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A Phase 1b 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 trial to evaluate the safety and clinical efficacy of itolizumab for front-line treatment in patients who present with aGVHD. 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 received up to a total of 5 doses of itolizumab, administered bi-weekly over the course of 10 weeks. The Phase 1b data was presented to the FDA to inform the path forward for the aGVHD program, and the company is now in Pivotal Phase 3 planning and expected to be ready for enrollment in Q4 2021.