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Continued Treatment Study for Patients with Myelofibrosis, Post-Lung Transplant BOS, or Chronic Graft-Versus-Host Disease Using Itacitinib

Verified siteInvestigationalNo placebo
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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 providing continued treatment for participants who have been previously enrolled in studies involving the medication Itacitinib (also known by its code name INCB039110). The diseases being studied in this trial include Myelofibrosis, a condition where scar tissue forms in the bone marrow, chronic graft-versus-host disease, which can occur after a stem cell or bone marrow transplant, and bronchiolitis obliterans syndrome (BOS) that can develop after a lung transplant.

The purpose of this study is to continue evaluating the safety of Itacitinib for participants who are experiencing clinical benefits from this treatment. Participants will continue to receive the medication in tablet form, taken orally, as part of their ongoing care. The study is designed to monitor any side effects or adverse events that may occur while participants are on this medication.

Throughout the study, participants will have scheduled visits to ensure their treatment is progressing safely and effectively. The study aims to provide a seamless transition for those who have been benefiting from Itacitinib in previous trials, allowing them to continue their treatment under careful observation. The study is expected to run until 2027, ensuring long-term support and monitoring for participants.

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

    Enrollment confirmation

    Upon joining the study, confirm that you are currently enrolled and receiving treatment in an Incyte-sponsored itacitinib-based clinical study.

    Ensure that you are tolerating the treatment as defined by the previous study protocol and are receiving clinical benefit from the itacitinib-based treatment.

  2. Step 2

    Compliance verification

    Demonstrate compliance with the requirements of the previous study protocol, as assessed by the investigator.

    Express willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this protocol.

  3. Step 3

    Treatment continuation

    Continue receiving treatment with itacitinib in tablet form, administered orally.

    The dosage, frequency, and duration of administration will be determined by the study protocol and the investigator's assessment.

  4. Step 4

    Safety evaluation

    Participate in regular assessments to evaluate the safety of the treatment.

    Report any adverse events (AEs) or serious adverse events (SAEs) experienced during the study.

  5. Step 5

    Study completion

    The study is estimated to end on May 31, 2027.

    Continue to follow the study protocol and attend all scheduled visits until the study's completion.

Who can join the trial?

7 criteria

  • Currently enrolled and receiving treatment in an Incyte-sponsored **itacitinib** (INCB 39110)-based clinical study (parent protocol). **Itacitinib** is a type of medication used in the study.
  • Currently tolerating treatment as defined by the parent protocol. This means the patient is handling the treatment well according to the study's rules.
  • Currently receiving clinical benefit from **itacitinib**-based treatment, as determined by the investigator. This means the treatment is helping the patient, as judged by the study doctor.
  • Has demonstrated compliance, as assessed by the investigator, with the parent protocol requirements. This means the patient has been following the study's rules and instructions.
  • Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this Protocol. The patient agrees to attend all appointments and follow the treatment plan.
  • Willingness to avoid pregnancy or fathering children based on criteria in Section 5.1. The patient agrees to take steps to prevent pregnancy during the study.
  • Ability to comprehend and willingness to sign an **ICF**. **ICF** stands for Informed Consent Form, which is a document that explains the study and confirms the patient's agreement to participate.

Who cannot join the trial?

2 criteria

  • Patients who have not been receiving clinical benefit from an itacitinib-based therapy in an Incyte-sponsored clinical study cannot participate. Itacitinib is a type of medication used in certain treatments.
  • Patients who have not been part of an Incyte-sponsored clinical study using itacitinib-based therapy are excluded.
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Investigated drugs

Itacitinib is a medication being studied for its potential to help people with certain medical conditions. It works by targeting specific pathways in the body that are involved in inflammation and immune responses. In this clinical trial, participants who have been benefiting from itacitinib in previous studies are given the opportunity to continue their treatment. The main goal is to ensure that the medication is safe and continues to provide benefits to those who are already experiencing positive effects from it.

What is already known about the treatment

Itacitinib – Itacitinib is administered orally in the form of tablets. It is currently being studied in clinical trials and is not yet widely available in standard medical practice. The main therapeutic indications for itacitinib include conditions such as myelofibrosis, post-lung transplant bronchiolitis obliterans syndrome (BOS), and chronic graft-versus-host disease. At the molecular level, itacitinib works by inhibiting specific enzymes called Janus kinases (JAKs), which play a role in the signaling pathways that regulate immune responses and inflammation. Itacitinib is classified as a JAK inhibitor in pharmacology.

Investigated diseases

  • Myelofibrosis

    Myelofibrosis is a rare bone marrow disorder characterized by the replacement of bone marrow with fibrous tissue. This process disrupts the body's ability to produce blood cells, leading to anemia, weakness, and fatigue. As the disease progresses, the spleen and liver may enlarge due to the increased workload of producing blood cells. Patients may experience symptoms such as night sweats, fever, and bone pain. Over time, myelofibrosis can lead to severe complications related to blood cell production. The disease can evolve into acute leukemia in some cases.

  • Bronchiolitis Obliterans Syndrome (BOS) Post-Lung Transplant

    Bronchiolitis Obliterans Syndrome is a condition that affects the small airways of the lungs following a lung transplant. It is characterized by inflammation and fibrosis, leading to the narrowing and obstruction of the airways. This results in a progressive decline in lung function, causing symptoms such as coughing, shortness of breath, and wheezing. The condition is a form of chronic lung allograft dysfunction and is a major cause of long-term morbidity in lung transplant recipients. Over time, the obstruction of airways can become severe, significantly impacting respiratory function. The progression of BOS can vary among individuals.

  • Chronic Graft-Versus-Host Disease

    Chronic Graft-Versus-Host Disease is a complication that can occur after an allogeneic stem cell or bone marrow transplant. It arises when the donated immune cells attack the recipient's body tissues, recognizing them as foreign. This condition can affect multiple organs, including the skin, liver, and gastrointestinal tract, leading to symptoms such as skin rashes, jaundice, and digestive issues. The disease can also cause joint pain, dry eyes, and mouth, and can impact the quality of life. The severity and progression of symptoms can vary widely among patients. Chronic Graft-Versus-Host Disease can persist for months or even years.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501661-47-00Protocol codeINCB 39110-801Estimated enrolment14 patientsSponsorIncyte Corp.

sourced from the EU Clinical Trials Register and site verification

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