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

Brief Summary

Official Title: “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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
  • Study Primary Completion Date: October 2013

Interventions Used in this Clinical Trial

  • Drug: placebo
    • placebo matching BIBF1120, BID
  • Drug: BIBF 1120
    • BIBF1120 BID (twice daily)

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: BIBF 1120
    • patient receives capsules containing BIBF 1120 twice a day
  • Placebo Comparator: placebo
    • patient receives capsules identical to those containing active drug

Outcome Measures for this Clinical Trial

Primary Measures

  • Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks
    • Time Frame: 52 weeks
      Safety Issue?: No

Secondary Measures

  • Change From Baseline in Saint-George’s Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks
    • Time Frame: baseline and 52 weeks
      Safety Issue?: No
  • Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation
    • Time Frame: 52 weeks
      Safety Issue?: No
  • Absolute Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks
    • Time Frame: Baseline and 52 weeks
      Safety Issue?: No
  • Relative Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks
    • Time Frame: Baseline and 52 weeks
      Safety Issue?: No
  • Absolute Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks
    • Time Frame: Baseline and 52 weeks
      Safety Issue?: No
  • Relative Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks
    • Time Frame: Baseline and 52 weeks
      Safety Issue?: No
  • Absolute Categorical Change of FVC (% Predicted) by Categories Over 52 Weeks – 5% Threshold
    • Time Frame: Baseline and 52 weeks
      Safety Issue?: No
  • Absolute Categorical Change of FVC (% Predicted) by Categories Over 52 Weeks – 10% Threshold
    • Time Frame: Baseline and 52 weeks
      Safety Issue?: No
  • FVC Responders Using 10% Threshold at 52 Weeks
    • Time Frame: 52 weeks
      Safety Issue?: No
  • Proportion of FVC Responders Using 5% Threshold at 52 Weeks
    • Time Frame: 52 weeks
      Safety Issue?: No
  • Proportion of SGRQ Responders at 52 Weeks: Patient Reported Outcomes (PROs)
    • Time Frame: Baseline and 52 weeks
      Safety Issue?: No
  • Change From Baseline in SGRQ Symptom Score at 52 Weeks: Patient Reported Outcomes (PROs)
    • Time Frame: Baseline and 52 weeks
      Safety Issue?: No
  • Change From Baseline in SGRQ Impact Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)
    • Time Frame: Baseline and 52 weeks
      Safety Issue?: No
  • Change From Baseline in SGRQ Activity Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)
    • Time Frame: baseline and 52 weeks
      Safety Issue?: No
  • Change From Baseline in Idiopathic Pulmonary Fibrosis (IPF) Specific Version of SGRQ (SGRQ-I) Total Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)
    • Time Frame: Baseline and 52 weeks
      Safety Issue?: No
  • Change From Baseline in Shortness of Breath Questionnaire (SOBQ) at 52 Weeks: Patient Reported Outcomes (PROs)
    • Time Frame: baseline and 52 weeks
      Safety Issue?: No
  • Change From Baseline in Cough Symptoms Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs)
    • Time Frame: Baseline and 52 weeks
      Safety Issue?: No
  • Change From Baseline in Cough Impact Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks : Patient Reported Outcomes (PROs)
    • Time Frame: Baseline and 52 weeks
      Safety Issue?: No
  • Proportion of Patient’s Global Impression of Change (PGI-C) Responders at 52 Weeks: Patient Reported Outcomes (PROs)
    • Time Frame: 52 weeks
      Safety Issue?: No
  • Change From Baseline in EuroQol 5-Dimensional Quality of Life Questionnaire (EQ-5D) Health State up to 52 Weeks : Patient Reported Outcomes (PROs)
    • Time Frame: baseline, 12 weeks, 24 weeks and 52 weeks
      Safety Issue?: No
  • Risk of an Acute IPF Exacerbation Over 52 Weeks
    • Time Frame: 52 weeks
      Safety Issue?: No
  • Time to Death Over 52 Weeks
    • Time Frame: 52 weeks
      Safety Issue?: No
  • Time to Death Due to Respiratory Cause Over 52 Weeks (Adjudicated)
    • Time Frame: 52 weeks
      Safety Issue?: No
  • Time to On-treatment Death
    • Time Frame: 52 weeks
      Safety Issue?: No
  • Time to Death or Lung Transplant Over 52 Weeks
    • Time Frame: 52 weeks
      Safety Issue?: No
  • Time to Death or Lung Transplant or Qualifying for Lung Transplant Over 52 Weeks.
    • Time Frame: 52 weeks
      Safety Issue?: No
  • Change From Baseline in SpO2 (Oxygen Saturation, Expressed in Percent) at Rest up Over 52 Weeks
    • Time Frame: Baseline and 52 weeks
      Safety Issue?: No
  • Change From Baseline in Carbon Monoxide Diffusion Capacity (DLCO) at Rest Over 52 Weeks
    • Time Frame: Baseline and 52 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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;

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Boehringer Ingelheim
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01335464