A Phase 3 Study of Itolizumab plus Corticosteroids to Treat Acute Graft-Versus-Host Disease


Full 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 (WIRB)


One potential complication of receiving a stem cell transplant from another person (“allogeneic transplant”) is graft-versus-host disease (GVHD). GVHD is caused when cells from the donor view the recipient’s cells as foreign, resulting in symptoms such as rash, diarrhea, nausea, vomiting, and liver dysfunction, among others. Corticosteroid drugs are usually used to treat GVHD, but they don’t always work well and have numerous side effects.

In this study, researchers want to see if adding a drug called itolizumab to corticosteroid treatment is more effective than corticosteroids alone to treat acute GVHD. Itolizumab interacts with a protein in the body called CD6, which plays an important role in the immune system. Laboratory studies have indicated that itolizumab may be useful for treating GVHD. In this study, participants with acute GVHD will be randomly assigned to receive corticosteroids with either itolizumab or a placebo. Itolizumab is given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have acute GVHD following an allogeneic stem cell transplant.
  • This study is for patients age 12 and older.


For more information and to ask about eligibility for this study, please contact the office of Dr. Andrew Harris at 212-639-6715.




Phase III (phase 3)



ClinicalTrials.gov ID