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A Phase 1b/2 Dose-Escalation Study of Intravenous Itolizumab (EQ001) in Subjects With Acute Graft-Versus-Host Disease
Disease: Acute Graft-Versus-Host Disease (aGVHD)
The EQUATE study is a Phase 1b/2 trial that will evaluate the safety and clinical efficacy of itolizumab for front-line treatment in patients who present with aGVHD. The study will be conducted in two parts. The part of the study is an open-label dose escalation study in adult patients who present with high risk aGVHD who typically respond poorly to steroids. Patients in this study will receive a total of 5 doses of itolizumab, administered bi-weekly over the course of 10 weeks. The Phase 1b will inform selection of the dose to be used in the Phase 2 portion of the study. The Phase 2 part of the study is a randomized, double-blind, placebo-controlled study that will enroll patients with Grade II through IV disease in patients age 12 and older.