Phase 3 Interstitial Lung Disease Trial, Recruiting

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

Who might be able to join this trial:

• Adults aged 18 or older
• People whose interstitial lung disease (a type of scarring/inflammation in the lungs) has gotten worse within the last 24 months, shown by at least one of the following: a significant drop in lung capacity (measured by a breathing test called FVC), a moderate drop in lung capacity combined with worsening breathing symptoms, worsening on a lung scan, or a drop in another lung measurement (DLCO); or worsening breathing symptoms alongside changes visible on a lung scan
• People whose lung condition shows signs of inflammation, confirmed either by a previous lung tissue sample showing certain immune cell patterns, or by a previous fluid sample from the lungs (a procedure called bronchoalveolar lavage) showing a high level of a specific immune cell type (lymphocytes above 20%)
• People who are covered by the French social security health system
• People who are willing and able to give written consent to participate
• People who are able to follow the study requirements throughout the trial

Who may not be able to join:

• People with certain other known lung conditions, such as asthma, tuberculosis, a fungal lung infection (aspergillosis), cystic fibrosis, a specific type of lung scarring called idiopathic pulmonary fibrosis (IPF), lung disease related to autoimmune conditions, sarcoidosis, a condition called desquamative interstitial pneumonia, high blood pressure in the lungs, or serious heart failure
• People with another serious, unstable, or worsening medical or surgical condition that the study doctor considers a safety concern, including heart muscle disease or heart failure
• People who are unable to walk more than 100 metres during a standard 6-minute walk test
• People whose lung scan shows a specific pattern called "typical usual interstitial pneumonia (UIP)"
• People whose lung tissue sample shows a typical pattern of NSIP or a definitive UIP pattern
• People who have started a new medication, or had a change or interruption to their current medication dose, within 6 weeks before the first study visit
• People who have previously been treated with a medicine called rituximab
• People with a known allergy or sensitivity to rituximab, to proteins from mice, to certain other ingredients in the medicine, or to a class of antibiotics called sulfonamides
• People who have been treated with certain immune-modifying medicines called monoclonal antibodies (such as etanercept, adalimumab, infliximab, or similar) within the 6 months before joining the trial
• People who are on a waiting list for a lung transplant
• Women who are pregnant or breastfeeding, or women who could become pregnant and are not using a reliable form of contraception during the study and for 12 months after the treatment ends
• People considered at high risk of serious infections, including those who are HIV-positive, have other immune system conditions, have hepatitis B or C, have had COVID-19 within the past 3 months, have another known viral infection, or have needed treatment for an infection within 4 weeks of joining
• People who have not completed a recommended COVID-19 vaccination course, unless a specific antibody treatment for COVID-19 has been received instead (confirm with trial site)
• People under legal guardianship or who have had their liberty restricted by a court
• People currently taking part in another clinical trial involving an investigational medicine or medical device

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