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Study on the Effectiveness and Safety of Nipocalimab for Adults with Moderate to Severe Sjögren's Disease

Fast replyInvestigationalNo placebo
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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 Disease, a condition that affects the body's moisture-producing glands, leading to symptoms like dry mouth and dry eyes. The treatment being tested is called Nipocalimab, which is given as a solution for injection under the skin. The study will compare the effects of Nipocalimab to a placebo, which is a substance with no active medication, to see how well it works and how safe it is for people with moderate to severe Sjögren's Disease.

The purpose of the study is to evaluate the effectiveness of Nipocalimab in improving the symptoms of Sjögren's Disease. Participants in the study will receive either Nipocalimab or a placebo over a period of time. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results. The main goal is to observe any changes in the disease activity from the start of the study to the end, which is planned to last for several months.

Throughout the study, participants will be monitored regularly to assess their health and any changes in their condition. This will involve routine check-ups and tests to track the progress of the disease and the effects of the treatment. The study aims to provide valuable information on whether Nipocalimab can be an effective treatment option for those suffering from moderate to severe Sjögren's Disease.

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

    Joining the study

    Upon joining the study, you will be randomly assigned to receive either the study medication, nipocalimab, or a placebo. A placebo is a substance that looks like the study medication but does not contain any active ingredients.

    The study is designed to be double-blind, meaning neither you nor the study team will know which treatment you are receiving. This helps ensure the results are not influenced by expectations.

  2. Step 2

    Treatment administration

    You will receive the treatment as a solution for injection under the skin, known as subcutaneous use. The exact dosage and frequency will be determined by the study protocol and communicated to you by the study team.

    The treatment period will last for a specified duration, during which you will be monitored regularly to assess the effects of the treatment on your condition.

  3. Step 3

    Regular monitoring

    Throughout the study, you will have regular visits with the study team. These visits will include physical examinations, discussions about any changes in your health, and possibly additional tests to monitor your condition.

    Your progress will be evaluated using a specific score called the Clinical European League Against Rheumatism Sjogren’s Syndrome Disease Activity Index (ClinESSDAI). This score helps measure the activity of your Sjogren's Disease.

  4. Step 4

    End of treatment evaluation

    At the end of the treatment period, which is expected to be around 48 weeks, your condition will be assessed to determine any changes from the start of the study.

    The primary goal is to observe any change in your ClinESSDAI score, which will help evaluate the effectiveness of the treatment.

  5. Step 5

    Follow-up

    After completing the treatment phase, there may be additional follow-up visits to monitor your health and gather further information about the long-term effects of the treatment.

    These follow-up visits are important to ensure your well-being and to collect comprehensive data for the study.

Who can join the trial?

5 criteria

  • The patient must be medically stable. This means their health is steady based on a physical exam, medical history, vital signs, heart test (ECG), and lab tests done at the start of the study.
  • The patient must have a diagnosis of Sjögren's Disease (SjD) according to specific guidelines set by medical organizations in 2016.
  • The patient must test positive for antibodies to Ro/SSA at the start of the study. Antibodies are proteins made by the immune system to fight infections, and Ro/SSA is a specific type related to SjD.
  • The patient must have a Total ClinESSDAI score of 5 or higher at the start of the study. This score measures the activity of SjD in the body.
  • If the patient can have children, they must have a negative pregnancy test at the start of the study and again before the study begins.

Who cannot join the trial?

10 criteria

  • Participants cannot join if they have any other serious health conditions that might interfere with the study.
  • Individuals who are pregnant or breastfeeding are not allowed to participate.
  • Participants must not have a history of severe allergic reactions to any medication.
  • People who have been part of another clinical trial within the last 30 days cannot participate.
  • Participants should not have any active infections that require treatment.
  • Individuals with a history of drug or alcohol abuse in the past year are excluded.
  • Participants must not have received any investigational drug within the last 30 days.
  • People with a history of cancer within the last 5 years, except for certain skin cancers, are not eligible.
  • Participants should not have any uncontrolled medical conditions that could affect their safety or the study results.
  • Individuals with a history of certain autoimmune diseases, other than Sjögren's Disease, are excluded.
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Investigated drugs

Nipocalimab is a medication being studied for its potential to help people with moderate to severe Sjögren's Disease, a condition where the body's immune system mistakenly attacks its own moisture-producing glands. This medication works by targeting and blocking a specific protein in the immune system that is thought to contribute to the symptoms of Sjögren's Disease. By doing this, nipocalimab may help reduce inflammation and improve symptoms such as dry mouth and dry eyes, which are common in people with this condition. The goal of the trial is to see if nipocalimab can effectively and safely improve the quality of life for those affected by Sjögren's Disease.

What is already known about the treatment

Nipocalimab – Nipocalimab is administered through an intravenous infusion, meaning it is delivered directly into the bloodstream via a vein. It is currently being studied in clinical trials for its potential use in treating moderate to severe Sjögren's Disease, an autoimmune condition. The medication works by targeting and blocking specific proteins in the immune system that are involved in inflammation, helping to reduce the symptoms of the disease. Nipocalimab is classified as an immunomodulatory agent, which means it helps to regulate or normalize the immune system's response.

Investigated diseases

Sjögren's Disease – Sjögren's Disease is an autoimmune disorder characterized by the body's immune system mistakenly attacking its own moisture-producing glands. This leads to symptoms such as dry mouth and dry eyes, as the salivary and tear glands are primarily affected. Over time, the disease can also impact other parts of the body, including joints, skin, and organs like the kidneys and lungs. The progression of the disease varies among individuals, with some experiencing mild symptoms and others facing more severe complications. As the disease advances, it may lead to increased discomfort and potential damage to affected tissues. The condition is chronic, meaning it persists over a long period and requires ongoing management.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513965-38-01Protocol code80202135SJS3001Estimated enrolment816 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).