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A study to evaluate the effect of obinutuzumab on removing specific immune cells in the tissues of patients with Sjögren’s syndrome.

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What is this study about?

This study focuses on Sjögren’s syndrome, an autoimmune condition where the body’s immune system attacks its own healthy cells, often causing dryness in the eyes and mouth. The research aims to determine if the drug obinutuzumab can reduce the number of harmful immune cells in the tissues affected by the disease. These specific cells, known as B cells, are responsible for producing proteins that mistakenly attack the body.

Participants in the study will receive the medication through an intravenous infusion, which means the medicine is delivered directly into the bloodstream through a needle in a vein. During the course of the study, medical professionals will monitor the effects of the treatment on the body over several months. This process includes observing changes in the salivary glands, which are the organs that produce saliva, and the lymph nodes, which are small structures that part of the immune system.

Who Can Join the Study?

  • You must be an adult, meaning you are 18 years of age or older.
  • You must have primary Sjögren’s syndrome, which is a condition where the body’s immune system attacks its own healthy cells, specifically those that produce moisture.
  • Your diagnosis must meet specific medical standards called the EULAR/ACR 2016 classification criteria, which are sets of rules doctors use to confirm the disease.
  • Your blood tests must show the presence of certain markers, including ANA (anti-nuclear antibodies, which are proteins that mistakenly attack the center of your cells), anti-Ro60, and anti-La.
  • You must have cryoglobulinemia (a condition where certain proteins in the blood become thick or gel-like in cold temperatures) or show signs that could lead to lymphoproliferative disease (a group of conditions where white blood cells grow too much).
  • Signs that could indicate future disease include having rheumatoid factor antibodies (proteins that often cause inflammation), a history of lymphadenopathy (swollen lymph nodes), a history of salivary gland swelling, or a history of purpuric lesions (purple spots on the skin caused by bleeding) or vasculitis (inflammation of the blood vessels).
  • A lymphocytic focus score of 3 or more in a salivary gland biopsy (a small sample of tissue taken from the gland) is also a requirement.
  • Women of childbearing age must use a reliable method of contraception (birth control) during the study and for at least 18 months after the final injection.
  • You must provide signed written informed consent, which means you have read and agreed to all the study details in writing.
  • You must be willing to participate in all study activities, including tissue biopsies, which involve taking a small sample of tissue from the body for testing.

Who Cannot Join the Study?

  • You have an active inflammatory condition (a state where the body’s immune system causes swelling and irritation) or an infectious condition (an illness caused by germs like bacteria or viruses).
  • The medication Obinutuzumab is listed as contra-indicated (meaning it is not safe for you to use) based on medical guidelines.
  • You need to receive live or attenuated viral vaccines (vaccines that use a weakened form of a germ) during the study or until your B-cells (a specific type of white blood cell that helps fight infection) return to normal levels.
  • You are currently participating in any other interventional clinical trials (medical studies where you receive a specific treatment).
  • You have previously used Obinutuzumab in a clinical trial or as a regular treatment.
  • You are currently using biologic DMARDs, targeted synthetic DMARDs, or classical DMARDs (these are different types of medicines used to suppress an overactive immune system).
  • You have received treatment with rituximab or other anti-CD20 therapies (medicines that target a specific protein on B-cells) less than 9 months before starting the study.
  • If you received rituximab or other anti-CD20 therapies between 9 and 12 months ago, your CD19+ B-cell count (a specific measurement of certain immune cells in your blood) must be lower than 80 cells per microliter.
  • You are currently taking more than 10 mg of prednisone (a type of steroid medicine) by mouth.
  • Your dose of prednisone has changed within the 4 weeks before your first visit.
  • You have received prednisone through an injection into a muscle, a joint, or a vein within the 4 weeks before your first visit.
  • You have tested positive for hepatitis B, hepatitis C, or Human Immunodeficiency Virus (HIV).
  • You are unable to follow the study rules or procedures, or you are staying in an institution due to a legal or regulatory order.
  • You have a positive pregnancy test or are currently breastfeeding.
  • You had an opportunistic infection (an infection that occurs more often in people with weakened immune systems) in the last 3 months.
  • You show signs of active tuberculosis (TB) through medical exams or lab tests.
  • You have a history of active tuberculosis that was treated within the last 3 years.
  • You have latent TB (a condition where the tuberculosis bacteria are in your body but are inactive and not causing illness).
  • You consume a large amount of alcohol, defined as more than 3 drinks per day.
  • You have liver cirrhosis (permanent scarring of the liver) or severe renal insufficiency (a serious decrease in how well your kidneys work).

Where you can join this trial?

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Other Sites

Site Name City Country Status
Stichting Radboud University Medical Center Nijmegen The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not yet recruiting
01.01.2026

Trial locations

Investigated drugs:

Obinutuzumab is a medication given through a vein that works by targeting and removing specific types of immune cells called B cells. In this study, it is being used to see if it can reduce the harmful B cells that produce antibodies in people with Sjögren’s syndrome.

Investigated diseases:

Sjögren’s syndrome – This is a condition where the body’s immune system mistakenly attacks its own healthy cells, particularly those in the glands that produce moisture. It primarily affects the salivary and tear glands, leading to reduced fluid production. Over time, the inflammation can cause dryness in the eyes, mouth, and other mucosal surfaces. The disease may also affect other parts of the body, including the joints, skin, and internal organs. The progression often involves a continuous immune response that can impact various bodily systems.

Trial ID:
2024-519884-16-00
Trial Phase:
Therapeutic exploratory (Phase II)

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