Remibrutinib is a highly selective, potent oral BTK inhibitor.
Also known as: LOU064
Pharmaceutical Company: Novartis
Route and Dose of Administration: Oral (once daily)
Emerging Treatment for: Relapsing Multiple Sclerosis
Status: In Phase III clinical trial
Remibrutinib selectively inhibits the protein, Bruton’s tyrosine kinase or BTK, to reduce the activation of B cells that contribute to brain and spinal cord inflammation in MS.
Phase III trial
This is a phase III, randomized, double-blind, double-dummy, active comparator-controlled, fixed-dose, parallel-group, multi-center study that will compare the efficacy and safety of remibrutinib compared to teriflunomide in people with relapsing MS. Primary outcome measures will evaluate the annualized relapse rate for up to 2.5 years of treatment. Disability progression and serum neurofilament light chain will also be measured among study participants.
Eligible participants from the core phase 3 trial will take part in an open-label, single-arm, fixed-dose extension study of remibrutinib for up to 5 years.
Participant recruitment is ongoing. The anticipated study completion date is November 2029.