Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Select Inclusion Criteria:

1. Diagnosis of definite or probable Idiopathic Pulmonary Fibrosis (IPF) per the ATS
2011 Guidelines up to 48 months before randomization

2. Age 40 to 80 at randomization

3. Percent Forced Vital Capacity (%FVC) ≥50% and ≤90% at screening

4. Percent Carbon Monoxide Diffusing Capacity (%DLCO) ≥30% and ≤90% at screening

Select Exclusion Criteria:

1. Forced expiratory volume in one second (FEV1)/FVC ratio <0.8 after administration of
bronchodilator at Screening

2. Expected to receive a lung transplant within 1 year from randomization or, for
patients at sites in the United States, on a lung transplant waiting list at
randomization

3. Known explanation for interstitial lung disease

4. History of asthma or chronic obstructive pulmonary disease

5. Active infection

6. Ongoing IPF treatments including investigational therapy, immunosuppressants, and
cytokine modulating agents

7. History of unstable or deteriorating cardiac or pulmonary disease (other than IPF)
within the previous 6 months