AURA-IPF: A Randomized Phase 2 Study to Evaluate the Safety and Efficacy of AP02 (Nintedanib Solution) in IPF

Korábbi kezelés

• Current treatment with oral nintedanib, oral pirfenidone, or previous treatment with oral nintedanib or oral pirfenidone within 3 months prior to screening. Participants who have taken both oral nintedanib and pirfenidone together as a treatment will not be able to join the study.
• History of diverticular disease or abdominal surgery within 4 weeks prior to screening visit
• Participants who have smoked within the past 3 months prior to screening, who are not willing to stop smoking during the study, or who currently use illegal drugs or drugs of abuse
• Use of any investigational drugs including those for IPF within the past 30 days prior to screening
  • Further inclusion/exclusion criteria apply

Más betegség

• Participants with a history of serious cardiovascular disease, bleeding problems or significant liver or kidney disease (as defined in the study protocol)
• History of cancer within the past 5 years (except for certain types explained in the protocol)

Egyéb

• Forced expiratory volume (FEV) in the first second/FVC (FEV1/FVC) ratio ≥0.7 based on pre-bronchodilator value
• Female participants who are pregnant or nursing

• Male or female patients aged ≥40 years at the time of signing the written informed consent form
• Diagnosis of idiopathic pulmonary fibrosis (IPF) as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/ Asociación Latinoamericana de Tórax IPF guidelines within 5 years
• Combination of High-Resolution Computerized Tomography (HRCT) pattern, and if available, surgical lung biopsy pattern consistent with diagnosis of IPF
• In a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation
• Forced vital capacity (FVC) ≥45% predicted of normal
• Lung diffusion test (DLCO) corrected for hemoglobin (Hgb) ≥30% and ≤80% predicted of normal.
• Women and men of childbearing potential must use highly effective contraception measures until 90 days after the last dose of study drug.