Novel Anti-CD40 Monoclonal Antibody CFZ533 in Patients with Primary Sjogren Syndrome: A Phase Iia Double-Blind, Placebo–Controlled Randomized Trial

Objectives: Primary Sjogren syndrome (pSS) is a progressive autoimmune disease characterized by formation of ectopic germinal centers in exocrine glands and secretory gland dysfunction with subset of patients developing extraglandular manifestations. CFZ533 is a novel monoclonal antibody that selectively blocks CD40, a co-stimulatory pathway receptor essential for germinal center reactions and other immune-mediated functions implicated in pSS pathogenesis. We conducted a randomized, double-blind, placebo-controlled, multicentric, partial crossover, Phase IIa Proof of Concept (PoC) study to evaluate the safety, tolerability and efficacy of CFZ533 in patients with pSS.