Novartis Initiates Phase III Trial of BTK Inhibitor Remibrutinib Versus Omalizumab in Chronic Spontaneous Urticaria

On September 18, the clinicaltrials.gov website showed that Novartis' BTK inhibitor Remibrutinib (LOU064) had initiated a new Phase III clinical trial aimed at evaluating the efficacy and safety of Remibrutinib (25mg, twice daily), placebo, and omalizumab (300mg, once monthly) in treating Chronic Spontaneous Urticaria (CSU).

The study plans to enroll 468 adult CSU patients whose conditions remain inadequately controlled after treatment with histamine H1 receptor antagonists, with a treatment period of 52 weeks. Enrolled patients will be randomly assigned in a 2:1:1:2 ratio to four cohorts: the Remibrutinib group, the Remibrutinib placebo group, the Omalizumab group, and the Omalizumab placebo group. The primary endpoint of the study is the absolute change from baseline in the Urticaria Activity Score over 7 days (UAS7) at week 12. The study is expected to commence in November 2023 and conclude in June 2026.

Remibrutinib is a novel covalent BTK inhibitor developed by Novartis. It can bind to the inactive conformation of BTK and exhibits selectivity different from other BTK inhibitors. Currently, Novartis has initiated multiple Phase III clinical trials of Remibrutinib for multiple sclerosis, chronic inducible urticaria, and CSU.

Last month, Novartis successfully completed two Phase III clinical trials of Remibrutinib for the treatment of CSU (see: ). The results showed that, compared with the placebo group, the UAS7 scores of patients in the Remibrutinib group significantly improved. Based on this, Novartis plans to submit the marketing application for Remibrutinib next year.

Currently, seven BTK inhibitors have been approved globally, all of which are used in the field of oncology. No BTK inhibitor has been approved yet for treating autoimmune diseases like CSU. In the CSU field, only four drugs have been approved: desloratadine, omalizumab, levocetirizine, and fexofenadine. Except for omalizumab, the other three are histamine H1 receptor antagonists.

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