Great News for Lupus Nephritis Treatment: Itolizumab Fast-Tracked by FDA

December 10, 2019

The Lupus Research Alliance (LRA) is pleased to share that a potential new treatment in development by Equillium, Inc. for lupus nephritis, itolizumab, was granted Fast Track designation by the U.S. Food and Drug Administration.  As defined by the FDA, this designation is “designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.”

In September, 2019 Equillium, Inc. began a Phase 1b study called EQUALISE to study itolizumab in lupus nephritis.  The EQUALISE study is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of itolizumab in patients with lupus and lupus nephritis (NCT 04128579). The study will have two cohorts (groups) of patients: Type A is an open-label cohort and will treat patients with systemic lupus erythematosus for four weeks; Type B is a double-blind, placebo-controlled cohort and will treat patients with active proliferative lupus nephritis, the most serious form of the disease, for 12 weeks.

The LRA is especially proud of this milestone; affiliate Lupus Therapeutics was  involved from the outset in helping  design the EQUALISE trial.  As noted in the press release from Equillium, “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.” Our team reviewed patient materials about the trial and enlisted people with lupus as an advisory board to provide the perspective of potential participants.

The LRA encourages patients to talk with their physicians about whether to consider taking part in EQUALISE. And we very much look forward to seeing the results of the trial.