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 study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Groupe Hospitalier Du Sud Ile De France	Melun	France

Other Sites

Site Name	City	Country
Centre Hospitalier Blois Simone Veil	Blois	France
Centre Hospitalier Le Mans	Le Mans	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hospital Foch	Suresnes	France
Centre Hospitalier Universitaire De Nimes	Nimes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Centre Hospitalier De Valenciennes	Valenciennes	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Chjprx Hoeylrkdjhx Usvvlllnywato Dx Dakae	Dijon	France
Aiixmflytm Phxyodvo Hmgswigt Dw Mihslmcxu	Marseille	France
Cxsrdj Hlotnofjczx Rcxusspl Uydfkackhupxf Dt Tghtj	Tours	France
Hnfvtrkw Utzsaijtjhqqac Szscivfbcc &umuhil Hlsyfow do Hhomkvzupct	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.10.2025

Trial locations

Investigated drugs:

Obinutuzumab

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.

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 ID:

2023-508930-33-00

Protocol code:

APHP230848

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?