The EQUIP study is a Phase 1b randomized, double-blind, placebo-controlled study in patients with uncontrolled moderate to severe asthma. In this 12-week multiple ascending dose study, patients receive either Itolizumab or placebo administered subcutaneously every two weeks, for a total of 5 doses, with 4 weeks of follow-up. The primary endpoints of the study are safety and tolerability of Itolizumab in patients with uncontrolled moderate to severe asthma. The secondary endpoints include characterizing pharmacokinetics (PK), pharmacodynamics (PD), PK/PD relationship and clinical activity of Itolizumab.

The EQUATE study is a Phase 1b/2 trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of Itolizumab for first-line treatment in patients who present with aGVHD. The Phase 1b part of the trial is an open-label dose escalation study in adult patients who present with high-risk aGVHD and typically respond poorly to steroids. The Phase 1b data will inform selection of the dose to be used in the next phase of development for the program.

The EQUALISE study is a Phase 1b open-label proof-of-concept multiple ascending-dose clinical study of Itolizumab in patients with systemic lupus erythematosus and lupus nephritis. The study is evaluating the safety and tolerability of subcutaneous delivery of Itolizumab in patients with systemic lupus erythematosus and lupus nephritis. The treatment period for patients with systemic lupus erythematosus is two weeks in duration, while treatment for patients with active proliferative lupus nephritis is 24 weeks in duration.