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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Graft Versus Host Disease, GVHD, Acute-graft-versus-host Disease, Acute GVHD, aGVHD

In brief

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

Key facts

Study ID

NCT05263999

Run by

Equillium

People needed

158

Starts

2022-04-29

Expected to finish

2025-05-12

Last updated by the study team

2025-06-17

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is willing and able to provide written informed consent/assent and to comply with all protocol procedures and assessments required for the study.
• Is age ≥12 years and >40kg at informed consent/assent.
• Has had an initial allogeneic HSCT for any indication using any graft source, donor source, conditioning regimen intensity or prophylaxis.
• Has evidence of myeloid engraftment
• 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.
• 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 may not qualify if…

• Evidence of morphological relapsed, progressive, persistent, or untreated malignancy, with the exception of nonmelanoma skin cancer and in situ ductal carcinoma of the breast.
• An unplanned donor lymphocyte infusion for persistent or recurrent malignancy after HSCT.
• Evidence of persistent molecular disease requiring treatment that was not specified prior to HSCT.
• Evidence of cGVHD or overlap syndrome
• Use of immunosuppressants other than corticosteroids for the treatment of aGVHD.
• 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.

Where it is running

• City of Hope — Duarte, California, United States
• University of California, San Diego (UCSD) - Moores Cancer Center — La Jolla, California, United States
• University of Southern California — Los Angeles, California, United States
• University of California, Los Angeles (UCLA) - Medical Center — Los Angeles, California, United States
• Stanford Cancer Center — Stanford, California, United States
• AdventHealth Orlando — Orlando, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• The University of Chicago Medical Center (UCMC) — Chicago, Illinois, United States
• Loyola University Chicago, performing research at Loyola University Medical Center — Maywood, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• Tulane University Medical Center — New Orleans, Louisiana, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Spectrum Health — Grand Rapids, Michigan, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• John Theurer Cancer Center At Hackensack UMC — Hackensack, New Jersey, United States
• Rutgers Cancer Institute of NJ — New Brunswick, New Jersey, United States
• Northwell Health — Lake Success, New York, United States
• David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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