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Study on the Effects of Ianalumab in Patients with Sjögren’s Syndrome

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What is this study about?

This clinical trial is focused on studying *Sjögren’s syndrome*, a condition that affects the body’s moisture-producing glands, leading to symptoms like dry mouth and eyes. The study will use a treatment called *ianalumab*, also known by its code name *VAY736*. This treatment is administered as a solution for injection. The purpose of the study is to understand how *ianalumab* affects the salivary glands in patients with *Sjögren’s syndrome*.

Participants in the study will receive *ianalumab* over a period of time, and researchers will observe changes in the salivary glands. The study will also monitor the safety and tolerability of the treatment, which means checking for any side effects or reactions. Throughout the study, participants will have regular check-ups to assess their health and the effects of the treatment.

The study aims to provide insights into how *ianalumab* works in the body and its potential benefits for people with *Sjögren’s syndrome*. By examining the changes in the salivary glands, researchers hope to better understand the relationship between the treatment and clinical outcomes. This information could help improve future treatments for *Sjögren’s syndrome* and enhance the quality of life for those affected by this condition.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, you will undergo a series of assessments to confirm your eligibility. These assessments include a review of your medical history and a physical examination.

You will also be asked to provide written informed consent, which means you agree to participate in the study after understanding all the details and potential risks involved.

2 screening tests

Screening tests will be conducted to ensure you meet the study criteria. These tests include blood tests to check for specific antibodies and an evaluation of your symptoms using a questionnaire called the EULAR Sjögren’s syndrome patient reported index (ESSPRI).

The ESSPRI score must be 5 or higher for you to continue in the study.

3 treatment phase

If you qualify, you will begin the treatment phase. You will receive a medication called ianalumab, administered as a solution for injection under the skin (subcutaneous).

The treatment will continue for a specified period, and you will be monitored regularly to assess the effects of the medication on your condition.

4 regular monitoring

Throughout the study, you will have regular visits to monitor your health and the effects of the treatment. These visits will include physical examinations, blood tests, and assessments of your salivary gland function.

You will also be asked about any side effects or changes in your symptoms.

5 end of treatment

At the end of the treatment period, a final assessment will be conducted. This will include a review of your overall health, any changes in your symptoms, and the results of various tests.

The primary focus will be on changes in your salivary gland tissue, which will be evaluated through a biopsy.

6 follow-up

After the treatment phase, follow-up visits will be scheduled to monitor your health and any long-term effects of the treatment.

These visits will help gather information on the safety and effectiveness of the medication over time.

Who Can Join the Study?

  • Written informed consent must be obtained before any assessment is performed. This means you need to agree in writing to participate in the study after being informed about it.
  • Male and female patients 18 years of age or older at the time of screening.
  • Must have a diagnosis of Sjögren’s syndrome according to the 2016 ACR/EULAR criteria at screening. These are specific guidelines used by doctors to diagnose the condition.
  • Must be seropositive at screening for anti-Ro/SSA antibodies. This means a blood test shows the presence of specific antibodies related to Sjögren’s syndrome.
  • Must have a Screening EULAR Sjögren’s syndrome patient reported index (ESSPRI) score of 5 or higher. This is a score based on your symptoms, and a score of 5 or more indicates a certain level of symptom severity.
  • Able to communicate well with the investigator, and understand and comply with the requirements of the study. This means you should be able to talk with the study team and follow the study instructions.

Who Cannot Join the Study?

  • Patients who do not have Sjögren’s syndrome cannot participate. Sjögren’s syndrome is a condition where the body’s immune system attacks its own healthy cells that produce saliva and tears.
  • Patients who are not within the specified age range cannot participate. The age range for this study is from 18 to 65 years old.
  • Patients who are not willing to undergo a salivary gland biopsy cannot participate. A biopsy is a procedure where a small piece of tissue is taken from the body to be examined more closely.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have any other serious health conditions that might interfere with the study cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have a history of allergic reactions to similar treatments cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name City Country Status
Centre Hospitalier Regional Et Universitaire De Brest Brest France

Other Sites

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

Trial status

Country Status Recruitment Start
France France
Not recruiting
30.12.2021

Trial locations

Investigated drugs:

Ianalumab is a medication being studied for its effects on Sjögren’s syndrome, a condition that affects the glands that produce moisture in the body, like saliva and tears. This medication is designed to help understand how it works in the body, how it affects the disease, and whether it is safe and well-tolerated by patients. The study aims to see if ianalumab can change the structure of the salivary glands, which are often affected in people with Sjögren’s syndrome. By examining these changes, researchers hope to learn more about how the medication might help manage or treat the symptoms of this condition.

Investigated diseases:

Sjögren’s syndrome – Sjögren’s syndrome is an autoimmune disorder primarily affecting the body’s moisture-producing glands. It often leads to dry mouth and dry eyes due to the immune system attacking the glands that produce saliva and tears. Over time, this condition can also affect other parts of the body, including joints, skin, and organs such as the kidneys and liver. The progression of the disease can vary, with some individuals experiencing mild symptoms while others may develop more severe complications. The inflammation caused by the immune response can lead to damage in the affected glands, reducing their ability to function properly. As the disease progresses, patients may experience increased discomfort and a broader range of symptoms.

Trial ID:
2023-508957-24-00
Protocol code:
CVAY736A2103
NCT ID:
NCT05124925
Trial Phase:
Therapeutic exploratory (Phase II)

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