An Open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)
This is a multi-centre, multi-national, prospective, open label extension clinical trial. it is planned to include approximately 750 patients with iPF who have completed 52 weeks of treatment and the follow up period of the phase iii parent trials. only patients enrolled in the parent trials (1199.32 and 1199.34) will be eligible. after signing informed Consent and if all eligibility criteria are met, patients will initiate treatment with BiBF 1120 (Visit 2). Please refer to Section 4.1.2 for the method of assigning patients to treatment groups.
overall, the trial is estimated to last a total of approximately 6 [1/2]) years. Treatment will be stopped if a reason for withdrawal is met (refer to Section 3.3.4). Patients' participation starts once they have signed the informed Consent form and it is
concluded when they have undergone the Follow-up Visit (unless the patient is lost to follow up or informed consent is withdrawn). adverse events are collected during all the trial period and are considered under treatment until 28 days after drug discontinuation.
in the parent blind phase iii trials (1199.32 and 1199.34) patients are assigned either active drug (BiBF 1120 150 mg bid) or placebo. in case patients experience adverse events related to drug tolerability, a dose reduction to 100 mg bid is allowed (both in active or placebo group). at the end of treatment (Visit 9) in the parent trials, patients will be taking either 150 mg bid blinded study medication (active drug or placebo) or 100 mg bid blinded study medication (active drug or placebo) if their dose was permanently reduced during the trial. Patients taking 150 mg bid blinded study medication (active drug or placebo) in the parent trial will be treated with BiBF 1120 150 mg bid in the current extension trial. Patients who had the dose reduced to 100 mg bid (active drug or placebo) in the parent trial will be allowed to be treated with BiBF 1120 100 mg bid or 150 mg bid. This will ensure that patients who were on reduced dose placebo in the parent trial will have a chance to get the full dose in the extension trial. The daily dose of BiBF 1120 will be decided at Visit 2 based on discussion between the patient and the investigator.
Patients with IPF are eligible for inclusion if they fulfil all the inclusion criteria (Section
3.3.2) and do not present any of the exclusion criteria (Section 3.3.3).
In general patients who have completed the parent trial are eligible. However treatment interruption between the parent trial and the extension open label study should not be > 12 weeks. Patients who had experienced adverse events in the parent trial but were allowed to continue receiving blinded study medication either at 150 mg bid dose or at the reduced dose level 100 mg bid, will be offered participation in the extension trial.
1. Signed Informed Consent consistent with ICH-GCP and local laws prior to trial
2. Patients from trials 1199.32 or 1199.34 who completed the 52 weeks treatment period
and performed the follow-up visit.