A Phase 1b Multiple Ascending-dose Study of itolizumab (EQ001) in Subjects With Systemic
Lupus Erythematosus With or Without Active Proliferative Lupus Nephritis
The EQUALISE study was a Phase 1b study to evaluate the safety and tolerability of itolizumab in patients with lupus and lupus
nephritis. The study, with topline data announced in April 2024, had 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 was 4 weeks in
duration, and treatment for patients with active proliferative lupus nephritis in Type B Cohort was 24 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.