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Study on Anifrolumab for Patients with Primary Sjogren'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 primary 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 trial will test the effectiveness and safety of a treatment called anifrolumab, also known by its code name MEDI-546. Anifrolumab is given as a solution through an intravenous infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to explore how well anifrolumab works in treating primary Sjögren's syndrome. Participants in the study will receive either the anifrolumab treatment or a placebo, which is a substance with no active medication. The study will last for 24 weeks, during which participants will have regular check-ups to monitor their health and any changes in their symptoms. These check-ups will help researchers understand the treatment's impact on the disease.

Throughout the study, researchers will assess various aspects of the disease, such as systemic disease activity, patient-reported symptoms, and the function of tear and salivary glands. The study aims to determine if anifrolumab can improve these areas and provide relief to those with primary Sjögren's syndrome. Safety will also be closely monitored to ensure the treatment is well-tolerated by participants.

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 participant will receive a detailed explanation of the trial procedures and provide written informed consent.

    Eligibility is confirmed based on criteria such as age, disease duration, and specific medical conditions.

  2. Step 2

    Baseline assessments

    Initial assessments include a parotid gland biopsy, which may be repeated at the end of the study.

    Baseline measurements of various health indicators are taken, including systemic disease activity and patient-reported symptoms.

  3. Step 3

    Treatment administration

    Participants receive either anifrolumab or a placebo through an intravenous infusion.

    The treatment is administered over a period of 24 weeks.

  4. Step 4

    Regular monitoring

    Participants attend regular visits at weeks 0, 4, 8, 12, 16, 20, and 24 for monitoring.

    Safety and tolerability are assessed through the observation of any adverse events and laboratory tests.

  5. Step 5

    Evaluation of treatment effects

    The primary outcome is measured using the Composite of Relevant Endpoints for Sjögren’s Syndrome (CRESS) at week 24.

    Secondary outcomes include various health assessments at specified intervals, such as systemic disease activity and quality of life measures.

  6. Step 6

    Final assessments

    At the end of the 24-week period, a final parotid gland biopsy is conducted to compare with the baseline.

    Final evaluations of health indicators and treatment effects are completed.

Who can join the trial?

9 criteria

  • Provide written informed consent, which means you agree to participate in the study after being informed about it.
  • Be a female or male aged 18 years or older.
  • Have had the disease for 10 years or less. If the disease started in childhood, it can be up to 15 years if there is still some gland function.
  • Meet the 2016 ACR-EULAR classification criteria for primary Sjögren's syndrome, which are specific guidelines used to diagnose the condition.
  • Have anti-SSA antibodies, which are specific proteins in the blood related to the disease.
  • Have an ESSDAI score of 5 or more and/or an ESSPRI score of 5 or more. These scores measure disease activity and symptoms. At least half of the participants need to have an ESSDAI score of 5 or more.
  • Be willing to have a parotid gland biopsy at the start and 24 weeks after treatment begins. If a recent biopsy is available, it can be used if there is enough material.
  • Use a reliable method of contraception if you can have children.
  • Be vaccinated against COVID-19 with at least two doses, or have recovered from a confirmed COVID-19 infection with at least one vaccination or a positive antibody test.

Who cannot join the trial?

9 criteria

  • Patients who have a different condition than Sjogren's disease cannot participate. This study is specifically for those with this condition.
  • Individuals who are not within the specified age range for the study are excluded. The study has specific age requirements.
  • Participants who are not able to follow the study procedures or instructions will not be able to join.
  • People who have other serious health issues that might interfere with the study or its results are not eligible.
  • Individuals who are pregnant or breastfeeding are not allowed to participate in the study.
  • Patients who are currently participating in another clinical trial are excluded to avoid interference with the study results.
  • Anyone who has had a recent major surgery or is planning to have one during the study period cannot participate.
  • Individuals with a history of substance abuse or alcohol dependency may be excluded to ensure the safety and accuracy of the study.
  • Patients who have received certain medications or treatments that might affect the study results are not eligible.
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Investigated drugs

Anifrolumab is a medication being studied for its potential to help patients with primary Sjögren’s syndrome. This condition is an autoimmune disorder where the body's immune system mistakenly attacks its own moisture-producing glands, leading to symptoms like dry mouth and eyes. Anifrolumab works by targeting and blocking a specific protein in the immune system that is believed to play a role in the inflammation and tissue damage seen in autoimmune diseases. The goal of this trial is to assess how effective and safe anifrolumab is for treating the symptoms of primary Sjögren’s syndrome over a 24-week period.

What is already known about the treatment

Anifrolumab – Anifrolumab is administered through intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently being studied in clinical trials for its potential use in treating primary Sjögren's syndrome, a condition characterized by dry mouth and eyes due to immune system dysfunction. The medication works by targeting and blocking a specific receptor involved in the immune response, which may help reduce inflammation and other symptoms associated with the disease. Anifrolumab is classified as a monoclonal antibody, a type of biologic drug designed to interfere with specific pathways in the immune system.

Investigated diseases

Sjogren's Syndrome – Sjogren's Syndrome 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 eyes and dry mouth, as the tear and salivary glands are primarily affected. Over time, the condition can also impact other parts of the body, including joints, skin, and organs like the kidneys and liver. Patients may experience fatigue, joint pain, and swelling, which can vary in severity. The progression of the disease is typically slow, and symptoms can fluctuate over time. It is more common in women and often occurs in conjunction with other autoimmune diseases.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516770-29-00Protocol codeESR-21-21284Estimated enrolment30 patientsSponsorUniversitair Medisch Centrum Groningen

sourced from the EU Clinical Trials Register and site verification

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