MedDRA version: 19.0 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: nint
Sponsors
Boehringer Ingelheim Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Written informed consent consistent with ICH-GCP and local laws, signed prior to participation in the trial including any study related procedures being performed; - Male or female patients aged =40 years at Visit 1; - A clinical diagnosis of IPF within the last 3 years from visit 0, based upon the ATS/ERS/JRS/ALAT 2011 guideline; - Chest high resolution computed tomography (HRCT) scan performed within 18 months of Visit 0; - Combination of HRCT pattern, and surgical lung biopsy pattern (the latter if available) as assessed by central review are consistent with the diagnosis of IPF; - FVC =80% 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 330 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
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; - Patients with underlying chronic liver disease (Child Pugh A, B or C hepatic impairment); - Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC 2 at visit 1; -- Prothrombin time (PT) and partial thromboplastin time (PTT) > 150% of 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; - Creatinine clearance 15 mg daily or >30 mg every 2 days OR use of other systemic corticosteroids as well as other investigational drugs within 4 weeks of visit 2; - Known hypersensitivity to nintedanib, peanut, soya or to any other components of the study medication; - Prior discontinuation of nintedanib treatment due to intolerability/ adverse events considered drug related; - 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 the treatment and would affect patient's ability to participate in this trial; - Patients not able to understand and follow study procedures such as but not limited to home spirometry, including completion of self-administered questionnaires without help; - Women who are pregnant, nursing, who plan to become pregnant while in the trial or female patients with positive ß-HCG test at visit 1 and/or visit 2; - 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 correctly; - Patients with acute IPF exacerbation or any respiratory tract infection in the four weeks prior to Visit 1 or during the screening period. Visit 1 and/or Visit 2 should be postponed in case of an IPF exacerbation or respiratory tract infection. Refer to Section 6.1 for information on re-scheduling
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: A secondary objective is to confirm the observed results from the PROFILE cohort, i.e. to assess the predictive value of change in extracellular matrix (ECM) biomarkers CRPM, C1M and C3M over 12 weeks for disease progression as defined by FVC decline =10% or death over 52 weeks. ; Primary end point(s): 1: The rate of change (slope) in blood CRPM from baseline to week 12. ; Timepoint(s) of evaluation of this end point: 1: 12 weeks ; Main Objective: The primary objective of the trial will be to assess the effect of nintedanib on rate of change in extracellular matrix (ECM) turnover biomarker CRPM over 12 weeks which has shown to strongly associate with disease progression in patients with IPF in the PROFILE cohort. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The key secondary endpoint 1: Proportion of patients with disease progression as defined by absolute FVC (% predicted) decline =10% or death until week 52 based on in clinic supervised spirometry. Secondary endpoints: 2: Rate of change (slope) in blood C1M from baseline to week 12 3: Rate of change (slope) in blood C3M from baseline to week 12. ; Timepoint(s) of evaluation of this end point: 1: 52 weeks 2: 12 weeks 3: 12 weeks | — |
Countries
Australia, Belgium, Czech Republic, Finland, France, Germany, Hungary, Japan, Korea, Republic of, Poland, Spain, United Kingdom, United States
Contacts
Public ContactQPRE pSc CT Information Disclosure
Boehringer Ingelheim Pharma GmBh & Co. Kg
Outcome results
None listed