AuthorisedTherapeutic exploratory (Phase II)Interventional

Ultimate dePletion of autoReactive b cells using Obinutuzumab from sjÖgren's syndrome affected Tissues study- UPROOT study

The UPROOT study is investigating a new treatment approach for Sjögren's syndrome, a long-term condition that causes dryness, particularly in the eyes and mouth. Researchers are using a medicine called Gazyvaro (also known as Obinutuzumab). The main goal is to see if this medicine can lower the levels of specific immune cells, called B cells, in the blood, salivary glands, and lymph nodes of people with Sjögren's syndrome. These B cells are thought to play a role in the disease. By reducing these cells, the study hopes to understand if Gazyvaro can help lessen the symptoms and impact of Sjögren's syndrome. This is an early-stage study (Phase II), meaning it's exploring how well the treatment works and if it's safe.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Radboud universitair medisch centrum Stichting

Enrolment target

Start

11 Mar 2026

Sjögren's syndrome

What is this study about?

Sjögren's syndrome is a condition where your immune system mistakenly attacks your body's own healthy cells, often leading to very dry eyes and mouth, as well as tiredness and joint pain. In people with Sjögren's, certain immune cells called B cells can become overactive and produce harmful substances that contribute to the disease. The UPROOT study is trying to find out if a new medicine called Gazyvaro can help by reducing these specific overactive B cells.

The main aim of this study is to see if Gazyvaro can lower the number of these particular B cells in the blood, the affected salivary glands, and lymph nodes three months after starting treatment. Researchers will compare samples taken before and after the treatment to see if there's a significant change. Other things they will look at include how the medicine affects your overall Sjögren's symptoms, how your doctor rates your disease activity, and how you feel your symptoms are affecting you. They will also measure things like tear and saliva production.

By carefully studying these changes, the researchers hope to understand if Gazyvaro could be a helpful new treatment option for people living with Sjögren's syndrome. This is called a 'Phase II' study, which means it's an early step to see if the treatment works and is safe enough to be tested in larger groups of people later on.

Key takeaways

This study is exploring a new medicine for Sjögren's syndrome called Gazyvaro.
It aims to see if Gazyvaro can reduce specific immune cells linked to the disease.
The study will assess improvements in symptoms like dryness and overall disease activity.
It's an early-stage research study (Phase II) to check effectiveness and safety.
Participation involves receiving the medicine, blood tests, and check-ups.
You can stop participating in the study at any time.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 years or older, with a diagnosis of Sjögren's syndrome. Both men and women can take part.

There will be other specific medical criteria that determine if this study is suitable for you, as is common with all clinical trials. These will be discussed in detail by the study team to ensure your safety and that the study results are as clear and accurate as possible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Am I 18 years old or older?
Do I have a confirmed diagnosis of Sjögren's syndrome?
Am I able to attend regular appointments for treatment and tests?
Am I comfortable with having blood tests and possibly small tissue samples taken?
Am I available for follow-up over several months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the UPROOT study, you would receive the study medicine, Gazyvaro, through an infusion (like a drip) over a period of time. Before starting treatment, and at various points during and after, you would have appointments for blood tests and possibly small tissue samples (biopsies) from your salivary glands or lymph nodes to measure the B cells.

Throughout the study, you would also have regular check-ups to assess your symptoms, how you're feeling, and to perform specific tests like measuring tear and saliva production. The study aims to follow participants for several months to understand the full effect of the treatment. The total duration of your participation, including follow-up appointments, would be fully explained by the study team.

Potential risks and benefits

Taking part in a clinical trial like UPROOT might offer the potential benefit of accessing a new treatment that could improve your Sjögren's symptoms before it's widely available. However, there are also potential risks involved, such as side effects from the study medication, or discomfort from procedures like blood tests or biopsies. It's important to remember that the study medicine may not work for everyone, and it's also possible that it may not offer any benefit. You have complete control and can decide to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is Sjögren's syndrome?

Sjögren's syndrome is a long-term condition where your immune system attacks your moisture-producing glands, primarily causing dry eyes and dry mouth.

What is Gazyvaro?

Gazyvaro is a medicine being tested in this study. It's designed to target and reduce certain immune cells called B cells, which are involved in Sjögren's syndrome.

What does a 'Phase II' study mean?

Phase II means it's an early-stage study to see if a new treatment is effective and safe in a small group of people, before testing it more widely.

Will I get the actual medicine or a dummy treatment?

The study description focuses on giving Gazyvaro; it does not mention a dummy treatment (placebo) arm. The study team can clarify this.

How long will the study last?

The study will look at effects over 3 months, with symptoms checked at 12, 24, and 36 weeks. The full duration of your involvement, including follow-up, will be discussed by the study team.