diet, physical activity, or habits were reported.

This open-label, multi-center roll-over protocol is designed for participants with chronic spontaneous urticaria who have completed a previous Novartis-sponsored remibrutinib study or who otherwise meet the specified continuation criteria and are judged by the investigator to benefit from ongoing treatment. The study evaluates long-term safety through the occurrence of adverse events and serious adverse events. Participants receive oral remibrutinib 50 mg as a film-coated tablet during continued treatment. The overall trial duration is estimated from 2026-05-20 to 2034-01-09. Study procedures include an inclusion screening visit to confirm eligibility and assess continued benefit, follow-up visits during treatment to monitor safety, and an end-of-study visit to complete final assessments. Participant involvement is expected to continue until study completion or until early termination, which may occur if eligibility criteria are no longer met, if the investigator judges that the risk outweighs the benefit, or if continued treatment is no longer appropriate for any other protocol-defined reason.

The investigational treatment was remibrutinib, supplied as a film-coated tablet for oral administration at a dose of 50 mg. Administration was performed once daily in the study protocol. The trial was open-label and evaluated continued treatment with remibrutinib in participants who had completed a previous Novartis-sponsored remibrutinib study and were judged by the investigator to benefit from ongoing treatment. Long-term safety was assessed through the occurrence of adverse events and serious adverse events. No non-experimental comparator, placebo, or standard-of-care treatment was specified in the source data. Information on additional dosing modifications, administration procedures, or compliance monitoring was not provided in the source data.

The efficacy of chronic spontaneous urticaria treatment will not be formally evaluated in this protocol. The study is designed as an open-label, multi-center rollover protocol with a primary objective of long-term safety assessment, based on the occurrence of adverse events and serious adverse events. No efficacy endpoints, measurement tools, schedules, or analysis methods are specified.