This study focuses on treating Acute Graft Versus Host Disease, a condition that can occur as a complication after bone marrow transplants. The research evaluates a new medication called itolizumab used together with corticosteroids (a type of anti-inflammatory medication) as an initial treatment for this disease.
The study tests whether adding itolizumab to corticosteroid treatment works better than adding placebo to corticosteroids for patients with Acute Graft Versus Host Disease. The medication is given through an intravenous infusion (delivered directly into a vein) over a period of 84 days. The total amount of medication given depends on the patient’s weight.
During the study, participants receive either itolizumab (given as EQ001 solution for infusion) or a matching placebo along with corticosteroid treatment. The study uses specific methods to ensure neither the doctors nor the patients know which treatment each person receives. The main goal is to see how well patients respond to the treatment, particularly in the early stages of the disease.
1Initial evaluation
Your diagnosis of acute Graft Versus Host Disease (a complication after bone marrow transplant) will be confirmed
Medical staff will verify that you meet all study requirements, including having received a bone marrow transplant and showing signs of successful engraftment
2Start of treatment
You will begin receiving corticosteroid treatment at a dose of 2 mg/kg/day of methylprednisolone or equivalent medication
Within 72 hours of starting corticosteroids, you will be randomly assigned to receive either itolizumab or placebo through intravenous infusion
Neither you nor your doctor will know whether you are receiving itolizumab or placebo (this is called double-blind)
3Treatment period – Day 1 to Day 29
You will receive the study medication (itolizumab or placebo) through intravenous infusion
You will continue taking corticosteroids as prescribed
Medical staff will monitor your response to treatment
Your complete response to treatment will be evaluated on Day 29
4Extended observation – Day 29 to Day 99
Your condition will continue to be monitored
Medical staff will evaluate whether any improvements in your condition are lasting
The durability of your response to treatment will be assessed through Day 99
Who Can Join the Study?
Must be at least 12 years old and weigh more than 40 kg at the time of giving consent. Participants under 18 years can only join where locally allowed
Must have received an initial allogeneic stem cell transplant (a procedure where stem cells from a donor are transferred to the patient). A second transplant may be allowed if no graft versus host disease occurred after the first one
Must show signs of successful stem cell growth, shown by having a neutrophil count (a type of white blood cell) of at least 500 per cubic millimeter, confirmed by 3 separate blood tests on different days
Must have been diagnosed with acute Graft Versus Host Disease that is either:
– Grade III-IV (severe), or
– Grade II with lower digestive tract involvement
based on specific medical criteria (MAGIC). While tissue samples are recommended, they are not required
Must have started treatment with corticosteroids (medications that reduce inflammation) at a dose of at least 1mg/kg/day within 72 hours before starting the study medication, and must receive 2mg/kg/day on the first day of the study
Who Cannot Join the Study?
Previous treatment with any other investigational drug within 30 days before starting this study
History of allergic reactions to similar medications or compounds
Active uncontrolled infections, including but not limited to:
bacterial infections (infections caused by bacteria)
viral infections (infections caused by viruses)
fungal infections (infections caused by fungi)
Severe liver problems, indicated by liver function tests more than 3 times above normal limits
Severe kidney problems requiring dialysis (mechanical blood filtering)
Uncontrolled heart conditions
Active cancer other than the condition being treated
Pregnancy or breastfeeding
Unable to follow study procedures or attend scheduled visits
Mental conditions that prevent understanding of study requirements
Itolizumab is a medication being studied for treating acute Graft Versus Host Disease (aGVHD), a condition that can occur after bone marrow transplantation. It works by targeting specific proteins in the immune system to help reduce inflammation and control the immune response.
Corticosteroids are anti-inflammatory medications that help suppress the immune system. They are commonly used to treat various inflammatory conditions and are being used in combination with itolizumab in this study to help manage acute Graft Versus Host Disease symptoms.
Acute Graft Versus Host Disease – A condition that occurs after receiving tissue or cells from a donor, typically following bone marrow or stem cell transplantation. The donor’s immune cells recognize the recipient’s body tissues as foreign and begin to attack them. The condition typically develops within the first 100 days after transplantation. It primarily affects the skin, liver, and digestive tract, causing symptoms such as rash, liver problems, and digestive issues. The severity can range from mild to severe, with symptoms appearing suddenly and progressing over time.
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