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Study on Axatilimab and Ruxolitinib for Patients 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 known as chronic graft-versus-host disease (cGVHD). This condition can occur after a bone marrow or stem cell transplant, where the donated cells attack the recipient's body. The study will explore the effects of a treatment combining two medications: Axatilimab and Ruxolitinib. Axatilimab, also known by its code name INCA034176, is given as a solution for infusion, which means it is administered directly into the bloodstream. Ruxolitinib, also known as Jakavi, is taken in tablet form and works by selectively inhibiting certain enzymes involved in the immune response.

The purpose of this study is to evaluate the safety and effectiveness of the combination of Axatilimab and Ruxolitinib in people who have been newly diagnosed with cGVHD. Participants in the study will receive these medications over a period of up to 24 months. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatment. The study will monitor how well the treatment works and any side effects that may occur.

Throughout the study, participants will have regular check-ups to assess their response to the treatment and to ensure their safety. The study aims to provide valuable information on whether the combination of Axatilimab and Ruxolitinib can improve outcomes for individuals with cGVHD. This research could potentially lead to better treatment options for those affected by this challenging condition.

The research process

The trial runs in 6 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 will be informed about the trial's purpose and procedures. Participants must be 12 years or older, with new-onset moderate or severe chronic graft-versus-host disease (cGVHD).

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate the participant's health status and confirm eligibility based on the 2014 NIH Consensus Criteria for cGVHD.

  3. Step 3

    Treatment phase

    Participants will receive a combination of axatilimab and ruxolitinib. Axatilimab is administered either intravenously (IV) or subcutaneously (SC), while ruxolitinib is taken orally in the form of Jakavi 5 mg tablets.

    The dosage and frequency of administration will be determined by the study protocol and the participant's specific needs.

  4. Step 4

    Monitoring and follow-up

    Participants will be monitored regularly to assess the treatment's safety and effectiveness. This includes evaluating the frequency and severity of any adverse effects and changes in clinical and laboratory assessments.

    The primary goal is to achieve an overall response at 6 months, defined as complete or partial response without the need for new systemic therapy for cGVHD.

  5. Step 5

    Response evaluation

    At 6 months, the participant's response to the treatment will be evaluated based on the 2014 NIH Criteria. The study aims to determine the best overall response within the first 6 months and throughout the study.

  6. Step 6

    Extended observation

    Participants will continue to be observed for up to 12 months to assess long-term outcomes, including the duration of response and any improvements in symptoms.

    The study will also evaluate pharmacokinetic parameters for axatilimab and ruxolitinib to understand how the drugs are processed in the body.

Who can join the trial?

4 criteria

  • Participants must be **12 years or older** at the time of giving consent to join the study. However, those aged 12-17 years will not be included in certain regions.
  • Participants should have **new-onset moderate or severe chronic graft-versus-host disease (cGVHD)**. This is a condition that can occur after a stem cell transplant, where the donated cells attack the recipient's body.
  • Participants must have a **history of one allogeneic stem cell transplant (allo-SCT)**. This means they have received stem cells from a donor.
  • Participants must be willing to **avoid pregnancy or fathering children** during the study.

Who cannot join the trial?

7 criteria

  • Patients who have a different condition than chronic graft-versus-host disease cannot participate. This is a condition that can occur after a bone marrow transplant, where the donated cells attack the recipient's body.
  • Patients who are not within the specified age range cannot participate. The trial is open to certain age groups, so those outside these groups are excluded.
  • Patients who are not able to follow the study procedures or who have other health issues that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate, as the effects on the baby are unknown.
  • Patients who are taking certain medications that might interfere with the study drugs cannot participate.
  • Patients who have had a recent infection or other serious health condition that might affect the study results cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible to participate in this one.
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Investigated drugs

  • Axatilimab

    is a medication being studied for its potential to help treat chronic graft-versus-host disease (cGVHD). It is being tested to see how well it works when used together with another medication, ruxolitinib. The goal is to understand if axatilimab can improve the treatment outcomes for patients with this condition.

  • Ruxolitinib

    is a medication that is already used to treat certain conditions, including cGVHD. In this study, it is being combined with axatilimab to see if the combination can provide better results for patients who have been newly diagnosed with chronic graft-versus-host disease.

What is already known about the treatment

  • Axatilimab

    Axatilimab is administered intravenously and is currently being studied in clinical trials for its potential use in treating chronic graft-versus-host disease (cGVHD). It is not yet widely available in medical practice, as it is still under investigation. The medication works by targeting specific immune cells to reduce inflammation and tissue damage associated with cGVHD. Axatilimab is classified as a monoclonal antibody, which is a type of biological therapy designed to interact with the immune system.

  • Ruxolitinib

    Ruxolitinib is taken orally in tablet form and is already approved for use in certain conditions, including myelofibrosis and polycythemia vera. In the context of this clinical trial, it is being evaluated in combination with axatilimab for the treatment of chronic graft-versus-host disease. Ruxolitinib works by inhibiting specific enzymes known as Janus kinases (JAKs), which play a role in the signaling pathways that lead to inflammation. It is classified as a JAK inhibitor, a type of medication that helps to modulate the immune response.

Investigated diseases

Chronic Graft-Versus-Host Disease – This condition occurs when donor cells attack the recipient's body after a stem cell or bone marrow transplant. It 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 fibrosis of affected tissues. The disease can vary in severity and may persist for months or even years. It is a complex condition that requires careful management to control symptoms and prevent complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502168-19-00Protocol codeINCA34176-254Estimated enrolment120 patientsSponsorIncyte Corp.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).