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Study of Obinutuzumab treatment for patients with non-infectious cryoglobulinemia vasculitis who did not respond to or cannot tolerate Rituximab

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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 patients with non-infectious cryoglobulinemia vasculitis, a condition where abnormal proteins in the blood cause inflammation of blood vessels. The study will test a medication called Obinutuzumab (Gazyvaro) in patients whose condition has not improved with or who cannot tolerate another medication called Rituximab. The medication will be given through an intravenous infusion directly into a vein.

The purpose of this research is to determine if Obinutuzumab is effective and safe for treating this type of vasculitis. During the study, patients will receive Obinutuzumab as a concentrated solution that will be diluted for infusion. The maximum single dose will be 1,000 mg, with a total maximum dose of 2,000 mg over a treatment period of up to 7 days.

The study will monitor patients for 48 weeks to check how well the treatment works and if there are any side effects. Doctors will look for improvements in various body systems that can be affected by the disease, including the skin, joints, kidneys, nerves, digestive system, lungs, and heart. They will also track changes in specific blood tests that show disease activity.

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

    Initial treatment phase

    You will receive Gazyvaro (obinutuzumab) through an intravenous infusion. This means the medication will be given directly into your vein.

    The treatment is intended for patients with cryoglobulinemia vasculitis (a condition affecting blood vessels) who have not responded well to or cannot tolerate a previous medication called Rituximab.

  2. Step 2

    Monitoring at 12 weeks

    Your health will be evaluated to check how well the treatment is working.

    The medical team will assess any changes in your symptoms, including effects on your skin, joints, kidneys, nerves, digestive system, lungs, or heart.

    Blood tests will be performed to check your immune system response.

  3. Step 3

    Evaluation at 24 weeks (6 months)

    A thorough assessment will determine if you have achieved a complete clinical response, which means all affected organs have improved.

    Your medication needs will be reviewed, particularly regarding corticosteroid use.

    Additional blood tests will be conducted to monitor your progress.

  4. Step 4

    Final assessment at 48 weeks

    A final comprehensive evaluation will take place to assess the long-term effectiveness of the treatment.

    Your overall health status will be reviewed, including any side effects or complications.

    The medical team will perform final blood tests and health assessments.

  5. Step 5

    Follow-up period

    Your health will continue to be monitored to track any long-term effects of the treatment.

    Regular checks will be made for any signs of infection or other health changes.

    The total study duration may extend until July 2028.

Who can join the trial?

8 criteria

  • Must be at least 18 years old
  • Must provide written informed consent to participate
  • Must have active mixed cryoglobulinemia vasculitis with at least one of these symptoms: - Skin problems - Joint issues - Kidney involvement - Nerve problems - Brain-related symptoms - Digestive system issues - Lung problems - Heart-related symptoms
  • Must be either not responding to (refractory) or unable to tolerate (intolerant) the medication called Rituximab
  • Must test negative for HIV within 3 months before starting the study
  • Must test negative for hepatitis B surface antigen (HBs Ag) within 3 months before starting the study
  • Must either: - Test negative for hepatitis C (HCV), or - If previously tested positive for HCV, must have a negative HCV RNA test within 3 months before starting the study
  • Must be registered with the French social security system (including those with AME coverage)

Who cannot join the trial?

15 criteria

  • History of severe allergic or anaphylactic reactions to monoclonal antibodies (proteins used in medical treatments)
  • Active or chronic hepatitis B infection
  • Active tuberculosis infection
  • Severe heart, kidney, or liver disease
  • Active cancer or history of cancer in the past 5 years (except for successfully treated skin cancer)
  • Pregnant or breastfeeding women
  • Active serious infections requiring treatment
  • History of progressive multifocal leukoencephalopathy (PML - a rare brain infection)
  • Participation in another clinical trial within the past 30 days
  • Known HIV infection
  • Major surgery planned during the study period
  • Any medical condition that could interfere with the study procedures or patient safety
  • Previous treatment with Obinutuzumab
  • Mental conditions that could affect the ability to provide informed consent
  • Drug or alcohol abuse within the past 6 months
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Investigated drugs

  • Obinutuzumab

    is a medication used to treat certain types of blood vessel inflammation related to cryoglobulinemia vasculitis. It belongs to a class of drugs called monoclonal antibodies, which work by targeting specific cells in the immune system. This medication is being studied as a treatment option for patients who haven't responded well to or cannot tolerate Rituximab, which is another medication in the same class.

  • Rituximab

    is a monoclonal antibody medication that is commonly used to treat blood vessel inflammation caused by cryoglobulinemia vasculitis. It works by targeting specific immune cells called B cells. While this medication is not being tested in this trial, it is mentioned as the previous treatment that patients may have failed or not tolerated.

What is already known about the treatment

  • Obinutuzumab

    A monoclonal antibody medication administered through intravenous infusion that targets specific B-cells in the immune system. This medication is currently used in treating various B-cell disorders and has shown promise in clinical trials for treating cryoglobulinemia vasculitis, particularly in patients who don't respond well to or cannot tolerate Rituximab. Obinutuzumab works by binding to the CD20 protein on B-cells, triggering their destruction and reducing abnormal immune responses in the body. It belongs to the class of targeted immunotherapy drugs and represents an advanced treatment option in modern medicine.

  • Rituximab

    A well-established monoclonal antibody medication delivered through intravenous infusion, widely used in treating autoimmune conditions and certain types of blood cancers. It specifically targets CD20-positive B-cells and has been a standard treatment for cryoglobulinemia vasculitis, though some patients may become refractory or intolerant to its effects. The medication works by depleting B-cells in the body, thereby reducing inflammation and autoimmune responses. It belongs to the class of biological response modifiers and has been a cornerstone therapy in autoimmune disease treatment for many years.

Investigated diseases

Cryoglobulinemic Vasculitis - A condition where abnormal proteins called cryoglobulins are present in the blood, which can cause inflammation of blood vessels throughout the body. These proteins become solid or gel-like at cold temperatures and can block blood vessels. The condition affects multiple organs, including the skin, joints, kidneys, and nerves. It typically causes a combination of symptoms such as skin rashes, joint pain, and weakness. The disease can occur either on its own or as a result of other underlying conditions.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508930-33-00Protocol codeAPHP230848Estimated enrolment30 patientsSponsorAssistance Publique Hopitaux De Paris

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).