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A drug, itolizumab, in combination with steroids, to treat acute graft-versus-host disease (GVHD)

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12 and older

Phase 3

12 Locations

NCT05263999

Clinical Trial Goal


To find out if itolizumab, in combination with steroids, is safe and works well to treat acute GVHD

You may be able to join this trial if you:


  • Are 12 years old or older 
  • Have acute GVHD
  • Have not taken other types of medication to treat the GVHD other than steroids. Your doctor can tell you this
  • Do not have cancer that has come back (relapsed)
  • You agree to have other standard tests done to see if you can be in the clinical trial

Trial Details


Itolizumab is a monoclonal antibody that targets CD6 on certain cells.

In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you and the clinical trial doctors won’t know which group you’re in until after the trial is finished:
  • Group 1 – Itolizumab plus steroids
  • Group 2Placebo plus steroids

Randomized means doctors will use a computer to assign you to either group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You, your doctor or the clinical trial doctor won’t have any control over which group you’ll be assigned. This means you won’t be able to choose your group.
 
You’ll get:
  • Itolizumab (Group 1 only) – Given an IV infusions 1 time every 2 weeks for 14 weeks. The dose you’ll get will be the highest dose shown to be safe in Phase 1
  • Placebo (Group 2 only) – Given as IV infusions with a liquid with no medicine in it 1 time every 2 weeks for 14 weeks
  • Steroids 

The clinical trial doctors will check your health for about 1 year.

The Food and Drug Administration (FDA) has not yet approved itolizumab.

Contacts


Clinical Trial Manager, 858-240-1200, clinicaltrials@equilliumbio.com

Locations

University of Alabama at BirminghamRecruiting

Birmingham, Alabama

City of HopeRecruiting

Duarte, California

Stanford Cancer CenterRecruiting

Stanford, California

University of California, Los Angeles (UCLA) - Medical CenterRecruiting

Los Angeles, California

University of Southern CaliforniaRecruiting

Los Angeles, California

Dana-Farber Cancer InstituteRecruiting

Boston, Massachusetts

Wake ForestRecruiting

Winston-Salem, North Carolina

University Hospitals Cleveland Medical CenterRecruiting

Cleveland, Ohio

University of Pennsylvania Abramson Cancer CenterRecruiting

Philadelphia, Pennsylvania

University of Pittsburgh Medical Center (UPMC) - Hillman Cancer CenterRecruiting

Pittsburgh, Pennsylvania

Sarah Cannon Research Institute, LLC (SCRI)Recruiting

Nashville, Tennessee

Fred Hutchinson Cancer Research CenterRecruiting

Seattle, Washington

ClinicalTrials.gov record


NCT05263999

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