Featured Trial
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:
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 2 – Placebo 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.
Locations
Sponsors
collaborator: Biocon Limited, lead: Equillium
