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Study on Hydroxychloroquine, Leflunomide, and Mycophenolate Mofetil 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 that affects the body's moisture-producing glands, leading to symptoms like dry mouth and eyes. The study will explore the effectiveness of different treatment combinations to help manage this condition. The treatments being tested include a combination of hydroxychloroquine with leflunomide, and hydroxychloroquine with mycophenolate mofetil. These medications are commonly used to treat autoimmune diseases, where the immune system mistakenly attacks the body's own tissues.

The purpose of the study is to evaluate how well these treatment combinations work in improving the symptoms of Primary Sjögren's Syndrome. Participants in the study will receive one of the treatment combinations or a placebo. The study will last for a period of 24 weeks, during which the participants' responses to the treatments will be monitored and assessed. The goal is to determine the proportion of patients who show improvement in their symptoms by the end of the study period.

Throughout the study, participants will be closely monitored to ensure their safety and to gather data on the effectiveness of the treatments. This research aims to provide valuable insights into better managing Primary Sjögren's Syndrome and improving the quality of life for those affected by this condition.

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 patient is required to provide written informed consent. This is a formal agreement to participate in the trial after understanding its purpose and procedures.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm the diagnosis of primary Sjögren's syndrome. This includes meeting specific criteria set by medical organizations.

    A pregnancy test is performed for female patients to ensure eligibility.

  3. Step 3

    Treatment allocation

    Patients are assigned to one of the treatment groups. The treatments involve combinations of medications taken orally.

    The medications used are hydroxychloroquine sulfate, mycophenolate mofetil, and leflunomide. Each medication is provided in the form of film-coated tablets.

  4. Step 4

    Medication administration

    The patient takes hydroxychloroquine sulfate as part of the treatment regimen. The dosage is 200 mg per tablet.

    If assigned to the combination with mycophenolate mofetil, the patient takes 500 mg tablets.

    If assigned to the combination with leflunomide, the patient takes 20 mg tablets.

    The frequency and duration of administration are determined by the study protocol, with a focus on achieving the desired response by week 24.

  5. Step 5

    Monitoring and evaluation

    Throughout the trial, the patient's response to the treatment is monitored. This involves regular check-ups and assessments to evaluate the effectiveness of the medication.

    The primary goal is to determine the proportion of patients who respond positively to the treatment by week 24.

  6. Step 6

    Completion of the trial

    The trial is expected to conclude by January 25, 2026. At this point, the final assessments are conducted to gather data on the treatment's efficacy.

    The results will contribute to understanding the best treatment options for patients with primary Sjögren's syndrome.

Who can join the trial?

6 criteria

  • Must have given written informed consent before starting any study-related procedures. This means you agree to participate and understand what the study involves.
  • Must use highly reliable contraception during the study treatment, starting from the screening and continuing for two years after stopping treatment. This is to prevent pregnancy during and after the study.
  • Must have a negative pregnancy test at the start of the study (checked through a blood test).
  • Must be diagnosed with **Primary Sjogren's syndrome** (pSS) according to specific medical criteria (ACR/EULAR 2016 or AECG 2002). These are guidelines used by doctors to confirm the condition.
  • For Cohort 1: Must have a high level of symptoms, with a score of 5 or more on the **ESSPRI** scale, which measures symptoms like dryness, pain, and fatigue. Must also have low systemic disease activity, meaning the disease is not affecting the whole body severely.
  • For Cohort 2: Must have moderate to high systemic disease activity, with a score of 5 or more on the **ESSDAI** scale, which measures how much the disease is affecting the body.

Who cannot join the trial?

10 criteria

  • Patients who are pregnant or breastfeeding cannot participate.
  • Individuals with a history of severe allergic reactions to the study medications are excluded. This means if you have had a serious allergic response to the drugs being tested, you cannot join.
  • People with other autoimmune diseases, which are conditions where the body's defense system attacks its own tissues, are not eligible.
  • Participants who have had recent infections that required treatment with antibiotics or antiviral medications are excluded. This means if you have had an infection needing these treatments recently, you cannot take part.
  • Individuals with significant liver or kidney problems cannot participate. These are important organs in your body, and if they are not working well, you cannot join the study.
  • Patients who are currently using other medications that might interfere with the study drugs are not eligible. This means if you are taking certain other medicines, you cannot participate.
  • People with a history of cancer within the last five years, except for certain types of skin cancer, are excluded. This means if you have had cancer recently, you cannot join, unless it was a specific type of skin cancer.
  • Individuals with uncontrolled high blood pressure, which means your blood pressure is not well-managed, cannot participate.
  • Participants who have had a recent heart attack or stroke are excluded. These are serious conditions affecting the heart and brain.
  • People with a history of drug or alcohol abuse within the past year cannot join the study. This means if you have had problems with drugs or alcohol recently, you are not eligible.
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Investigated drugs

  • Hydroxychloroquine

    is a medication commonly used to treat autoimmune diseases. In this trial, it is being tested in combination with other drugs to see if it can help improve symptoms in patients with primary Sjögren’s Syndrome.

  • Leflunomide

    is a medication that helps reduce inflammation and is often used to treat rheumatoid arthritis. In this study, it is combined with hydroxychloroquine to evaluate its effectiveness in treating primary Sjögren’s Syndrome.

  • Mycophenolate mofetil

    is an immunosuppressant drug that is used to prevent the body from rejecting transplanted organs and to treat autoimmune diseases. In this trial, it is being used alongside hydroxychloroquine to assess its potential benefits for patients with primary Sjögren’s Syndrome.

What is already known about the treatment

  • Hydroxychloroquine

    This medication is typically taken orally in tablet form. It is currently used in medicine to treat autoimmune conditions and is well-documented in medical literature. The main therapeutic indication for hydroxychloroquine in this trial is primary Sjogren's syndrome. It works by modulating the immune system, reducing inflammation at the molecular level. Hydroxychloroquine is classified as an antimalarial and immunomodulatory drug.

  • Leflunomide

    Administered orally as a tablet, leflunomide is used in the treatment of autoimmune diseases and is recognized in medical literature. In this trial, it is indicated for primary Sjogren's syndrome. Leflunomide acts by inhibiting the synthesis of pyrimidine, which is necessary for the proliferation of immune cells, thus reducing inflammation. It is classified as a disease-modifying antirheumatic drug (DMARD).

  • Mycophenolate mofetil

    This medication is taken orally in capsule or tablet form. It is well-established in medical literature for its use in autoimmune conditions. The trial uses mycophenolate mofetil for primary Sjogren's syndrome. It works by inhibiting the proliferation of lymphocytes, a type of immune cell, thereby reducing inflammation. Mycophenolate mofetil is classified as an immunosuppressant.

Investigated diseases

Primary Sjogren's Syndrome – This is an autoimmune disorder where the body's immune system mistakenly attacks its own moisture-producing glands. It primarily affects the salivary and tear glands, leading to symptoms such as dry mouth and dry eyes. Over time, it can also affect other parts of the body, including the joints, thyroid, kidneys, liver, lungs, skin, and nerves. The disease progresses slowly, and symptoms can vary widely among individuals. Some people may experience fatigue and joint pain, while others might have more severe complications affecting internal organs. The exact cause of Primary Sjogren's Syndrome is not fully understood, but it is believed to involve a combination of genetic and environmental factors.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510054-16-00Protocol codeAPHP190131Estimated enrolment235 patientsSponsorAssistance Publique Hopitaux De Paris

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