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Efficacy and safety of efgartigimod alfa in adults with Sjögren’s disease‑associated sensorimotor or sensory polyneuropathy: a phase 2 randomized placebo‑controlled study

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study looks at adults who have nerve damage linked to Sjogren’s disease-associated sensorimotor polyneuropathy, the type that affects both feeling and movement, or sensory polyneuropathy, the type that only affects feeling. The medication being tested is a subcutaneous injection called efgartigimod, given once a week. Some participants will receive a matching placebo that looks the same but does not contain the active drug.

The purpose of the study is to determine whether weekly injections of the drug improve nerve symptoms compared with the placebo. Participants will receive an injection each week for several months and will attend regular visits where doctors will check nerve function using a questionnaire called the mTCNS (a score that rates how severe the nerve problems are). Other questionnaires will also be used, such as the Norfolk QoL-DN (a quality‑of‑life survey for nerve disease), the clinESSDAI and ESSDAI (measures of overall disease activity), the NPQ (a questionnaire about pain), a NRS rating for difficulty thinking, and patient‑ and clinician‑rated impression scales (PGIS, PGIC, CGIS, and CGI). Fatigue will be measured with the FACIT-Fatigue questionnaire.

Throughout the study, safety will be monitored by checking vital signs, heart rhythm, blood tests, and any side effects that may occur. Participants will have the opportunity to report any adverse events, and the study team will evaluate the seriousness of any findings. The overall design allows comparison of the drug’s effect with the placebo while keeping participants and investigators unaware of which treatment is being given.

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

    Enrollment and baseline assessment

    After joining the study, you will receive a study number and undergo initial assessments that record your current nerve symptoms, quality of life, and basic health measurements such as blood tests and vital signs.

  2. Step 2

    Randomization to treatment or placebo

    Based on a computer‑generated list, you will be assigned either the active medication efgartigimod or a matching placebo. you will not know which one you receive.

  3. Step 3

    First subcutaneous injection

    The first dose will be given as a subcutaneous injection (injection under the skin) using a prefilled syringe. the active medication contains 1000 mg of efgartigimod in a solution for injection. the placebo is a syringe with no active drug but looks identical.

  4. Step 4

    Weekly injections

    You will receive an injection once every week for the duration of the treatment period. each injection will be 1000 mg of efgartigimod if you are in the active group, or the matching placebo if you are in the control group. the injection is administered under the skin by study staff.

  5. Step 5

    Regular study visits

    At scheduled visits, you will complete questionnaires that evaluate nerve symptom severity (mTCNS score), quality of life, disease activity, and fatigue. you will also have physical examinations, vital‑sign checks, an electrocardiogram (ECG), and laboratory tests to monitor safety.

  6. Step 6

    Monitoring for side effects

    Throughout the study you will be asked to report any new or worsening symptoms. study staff will assess the severity and possible relationship of any adverse events to the study medication.

  7. Step 7

    Final assessment at end of part a

    At the end of the treatment period (the end of Part A), you will undergo the same set of assessments as at baseline to determine changes in nerve symptom scores, quality of life, disease activity, and other outcome measures.

Who can join the trial?

10 criteria

  • You must be at least 18 years old and old enough under local laws to give consent for a clinical study.
  • You need a confirmed diagnosis of Sjogren’s Disease that meets the 2016 classification rules set by the American College of Rheumatology and the European Alliance of Associations for Rheumatology.
  • Your Sjogren’s Disease must be at least moderate‑to‑severe, which means you score 5 or higher on the ESSDAI (a disease activity index) or 6 or higher on the clinical version (clinESSDAI) with a peripheral nervous system (PNS) score of 5 or more at the screening visit.
  • You must test positive for the antibodies called anti‑Ro/SS‑A in a central laboratory test performed at screening.
  • You must have a type of nerve problem linked to Sjogren’s Disease, called polyneuropathy, that fits the study’s definition.
  • A doctor must perform a neurological exam that includes nerve conduction studies (NCS) and find results that match the required diagnosis.
  • Your nerve problem must have started **five years or less** before joining the study.
  • You must have had **active nerve disease** (symptoms that are currently affecting you) within the past 12 months.
  • Your total score on the modified Total Neuropathy Score (mTCNS) must be 6 or higher.
  • The sensory part of the mTCNS must be lower than level 3, meaning the sensory symptoms are not extremely severe.

Who cannot join the trial?

7 criteria

  • Any other known medical condition that could make it hard to judge your symptoms accurately or could put you at extra risk during the study.
  • Having secondary Sjögren’s disease, which means you also have another autoimmune (your immune system attacks your own body) disease such as rheumatoid arthritis, lupus, scleroderma, or inflammatory muscle disease.
  • Having active fibromyalgia (a condition causing widespread pain) that is not well‑controlled, or taking fibromyalgia medicines that have not been stable for at least 12 weeks before screening.
  • Having another clear cause for the nerve problem, such as vasculitic neuropathy (inflammation of blood vessels affecting nerves) or diabetes mellitus (high blood sugar), or not enough proof that the nerve problem is due to Sjögren’s.
  • Having a severe Sjögren’s symptom or another health problem that is not well‑controlled at the start of the study and could put you at undue risk.
  • Having other illnesses like asthma or chronic obstructive pulmonary disease that required three or more courses of systemic glucocorticoids (steroid medicines taken by mouth, IV, or injection) in the past 12 months.
  • Having a history of cancer unless it was completely cured, with no evidence of it coming back for at least three years before receiving the first study medication.
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Investigated drugs

Vyvgart is a medication that contains a protein called efgartigimod alfa. In this study it is given as a liquid that is injected under the skin (subcutaneous injection). Participants receive it once each week. The purpose of Vyvgart in the trial is to see if it can improve the nerve problems (sensorimotor or sensory polyneuropathy) that are linked to Sjogren’s disease, compared with a placebo.

What is already known about the treatment

Vyvgart 1 000 mg solution for injection in pre-filled syringe - It is given as a subcutaneous injection using a pre‑filled syringe, with a dose of 1000 mg once each week. The drug is already approved for certain autoimmune conditions and is being studied for Sjogren’s disease‑associated sensorimotor or sensory polyneuropathy. It works by attaching to the neonatal Fc receptor (FcRn) and stopping the recycling of IgG antibodies, which lowers the level of harmful auto‑antibodies in the body. Efgartigimod alfa is classified as an FcRn antagonist and an immunoglobulin‑G‑reducing immunomodulator.

Investigated diseases

  • Sjogren's syndrome-associated sensorimotor polyneuropathy

    This condition is a nerve disorder that occurs in people with Sjogren's syndrome. It affects both sensory nerves, which convey feeling, and motor nerves, which control muscle movement. Patients may notice tingling, numbness, and a gradual loss of strength in the hands and feet. Symptoms often start in the toes or fingers and can spread upward over time. The disorder typically worsens slowly, leading to increasing difficulty with daily activities.

  • Sjogren's syndrome-associated sensory polyneuropathy

    This is a nerve disorder linked to Sjogren's syndrome that primarily involves the sensory nerves. It causes sensations such as numbness, tingling, and burning, usually beginning in the extremities. The symptoms develop gradually and may extend to larger areas of the limbs. Over time, the abnormal sensations can become more persistent and affect balance and coordination. The condition generally progresses slowly, with symptoms becoming more noticeable during daily tasks.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-526218-10-00Protocol codeARGX-113-15-SjD-2003Estimated enrolment74 patientsSponsorArgenx

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