Phase 2 Study of Bruton's Tyrosine Kinase Inhibitor in Multiple Sclerosis

Bruton's tyrosine kinase (BTK) is part of the signaling pathway for B cells and myeloid cells. Evobrutinib is an oral BTK inhibitor being evaluated for treating multiple sclerosis (MS), among other autoimmune diseases. For this randomized, multicenter, industry-sponsored phase II study, 267 patients with MS were randomized to placebo, evobrutinib (at doses of 25 mg daily, 75 mg daily, or 75 mg twice daily), or dimethyl fumarate (DMF). The primary endpoint was the cumulative number of gadolinium-enhancing MRI lesions at weeks 12 through 24. Secondary endpoints included relapses and change in disability score.

Mean number of cumulative gadolinium-enhancing lesions was 3.9 with placebo, 4.1 with evobrutinib 25 daily, 1.7 with evobrutinib 75 mg …