Novartis data show rapid and effective disease activity control with remibrutinib (LOU064) in patients with chronic spontaneous urticaria

  • Results from a Phase IIb study show all remibrutinib doses provided significant improvements in UAS7 change from baseline at week 4 and week 12 compared to placebo, and a favorable safety profile across the entire dose range tested
  • All doses provided clinically meaningful improvements with respect to the proportion of patients achieving UAS7=0 (complete absence of hives and itch) and UAS7=6 (well-controlled disease activity) vs. placebo over the treatment period, starting as early as Week 1
  • Remibrutinib is a highly selective, potent oral BTK inhibitor with a potential best-in-class profile, under investigation for a number of immune-mediated conditions; Phase III studies in CSU are expected to begin enrolling patients by the end of 2021
  • Novartis datasets at EADV 2021 demonstrate our continued commitment to innovation in immuno-dermatology, aiming to ease the burden of these life-limiting diseases
  • CSU is a distressing and unpredictable disease that remains inadequately controlled for many, highlighting the importance of pursuing new modes of action


Basel, September 30, 2021 - Novartis today announced positive Phase IIb data showing remibrutinib (LOU064), a potentially best-in-class oral BTK inhibitor, demonstrated rapid and effective disease control in patients with inadequately controlled chronic spontaneous urticaria (CSU). The data were presented as a late-breaking abstract at the European Academy of Dermatology and Venereology (EADV) 30th Anniversary Congress.

This randomized, double-blind, placebo-controlled study (NCT03926611) evaluated the efficacy and safety of remibrutinib over 12 weeks in patients inadequately controlled with antihistamines. Patients (n=311) were randomized to placebo or different doses of remibrutinib, taken orally. The primary endpoint was achieved with remibrutinib showing a statistically significant dose-response compared to placebo with respect to change from baseline in UAS7 score at Week 4¹.

All remibrutinib doses provided significant improvements with respect to change from baseline in UAS7 at Week 4 and at Week 12 (p<0.0001 for all doses vs placebo) and demonstrated a rapid improvement as of Week 1. Compared with placebo, more patients receiving any remibrutinib dose achieved a complete control with absence of hives and itch (UAS7=0) or well-controlled disease (UAS7

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