At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of EQ001 in Subjects With Newly Diagnosed Acute Graft Versus Host Disease
In Brief
A Phase 1 clinical trial evaluating EQ001 and EQ001 Placebo for Acute-graft-versus-host Disease and 3 related conditions. Completed, enrolled 30 participants across 16 sites.
Signals
Detailed Summary
This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of EQ001 in subjects with Acute Graft Versus Host Disease (aGVHD).
Study Details
Timeline
Arms & Interventions
Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses.
EQ001 administered in a blinded fashion using the optimal dose selected from Part A by intravenous infusion every two weeks for a total of 5 doses.
Placebo administered in a blinded fashion by intravenous infusion every two weeks for a total of 5 doses.
Interventions
Itolizumab \[Bmab 600\])
EQ001 Placebo