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Safety Study of Efgartigimod in Adults with Primary Sjögren's Syndrome

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 safety of a treatment called efgartigimod alfa in adults with Primary Sjögren's Syndrome. Primary Sjögren's Syndrome is an autoimmune disease 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, efgartigimod alfa, is given as a solution through an intravenous infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of this study is to evaluate the long-term safety of efgartigimod alfa in patients who have completed previous studies involving this treatment. Participants will receive the treatment over a period of 48 weeks. During this time, researchers will monitor the participants' health closely to identify any side effects or changes in their condition. The study will also track various health indicators, such as laboratory test results and vital signs, to ensure the treatment is safe for long-term use.

Throughout the study, participants will have regular check-ups to assess their response to the treatment. The researchers will look for improvements in disease activity and symptoms, as well as any changes in specific markers in the blood. This information will help determine if efgartigimod alfa is a safe and effective option for managing Primary Sjögren's Syndrome over an extended period.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment phase

    The efgartigimod alfa (argx-113) medication is administered through an iv infusion, which means the medicine is delivered directly into a vein. the dose for this iv infusion is 1200 mg.

    This treatment phase is part of an open-label extension study, where the medication is provided to monitor long-term safety for individuals with primary Sjögren's syndrome (an autoimmune condition that often causes dry eyes and a dry mouth).

  2. Step 2

    Monitoring and assessment

    Safety is monitored by tracking adverse events (unwanted medical occurrences), vital signs (such as blood pressure and heart rate), laboratory test results, and ecg results (a test that records the electrical activity of the heart).

    The treatment period lasts for 48 weeks.

    Clinical improvements and disease activity are evaluated at week 24 and week 48 using specific measurement scales, such as the essdai and esspri, which are used to track symptoms and disease severity.

    Blood samples are analyzed during the 48-week period to measure total igg levels (a type of protein in the blood used by the immune system), autoantibodies (proteins that mistakenly attack the body's own tissues), and the concentration of efgartigimod in the blood.

    The presence of ada (antibodies that the body may create against the medication) is also monitored throughout the 48-week period.

Who can join the trial?

6 criteria

  • You must be at least the legal age of consent, which means you are old enough to legally sign documents and join a medical study.
  • You must be able to provide informed consent, which is a written agreement showing that you understand the study and agree to take part.
  • You must be able to follow all the rules and requirements of the study.
  • If you are a person of childbearing potential, you must have a negative urine pregnancy test before receiving the investigational medicinal product, which is the study drug being tested.
  • You must agree to use contraceptive measures, such as birth control, according to local laws.
  • You must have already finished previous studies testing efgartigimod for Primary Sjögren's Syndrome and agree to keep taking the study medicine without any breaks.

Who cannot join the trial?

5 criteria

  • You have a serious health condition, such as a newly discovered malignancy (cancer) or cardiovascular disease (heart or blood vessel problems).
  • You plan to have surgery (an operation) while the study is ongoing.
  • You have any other medical condition that, in the doctor's opinion, might make it difficult to see if the study treatment works or might put you at unnecessary danger.
  • You are currently pregnant or are planning to become pregnant during the study.
  • You have any severe systemic manifestations (serious symptoms that affect your entire body) of your condition that the doctor believes could put you at high risk.
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Investigated drugs

Efgartigimod is a medication given through a vein as an infusion to help manage symptoms in patients with a condition called primary Sjögren’s syndrome.

What is already known about the treatment

Efgartigimod alfa - This medication is given as a liquid through an intravenous infusion directly into a vein. It is currently being studied in clinical trials to determine its long-term safety for treating autoimmune conditions like primary Sjögren's syndrome. The drug works by blocking a specific part of the immune system that helps regulate the production of harmful antibodies, thereby reducing the body's attack on its own healthy tissues. It is classified as a neonatal Fc receptor blocker.

Investigated diseases

Primary Sjögren's Syndrome - This is an autoimmune condition where the immune system mistakenly attacks the body's own healthy cells. It primarily targets the glands that produce moisture, such as the salivary and tear glands. As the condition progresses, these glands become inflamed and lose their ability to function properly. This typically leads to persistent dryness in the mouth and eyes. The disease can also involve other parts of the body, such as the joints or internal organs, through ongoing inflammation.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503915-14-00Protocol codeARGX-113-2211Estimated enrolment27 patientsSponsorArgenx

sourced from the EU Clinical Trials Register and site verification

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