Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

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

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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), which is a type of medication known as a monoclonal antibody. This medication is designed to target specific parts of the immune system to help reduce the symptoms of the disease. In this study, some participants will receive ianalumab, while others will receive a placebo, which looks like the treatment but does not contain the active medication.

The purpose of the study is to determine if ianalumab is more effective than a placebo in improving the condition of patients with active Sjögren’s syndrome. Participants in the study will receive the treatment or placebo through an injection under the skin, known as a subcutaneous injection, over a period of 52 weeks. Throughout the study, participants will be monitored to assess changes in their symptoms and overall health.

This trial aims to provide valuable information on the safety and effectiveness of ianalumab for treating Sjögren’s syndrome, potentially offering a new option for managing this condition. Participants will be closely observed by healthcare professionals to ensure their well-being and to gather data on how the treatment affects their symptoms over time.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    Upon joining the study, participants are randomly assigned to one of two groups: one receiving the active medication ianalumab (also known as VAY736) and the other receiving a placebo. This process is double-blind, meaning neither the participants nor the researchers know who is receiving the active medication or the placebo.

  2. Step 2

    Treatment administration

    Participants receive the assigned treatment through subcutaneous injection using a pre-filled syringe. The active medication, ianalumab, is administered at a dose of 150 mg per 1 mL.

    The treatment period lasts for 52 weeks, during which the medication is administered according to the study protocol.

  3. Step 3

    Monitoring and assessments

    Throughout the study, participants undergo regular assessments to monitor the effectiveness and safety of the treatment. These assessments include measuring changes in the ESSDAI score, which evaluates disease activity in Sjögren’s syndrome.

    Additional assessments may include evaluations of salivary flow rate, systemic disease activity, and patient-reported outcomes.

  4. Step 4

    End of treatment evaluation

    At the end of the 52-week treatment period, participants undergo a final evaluation to assess the overall impact of the treatment on their condition.

    The primary focus is on the change in the ESSDAI score from the beginning of the study to the end of the treatment period.

Who can join the trial?

11 criteria

  • You must sign a form to show you agree to participate 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.
  • If you are taking certain medications called **disease-modifying antirheumatic drugs (DMARDs)** or specific Traditional Chinese Medicines, you must stop these at least 30 days before starting the study. One exception is a medication called leflunomide, which must be stopped 8 weeks before unless a special procedure is done.
  • You must be 18 years of age or older.
  • You must have **Sjögren's syndrome** diagnosed according to specific criteria from 2016.
  • You must 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 this test is negative, you can still participate if a salivary gland biopsy is positive, but only a small number of such patients will be included.
  • Your **ESSDAI score** (a measure of disease activity) must be 5 or higher in certain areas of the body.
  • Your **salivary flow rate** (how much saliva you produce) must be at least 0.05 mL per minute at screening.
  • You must be able to communicate well with the study team and agree to follow the study requirements.
  • If you are taking medications like hydroxychloroquine, methotrexate, or azathioprine, you can continue them if the dose has been stable for at least 30 days before starting the study and stays stable during the study.

Who cannot join the trial?

10 criteria

  • Patients with any other autoimmune disease that might interfere with the study results.
  • Patients who have had a serious infection within the last 3 months.
  • Patients who have received any live vaccines within 4 weeks before the study starts.
  • Patients who are currently receiving treatment with another investigational drug.
  • Patients with a history of cancer, except for certain types of skin cancer that have been treated.
  • Patients with severe heart, liver, or kidney problems.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of drug or alcohol abuse within the last year.
  • Patients who have had a major surgery within the last 4 weeks.
  • Patients with a known allergy to the study medication or its ingredients.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Ianalumab is a medication being studied for its effectiveness and safety in treating patients with active Sjögren’s syndrome. The trial aims to show that ianalumab can improve symptoms of the disease, as measured by a specific score, over a period of 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 proteins in the immune system to reduce inflammation and symptoms associated with the disease. Ianalumab is classified as a monoclonal antibody, which is a type of biologic drug 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 impact other parts of the body, including joints, kidneys, lungs, and nerves. The disease often progresses slowly, with symptoms developing over time. Patients may experience fatigue, joint pain, and swelling. In some cases, Sjögren’s Syndrome can occur alongside other autoimmune diseases, such as rheumatoid arthritis or lupus. The severity and combination of symptoms can vary widely among individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511069-12-00Protocol codeCVAY736A2301Estimated enrolment276 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.