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Study on the Effectiveness of Inebilizumab for Patients with IgG4-Related 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 IgG4-related disease (IgG4-RD). This is a rare condition where the immune system, which normally protects the body, mistakenly attacks healthy tissues, leading to inflammation and damage in various organs. The study is testing a treatment called inebilizumab, which is a type of medication known as a monoclonal antibody. Monoclonal antibodies are proteins made in a lab that can bind to specific targets in the body, in this case, to help reduce the immune system's attack on healthy tissues.

The purpose of the study is to evaluate how effective inebilizumab is in reducing the risk of a disease flare, which is a sudden worsening of symptoms, in patients with IgG4-related disease. Participants in the study will receive either the medication or a placebo, and the study will follow them over a period to see how well the treatment works in preventing flares. The study is designed to be double-blind, meaning neither the participants nor the researchers know who is receiving the actual medication or the placebo, to ensure unbiased results.

Throughout the study, participants will receive regular check-ups and monitoring to assess their health and the effectiveness of the treatment. The study aims to provide valuable information on whether inebilizumab can be a safe and effective treatment option for managing IgG4-related disease and reducing the frequency of flares. This research could potentially lead to better treatment options 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, the patient will be randomly assigned to receive either the medication inebilizumab or a placebo. This process is double-blind, meaning neither the patient nor the study team will know which treatment is being administered.

  2. Step 2

    Initial treatment phase

    The patient will receive inebilizumab through an intravenous infusion. The solution contains 20 mM histidine/histidine hydrochloride, 70 mM sodium chloride, 106 mM (4% [w/v]) trehalose dihydrate, and 0.01% (w/v) polysorbate 80.

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

  3. Step 3

    Monitoring and follow-up

    Throughout the study, the patient will be monitored for any signs of a disease flare. A flare is defined as a worsening of symptoms that requires additional treatment.

    The primary goal is to evaluate the time it takes for a disease flare to occur from the first day of dosing.

  4. Step 4

    Secondary assessments

    Secondary assessments will include measuring the annualized flare rate, the proportion of patients achieving remission without treatment, and the time to first treatment for new or worsening symptoms.

    The study will also track the use of glucocorticoids, a type of medication used to control inflammation, and any adverse events related to the treatment.

  5. Step 5

    Completion of the study

    The study is expected to last until November 3, 2028. At the end of the study, the patient's overall health and response to the treatment will be evaluated.

    The study aims to determine the effectiveness and safety of inebilizumab in reducing the risk of disease flares in patients with IgG4-related disease.

Who can join the trial?

6 criteria

  • Male or female adults who are old enough to give legal consent in their region (for example, 18 years or older in the US).
  • Have a clinical diagnosis of **Immunoglobulin G4-related disease (IgG4-RD)**, which is a specific medical condition.
  • Meet the 2019 **ACR/EULAR classification criteria**, which are guidelines used by doctors to diagnose IgG4-RD.
  • Currently experiencing or have recently experienced a **flare** of IgG4-RD, which means a worsening of symptoms, and need to start or continue treatment with **glucocorticoids (GC)**, a type of medication.
  • Have IgG4-RD affecting at least two different organs or body parts at any time during the illness. One of these must meet the ACR/EULAR criteria, and the other is determined by the doctor.
  • Non-sterilized male participants who are sexually active with a female partner who can become pregnant must use a condom with spermicide (if available) from the start of the study until at least 6 months after the last dose of the study medication. Female participants who can become pregnant and are sexually active with a non-sterilized male partner must use a highly effective method of birth control.

Who cannot join the trial?

5 criteria

  • Patients who have a different condition than Immunoglobulin G4-related disease (IgG4-RD) cannot participate. This is a specific disease where the immune system affects different parts of the body.
  • Patients who are not within the specified age range for the study cannot participate. The study is looking for people in certain age groups.
  • Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for people with certain characteristics or conditions.
  • Patients who are not male or female cannot participate. The study is open to both men and women.
  • Patients who are not considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, elderly, or those with certain health conditions.
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Investigated drugs

Inebilizumab is a medication being studied for its ability to reduce the risk of disease flare-ups in patients with IgG4-Related Disease (IgG4-RD). This condition involves inflammation and tissue damage in various parts of the body. Inebilizumab works by targeting specific cells in the immune system that are thought to contribute to this inflammation, potentially helping to control the disease and prevent symptoms from worsening.

What is already known about the treatment

Inebilizumab – Inebilizumab is administered as an intravenous infusion, typically given in a healthcare setting. It is currently being studied in clinical trials for its effectiveness in treating Immunoglobulin G4-related disease (IgG4-RD), a condition characterized by inflammation and tissue damage. The main therapeutic indication for inebilizumab is to reduce the risk of disease flare-ups in patients with IgG4-RD. At the molecular level, inebilizumab works by targeting and depleting B cells, a type of white blood cell involved in the immune response, which helps to reduce inflammation. It is classified as a monoclonal antibody, a type of biologic medication designed to target specific proteins in the body.

Investigated diseases

Immunoglobulin G4-related disease (IgG4-RD) – This is a chronic inflammatory condition characterized by the infiltration of IgG4-positive plasma cells into various organs, leading to tissue swelling and fibrosis. The disease can affect multiple organs, including the pancreas, salivary glands, kidneys, and lymph nodes, causing them to become enlarged and dysfunctional. Symptoms vary depending on the organs involved but may include swelling, pain, and impaired organ function. Over time, the inflammation can lead to the formation of fibrous tissue, which may cause permanent damage to the affected organs. The progression of the disease is often marked by periods of flare-ups and remission.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508290-81-00Protocol codeVIB0551.P3.S2Estimated enrolment200 patientsSponsorHorizon Therapeutics Ireland Designated Activity Company

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