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Study of Belumosudil and Prednisone for Patients Aged 12 and Older with Newly Diagnosed Chronic Graft Versus Host Disease

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What is this trial about?

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

This clinical trial is focused on studying a condition called chronic graft versus host disease (cGVHD). This condition can occur after a person receives a stem cell or bone marrow transplant, where the donated cells attack the recipient's body. The study is testing a new oral medication called belumosudil, which is being used in combination with corticosteroids, a type of medication that helps reduce inflammation and suppress the immune system. The trial will compare the effects of belumosudil combined with corticosteroids against a placebo combined with corticosteroids.

The purpose of the study is to see if belumosudil, when used with corticosteroids, is more effective than corticosteroids alone in improving the condition of patients with newly diagnosed cGVHD. Participants in the study will be randomly assigned to receive either the combination of belumosudil and corticosteroids or a placebo and corticosteroids. The study will monitor participants over a period to assess their health and any changes in their condition.

Throughout the study, participants will take the medication orally, and their progress will be closely observed by the research team. The trial aims to provide valuable information on the safety and effectiveness of belumosudil in treating cGVHD, potentially offering a new treatment option for those affected by this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participants must be at least 12 years old and have a newly diagnosed condition known as chronic graft versus host disease (cGVHD).

    Participants must require treatment with corticosteroids and should not have received any prior systemic treatment for cGVHD.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the study medication, belumosudil, in combination with prednisone, or a placebo in combination with prednisone.

    This process is double-blind, meaning neither the participants nor the researchers know who receives the study medication or the placebo.

  3. Step 3

    Medication administration

    Participants take the study medication or placebo orally. The specific dosage and frequency are determined by the study protocol.

    The treatment continues for a specified duration, which is determined by the study's design and objectives.

  4. Step 4

    Monitoring and assessments

    Participants undergo regular monitoring to assess the effectiveness and safety of the treatment.

    Assessments include measuring event-free survival, which is the time from randomization to the occurrence of any predefined event.

  5. Step 5

    Completion of the study

    The study is estimated to conclude by September 29, 2028.

    Participants' health and response to the treatment are evaluated to determine the study's outcomes.

Who can join the trial?

8 criteria

  • Patients must be at least 12 years old at the time of signing the informed consent.
  • Participants should have had a type of stem cell transplant called allogenic HCT and have newly diagnosed moderate to severe chronic graft versus host disease (cGVHD) as per specific guidelines from 2014.
  • Participants need to require treatment with a type of medication called corticosteroids for their cGVHD.
  • Participants should not have received any previous treatment that affects the whole body for cGVHD, including a treatment known as ECP (extracorporeal photopheresis).
  • If participants are taking other medications that suppress the immune system to prevent or treat a different condition called acute GVHD, the dose should be below a certain level specified in the study protocol.
  • Participants must weigh at least 40 kilograms.
  • Men and women participating in the study should use birth control methods that comply with local rules for clinical studies.
  • Participants or their legally authorized representative must be able to provide signed informed consent, which means they agree to take part in the study after understanding what it involves.
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Investigated drugs

  • Belumosudil

    is a medication being studied for its potential to help people with chronic graft versus host disease (cGVHD). It is being tested to see if it can improve the condition when used together with corticosteroids, which are commonly used to reduce inflammation and suppress the immune system.

  • Prednisone

    is a type of corticosteroid used in this study. It is a medication that helps reduce inflammation and suppress the immune system, which can be beneficial in managing chronic graft versus host disease (cGVHD). The study is comparing the effects of prednisone alone to prednisone used in combination with belumosudil.

What is already known about the treatment

Belumosudil – Belumosudil is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating chronic graft versus host disease (cGVHD). The medication works by inhibiting a specific enzyme that plays a role in immune response, helping to reduce inflammation and tissue damage. It is classified as a kinase inhibitor and is being evaluated for its potential to improve outcomes when used alongside corticosteroids like prednisone.

Investigated diseases

Chronic Graft Versus Host Disease – This condition occurs when donor cells from a transplant attack the recipient's body. It typically develops after a bone marrow or stem cell transplant. The disease can affect various organs, including the skin, liver, and digestive tract. Symptoms may include skin rashes, dry eyes, and mouth, as well as liver dysfunction. Over time, it can lead to scarring and damage to the affected organs. The progression and severity can vary widely among individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505394-32-00Protocol codeEFC17757Estimated enrolment350 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

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