Idiopathic Pulmonary Fibrosis MedDRA version: 18.0 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: nintedanib
CAS Number: 656247-17-5
Other descriptive name: NINTEDAN
Sponsors
Boehringer Ingelheim France
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Written informed consent consistent with ICH-GCP and local laws, signed prior to any study procedures being performed (including any required washout) -Male or female patients aged greater than or equal to 40 years at visit 1 -Idiopathic Pulmonary Fibrosis (IPF) diagnosis, based upon the ATS/ERS/JRS/ALAT 2011 guideline and confirmed by the investigator based on chest high resolution computed tomography (HRCT) scan performed within 12 months of visit 1 -FVC greater than or equal to 50% of predicted normal at visit 1 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: -ALT, AST > 1.5 fold upper limit of normal (ULN) at visit 1 -Total bilirubin > 1.5 fold ULN at visit 1 -Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC 2 at visit 1, Prothrombin time and partial thromboplastin time (PTT) > 150% of institutional ULN at visit 1 -Planned major surgery during the trial participation, including lung transplantation,major abdominal or major intestinal surgery. -History of thrombotic event (including stroke and transient ischemic attack) within 12 months of visit 1 -History of end-stage renal disease requiring dialysis -Treatment with NAC, prednisone >15 mg daily or >30 mg every 2 days OR equivalent dose of other oral corticosteroids and/or fluvoxamine within 2 weeks of visit 2 -Treatment with azathioprine, cyclophosphamide, cyclosporine as well as any other investigational drug within 8 weeks of visit 2 -Previous treatment with pirfenidone -Permanent discontinuation of nintedanib in the past due to AEs considered drug-related -Known hypersensitivity to nintedanib, pirfenidone, peanut or soya or to any of the excipients -A disease or condition which in the opinion of the investigator may interfere with testing procedures or put the patient at risk when participating in this trial -Alcohol or drug abuse which in the opinion of the treating physician would interfere with treatment -Women who are pregnant, nursing, or who plan to become pregnant while in the trial. -Women of childbearing potential not willing or able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly5 for 28 days prior to and 3 months after nintedanib administration -Patients not able to understand and follow study procedures including completion of selfadministered questionnaires without help -Patients who require dose reduction and/or temporary interruption during the run-in period with nintedanib 150 mg bid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial will be to assess safety and tolerability of combined treatment with nintedanib and pirfenidone;Secondary Objective: A secondary objective is to assess the exposure, based on pharmacokinetic trough concentration values, to nintedanib either given alone or in combination with pirfenidone and to assess the assess the exposure of pirfenidone when combined with nintedanib;Primary end point(s): 1: The primary endpoint is the percentage of patients with on-treatment gastrointestinal (GI) AEs (SOC GI disorders) from baseline to week 12 ;Timepoint(s) of evaluation of this end point: 1: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1: Pre-dose plasma concentrations at steady state (Cpre,ss) of nintedanib at baseline, weeks 2 and 4 2: Pre-dose plasma concentrations at steady state (Cpre,ss) of pirfenidone at weeks 2 and 4. ;Timepoint(s) of evaluation of this end point: 1: baseline, week 2 and week 4 2: week 2 and week 4 | — |
Countries
Canada, France, Germany, Italy, Netherlands, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim
Outcome results
None listed