Posted by Michael Wonder on 10 Dec 2019
Equillium granted U.S. FDA fast track designation for itolizumab for the treatment of lupus nephritis
9 December 2019 - Equillium today announced that the U.S. FDA has granted fast track designation for itolizumab for the treatment of lupus nephritis.
Equillium initiated the EQUALISE Phase 1b study of itolizumab in patients with lupus and lupus nephritis in September 2019.
The study will have two cohorts: Type A is an open-label cohort and will treat patients with systemic lupus erythematosus for 4 weeks; Type B is a double-blind, placebo-controlled cohort and will treat patients with active proliferative lupus nephritis for 12 weeks. The trial design was informed by members of the lupus community, including leading clinical and scientific experts in the lupus field, the Lupus Research Alliance, and patients living with lupus and/or lupus nephritis.
