Testing Itacitinib for Non-Severe Hemophagocytosis Lymphohistiocytosis treatment

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    What is this study about?

    In this study, researchers are investigating the efficacy of a drug called Itacitinib in treating Hemophagocytic Lymphohistiocytosis (HLH), a rare disease characterized by the immune system attacking its own cells and tissues. Itacitinib is believed to be beneficial because it can disrupt the production of certain inflammatory chemicals in the body, potentially mitigating the harmful effects of HLH. Initially, this new treatment approach will be administered to participants with less severe forms of HLH. The primary objectives of the study are to assess the effectiveness of the medication after a 15-day period, determine the rate of complete response to the treatment, and identify any adverse effects unrelated to HLH. If the condition worsens while receiving Itacitinib, the drug will be discontinued, and patients will receive specific treatment for HLH.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Bobigny , France

      You can join this study in:

      France: Bobigny.


      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      In this clinical trial, as a participant, you need to follow these steps:

      1. Take 300 mg of ITACITINIB orally every day.
      2. Continue this medication regimen for a duration of 30 days.
      3. If adverse events (AEs) are observed, or if ITACITINIB is co-administered with a strong CYP3A inhibitor, the dose may be reduced to 200 mg for safety reasons.

      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you need to have systemic juvenile idiopathic arthritis and be classified as having Hemophagocytic Lymphohistiocytosis (HLH).


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Here are the conditions you must meet to join the study, along with explanations of medical terms where needed:

      1. Age Criteria: Patients must be over 18 years old.
      2. Consent: You must be willing to provide written informed consent prior to enrolment and agree to follow the study protocol.
      3. Diagnosis of HLH: Patients known to have systemic juvenile idiopathic arthritis are classified as having Hemophagocytic Lymphohistiocytosis (HLH). Explanation: HLH is a rare but severe immune disorder where the body produces too many activated immune cells called macrophages and lymphocytes.
      4. Pregnancy Status: Women who can become pregnant must have a negative pregnancy test and should use reliable contraception for the duration of the study.
      5. Social Security: Be either affiliated to, or a beneficiary of, a social security category.

      These are the inclusion criteria.

      What Reasons Could Exclude Me from the Study?

      Here are the conditions that may disqualify you from taking part in the study, along with explanations of the medical terms:

      1. Organ failure: This can include several types of failure:
        1. Confusion.
        2. Organic kidney failure (KDIGO 2 criteria): This criteria assess the function of your kidneys, where KDIGO stage 2 indicates a moderate loss of kidney function.
        3. Liver failure (Factor V < 50%): Here Factor V is a protein necessary for blood clotting and a level below 50% indicates serious liver dysfunction.
        4. Heart failure: This refers to the heart’s inability to pump sufficient blood.
        5. Respiratory failure: This is a condition in which your lungs cannot adequately exchange gases to meet your body’s needs.
      2. Fibrinogen < 0.50 g/l: Fibrinogen is a protein that helps in blood clotting. Levels below 0.50 grams per liter are concerning.
      3. Platelets < 20G/L: Platelets are cells that help stop bleeding. A count below 20 billion per liter is very low and increases the risk of bleeding.
      4. Indication to intensive care unit transfer: If you require critical care due to organ failure that requires assistance such as dialysis or ventilation, or you have shock regardless of the cause, you cannot participate.
      5. Breastfeeding women: If you are currently breastfeeding, you are not eligible for the study.
      6. Participation in another investigational therapeutic study: You can’t join this study if you are already part of another experimental treatment study.
      7. Positive pregnancy test or not willing to take contraceptive measures: Women who are pregnant or not using reliable birth control may not participate.
      8. Known allergies, hypersensitivity, or intolerance: This refers to negative reactions specifically to the study drug ITACITINIB or its components.
      9. History of recurrent infections: Particularly concerns the hepatitis B virus (HBV), hepatitis C virus (HCV), or if you are at risk for HBV reactivation shown by a positive HBs Ag serology test.
      10. HIV infection with a positive viral charge: Positive viral charge means detectable levels of the HIV virus in blood.
      11. Protected adults: Adults under guardianship by court order.
      12. Vulnerable adults: Those under a safeguard of justice measure.
      13. Adults deprived of liberty: By judicial or administrative decision.
      14. Persons under psychiatric care without their consent:
      15. Persons in social institutions: For purposes other than this research.
      16. Legal protection: Adults under legal protection such as guardianship or curatorship.
      17. Inability to express consent: If a person is unable to understand the study sufficiently to give informed consent, they cannot participate.

      Please let me know if you need further clarification on any of the points listed.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drug involved in the study is Itacitinib. Here’s a brief description of the active substance:

      1. Itacitinib: Itacitinib is a selective inhibitor of Janus kinase 1 (JAK1). It works by interfering with the JAK-STAT signaling pathway, which is involved in the inflammatory and immune response. By inhibiting JAK1, itacitinib reduces the production and effects of pro-inflammatory cytokines such as interferon-gamma (IFN-γ) and other cytokines involved in inflammation and immune responses. In this clinical trial, itacitinib is being tested for its potential to treat non-severe hemophagocytosis lymphohistiocytosis (HLH) by possibly offering a safer and more effective alternative to corticosteroids.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The active substance participating in the clinical trial is Itacitinib. Here is a description of Itacitinib in relation to its known status in medicine and medical literature:

      1. Itacitinib: Itacitinib is evaluated for its response in patients who have been treated with it for at least seven days. The evaluation is based on the major and minor diagnostic criteria of Hemophagocytic Lymphohistiocytosis (HLH). Additionally, the trial assesses the toxicity of Itacitinib not related to the evolution of HLH. Such toxicity could include cytopenia, worsening of hepatic balance, or secondary infections.

      Itacitinib is a known Janus kinase (JAK) inhibitor that is being researched and developed for various conditions, including inflammation and hematologic conditions, and its effects and potential are documented in medical literature.


      Study ID

      CT-EU-00088814

      Recruitment status

      Recruting new patients

      Start of the trial

      2 years ago

      Study phase

      Phase
      II

      Medicinal Product