To Evaluate the Efficacy, Safety, and Tolerability of BBT-877 in Patients With IPF

Inclusion Criteria

• •Male patients who have completed family planning or female patient, aged 40 years or older
• •Diagnosis of IPF in accordance with American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines for diagnosis in effect at the time of screening
• •Chest high-resolution computed tomography (HRCT) performed according to ATS guidelines within 12 months prior to screening and according to minimum requirements for IPF diagnosis by central review based on HRCT and lung biopsy. If no historical acceptable HRCT is available prior to screening, an HRCT can be performed during screening. In both cases, a central reading of the HRCT has to be done as well as a review of lung biopsy slides, if available and potentially supportive for diagnosis.
• •Able to walk at least 150 meters during the 6MWT at screening
• •Resting oxygen saturation of ≥89% using a maximum of 6 L/min of supplemental oxygen at sea level, and up to 8 L/min at altitude during screening
• •FVC ≥45% predicted of normal
• •Ratio of forced expiratory volume in the first second (FEV1) to FVC ≥0.7
• •Diffusing capacity for the DLCO corrected for hemoglobin ≥30% predicted of normal
• •Absence of IPF improvement in the past year, as determined by the investigator
• •Patients receiving either pirfenidone or nintedanib, should be on it for at least 3 months and with a stable dose in the 4 weeks prior to screening, OR taking neither pirfenidone