Phase 2 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:

• People between 40 and 80 years old at the time of signing the consent form and entering the screening process.
• People who have been diagnosed with IPF (idiopathic pulmonary fibrosis) according to current international medical guidelines.
• People who are either not currently on any IPF treatment, or who have been on a stable dose of pirfenidone and/or nerandomilast for at least 3 months before screening.
• People who weigh more than 40 kg (88 lb) at the time of screening.
• Women who could become pregnant must have a negative pregnancy test at screening and must use an approved form of birth control from screening until at least 1 month after the last study dose.
• Men who could father a child and are sexually active with women who could become pregnant must use an approved form of birth control during treatment and for at least 3 months after the last study dose, and must not donate sperm during that same period.
• People who are willing to follow all study rules and attend all required visits and procedures.
• People who are able to complete lung function (breathing) tests as required by the study.

Who may not be able to join:

• People who have a lung disease caused by something other than IPF.
• People who have a connective tissue or autoimmune condition, such as lupus, scleroderma, or rheumatoid arthritis.
• People who have another condition that significantly affects their breathing.
• People who have serious heart or blood vessel disease.
• People who have a recent or current infection.
• People who were recently hospitalised for COVID-19, an IPF flare-up, or a lung infection.
• People with a history of asthma, except for childhood asthma that has fully resolved.
• People who have another medical condition or abnormal test result that may affect their safety or ability to participate.
• People who are unable to complete high-quality lung function (spirometry) testing.
• People who have obstructive lung disease.
• People who have abnormal liver function test results.
• People who have moderate to severe liver disease.
• People who have severe kidney disease.
• People who have recently used high-dose steroids or other medications that suppress the immune system.
• People who have active cancer or have recently undergone cancer treatment.
• People who are on, or expected to be placed on, an organ transplant waiting list.
• People who have had major surgery recently or have planned procedures that could interfere with the study.
• People who have had a severe reaction to nintedanib or for whom nintedanib would not be safe to take.
• People who have recently used certain medications that may interact with the study drug, or who are currently using or plan to use prohibited medications during the study.
• People who have recently taken part in another clinical trial.
• People who currently have alcohol or drug abuse issues.
• People who have donated a significant amount of blood recently.
• People who have recently received a live vaccine.
• People who currently smoke, have smoked recently, or stopped smoking less than 1 year ago.
• People who require more than 6 litres per minute of supplemental oxygen while at rest.

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