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Study on the Effectiveness and Safety of Ianalumab for Patients with Diffuse Cutaneous Systemic Sclerosis

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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 a condition known as diffuse cutaneous systemic sclerosis, a type of autoimmune disease that causes hardening and tightening of the skin. The study will evaluate the effectiveness and safety of a treatment called ianalumab, also known by its code name VAY736. This treatment is administered as a solution for infusion, which means it is given through a needle into a vein. The trial will compare the effects of ianalumab to a placebo to determine if it is more effective in treating this condition.

The purpose of the study is to see if ianalumab can improve symptoms of diffuse cutaneous systemic sclerosis over a period of 52 weeks. Participants will be randomly assigned to receive either ianalumab or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. This is known as a double-blind study. The study will involve regular visits to the clinic for assessments and monitoring of health, including blood tests and other evaluations to check the response to the treatment and any side effects.

In addition to ianalumab, the study will also involve other medications such as tenofovir alafenamide, emtricitabine, tenofovir disoproxil, and entecavir, which are antiviral drugs. These medications are taken orally, meaning they are swallowed in pill form. The study aims to gather information on how these treatments affect the disease and to ensure they are safe and well-tolerated by participants. The trial is expected to continue until 2030, with the recruitment of participants starting in 2024.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of systemic sclerosis, and disease duration.

    Eligibility criteria include a diagnosis of systemic sclerosis as per specific classification criteria, and disease duration of 60 months or less.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the study medication, ianalumab, or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

  3. Step 3

    Treatment administration

    The study medication, ianalumab, is administered via subcutaneous injection. The placebo is administered in the same manner.

    The treatment period lasts for 52 weeks, during which the participant receives regular doses as per the study protocol.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, participants undergo regular monitoring to assess the efficacy and safety of the treatment. This includes measuring changes in specific health indicators and monitoring for any adverse effects.

    Blood samples are collected periodically to measure ianalumab concentrations and to check for the presence of anti-drug antibodies.

  5. Step 5

    Final assessment

    At the end of the 52-week treatment period, a final assessment is conducted to evaluate the overall response to the treatment.

    The primary goal is to determine if the participant achieves a specific response as defined by the study's criteria.

Who can join the trial?

14 criteria

  • Participants must be **male or female** and between **18 and 70 years old** at the time of the screening visit.
  • Participants must have a **diagnosis of systemic sclerosis**, a condition defined by specific criteria from medical organizations.
  • The **disease duration** must be **60 months or less**. This means the time since the first symptoms, like puffy hands or difficulty breathing, should be no more than 5 years.
  • The **mRSS score**, which measures skin thickness, must be between **15 and 45** at the screening visit.
  • The disease must be **active**, meeting at least one of the following conditions at screening:
    • Disease duration of **18 months or less** since the first symptoms.
    • An increase in the mRSS score by **3 or more units** compared to the last assessment in the past 6 months.
    • Involvement of a new body area and an increase in mRSS by **2 or more units** compared to the last assessment in the past 6 months.
    • Involvement of **two new body areas** in the past 6 months.
    • **Elevated acute phase reactants**, which are markers of inflammation, such as ESR of **30 mm/hr or more** or hsCRP of **6 mg/dL or more**.
    • Presence of **interstitial lung disease** and a positive test for ATA autoantibody.
    • A **modified EUSTAR disease activity index** score greater than **2.5**.
    • Participants must test **positive for at least one autoantibody**, which are proteins made by the immune system:
      • **Anti-topoisomerase I (ATA)**, also known as anti-SCL-70.
      • **Anti-RNA polymerase III (anti-RNAP3)**.
      • **Anti-nuclear antibody (ANA)** with a level of **1:80 or higher**. However, if a participant is only positive for ANA and negative for the other two, they will be limited to 30% of the study group.

Who cannot join the trial?

3 criteria

  • Patients who do not have diffuse cutaneous systemic sclerosis (dcSSc). This is a condition that affects the skin and sometimes other parts of the body.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population that the study is not designed to include.
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Investigated drugs

Ianalumab is a medication being studied for its potential to treat diffuse cutaneous systemic sclerosis, a condition that affects the skin and other organs. The trial aims to determine if ianalumab is more effective than a placebo in improving symptoms over a 52-week period.

What is already known about the treatment

Ianalumab – Ianalumab is administered through an injection, typically under the skin. It is currently being studied in clinical trials for its effectiveness in treating diffuse cutaneous systemic sclerosis, a condition characterized by skin thickening and hardening. The medication works by targeting specific immune cells, aiming to reduce inflammation and slow disease progression. Ianalumab is classified as a monoclonal antibody, a type of medication designed to interact with the immune system.

Investigated diseases

Diffuse Cutaneous Systemic Sclerosis – This is a rare autoimmune disease characterized by the hardening and tightening of the skin and connective tissues. It primarily affects the skin but can also involve internal organs such as the lungs, heart, and kidneys. The disease progresses with the overproduction of collagen, leading to thickened skin and potential organ dysfunction. Patients may experience symptoms like skin stiffness, joint pain, and reduced mobility. As the condition advances, it can lead to complications in various organ systems. The progression and severity of symptoms can vary significantly among individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511933-36-00Protocol codeCVAY736S12201Estimated enrolment200 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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