Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01335464
First received: April 13, 2011
Last updated: March 28, 2014
Last verified: March 2014

April 13, 2011
March 28, 2014
April 2011
October 2013   (final data collection date for primary outcome measure)
annual rate of decline in FVC (expressed in mL over 52 weeks). [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01335464 on ClinicalTrials.gov Archive Site
  • Change from baseline in Saint-George Respiratory Questionnaire (SGRQ) total score at 52 weeks (expressed in points). [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Time to first acute exacerbation (days). [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Respiratory mortality (adjudicated; all data collected based on randomized set, including vital status follow-up, censored at 52 weeks). [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Overall survival (all data collected based on randomized set, including vital status follow-up, censored at 52 weeks). [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • On-treatment survival (on-treatment based on fatal adverse event + 28 days). [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Absolute and relative change from baseline of FVC and FVC %pred up to 52 weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • risk ratio of an acute IPF exacerbation [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • changes from baseline in SGRQ domains : [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Time to death or lung transplant. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Absolute categorical change of FVC% up to 52 weeks: decrease by > 5, increase by > 5, and change within <= 5. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Absolute categorical change of FVC% up to 52 weeks: decrease by >10, increase by > 10, and change within <= 5. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • change from baseline in Shortness Of Breath Questionnaire (SOBQ) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • change from baseline in Cough And Sputum Assessment (CASAQ) score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • change from baseline in EuroQol 5-Dimensional Quality of Life Questionnaire (EQ5D) score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • proportion of Patient's Global Impression of Change (PGIC) responders [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • proportion of SGRQ responders [ Time Frame: 52weeks ] [ Designated as safety issue: No ]
  • change from baseline in SGRQ-I total score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • change from baseline in SPO2 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • change from baaseline in DLCO [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Saint-George Respiratory Questionnaire (SGRQ) total score at 52 weeks (expressed in points). [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Time to first acute exacerbation (days). [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Respiratory mortality (adjudicated; all data collected based on randomized set, including vital status follow-up, censored at 52 weeks). [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Overall survival (all data collected based on randomized set, including vital status follow-up, censored at 52 weeks). [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • On-treatment survival (on-treatment based on fatal adverse event + 28 days). [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Further analyses on FVC: Absolute and relative change from baseline of FVC and FVC %pred up to 52 weeks Absolute categorical change of FVC% up to 52 weeks: decrease by > 5, increase by > 5, and change within = 5. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Acute exacerbations: Proportion of patients with at least one acute exacerbation during the 52 weeks. Exacerbation days (defined by number of days with an exacerbation per patient) during the 52 weeks. Number of exacerbations during the 52 weeks. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Patient reported outcomes: changes in SGRQ, Shortness Of Breath Questionnaire (SOBQ), Cough And Sputum Assessment (CASAQ), Patient's Global Impression of Change (PGIC), EuroQol 5-Dimensional Quality of Life Questionnaire (EQ5D), up to 52 weeks : [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Time to death or lung transplant. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients
A 52 Weeks, 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)

Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in scarring of the lung and there is a high unmet medical need for effective treatment to halt lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the death rate.

In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of patients treated with high dose of BIBF 1120 compared to placebo.

Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial will be conducted as a prospective, randomised design with the aim to collect safety and efficacy data.

Respiratory function is globally accepted for assessment of treatment effects in IPF patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in IPF patients.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Pulmonary Fibrosis
  • Drug: placebo
    placebo matching BIBF1120, BID
  • Drug: BIBF 1120
    BIBF1120 BID (twice daily)
  • Experimental: BIBF 1120
    patient receives capsules containing BIBF 1120 twice a day
    Intervention: Drug: BIBF 1120
  • Placebo Comparator: placebo
    patient receives capsules identical to those containing active drug
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
515
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Age >= 40 years;
  2. IPF diagnosed, according to most recent American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), Latin American Thoracic Association (ALAT) IPF guideline for diagnosis and management, within 5 years;
  3. Combination of High Resolution Computerized Tomography (HRCT) pattern, and if available surgical lung biopsy pattern, as assessed by central reviewers, are consistent with diagnosis of IPF
  4. Dlco (corrected for Hb): 30%-79% predicted of normal;
  5. FVC>= 50% predicted of normal

Exclusion criteria:

  1. Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) > 1.5 x Upper Limit of Normal (ULN)
  2. Bilirubin > 1.5 x ULN;
  3. Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC < 0.7);
  4. Patient likely to have lung transplantation during study (being on transplantation list is acceptable for participation);
  5. Myocardial infarction within 6 months;
  6. Unstable angina within 1 month;
  7. Bleeding risk (genetic predisposition; fibrinolysis or full-dose therapeutic anticoagulation or high dose antiplatelet therapy; history of hemorrhagic CNS event within 12 months; haemoptysis or haematuria or active gastro-intestinal bleeding or ulcers or major injury or surgery within 3 months);
  8. Thrombotic risk (inherited predisposition; history of thrombotic event (including stroke and transient ischemic attacks) within 12 months;
  9. International normalised ratio (INR) > 2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by > 50% of institutional ULN);
  10. N-ACetyl Cystein, prednisone > 15mg/day or equivalent received within 2 weeks of visit 1;
  11. Pirfenidone, azathioprine, cyclophosphamide, cyclosporine A received within 8 weeks of visit 1;
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   France,   Ireland,   Italy,   Czech Republic,   United Kingdom,   Germany,   Australia,   Japan,   China,   India,   Israel
 
NCT01335464
1199.32, 2010-024251-87
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP