The EQUALISE Study

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A Phase 1b Randomized, Double-blind, Placebo-controlled, Multiple Ascending-dose Study of itolizumab (EQ001) in Subjects With Systemic Lupus Erythematosus With or Without Active Proliferative Lupus Nephritis

TRIAL OVERVIEW

Disease: Lupus Nephritis

The EQUALISE study is a Phase 1b randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of itolizumab in patients with lupus and lupus nephritis. The study will have two cohorts studied over three defined periods – screening, treatment, and follow-up. The treatment period for patients with systemic lupus erythematosus in Type A Cohort will be 4 weeks in duration. Treatment for patients with active proliferative lupus nephritis in Type B Cohort will be 12 weeks in duration. 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.

Poster: Design of a Randomized Double-blind Placebo-controlled Trial of Itolizumab, a Novel Monoclonal Antibody to CD6, in patients with SLE and Lupus Nephritis