#1 Clinical Trials Search in Europe

Sjogren’s syndrome – Trials in Disease

Go back

Ongoing Clinical Trials for Sjögren’s Syndrome

Sjögren’s syndrome is an autoimmune condition where the body’s immune system attacks moisture-producing glands, leading to symptoms like dry eyes and dry mouth. Currently, there are 19 ongoing clinical trials testing new treatments to help manage this condition and improve quality of life for patients. (Also known as: Sjögren’s Disease, Primary Sjögren’s Syndrome, Sjogren’s Syndrome)

Clinical trial locations

Study on the Effectiveness and Safety of Deucravacitinib for Adults with Active Sjogren’s Syndrome

This trial is testing a medication called deucravacitinib in adults who have active symptoms of the condition. Deucravacitinib is a pill that works by blocking specific pathways in the immune system that cause inflammation.

Who can participate: Adults aged 18 or older who have been diagnosed according to 2016 medical criteria, with moderate to severe disease activity measured by a score called ESSDAI of 5 or higher. Participants must test positive for anti-SSA/Ro antibody and have had symptoms for 10 years or less. They also need to have a minimum level of saliva production.

Who cannot participate: People with other serious health conditions that could interfere with the study, those who are pregnant or breastfeeding, individuals with recent infections requiring antibiotics, those who received live vaccines recently, people with a history of cancer in the past five years (except certain skin cancers), and those with substance abuse issues.

What the trial involves: Participants will be randomly assigned to receive either deucravacitinib at doses of 3 mg or 6 mg, or a placebo. The trial lasts about one year, with regular check-ups to monitor health and symptom changes. The main goal is to see if there is improvement in disease activity after 52 weeks of treatment.

Study on the Effectiveness and Safety of Efgartigimod for Adults with Primary Sjögren’s Syndrome

This study examines efgartigimod, a medication given as an injection under the skin. The trial compares efgartigimod with a placebo to see how it affects disease activity and symptoms.

Who can participate: Adults aged 18 or older with a diagnosis meeting 2016 ACR/EULAR criteria, a disease activity score (clinESSDAI) of 6 or higher, positive anti-Ro/SS-A antibodies, and a minimum saliva production level of at least 0.01 mL/min.

Who cannot participate: People with other autoimmune diseases besides primary Sjögren’s, those with recent or current infections, individuals who received investigational drugs recently, people with severe allergies to medications, pregnant or breastfeeding women, those with cancer history in the past 5 years (except certain skin cancers), people with drug or alcohol abuse history, and those who cannot follow study procedures.

What the trial involves: Participants receive either efgartigimod or placebo through subcutaneous injections over 48 weeks. Regular visits monitor disease activity and any side effects. The study includes an open-label extension phase where all participants may receive the active medication.

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

This trial investigates nipocalimab, a medication given as an injection under the skin, compared to a placebo. Nipocalimab targets specific proteins in the immune system that contribute to inflammation.

Who can participate: Adults who are medically stable based on physical exam and lab tests, with a diagnosis according to 2016 criteria, positive for Ro/SSA antibodies, and a disease activity score (Total ClinESSDAI) of 5 or higher. Women of childbearing potential must have negative pregnancy tests.

Who cannot participate: People with other serious health conditions that could interfere, those participating in another clinical trial, individuals with recent infections requiring treatment, people with severe allergic reactions history, pregnant or breastfeeding women, those with drug or alcohol abuse history, people who received investigational drugs recently, those with cancer history in the past 5 years (except certain skin cancers), individuals with uncontrolled medical conditions, and those with certain other autoimmune diseases.

What the trial involves: Participants receive either nipocalimab or placebo subcutaneously over 48 weeks. Regular monitoring assesses disease activity changes, with the primary goal of observing improvement in the ClinESSDAI score from baseline to week 48.

Study on the Effectiveness of CL-AD-MSC-002 Injections for Dry Mouth in Patients with Sjögren’s Syndrome

This trial in Denmark tests a special cell therapy using adipose-derived mesenchymal stem cells. These cells are injected directly into the salivary glands to see if they can help improve saliva production and reduce dry mouth symptoms.

Who can participate: Adults over 18 years old diagnosed with primary Sjögren’s Syndrome according to 2016 ACR-EULAR criteria, who have dry mouth and a saliva flow rate between 0.05 ml/min and 3.0 ml/min, and can provide informed consent.

Who cannot participate: People without a confirmed diagnosis, those outside the specified age range, individuals in certain clinical trial groups not included in this study, and vulnerable populations.

What the trial involves: Participants receive an injection in the submandibular glands containing either stem cells or a placebo (sterile saline). The study monitors saliva flow rate over four months to determine treatment effectiveness.

Study on the Safety and Effects of Rapcabtagene Autoleucel, Tocilizumab, Fludarabine Phosphate, and Cyclophosphamide for Patients with Rheumatoid Arthritis and Sjogren’s Disease

This trial studies a new cell therapy called rapcabtagene autoleucel (YTB323) for people with severe, hard-to-treat disease. The treatment uses specially modified immune cells to target the disease, combined with other medications.

Who can participate: Adults aged 18-65 who provide informed consent. For those with severe, refractory disease with organ involvement, they must have a diagnosis according to specific criteria and show moderate to high disease activity despite previous treatments.

Who cannot participate: Those with severe organ-involving disease that is refractory to treatment, as this particular group cannot participate in this study phase.

What the trial involves: Participants receive preparatory medications (fludarabine and cyclophosphamide) followed by the cell therapy rapcabtagene autoleucel and other medications including tocilizumab. The study monitors safety and cellular behavior throughout the treatment period.

Title: Study of Sibeprenlimab Treatment for Adults with Sjögren’s Disease Using Subcutaneous Injections

This study evaluates sibeprenlimab (VIS649) given as injections under the skin, compared to placebo, in addition to patients’ regular treatments. The goal is to reduce disease activity after 28 weeks.

Who can participate: Adults aged 18-75 who meet 2016 ACR/EULAR criteria, test positive for anti-Ro antibodies, have an ESSDAI score of 5 or more, salivary flow rate of at least 0.05 mL per minute, and blood IgG levels above 900 mg/dL. Patients may continue stable doses of certain background medications like hydroxychloroquine, methotrexate, leflunomide, or azathioprine.

Who cannot participate: People under 18, those with active tuberculosis, history of lymphoma or other cancers in the past 5 years, severe or uncontrolled infections, pregnant or breastfeeding women, those with significant heart/liver/kidney disease, recent live vaccinations, treatment with experimental medications within 3 months, known allergies to similar medications, uncontrolled diabetes, active hepatitis B or C, HIV infection, severe mental health conditions, or drug/alcohol abuse within the past year.

What the trial involves: Participants receive subcutaneous injections of sibeprenlimab or placebo for 28 weeks, with regular monitoring of disease activity, tear and saliva production, fatigue levels, and overall symptoms. Maximum single dose is 400 mg.

Study of AlloNK and rituximab with cyclophosphamide and fludarabine in adults with relapsing rheumatoid arthritis, inflammatory myopathies, systemic sclerosis, or Sjögren’s disease

This trial tests a combination of AlloNK (natural killer cells from cord blood) with rituximab in patients whose conditions have not responded well to standard treatments. Before the main treatment, patients receive cyclophosphamide and fludarabine to prepare the immune system.

Who can participate: Adults 18 or older with adequate lung function (DLCO ≥60%, FVC ≥70%), heart function (LVEF ≥45%), acceptable blood counts and organ function. For those with this condition specifically, they must meet diagnostic criteria, have active disease symptoms, and adequate saliva production. Must use effective contraception during the trial and for 1 year after treatment.

Who cannot participate: Those with allergic reactions to rituximab, active or chronic infections (hepatitis B, hepatitis C, HIV, tuberculosis), severe heart conditions or uncontrolled high blood pressure, active cancer or history in past 5 years (except certain skin cancers), pregnant or breastfeeding women, severe kidney or liver problems, mental health conditions affecting informed consent, participation in other trials within 30 days, live vaccines within 4 weeks, substance abuse or alcohol dependency within the past year, certain blood disorders, or major surgery recently.

What the trial involves: Treatment begins with lymphodepletion using fludarabine and cyclophosphamide, followed by AlloNK cells and rituximab through intravenous infusion. Regular monitoring up to 52 weeks includes disease activity measurements specific to each condition, safety assessments, physical examinations, blood tests, heart monitoring, and tracking of side effects.

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

This long-term safety study is for patients who have completed previous studies with efgartigimod. It evaluates the medication’s safety over 48 weeks of continued treatment.

Who can participate: Adults at least 18 years old (or legal age of consent) with a diagnosis according to 2016 criteria who have completed qualifying studies with efgartigimod and can provide informed consent. Women of childbearing potential must have negative pregnancy tests.

Who cannot participate: Those with other serious health conditions that could interfere, people currently in another clinical trial, individuals with recent infections requiring antibiotics, those with severe allergic reaction history, pregnant or breastfeeding women, people with drug or alcohol abuse history, those who received certain medications affecting study results, individuals with cancer history in the past 5 years (except certain skin cancers), people with heart problems, and those who had major surgery within 3 months.

What the trial involves: Participants receive efgartigimod through intravenous infusion over 48 weeks. Regular assessments monitor for adverse events, changes in laboratory results, vital signs, and ECG results. The study evaluates improvements in disease activity scores (ESSDAI and clinESSDAI) at weeks 24 and 48.

Study on Anifrolumab for Patients with Primary Sjogren’s Syndrome

This trial in the Netherlands tests anifrolumab (MEDI-546) given as an intravenous infusion compared to placebo over 24 weeks. The medication works by blocking specific proteins in the immune system involved in inflammation.

Who can participate: Adults aged 18 or older with disease duration of 10 years or less (15 years if started in childhood with remaining gland function), meeting 2016 ACR-EULAR criteria, with anti-SSA antibodies, ESSDAI score of 5 or more and/or ESSPRI score of 5 or more. At least half of participants need ESSDAI score of 5 or more. Must be willing to have parotid gland biopsies and use reliable contraception. Need COVID-19 vaccination (at least two doses) or recovery from confirmed infection with vaccination or positive antibodies.

Who cannot participate: Those with a different condition, outside the specified age range, unable to follow study procedures, with other serious health issues that might interfere, pregnant or breastfeeding women, currently in another clinical trial, those who had recent major surgery or planning one during the study, individuals with substance abuse or alcohol dependency history, and those who received certain medications or treatments affecting study results.

What the trial involves: Participants receive anifrolumab or placebo through intravenous infusion over 24 weeks, with visits at weeks 0, 4, 8, 12, 16, 20, and 24. The study includes parotid gland biopsies at baseline and week 24, measuring various outcomes including the Composite of Relevant Endpoints for Sjögren’s Syndrome (CRESS) as the primary outcome at week 24.

Study on Hydroxychloroquine, Leflunomide, and Mycophenolate Mofetil for Patients with Primary Sjogren’s Syndrome

This 24-week study tests combinations of commonly used medications: hydroxychloroquine with leflunomide, or hydroxychloroquine with mycophenolate mofetil, compared to placebo. These medications are taken as oral tablets.

Who can participate: Adults over 18 years old with a diagnosis according to ACR/EULAR 2016 or AECG 2002 criteria who can provide written informed consent and use highly reliable contraception. Women must have negative pregnancy tests. For Cohort 1: ESSPRI score of 5 or more with low systemic disease activity. For Cohort 2: ESSDAI score of 5 or more with moderate to high systemic disease activity.

Who cannot participate: Pregnant or breastfeeding women, those with severe allergic reactions to study medications, people with other autoimmune diseases, individuals with recent infections requiring antibiotics or antivirals, those with significant liver or kidney problems, people currently using medications interfering with study drugs, individuals with cancer history within five years (except certain skin cancers), those with uncontrolled high blood pressure, people who had recent heart attack or stroke, and those with drug or alcohol abuse history within the past year.

What the trial involves: After providing informed consent and confirming eligibility, participants are randomly assigned to receive hydroxychloroquine combined with either mycophenolate mofetil or leflunomide, taken as film-coated tablets. Regular monitoring assesses treatment response, with the goal of determining improvement proportion by week 24.

Summary

The 19 ongoing clinical trials for Sjögren’s syndrome span across Europe, with notable concentrations in countries like France, Germany, Poland, and Spain. These trials reflect a strong international effort to find better treatments for this challenging autoimmune condition.

Several medications appear in multiple trials, indicating they are considered promising candidates. Ianalumab is being tested in at least four separate studies, suggesting significant interest in this treatment approach. Efgartigimod appears in three trials, including a long-term safety extension study. Other medications being investigated include deucravacitinib, nipocalimab, sibeprenlimab, anifrolumab, and abiprubart, each representing different approaches to managing the immune system dysfunction underlying the condition.

The trials employ various treatment approaches. Most test biological medications given by injection, either under the skin or into a vein. Some studies examine combinations of established oral medications like hydroxychloroquine, leflunomide, and mycophenolate mofetil. One innovative trial in Denmark tests stem cell therapy injected directly into salivary glands to restore function.

Trial duration varies from 24 weeks to over a year, with some including long-term extension phases lasting several years. Most studies measure success using standardized scores like ESSDAI (disease activity) and ESSPRI (patient-reported symptoms), allowing consistent comparison of results across different treatments.

Participation requirements are generally similar across trials: adults typically aged 18-75 with confirmed diagnosis, positive specific antibody tests, minimum disease activity levels, and some remaining gland function. Common exclusions include pregnancy, recent infections, other serious health conditions, and recent participation in other trials.

These diverse approaches reflect the complexity of treating Sjögren’s syndrome and the medical community’s commitment to developing more effective therapies to improve patients’ quality of life.

Ongoing Clinical Trials on Sjogren’s syndrome

  • Study on the Effectiveness and Safety of Efgartigimod for Adults with Primary Sjögren’s Syndrome

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Bulgaria Estonia France Germany +12

  • Study on the Effects of Ianalumab in Adults with Rheumatoid Arthritis, Systemic Lupus Erythematosus, or Sjögren’s Disease

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Germany Hungary Italy The Netherlands Poland +1

  • Study on the Effectiveness of Human Normal Immunoglobulin for Treating Painful Nerve Damage in Patients with Primary Sjögren’s Syndrome

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Hydroxychloroquine, Leflunomide, and Mycophenolate Mofetil for Patients with Primary Sjogren’s Syndrome

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France Greece Italy The Netherlands Norway Spain +1

  • Study on Leflunomide and Hydroxychloroquine for Patients with Primary Sjögren’s Syndrome

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on Long-Term Safety and Efficacy of Ianalumab for Patients with Sjögren’s Syndrome

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Bulgaria Czechia France Germany +10

More information about
Sjogren’s syndrome:

Connected medications: