Key eligibility criteria for participation in INMARK®
Key inclusion criteria | Key exclusion criteria |
Age ≥40 years | ALT or AST or total bilirubin >1.5 × upper limit of normal at screening |
Diagnosis of IPF according to ATS/ERS/JRS/ALAT guidelines (Raghu et al, 20111 within last 3 years) | FEV1/FVC<0.70 (prebronchodilator) |
Chest HRCT (performed within 18 months of screening) and surgical lung biopsy pattern (if available) consistent with a diagnosis of IPF, assessed by central review | Myocardial infarction within 6 months or unstable angina within 1 month of screening |
FVC ≥80% predicted at screening | Bleeding risk (eg, requiring full-dose therapeutic anticoagulation or high-dose antiplatelet therapy) |
History of a thrombotic event within 12 months of screening | |
Treatment with nintedanib, pirfenidone, azathioprine, cyclophosphamide, cyclosporine or any investigational drug was not permitted within 4 weeks of randomisation |
ALT, alanine transaminase; AST, aspartate transaminase; FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity; HRCT, high-resolution CT; IPF, idiopathic pulmonary fibrosis.