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.
Interstitial lung disease of known etiology (e.g., domestic and occupational environmental exposures, connective tissue disease, drug toxicity, etc.).
Other pulmonary diseases considered clinically significant by the investigator (e.g., asthma, chronic obstructive pulmonary disease, cavitary or pleural disease, etc.).
Emphysema ≥ 50%, or emphysema greater than fibrosis, as determined by independent central imaging review of HRCT.
Acute exacerbation of IPF within 3 months prior to screening or during the screening period, as judged by the investigator.
Parallel
BC006
DrugA 1.0 mg/kg or 0.3 mg/kg IV infusion of BC006 based on the patients weight will be administered Q2W to Week 24.
Placebo
Druglacebo matching BC006 will be administered by IV infusion on Days 1, 3 and 5, followed by infusions Q4W to Week 48.
Adverse Events (AE), Serious Adverse Events (SAE), Adverse Events of Special Interest (AESI), as well as vital signs, physical examination, 12-lead ECG, and laboratory tests, etc.
For safety run-in phase
Absolute change in FVC (mL) from baseline in week 24
For randomized phase
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