E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Idiopathic pulmonary fibrosis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10021240 |
E.1.2 | Term | Idiopathic pulmonary fibrosis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the efficacy and safety of four doses strategies of BIBF 1120 treatment for 12 months compared to placebo in patients with Idiopathic Pulmonary Fibrosis |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patient ≥40 years 2. Written informed consent signed prior to entry into the study 3. IPF diagnosed (according to ATS / ERS criteria) less than 5 years prior to screening visit. 4. HRCT within 12 months of randomisation and biopsy (the latter if needed to fulfil ATS/ERS criteria) centrally reviewed and consistent with diagnosis. 5. FVC ≥50 % of predicted value 6. Single breath DLCO (corrected for Hb) 30 - 79% inclusive of predicted . 7. PaO2 ≥55 mmHg (sea level to 1500 m) or 50 mmHg (above 1500 m) room air
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E.4 | Principal exclusion criteria |
1. AST, ALT > 1.5 x ULN at screening 2. Bilirubin > 1.5 x ULN at screening 3. Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC < 0.7) at screening 4. Continuous oxygen supplementation at randomisation (defined as ≥ 15 hours supplemental oxygen per day). 5. Active infection at screening or randomisation. 6. Neutrophils < 1500 / mm3 at screening 7. International normalised ratio (INR) > 1.5 and/or Partial thromboplastin time (PTT) > 1.5 x ULN at screening 8. Platelets < 100 000 /mL at screening 9. Haemoglobin < 9.0 g/dL at screening 10. In the opinion of the Investigator, patient is likely to have lung transplantation during study (but being on transplantation list is acceptable for participation). 11. Life expectancy for disease other than IPF < 2.5 years (Investigator assessment). 12. Other disease that may interfere with testing procedures or in judgement of Investigator may interfere with trial participation or may put the patient at risk when participating to this trial. • Myocardial infarction during the previous 6 months • Unstable angina during the previous month 13. Other investigational therapy received within 8 weeks prior to screening visit. 14. Women who are breast feeding or of child bearing potential not using a highly effective method of birth control for at least one month prior to enrolment (highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1 % per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner). Female patients will be considered of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years. 15. Sexually active males not committing to using condoms during the course of the study (except if their partner is not of childbearing potential). 16. Known or suspected active alcohol or drug abuse. 17. Bleeding risk • Known inherited predisposition to bleeding. • Patients who require full-dose anticoagulation (e.g. vitamin K antagonists, heparin, hirudin etc). • Patients who require full-dose antiplatelet (e.g. acetyl salicylic acid, clopidogrel etc) therapy. • History of hemorrhagic CNS event within 12 months prior to screening (visit 1). • Any of the following within 3 months prior to screening : o Gross / frank haemoptysis or haematuria o Active gastro-intestinal bleeding or ulcers o Major injury or surgery. 18. Thrombotic risk • Known inherited predisposition to thrombosis. • History of thrombotic event (including stroke and transient ischemic attacks) within 12 months prior to screening 19. Surgical procedures planned to occur during trial period. 20. Coagulopathy. 21. Uncontrolled systemic arterial hypertension.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the rate of decline in FVC (expressed in mL per year), evaluated from baseline until 12 month of treatment, compared to placebo |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 45 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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last visit of last subject |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |