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Study of rituximab and mycophenolate mofetil combination therapy compared to placebo for patients with interstitial lung disease related to systemic sclerosis

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What is this trial about?

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

This study focuses on Interstitial Lung Disease related to systemic sclerosis, a condition where lung tissue becomes scarred and breathing becomes difficult. The study will test a combination of two medications: rituximab and mycophenolate mofetil. The purpose is to evaluate how well this combination treatment works on lung function compared to using mycophenolate mofetil with a placebo.

The treatment involves receiving rituximab through intravenous infusions, while mycophenolate mofetil is taken by mouth. Some participants will receive rituximab with mycophenolate mofetil, while others will receive a placebo with mycophenolate mofetil. Sodium chloride solution will be used for the intravenous administration of medications.

The study will last 48 weeks, during which participants' lung function will be monitored. Throughout the study, various tests will be performed to check breathing capacity and overall health status. The treatment involves taking mycophenolate mofetil daily and receiving rituximab or placebo at specific times during the study period.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and medication start

    Your treatment will begin with mycophenolate mofetil (MMF), taken by mouth twice daily up to 1500 mg if tolerated

    You will be randomly assigned to receive either rituximab or a placebo through intravenous infusion

    Initial tests will include lung function measurements and a chest scan

  2. Step 2

    12-week assessment

    A lung function test will be performed to measure your Forced Vital Capacity (FVC) - the amount of air you can exhale

    You will continue taking your assigned medications as prescribed

  3. Step 3

    24-week assessment

    Another lung function test will be conducted

    Your skin thickness will be measured using the Rodnan skin score

    You will complete quality of life questionnaires

    A walking test will be performed to assess your exercise capacity

    Your physical activity will be measured using an accelerometer device

  4. Step 4

    48-week final assessment

    Final lung function tests will be performed

    A chest scan will be taken to evaluate your lung condition

    Blood tests will be conducted to measure immune system markers

    Final walking test and quality of life assessments will be completed

    Your overall health status and any side effects will be evaluated

Who can join the trial?

15 criteria

  • Must be at least 18 years old
  • Must have been diagnosed with systemic scleroderma according to official medical criteria
  • Must be able to take MMF medication (a medicine that suppresses the immune system) up to 1500 mg twice daily
  • Must have one of these lung conditions:
    • Severe lung disease covering 20% or more of the lungs on CT scan
    • Breathing capacity (FVC) at or below 70% of normal
    • Or must have high risk factors for disease progression, including:
      • Age over 60 years
      • Male gender
      • Early skin disease (within 5 years)
      • African or Caribbean ethnicity
      • Presence of specific antibodies in blood
      • Signs of inflammation in blood tests
      • Must be covered by health insurance
      • Must be able to provide written informed consent
      • Must be able to follow study requirements and attend appointments
      • Women who can become pregnant must agree to use appropriate contraception

Who cannot join the trial?

14 criteria

  • Active or chronic infection, including tuberculosis (TB) or severe infections requiring hospitalization
  • History of severe allergic reactions or hypersensitivity to rituximab or similar medications
  • Presence of active cancer or cancer treatment within the past 5 years
  • Severe heart conditions or uncontrolled high blood pressure
  • Severe kidney disease requiring dialysis
  • Pregnancy or breastfeeding
  • Use of other immunosuppressive medications (drugs that weaken the immune system) not allowed in the study
  • Participation in other clinical trials within the past 30 days
  • Hepatitis B or C infection or positive test results
  • Unstable lung disease requiring oxygen therapy
  • History of severe mental illness that could interfere with study participation
  • Inability to follow study procedures or attend scheduled visits
  • Drug or alcohol abuse within the past 6 months
  • Known HIV infection
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Investigated drugs

Rituximab is a medication that works by targeting specific cells in the immune system. It is commonly used to treat various autoimmune conditions. In this trial, it is being studied for treating lung disease related to systemic sclerosis. Mycophenolate mofetil (MMF) is a medication that suppresses the immune system and is commonly used to prevent organ rejection after transplants. It is also used to treat various autoimmune conditions. In this trial, it is being studied in combination with rituximab for treating lung disease related to systemic sclerosis. The trial combines these medications to study their effectiveness in treating interstitial lung disease that occurs in patients with systemic sclerosis, a condition that causes hardening of the skin and internal organs.

What is already known about the treatment

  • Rituximab

    A biological medication administered through intravenous infusion, which belongs to the class of monoclonal antibodies. It works by targeting and reducing specific B-cells in the immune system, making it effective in treating autoimmune conditions, particularly systemic sclerosis with interstitial lung disease. The medication is well-established in medical literature and has shown promising results in clinical trials for treating various autoimmune disorders.

  • Mycophenolate mofetil (MMF)

    An immunosuppressive medication taken orally that works by preventing the growth of certain types of immune cells, specifically targeting the synthesis of guanine nucleotides required for T and B lymphocyte proliferation. It is commonly used to prevent organ rejection after transplantation and has shown effectiveness in treating interstitial lung disease associated with systemic sclerosis. The medication has a well-documented safety profile and is widely used in combination therapy for various autoimmune conditions.

Investigated diseases

  • Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)

    A condition that develops when systemic sclerosis affects the lungs, causing scarring (fibrosis) of lung tissue. The disease begins when the immune system triggers inflammation in the lungs, leading to gradual hardening and thickening of lung tissue. This process affects the tissue between and around the air sacs (alveoli) in the lungs. As the condition progresses, the scarring makes the lungs become stiffer and less elastic, making it harder to breathe. The disease typically develops slowly over time, with breathing difficulties becoming more noticeable as more lung tissue becomes affected.

  • Systemic Sclerosis (Scleroderma)

    A chronic autoimmune condition that causes hardening and tightening of the skin and connective tissues. The disease occurs when the body produces too much collagen, leading to thickening and scarring of various tissues. It can affect multiple body systems, starting with skin changes and potentially progressing to internal organs. The condition typically begins with swelling and tightening of the skin on the hands and face. The disease varies greatly in how it affects different people, with some experiencing mainly skin involvement while others develop complications in internal organs.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-510507-21-00Protocol codeDR230333Estimated enrolment102 patientsSponsorCentre Hospitalier Regional Universitaire De Tours

sourced from the EU Clinical Trials Register and site verification

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