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Study on the Effectiveness and Safety of Efgartigimod for Adults with Primary 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 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 dry eyes. The treatment being tested is called Efgartigimod, which is administered as a solution for injection using a pre-filled syringe. This study will compare the effects of Efgartigimod with a placebo to understand its impact on the disease.

The purpose of the study is to evaluate how effective and safe Efgartigimod is for patients with Primary Sjögren’s Syndrome. Participants in the study will receive either Efgartigimod or a placebo through subcutaneous injections, which means the injection is given under the skin. The study will follow participants over a period to observe changes in their condition, particularly looking at the activity of the disease and any improvements in symptoms.

Throughout the study, researchers will monitor participants to assess the treatment's impact on disease activity and overall safety. The study aims to provide valuable information on whether Efgartigimod can help manage symptoms and improve the quality of life for those living with Primary Sjögren’s Syndrome. The trial includes an open-label extension, meaning that after the initial phase, all participants may have the opportunity to receive Efgartigimod, allowing further observation of its long-term effects.

The research process

The trial runs in 7 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 informed about the trial's purpose, procedures, and your role. You will be required to sign an informed consent form, confirming your understanding and willingness to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes verifying that you are at least 18 years old and meet specific health criteria related to primary Sjögren’s disease.

  3. Step 3

    Randomization

    You will be randomly assigned to receive either the study medication, efgartigimod, or a placebo. This process is double-blinded, meaning neither you nor the study team will know which treatment you are receiving.

  4. Step 4

    Treatment administration

    The treatment involves a subcutaneous injection using a pre-filled syringe. The frequency and dosage will be explained to you by the study team. This phase will last for 48 weeks.

  5. Step 5

    Regular monitoring

    Throughout the trial, you will have regular visits to monitor your health and the effects of the treatment. These visits will include assessments of your disease activity and any side effects.

  6. Step 6

    End of treatment phase

    At the end of the 48-week treatment phase, your health and disease activity will be evaluated to measure any changes from the start of the trial.

  7. Step 7

    Open-label extension

    After completing the initial phase, you may have the option to continue in an open-label extension, where all participants receive the study medication. This phase allows further evaluation of the medication's long-term effects.

Who can join the trial?

6 criteria

  • Must be at least 18 years old and meet the legal age of consent for clinical studies in your area.
  • Must have a diagnosis of Primary Sjögren’s Disease according to specific medical guidelines (ACR/EULAR classification criteria 2016).
  • Must have a clinESSDAI score of 6 or higher. (clinESSDAI is a tool used by doctors to measure the activity of Sjögren’s Disease in the body.)
  • Must test positive for Anti-Ro/SS-A antibodies in a central laboratory test. (Anti-Ro/SS-A are specific proteins in the blood that are often found in people with Sjögren’s Disease.)
  • Must have a residual salivary flow of at least 0.01 mL/min when not stimulated. (This measures how much saliva your mouth produces without any stimulation.)
  • Both males and females are eligible to participate.

Who cannot join the trial?

9 criteria

  • Patients with any other autoimmune disease that is not **Primary Sjögren’s Disease**.
  • Patients who have had a recent infection or are currently experiencing an infection.
  • Patients who have received any investigational drug within the last 30 days.
  • Patients with a history of severe allergic reactions to any medication.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of cancer within the last 5 years, except for certain skin cancers.
  • Patients with significant heart, liver, or kidney disease.
  • Patients with a history of drug or alcohol abuse within the last year.
  • Patients who are unable to comply with the study procedures.
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Investigated drugs

Efgartigimod PH20 is a medication being tested in this clinical trial for its effectiveness in treating primary Sjögren’s Disease. 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 dry eyes. Efgartigimod PH20 is administered through a prefilled syringe under the skin, which is known as subcutaneous administration. The goal of this medication is to reduce the activity of the disease and improve the symptoms by modulating the immune system's response.

What is already known about the treatment

Efgartigimod PH20 – This medication is administered subcutaneously, meaning it is injected under the skin using a prefilled syringe. It is currently being studied in a Phase 3 clinical trial to assess its effectiveness, safety, and tolerability for treating Primary Sjögren’s Disease, a condition that affects the body's moisture-producing glands. Efgartigimod PH20 works by targeting and reducing the activity of certain proteins in the immune system that contribute to inflammation and tissue damage. It is classified as an immunomodulatory agent, which means it helps regulate or normalize the immune system's response.

Investigated diseases

Primary Sjögren’s Disease – Primary 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, causing fatigue and joint pain. The progression of the disease varies among individuals, with some experiencing mild symptoms and others developing more severe complications. The condition can also lead to inflammation in other areas, such as the lungs, kidneys, and nervous system. The disease is chronic and can fluctuate in intensity, with periods of increased activity and remission.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516609-22-00Protocol codeARGX-113-2306Estimated enrolment580 patientsSponsorArgenx

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