Phase 3 Interstitial Lung Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are 18 years old or older, male or female, and have been diagnosed with systemic scleroderma (a connective tissue disease) according to recognised international criteria
• You have lung scarring/fibrosis (called ILD) that is either severe — meaning it affects 20% or more of your lungs on a special scan, or your lung breathing capacity is 70% or less of normal
• Or you have lung scarring and are considered at higher risk of it getting worse — for example, if you are over 60, male, have had the skin form of the disease for 5 years or less, are of Afro-Caribbean or Afro-American background, have a specific antibody called anti-SCL70, or have signs of inflammation in your blood
• Or your lung scarring has been getting worse over the past 6 to 24 months — shown by a meaningful drop in breathing capacity, worsening breathlessness, or more scarring visible on scans
• You are eligible to be treated with a medication called mycophenolate mofetil (MMF)
• You are covered by the French social security system or an equivalent
• You are able and willing to give written consent, including agreeing to use contraception if required, and to follow the study requirements

Who may not be able to join:

• You have another significant lung condition such as asthma, tuberculosis, cystic fibrosis, idiopathic pulmonary fibrosis, sarcoidosis, or a smoking-related lung disease, or you have serious heart failure or severe heart muscle disease
• You have been diagnosed with certain types of high blood pressure affecting the lungs (pulmonary hypertension of specific types) (confirm with trial site)
• You have another serious or unstable medical or surgical condition that the doctor running the trial feels could put you at risk
• You are unable to walk more than 100 metres
• You are known to be intolerant to MMF
• You have started, stopped, or changed the dose of a treatment for your lung scarring within the 4 weeks before your initial assessment
• You have previously been treated with rituximab or MMF specifically for your lung scarring
• You have a known allergy or sensitivity to rituximab, proteins from mice, or certain antibiotics called sulphonamides
• You are currently taking certain immune-suppressing medicines at higher doses (such as high-dose steroids, azathioprine, cyclophosphamide, methotrexate, cyclosporine, tacrolimus, or JAK inhibitors) within 4 weeks before joining
• You have received certain biological medicines (such as adalimumab, infliximab, tocilizumab, or similar) within the past 6 months
• You are on a waiting list for a lung transplant
• You are pregnant, breastfeeding, under 18, or subject to legal protection measures; or you are a woman who could become pregnant (or a male partner of such a woman) and are not using two reliable forms of contraception, or you or your partner are planning a pregnancy within the year after joining the trial
• You have a high risk of serious infections — for example, if you are HIV positive, have hepatitis B or C, have had COVID-19 within the last 3 months, or have had an infection requiring treatment within the last 4 weeks
• Your COVID-19 vaccination is not up to date according to current recommendations, unless you have received specific anti-COVID antibody treatment (confirm with trial site)
• You are currently taking part in another clinical trial involving an experimental medicine or medical device

Important: Always verify eligibility with the trial site directly before applying.