A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)

a study on Graft Versus Host Disease

Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at UCLA UCSD
Dates
study started
completion around

Description

Summary

This is a multi-center study to compare the efficacy and safety of itolizumab versus placebo as first-line therapy for subjects with Grade III-IV aGVHD or Grade II with LGI involvement, in combination with corticosteroids

Official Title

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

Details

This study will enroll 200 subjects at approximately 125 sites globally. Subjects will be randomized in a 1:1 ratio to active or placebo and will receive a total of 7 doses administered intravenously approximately every 2 weeks. The study follows the patients for a total of approximately 365 days.

Keywords

Graft Versus Host Disease, GVHD, Acute-graft-versus-host Disease, Acute GVHD, aGVHD, Graft vs Host Disease, Itolizumab, Itolizumab (EQ001)

Eligibility

You can join if…

Open to people ages 12 years and up

  1. Is willing and able to provide written informed consent/assent and to comply with all protocol procedures and assessments required for the study.
  2. Is age ≥12 years and >40kg at informed consent/assent.
  3. Has had an initial allogeneic HSCT for any indication using any graft source, donor source, conditioning regimen intensity or prophylaxis.
  4. Has evidence of myeloid engraftment
  5. Has a clinical diagnosis of aGVHD Grades III-IV or Grade II with LGI involvement based on Mount Sinai Acute GVHD International Consortium (MAGIC) grading criteria.
  6. Began systemic corticosteroid treatment for aGVHD ≤72 hours prior to the start of study drug dosing AND must receive 2 mg/kg/day methylprednisolone or equivalent on Day 1.

You CAN'T join if...

  1. Evidence of morphological relapsed, progressive, persistent, or untreated malignancy, with the exception of nonmelanoma skin cancer and in situ ductal carcinoma of the breast.
  2. An unplanned donor lymphocyte infusion for persistent or recurrent malignancy after HSCT.
  3. Evidence of persistent molecular disease requiring treatment that was not specified prior to HSCT.
  4. Evidence of cGVHD or overlap syndrome
  5. Use of immunosuppressants other than corticosteroids for the treatment of aGVHD.
  6. Use of any systemic corticosteroids of >0.5 mg/kg/day methylprednisolone or equivalent for any indication other than aGVHD within 7 days before the onset of aGVHD.

Locations

  • University of California, San Diego (UCSD) - Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • University of California, Los Angeles (UCLA) - Medical Center accepting new patients
    Los Angeles California 90059 United States
  • University of Southern California accepting new patients
    Los Angeles California 90033 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States
  • Stanford Cancer Center accepting new patients
    Stanford California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Equillium
Links
Company website
ID
NCT05263999
Phase
Phase 3 Graft Versus Host Disease Research Study
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated