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Rituximab versus placebo for maintenance therapy in adults with stabilized systemic sclerosis‑associated interstitial lung disease

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What is this trial about?

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

The trial involves adults with a stable form of systemic sclerosis combined with interstitial lung disease, referred to as SSc‑ILD. After an initial course of the medication Rituximab, participants are randomly assigned to receive either additional Rituximab infusions or a placebo solution of sodium chloride.

The purpose of the study is to demonstrate the efficacy of maintaining RTX as a maintenance strategy in individuals with stabilized SSc‑ILD following RTX induction treatment. Participants receive the assigned infusion every few months for a total period of about 18 months, with clinic visits scheduled at regular intervals to monitor health.

During the study, lung function is checked using measurements such as FVC, which assesses the amount of air a person can forcefully exhale, and DLCO, which evaluates how well oxygen passes from the lungs into the blood. Imaging of the chest is performed with a HRCT scan, and physical capacity is measured with a 6‑min walk test that records the distance walked in six minutes. Additional assessments include questionnaires about quality of life and safety checks.

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

    Randomization and first infusion

    After joining the study, the patient is assigned to receive either rituximab or sodium chloride (placebo).

    The assigned product is given as an intravenous infusion. rituximab is provided as a 500 mg solution for infusion, while the placebo is 250 ml of sodium chloride solution.

    The infusion is administered during a clinic visit that lasts several hours, during which vital signs are monitored.

  2. Step 2

    Baseline assessments

    Immediately after the first infusion, the patient undergoes baseline measurements that include lung function tests such as forced vital capacity (fvc) and diffusing capacity for carbon monoxide (dlco), a 6‑minute walk test, and imaging of the chest.

    Questionnaires about health-related quality of life and disease activity are also completed.

  3. Step 3

    Follow‑up visit at month 6

    The patient returns to the clinic at month 6 for safety checks and repeat assessments.

    Lung function tests (fvc and dlco), the 6‑minute walk test, and chest imaging are repeated.

    Any adverse events are recorded, and the patient completes the same quality‑of‑life questionnaires.

  4. Step 4

    Second infusion (maintenance)

    At the month 6 visit, the patient receives a second intravenous infusion of the same product assigned at randomization (either rituximab 500 mg or sodium chloride 250 ml).

    The infusion procedure is identical to the first infusion.

  5. Step 5

    Follow‑up visit at month 12

    The patient attends a clinic visit at month 12 for the same set of safety evaluations and lung function measurements as at month 6.

    Questionnaires and imaging are repeated.

  6. Step 6

    Third infusion (maintenance)

    At the month 12 visit, a third intravenous infusion of the assigned product is given.

  7. Step 7

    Final assessments at month 18

    The patient completes the last study visit at month 18.

    All primary and secondary measurements are performed, including change in fvc from baseline, safety evaluation, disease‑related mortality, progression‑free survival, and health‑related quality‑of‑life scores.

    The study concludes for the patient after these assessments.

Who can join the trial?

12 criteria

  • Be an adult (aged 18 years or older).
  • Have a diagnosis of systemic sclerosis (SSc) confirmed by the standard 2013 ACR/EULAR criteria (a set of guidelines doctors use to identify this condition).
  • Have interstitial lung disease (ILD) shown on a high‑resolution CT scan (HRCT) done within the last 12 months, with scar‑like tissue (fibrosis) affecting at least 10 % of the lungs.
  • Have received the initial (induction) treatment with rituximab (RTX) – either two doses of 1000 mg given two weeks apart, or four doses of 375 mg/m² given every four weeks – and wait at least 6 months (plus or minus 15 days) before starting the maintenance phase.
  • Show a stable lung condition after RTX induction, meaning:
    • No new or worse breathing problems.
    • An absolute drop in forced vital capacity (FVC) of less than 5 % of the value predicted for you (FVC measures how much air you can forcefully exhale).
    • An absolute drop in diffusing capacity for carbon monoxide (DLCO) of less than 10 % (DLCO measures how well oxygen moves from your lungs into your blood).
    • No new signs of disease progression on the HRCT scan.
    • Have received all required vaccinations at least 4 weeks before the first study dose; a preventive medication for pneumocystis infection is recommended for scleroderma patients but is not mandatory.
    • If you are a woman who could become pregnant, you must use reliable birth control during the 12‑month treatment period and for 12 months after the last dose.
    • Be able to sign a written informed consent form agreeing to take part in the study.
    • Be covered by a social security or health‑insurance scheme; special assistance programs (AME) are not accepted.

Who cannot join the trial?

32 criteria

  • Forced vital capacity less than 40% of the value expected for your age, sex, and size (a breathing test that measures how much air you can exhale forcefully).
  • Any reason you cannot safely take the other medicines that are used together with the study drug.
  • Use of cyclophosphamide, tacrolimus, ciclosporin, or voclosporin within the two months before screening.
  • Having an active COVID‑19 infection (caused by SARS‑CoV‑2) or not having received a COVID‑19 vaccine in the past six months.
  • Receiving any biologic therapy (special medicines that target the immune system) such as anti‑CD20, anti‑CD19, anti‑plasma cell drugs, belimumab, ustekinumab, anifrolumab, secukinumab, or atacicept within two months before screening.
  • Taking any JAK, BTK, or TYK2 inhibitor (drugs that block specific immune pathways) such as baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib, fenebrutinib, or any experimental drug within two months before screening.
  • Receiving any live vaccine (a vaccine that contains a weakened form of the germ) within 28 days before screening.
  • Being at high risk for serious bleeding or needing procedures such as plasma exchange (plasmapheresis), intravenous (IV) immunoglobulin, or blood transfusion within 28 days before screening.
  • Being under court supervision, guardianship, or conservatorship (legal arrangements where someone else makes decisions for you).
  • Having a serious or uncontrolled medical condition that the doctor believes would make participation unsafe.
  • Having HIV infection, or not knowing your HIV status and not having been tested in the past three months.
  • Having major surgery that required a hospital stay within four weeks before screening.
  • Having active tuberculosis (TB) infection (testing for latent TB will be done if required; treated latent TB is allowed).
  • Having an active infection of any kind (except a nail fungus), especially if it required hospitalization, IV antibiotics within eight weeks, or oral antibiotics within two weeks before screening.
  • Having a history of serious, repeated, or long‑lasting infections.
  • Having a history of progressive multifocal leukoencephalopathy (PML), a rare brain infection.
  • Having had cancer (solid tumors, blood cancers, or carcinoma in situ) within the past five years, except for non‑melanoma skin cancers that have been removed and healed.
  • Being known to be allergic (hypersensitive) to the study drug, to mouse‑derived proteins, or to any other ingredients in the drug.
  • Having severe heart failure classified as New York Heart Association (NYHA) Class IV, or having uncontrolled serious heart disease.
  • Current alcohol or drug abuse, or a history of alcohol or drug abuse within the past 12 months.
  • Diffusion capacity of the lung for carbon monoxide (DLCO) less than 30% of the predicted value (a test that measures how well oxygen moves from your lungs into the blood).
  • Having had severe allergic or anaphylactic reactions to monoclonal antibodies, or being allergic to any part of the RTX infusion.
  • Certain abnormal lab results, including:
    • Liver enzymes (AST or ALT) more than 2.5 times the normal upper limit,
    • Low neutrophil count (<1.5 × 10⁹/L),
    • Positive hepatitis B surface antigen,
    • Positive hepatitis C test,
    • Low hemoglobin (<7 g/dL),
    • Low platelet count (<50,000 per µL),
    • Low gammaglobulin levels (<4 g/L).
    • Being pregnant or breastfeeding.
    • Participating in another interventional clinical study, or still being in the follow‑up period from a previous study.
    • Having a known contraindication or previous anaphylactic reaction to RTX (the study drug).
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Investigated drugs

Rituximab is a medication that targets certain cells of the immune system called B‑cells. In this study, it is given through an IV infusion after an initial short‑term (induction) treatment. The purpose of using rituximab here is to keep the disease under control over a longer period. Participants who have already been stabilized with the initial rituximab treatment continue to receive the drug as a maintenance therapy. The goal is to see if ongoing rituximab can help maintain lung function and reduce the progression of interstitial lung disease that can occur in people with systemic sclerosis.

What is already known about the treatment

  • Sodium Chloride

    Sodium chloride is given as an intravenous infusion of 250 ml of sterile saline solution. It is a standard, widely used fluid that serves as a placebo in clinical studies and is routinely used in medical practice to replace fluids. The main use is to provide water and electrolytes, not to treat disease. It works simply by adding sodium and chloride ions to the bloodstream, and it is classified as an isotonic electrolyte solution.

  • Rituximab

    Rituximab is supplied as a 500 mg solution for intravenous infusion and is administered through a drip into a vein. It is an approved medication that is used for certain cancers and autoimmune conditions, and it is being tested as a maintenance treatment for systemic sclerosis‑related lung disease. The drug works by attaching to a protein called CD20 on B‑cells, which leads to the removal of these cells from the body, helping to lower harmful immune activity. It belongs to the class of monoclonal antibodies and is considered an immunosuppressive therapy.

Investigated diseases

  • Systemic sclerosis

    Systemic sclerosis is a chronic autoimmune condition that causes the skin to become thick and tight. It can also affect blood vessels, muscles, and internal organs. The skin changes usually start on the fingers and may spread to other areas. Over time, the disease can lead to stiffness in joints and reduced flexibility. The condition often progresses gradually, with periods of slower and faster change.

  • Systemic sclerosis-associated interstitial lung disease

    This is a lung complication that occurs in people with systemic sclerosis, where the tissue between the air sacs becomes scarred. The scarring makes it harder for the lungs to expand and for oxygen to move into the blood. Symptoms may develop slowly and include shortness of breath during activity. The disease can advance gradually, leading to a steady decline in breathing capacity. Monitoring changes in lung function helps track its progression.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-521331-36-00Protocol codeAPHP240909Estimated enrolment120 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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