Equip Study
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.
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Equalise Study
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.
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