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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

Trial Profile

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

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 26 Nov 2019

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At a glance

  • Drugs Itolizumab (Primary) ; Corticosteroids
  • Indications Graft-versus-host disease
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms EQUATE
  • Sponsors Equillium
  • Most Recent Events

    • 26 Nov 2019 According to an Equillium media release, details of this trial design will be presented at the 61st American Society of Hematology (ASH) Annual Meeting and Exposition (7th-10th Dec 2019) in Orlando, Florida.
    • 01 Oct 2019 According to an Equillium media release, the company is working with U.S. Food and Drug Administration (FDA) to re-evaluate the entry criteria into the Phase 1b portion of the trial to further expand the pool of patients eligible for the study. Given the current progress, the company is revising guidance to announce topline data from the Phase 1b portion of this study to the second half of 2020.
    • 01 Oct 2019 According to an Equillium media release, physician interest and engagement in this program remains very high, and Equillium continues to activate additional centers to further increase the size of the pool of eligible patients.The company expects that opening these centers will help shift the dynamic of enrollment by allowing the company more opportunities to find eligible patients.
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