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 have agreed to take part and signed a consent form
• You have been diagnosed with a progressive scarring lung disease (called progressive fibrosing interstitial lung disease, or PF-ILD) confirmed by a special type of CT scan showing more than 10% of your lung tissue is affected — this includes conditions such as IPF, autoimmune-related lung fibrosis, hypersensitivity pneumonitis, or sarcoidosis-related lung fibrosis
• Your lung disease has been getting worse, shown by a meaningful decline in breathing test results within the past 12 months, worsening breathing symptoms, or increased scarring on CT scan within the past 24 months
• Your lung symptoms first started no more than 8 years before joining the trial
• Your blood tests at the screening visit show signs of inflammation (raised CRP or ESR levels) not caused by something else
• Your lung capacity (called FVC) is between 45% and 80% of what would normally be expected for someone your age and size

Who may not be able to join:

• Your lung's ability to transfer oxygen into the blood (called DLCO) is very low (below 30% of expected)
• You have significant airway blockage shown on breathing tests (confirm with trial site)
• You have taken certain medicines that block a protein called IL-6 (such as tocilizumab), unless they were used only to treat COVID-19 and it has been at least 6 months since your last dose
• You have received a medicine called rituximab within the past 12 months
• You are taking steroid tablets (such as prednisolone) at a dose higher than 10 mg per day, or your steroid dose has changed in the past 4 weeks, or a dose change is planned during the trial
• You have a history of bone marrow transplant, radiation to your lymph nodes, or very high-dose chemotherapy with cyclophosphamide
• You started taking mycophenolate mofetil or anti-fibrotic drugs (medicines that slow lung scarring) less than 12 months before joining — though there is an exception in some cases (confirm with trial site)
• You stopped taking anti-fibrotic drugs within the 6 months before joining (if you are not currently on them)
• You have taken part in another clinical trial within the past 30 days (or within a certain time period based on the other trial's medicine, whichever is longer)
• Certain blood test results are outside safe limits, including liver enzyme levels, platelet count, white blood cell count, or a type of white blood cell called neutrophils (confirm with trial site)
• You have been diagnosed with cancer, or have had cancer in the past 5 years
• You have an active infection of any kind at screening, have needed antibiotic or antiviral tablets within the past 4 weeks, have needed antibiotic injections within the past 6 weeks, or have been hospitalised for a serious or repeated infection within the past 6 months
• You have had a serious form of shingles (herpes zoster) — such as one affecting the brain — within the past 6 months that did not go away on its own
• You have any other ongoing serious infection that the trial doctors believe could put you at risk during the trial
• You have a condition affecting your bowel (such as diverticulitis or ulcerative colitis) that could lead to a tear or perforation, or have a history of such conditions
• You are a woman who could become pregnant, or a man whose partner could become pregnant, and you are not willing to use reliable contraception during the trial and for at least 3 months after your last dose
• You have a known allergy to the trial medicine (OKZ) or any of its ingredients
• You have had a severe allergic reaction to any similar type of medicine (a monoclonal antibody) in the past
• There may be additional reasons based on the full trial protocol (confirm with trial site)

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