A 52 week, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline, in patients with Idiopathic Pulmonary Fibrosis (IPF).
This is a multi-centre, multi-national, prospective, randomised, placebo controlled, double blind clinical trial to investigate the efficacy and safety of BIBF 1120 at a dose of 150 mg bid, in patients with IPF. A total of approximately 485 patients with confirmed IPF diagnosis will be randomised, 290 in active arm and 195 in placebo group. Following Informed Consent before or at visit 1, the diagnosis of IPF will be confirmed by Central reading of chest HRCT and Central review of surgical lung biopsy if available. After a screening visit, if the patient complies with all inclusion and exclusion criteria, randomisation will be performed by phone or Internet, using an Interactive phone/web Response System (IXRS). Patients will then enter the treatment phase for 52 weeks. Nine
visits (visit 2 to 9 + follow up) are planned within one year of treatment, and intermediate lab tests are planned when the interval between two visits increases Dose reduction procedures and short term drug interruptions in case of adverse events are described in section 4. The study will end when the last patient will have completed his/her 52 weeks treatment and the follow-up period of 28 days. Subjects who choose to discontinue study drug early will be asked to come in to all visits as planned in order to monitor lung function for the remainder of the study. After this trial, patients who have reached the 52 weeks visit will be offered to go into an open-label extension study where all patients will receive the active drug. Patients who discontinue drug early (before the 52 weeks visit) will be asked to come to all visits as planned. Prior to randomization, patients will be made aware of the requirement to attend follow-up visits also in case of early withdrawal.
1. Written Informed Consent consistent with ICH-GCP and local laws signed prior to entry
into the study (and prior shipment of HRCT/biopsy to reviewer)
2. Patient aged >= 40 years at visit 1.
3. IPF diagnosed, according to most recent ATS/ERS/JRS/ALAT IPF guideline (in press)
for diagnosis and management, within 5 years of visit 2. Refer to Appendix 10.2.
4. Chest HRCT performed within 12 months of visit 1.
5. Combination of HRCT pattern, and if available surgical lung biopsy pattern, as assessed
by central reviewers, are consistent with diagnosis of IPF (refer to Appendix 10.1)
6. Dlco (corrected for Hb [visit 1]): 30%-79% predicted of normal (refer to Appendix 10.3)
at visit 2
7. FVC >= 50% predicted of normal (refer to Appendix 10.3) at visit 2