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A study to evaluate the safety and effects of inebilizumab in children and adolescents with immunoglobulin G4-related disease

Verified siteRegistered drugNo placebo
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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 children and adolescents with Immunoglobulin G4-related Disease, which is a rare condition where the body's immune system causes swelling and damage to various organs and tissues. The purpose of the study is to evaluate how the drug inebilizumab works in this specific age group. This medication is an intravenous infusion, meaning it is delivered directly into a vein through a tube.

The research will examine how the body processes the medication, which is known as pharmacokinetics, and how the drug affects the body's biological functions, known as pharmacodynamics. During the study, researchers will also monitor the safety and how well the body tolerates the treatment. This involves checking how the drug impacts CD20+ B cells, which are a specific type of white blood cell involved in the immune response.

Participants will be monitored over a period of time to see how the medication affects the symptoms of the disease. The study will track how the drug behaves in the blood and observe any changes in the body's reaction to the treatment. This includes monitoring for any side effects or changes in health indicators to ensure the medication is being used safely in children and teenagers.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>administration of medication</b>

    The medication inebilizumab (sold under the name Uplizna) is provided as a solution for infusion.

    This medication is given through an intravenous use, which means it is delivered directly into a vein.

  2. Step 2

    <b>monitoring of results</b>

    During the study, changes in CD20+ B cell counts will be measured. These are specific types of white blood cells in the immune system.

    The way the body processes the medication, including how much is in the blood and how long it stays in the body, will be studied.

    Safety and tolerability will be monitored by tracking any adverse events, which are side effects or unwanted medical occurrences.

    Vital signs and laboratory parameters, such as blood test results, will be checked to ensure safety.

  3. Step 3

    <b>long-term observation</b>

    The study tracks disease activity over a period of 52 weeks.

    Observations include the time until the first flare, which is a sudden increase in symptoms of immunoglobulin G4-related disease (IgG4-RD).

    The amount of glucocorticoid (a type of steroid medication) used daily to control the disease will be evaluated at the 52-week mark.

    The presence of antidrug antibodies, which are proteins the body might make in response to the medication, will be checked before and after the treatment starts.

Who can join the trial?

8 criteria

  • The person must weigh at least 17 kg.
  • A legal representative (such as a parent or guardian) must sign a consent form to allow participation, and the child must also agree to join the study by providing assent, which is a child's way of showing they agree to participate.
  • The participant must be between 2 and 17 years old at the time they are checked for the study.
  • The person must have a confirmed medical diagnosis of Immunoglobulin G4-related Disease (IgG4-RD), which is a condition where the body's immune system causes swelling and damage in various organs.
  • The patient must meet specific medical standards set by experts to confirm their diagnosis. This includes having the disease affect at least one specific organ, such as the pancreas, lungs, kidneys, or thyroid gland, and meeting a certain number of required medical points.
  • The participant must have received all vaccinations that are normally required for their age before starting the study.
  • The participant must need medical treatment for their condition that is either different from or in addition to glucocorticoids (GCs), which are a type of steroid medicine used to reduce swelling and inflammation.
  • If the participant is already taking glucocorticoids (GCs) for their condition, they must have been taking the same amount (a stable dose) for at least 2 weeks before the study begins.

Who cannot join the trial?

34 criteria

  • People with high levels of certain **liver enzymes** (proteins in the blood that show how the liver is working), specifically **AST**, **ALT**, or **total bilirubin**, if the disease is affecting the liver or gallbladder.
  • People who have received treatments like **alemtuzumab**, **total lymphoid irradiation** (radiation that targets white blood cells), **bone marrow transplant**, or **T-cell vaccination therapy** before the study starts.
  • People who have had **malignancy** (cancer), excluding certain types of skin cancer or early-stage breast or cervical cancer, within the last 5 years.
  • People who have taken specific medications such as **azathioprine**, **mycophenolate mofetil**, **cyclosporine**, **methotrexate**, **cyclophosphamide**, **tocilizumab**, **satralizumab**, **eculizumab**, or **mitoxantrone** within the last 2 months.
  • People who have used **rituximab** or other drugs that lower **B-cells** (a type of white blood cell that helps fight infection) or drugs that target **B-cells** within the last 6 months, unless their **B-cell** counts have returned to at least half of the **lower limit of normal** (the bottom end of a healthy range).
  • People who have received **intravenous immunoglobulin (IVIG)** (a treatment containing antibodies) within 1 month before the study.
  • People who have taken **natalizumab** within the last 6 months.
  • People with a history of severe **anaphylaxis** (a life-threatening allergic reaction) or severe allergies to two or more foods or medicines, including certain pain relievers or allergy medications.
  • People who have received a **live or attenuated vaccine** (a vaccine made from a weakened version of a germ) within 4 weeks, the **BCG vaccine** within 1 year, or a **blood transfusion** within 4 weeks before the study.
  • People currently participating in another study testing a new drug or medical device, or those who finished such a study too recently.
  • People of childbearing potential who are unwilling to use specific **contraception** (methods to prevent pregnancy) during the study and for 6 months after.
  • People with a history of **immunodeficiency** (a condition where the immune system is weak), such as from **HIV** or having the **spleen** removed, which makes it harder to fight infections.
  • People who are breastfeeding or plan to breastfeed during the study or for 6 months after the last dose.
  • People planning to become pregnant during the study or for 6 months after the last dose.
  • People who have had major surgery within the 8 weeks before the study begins.
  • People who have a positive pregnancy test at the start of the study.
  • People whose partners are unwilling to avoid pregnancy through abstinence or other methods during the study and for 6 months after.
  • Men assigned male at birth whose partner is pregnant and who are unwilling to use protection or abstain from sex during the study and for 6 months after.
  • People who are unwilling to stop donating sperm during the study and for 6 months after.
  • People who are allergic to any of the products used during the study doses.
  • People who may not be able to attend all required visits or follow all the study rules.
  • People with any other significant health problems that, in a doctor's opinion, could make the study unsafe or difficult to complete.
  • People who test positive for **chronic hepatitis B** (a long-term liver infection caused by a virus).
  • People with evidence of significant problems with the **liver** (organ that cleans blood), **kidneys** (organs that filter waste), **metabolism** (how the body uses energy), or **hematology** (blood health), such as low **platelets** (cells that help blood clot), low **neutrophils** (white blood cells that fight infection), low **immunoglobulins** (antibodies), low **CD4 T lymphocytes** (specific immune cells), or low **hemoglobin** (protein in red blood cells that carries oxygen).
  • People with a low **estimated glomerular filtration rate** (a measure of how well the kidneys filter blood).
  • People with low **B-cell** counts.
  • People with another **autoimmune disease** (a condition where the immune system attacks the body) that is not well-controlled.
  • People with serious active infections (viral, bacterial, or fungal) that require medicine or hospital care within 2 months before the study.
  • People with a history of untreated **hepatitis C** (a liver infection) unless they have been cured and the virus is undetectable.
  • People with a history of **tuberculosis** (a serious bacterial infection) or a positive **TB test** unless they have completed treatment.
  • People who test negative for **varicella zoster virus-IgG** (antibodies that show past immunity to chickenpox).
  • People with high **liver enzyme** levels (AST, ALT, or bilirubin) when the disease is not currently active in the liver or gallbladder.
  • People with a history of alcohol or drug abuse that could affect their safety or ability to participate.
  • People who test positive for specific **antibodies** (proteins that recognize germs) known as **anti-neutrophil cytoplasmic antibodies** targeting certain proteins.
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Investigated drugs

Inebilizumab is a medication given through a vein that works by targeting and reducing specific immune cells in the body. In this study, it is being tested to see how it moves through the body, how it affects the immune system, and how safe and well-tolerated it is in children with a condition called Immunoglobulin G4-related disease.

What is already known about the treatment

Inebilizumab - This medication is administered as a solution through an intravenous infusion directly into a vein. It is currently used in medical practice to treat certain immune system conditions, such as IgG4-related disease, and is being studied for its effects in children. The drug works by targeting and removing specific white blood cells called B cells that are responsible for causing inflammation and tissue damage. It belongs to a class of drugs known as monoclonal antibodies.

Investigated diseases

Immunoglobulin G4-related disease - This is a condition where various organs and tissues become swollen due to an overactive immune response. It involves the buildup of specific cells and fibrous tissue in affected areas. The disease can impact several parts of the body, such as the pancreas, salivary glands, or lymph nodes. As it progresses, the inflammation can lead to the hardening of tissues in those locations. This process may cause the affected organs to function less effectively over time.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IITrial ID2025-520988-41-00Protocol code20240202Estimated enrolment15 patientsSponsorAmgen Inc.

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