A Phase II Clinical Study to Evaluate the Efficacy and Safety of BC006 in Patients With Idiopathic Pulmonary Fibrosis
This is a multicenter, Phase II clinical study to evaluate the efficacy and safety of BC006 over a 24-week treatment period in patients with idiopathic pulmonary fibrosis (IPF). The study consists of two phases: an open-label safety run-in phase and a double-blind, randomized, placebo-controlled phase.
• Must provide written informed consent form (ICF) indicating understanding of the study and voluntary participation.
• Aged ≥40 years at the time of signing the ICF, with no gender restriction.
• Diagnosis of idiopathic pulmonary fibrosis (IPF) according to the 2022 American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Society (ATS/ERS/JRS/ALAT) clinical practice guideline.
• HRCT pattern consistent with usual interstitial pneumonia (UIP) or probable UIP for IPF confirmed by independent central imaging review (acceptable-quality HRCT obtained within 12 months prior to screening or during the screening period). If HRCT shows indeterminate UIP, the diagnosis of IPF must be confirmed by histopathology from a prior lung biopsy (surgical/video-assisted thoracoscopic lung biopsy or bronchoscopic cryobiopsy) recognized by the investigator, if available.
• Forced vital capacity percent predicted (FVC% predicted) ≥45% during the screening period.
• Diffusing capacity of the lung for carbon monoxide percent predicted (DLCO% predicted), corrected for hemoglobin (Hb), ≥30% and ≤90% during the screening period.
• Meets either of the following:
‣ The patient has been on a stable dose of nintedanib or pirfenidone for at least 8 weeks prior to screening and during screening (nintedanib ≥100 mg BID, pirfenidone ≥400 mg TID, no dose changes), tolerates the treatment, and plans to continue this background therapy during the study.
⁃ The patient has not received nintedanib or pirfenidone for at least 4 weeks prior to screening and during screening (previous treatment discontinued or treatment-naïve), and does not plan to initiate or re-initiate nintedanib or pirfenidone during the study. No patient should discontinue approved therapy to participate in this study. Treatment-naïve patients must decline after full discussion with the investigator regarding the risks/benefits of such therapy.
• Patients of reproductive potential (male and female) must agree to use highly effective contraceptive methods (hormonal, barrier, or abstinence) from signing the ICF until at least 6 months after the last dose of study drug.