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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Itolizumab in Combination With Corticosteroids for the Initial Treatment of Acute Graft Versus Host Disease

Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Itolizumab in Combination With Corticosteroids for the Initial Treatment of Acute Graft Versus Host Disease

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 24 Jun 2025

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At a glance

  • Drugs Itolizumab (Primary) ; Corticosteroids
  • Indications Graft-versus-host disease
  • Focus Registrational; Therapeutic Use
  • Acronyms EQUATOR
  • Sponsors Equillium

Most Recent Events

  • 17 Jun 2025 Status changed from suspended to discontinued.
  • 24 Apr 2025 According to an Equillium media release, company has a plan to accelerate closure of the EQUATOR study.
  • 24 Apr 2025 According to an Equillium media release, company has received feedback from its Type D meeting with the U.S. Food and Drug Administration (FDA) to discuss the regulatory pathway for Accelerated Approval, as well as the companys filing for Breakthrough Therapy designation for itolizumab for first-line treatment of acute graft-versus-host disease (aGVHD).

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