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Study on the Effectiveness and Safety of Ianalumab for Patients with Active Sjögren’s Syndrome

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for Sjögren’s syndrome, a condition where the body's immune system mistakenly attacks its own moisture-producing glands, leading to symptoms like dry mouth and eyes. The treatment being tested is called ianalumab, also known by its code name VAY736. It is administered as a solution for injection using a pre-filled syringe. The study also includes a comparison with a placebo, which is a substance with no active medication, to evaluate the effectiveness of ianalumab.

The purpose of the study is to assess how well ianalumab works and how safe it is for patients with active Sjögren’s syndrome. Participants in the study will be randomly assigned to one of three groups: one receiving ianalumab, one receiving a placebo, and another group receiving a standard treatment known as glucocorticoids, which are a type of steroid medication taken orally. The study will last for a total of 52 weeks, during which participants will receive regular injections and have their health monitored closely by the research team.

Throughout the study, the main focus will be on changes in the participants' health, particularly looking at the ESSDAI score, which is a measure used to assess disease activity in Sjögren’s syndrome. The study aims to demonstrate whether ianalumab is more effective than the placebo in improving this score over the course of the study. Participants will also be monitored for any side effects or changes in their condition to ensure the treatment's safety and tolerability.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must have signed an informed consent form. This indicates understanding and agreement to participate in the study.

    The patient must meet specific criteria, such as being 18 years or older and having a diagnosis of Sjögren's syndrome according to established criteria.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm eligibility. This includes a positive anti-Ro/SSA antibody test or a positive salivary gland biopsy.

    The patient must have a stimulated whole salivary flow rate of at least 0.05 mL/min and an ESSDAI score of 5 or higher in specific domains.

  3. Step 3

    Medication administration

    The patient receives either ianalumab (VAY736) or a placebo. Ianalumab is administered as a solution for injection using a pre-filled syringe.

    The administration is subcutaneous, meaning it is injected under the skin.

  4. Step 4

    Treatment period

    The treatment period lasts for 52 weeks. During this time, the patient continues to receive the assigned medication.

    Patients on systemic corticosteroids must maintain a stable dose of 10 mg/day or less of predniso(lo)ne or equivalent throughout the treatment period.

  5. Step 5

    Ongoing assessments

    Regular assessments are conducted to monitor the patient's condition and response to treatment.

    These assessments include measuring changes in the ESSDAI score, which evaluates disease activity, and other health indicators.

  6. Step 6

    End of treatment evaluation

    At the end of the 52-week treatment period, a final evaluation is conducted.

    The primary focus is on the change in the ESSDAI score from the beginning of the study to week 48.

Who can join the trial?

11 criteria

  • You must sign a form to show you agree to take part in the study.
  • If you are taking **systemic corticosteroids** (a type of medication that reduces inflammation), your dose must be stable at 10 mg or less per day for at least 30 days before starting the study. The dose should stay the same during the study, but small changes are allowed as described in the study plan.
  • If you are taking certain medications like **disease-modifying antirheumatic drugs (DMARDs)** or specific Traditional Chinese Medicines, you need to stop these at least 30 days before starting the study. For the medication leflunomide, you need to stop it 8 weeks before unless you have a special treatment to remove it from your body.
  • You must be 18 years or older.
  • You need to have **Sjögren's syndrome** diagnosed according to specific criteria from 2016.
  • You should have been diagnosed with Sjögren's syndrome for 7.5 years or less at the time of screening.
  • You must have a positive test for **anti-Ro/SSA antibody** at screening. If you don't, you can still join if a special test of your salivary gland is positive, but only a small number of people without this antibody will be allowed in the study.
  • Your **ESSDAI score** (a measure of disease activity) must be 5 or higher in certain areas of your health.
  • Your saliva flow rate must be at least 0.05 mL per minute at screening.
  • You need to be able to communicate well with the study doctor and agree to follow the study requirements.
  • If you are taking medications like hydroxychloroquine, methotrexate, or azathioprine, you can continue them if your dose has been stable for at least 30 days before starting the study. The dose should stay stable during the study within certain limits.

Who cannot join the trial?

9 criteria

  • Patients who have a different condition than 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 for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for specific types of participants.
  • Patients who are not willing to follow the study procedures or take the study medication as directed cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate. This is to ensure the safety of the participants and the accuracy of the study results.
  • Patients who are pregnant or breastfeeding cannot participate. This is to protect the health of the mother and the baby.
  • Patients who have participated in another clinical trial recently cannot participate. This is to avoid any interference with the results of the current study.
  • Patients who have a history of substance abuse or alcohol abuse cannot participate. This is to ensure the safety and reliability of the study.
  • Patients who have a known allergy to the study medication or its ingredients cannot participate. This is to prevent any allergic reactions.
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Investigated drugs

Ianalumab is a medication being studied for its effectiveness and safety in treating patients with active Sjögren’s syndrome. This trial aims to determine if ianalumab can improve symptoms better than a placebo by measuring changes in a specific disease activity score over 48 weeks.

What is already known about the treatment

Ianalumab – Ianalumab is administered as an injection, typically given under the skin. It is currently being studied in clinical trials for its effectiveness in treating Sjögren’s Syndrome, an autoimmune condition. The medication works by targeting specific immune cells, aiming to reduce inflammation and improve symptoms associated with the disease. Ianalumab is classified as a monoclonal antibody, a type of medication designed to interact with the immune system at a molecular level.

Investigated diseases

Sjögren’s Syndrome – Sjögren’s Syndrome is an autoimmune disorder primarily affecting the glands that produce tears and saliva, leading to dry eyes and mouth. It can also cause joint pain, swelling, and stiffness, as well as fatigue. Over time, the condition may affect other parts of the body, including the kidneys, liver, and nervous system. The disease often progresses slowly, with symptoms varying in severity among individuals. It is more common in women and often occurs in conjunction with other autoimmune diseases, such as rheumatoid arthritis or lupus.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511068-10-00Protocol codeCVAY736A2302Estimated enrolment495 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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