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Study of Itolizumab with Corticosteroids for Initial Treatment of Acute Graft Versus Host Disease in Patients After Bone Marrow Transplant

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial 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

  2. Step 2

    Start 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)

  3. Step 3

    Treatment 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

  4. Step 4

    Extended 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 trial?

5 criteria

  • 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 trial?

13 criteria

  • 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
    • Current participation in other clinical trials
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Investigated drugs

  • 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.

What is already known about the treatment

  • Itolizumab

    A monoclonal antibody medication administered through intravenous infusion that is currently being investigated in clinical trials for the treatment of Acute Graft Versus Host Disease (aGVHD). This biological agent works by targeting CD6, a protein found on T cells, helping to modulate the immune response that causes GVHD following stem cell transplantation. The drug is being studied in combination with corticosteroids as an initial therapy for aGVHD, representing a novel approach to managing this serious transplant complication.

  • Corticosteroids

    A class of steroid medications typically administered orally or intravenously that serve as the standard first-line treatment for Acute Graft Versus Host Disease. These drugs work by suppressing the immune system and reducing inflammation throughout the body, helping to control the adverse immune response that occurs when transplanted cells attack the recipient's tissues. They are widely established in medical practice and are being studied in combination with itolizumab to potentially enhance treatment outcomes for patients with aGVHD.

Investigated diseases

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.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516064-28-00Protocol codeEQ-100-02Estimated enrolment200 patientsSponsorEquillium Inc.

sourced from the EU Clinical Trials Register and site verification

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