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Study Comparing Cyclophosphamide, Azathioprine, and Tacrolimus for Patients with Antisynthetase Syndrome-Related Interstitial Lung Disease

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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 a condition known as antisynthetase syndrome-related interstitial lung disease (ASS-ILD). This is a lung disease that can occur in people with antisynthetase syndrome, a rare autoimmune disorder. The study aims to compare the effectiveness of two different treatment approaches for this condition. One group of patients will receive a combination of two medications, Cyclophosphamide and Azathioprine, while the other group will be treated with Tacrolimus. These medications are used to suppress the immune system and reduce inflammation in the lungs.

The purpose of the study is to determine which treatment is more effective in managing ASS-ILD. Participants in the study will be randomly assigned to one of the two treatment groups. The study will last for a period of up to 12 months, during which participants will receive their assigned treatment. Throughout the study, participants will have regular check-ups to monitor their lung function and overall health. The study will also assess the impact of the treatments on participants' quality of life and any side effects they may experience.

By participating in this study, researchers hope to gather valuable information that could lead to better treatment options for people with ASS-ILD. The study is designed to ensure the safety and well-being of all participants, with regular monitoring and support provided by healthcare professionals. The findings from this study could help improve the management of this challenging condition and provide insights into the most effective treatment strategies.

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, eligibility is confirmed based on specific criteria such as age, diagnosis, and other health conditions.

    Informed consent is required, ensuring understanding of the study's purpose and procedures.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two treatment groups: one receiving tacrolimus and the other receiving a combination of cyclophosphamide and azathioprine.

  3. Step 3

    Treatment administration

    For those in the tacrolimus group, the medication is taken orally in the form of hard capsules. Dosage and frequency are determined by the study protocol.

    Participants in the cyclophosphamide and azathioprine group receive cyclophosphamide intravenously and azathioprine orally as film-coated tablets. Dosage and frequency are specified by the study protocol.

  4. Step 4

    Monitoring and assessments

    Regular monitoring includes assessments of lung function, muscle and joint involvement, and overall health.

    Tests such as the six-minute walk test and pulmonary function tests are conducted to evaluate progress.

  5. Step 5

    Evaluation of treatment effects

    The primary goal is to measure the time until the first event related to the lung disease occurs.

    Secondary evaluations include changes in walking distance, lung function, and quality of life.

  6. Step 6

    Completion of the study

    The study is expected to conclude by February 2026, with final assessments and data collection occurring at this time.

    Participants' health and treatment effects are reviewed to determine the overall efficacy and safety of the treatments.

Who can join the trial?

9 criteria

  • Must be 18 years or older.
  • Must have signed informed consent, which means you agree to participate after understanding the study.
  • Must be part of the Social Security system.
  • Must have a diagnosis of ASS (Antisynthetase Syndrome) with a positive test for any of the 5 specific antibodies, such as anti-Jo-1, anti-PL7, anti-PL12, anti-EJ, or anti-OJ, tested up to 3 months before joining the study.
  • Must have a diagnosis of ILD (Interstitial Lung Disease) related to ASS, confirmed by a special lung scan called HRCT (High-Resolution Computed Tomography).
  • Must have moderate to severe ILD based on lung function tests: FVC (Forced Vital Capacity) less than 80% and/or cDLCO (corrected Diffusing Capacity of the Lung for Carbon Monoxide) less than 70%.
  • For women who can have children, a negative pregnancy test is required.
  • Women who can have children must use an effective birth control method during the study and for 12 months after the last dose of the study treatment.
  • Men who are sexually active with women who can have children must agree to use birth control methods during the study and for 6 months after the last dose of the study treatment.

Who cannot join the trial?

4 criteria

  • Patients who do not have Antisynthetase syndrome-related interstitial lung disease cannot participate. This is a specific lung condition related to a syndrome that affects the immune system.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.
  • Patients who do not meet other specific health criteria set by the study cannot participate. These criteria are important to ensure the safety and effectiveness of the study.
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Investigated drugs

  • Cyclophosphamide

    is a medication used to suppress the immune system. In this trial, it is being tested to see how well it works in treating lung disease related to antisynthetase syndrome by reducing inflammation and slowing down the progression of the disease.

  • Azathioprine

    is another medication that helps to suppress the immune system. It is being used in combination with Cyclophosphamide to evaluate its effectiveness in managing lung disease associated with antisynthetase syndrome, aiming to improve lung function and reduce symptoms.

  • Tacrolimus

    is an immunosuppressant that is being tested as an alternative treatment in this trial. It works by decreasing the activity of the immune system, which may help in controlling the lung disease linked to antisynthetase syndrome and improving the patient's breathing and overall lung health.

What is already known about the treatment

  • Cyclophosphamide

    Cyclophosphamide is administered intravenously or orally and is currently used in medical practice for various conditions, including certain autoimmune diseases and cancers. It is being studied in clinical trials for its effectiveness in treating antisynthetase syndrome-related interstitial lung disease. Cyclophosphamide works by interfering with the DNA replication process in cells, which helps to suppress the immune system. It is classified as an alkylating agent in pharmacology.

  • Azathioprine

    Azathioprine is taken orally and is widely used in medicine to manage autoimmune conditions and prevent organ transplant rejection. It is under investigation in clinical trials for its role in treating antisynthetase syndrome-related interstitial lung disease. Azathioprine acts by inhibiting the synthesis of purine, a component of DNA, thereby reducing the activity of the immune system. It belongs to the class of immunosuppressive agents.

  • Tacrolimus

    Tacrolimus is administered orally or topically and is commonly used to prevent organ transplant rejection and treat certain autoimmune diseases. It is being evaluated in clinical trials for its potential in managing antisynthetase syndrome-related interstitial lung disease. Tacrolimus works by inhibiting calcineurin, a protein involved in activating T-cells of the immune system. It is classified as a calcineurin inhibitor in pharmacology.

Investigated diseases

Antisynthetase syndrome-related interstitial lung disease – This disease is a type of lung condition associated with antisynthetase syndrome, an autoimmune disorder. It primarily affects the lungs, leading to inflammation and scarring of lung tissue, known as interstitial lung disease (ILD). Patients may experience symptoms such as shortness of breath, cough, and fatigue. The disease progresses as the lung tissue becomes increasingly damaged, which can impair lung function over time. It may also be accompanied by muscle and joint involvement, causing muscle weakness and joint pain. The progression of the disease can vary, with some individuals experiencing a slow decline in lung function, while others may have more rapid deterioration.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511868-83-00Protocol codeP140938JEstimated enrolment76 patientsSponsorAssistance Publique Hopitaux De Paris

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