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)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-024251-87-DE

Enrollment

485

Registered

2011-02-09

Start date

2011-04-12

Completion date

Unknown

Last updated

2014-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis MedDRA version: 14.1 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: BIBF 1120 Product Code: BIBF 1120 Pharmaceutical Form: Capsule, soft Current Sponsor code: BIBF 1120 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age = 40 years; IPF diagnosed, according to most recent ATS/ERS/JRS/ALAT IPF guideline for diagnosis and management, within 5 years; Combination of HRCT pattern, and if available surgical lung biopsy pattern, as assessed by central reviewers, are consistent with diagnosis of IPF; Dlco (corrected for Hb): 30%-79% predicted of normal; FVC = 50% predicted of normal Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 235

Exclusion criteria

Exclusion criteria: Laboratory parameters (AST, ALT > 1.5 x ULN; Bilirubin > 1.5 x ULN); Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC 2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by > 50% of institutional ULN); N-ACetyl Cystein, prednisone > 15mg/day or equivalent received within 2 weeks of visit 1; Pirfenidone, azathioprine, cyclophosphamide, cyclosporine A received within 8 weeks of visit 1;

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate a reduction of lung function decline, as measured by a change of the yearly rate of decline of forced vital capacity (FVC).;Secondary Objective: To assess the patient's perception of his/her disease, and the time to IPF exacerbation. To investigate respiratory and overall survival, as well as causes of mortality. To assess safety and tolerability.;Primary end point(s): Annual rate of decline in FVC (expressed in mL over 52 weeks).;Timepoint(s) of evaluation of this end point: The data for the primary endpoint (FVC) are collected over the whole study period and are evaluated at the end of the trial.	—

Measure

Time frame

Main Objective: To demonstrate a reduction of lung function decline, as measured by a change of the yearly rate of decline of forced vital capacity (FVC).;Secondary Objective: To assess the patient's perception of his/her disease, and the time to IPF exacerbation. To investigate respiratory and overall survival, as well as causes of mortality. To assess safety and tolerability.;Primary end point(s): Annual rate of decline in FVC (expressed in mL over 52 weeks).;Timepoint(s) of evaluation of this end point: The data for the primary endpoint (FVC) are collected over the whole study period and are evaluated at the end of the trial.

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Secondary

Measure	Time frame
Secondary end point(s): Patient reported outcomes (SGRQ, SGRQ-I, SOBQ, CASA-Q(CD), EQ-5D, PGI-C); Time to first IPF exacerbation; Further analyses regarding acute exacerbations; Further analyses on lung function (e.g. FVC, Dlco, SPO2); Survival (on-treatment, overall); respiratory mortality; ;Timepoint(s) of evaluation of this end point: The data for the secondary endpoints are collected over the whole study period and are evaluated at the end of the trial.	—

Measure

Time frame

Secondary end point(s): Patient reported outcomes (SGRQ, SGRQ-I, SOBQ, CASA-Q(CD), EQ-5D, PGI-C); Time to first IPF exacerbation; Further analyses regarding acute exacerbations; Further analyses on lung function (e.g. FVC, Dlco, SPO2); Survival (on-treatment, overall); respiratory mortality; ;Timepoint(s) of evaluation of this end point: The data for the secondary endpoints are collected over the whole study period and are evaluated at the end of the trial.

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Countries

Argentina, Australia, Belgium, Brazil, China, Czech Republic, France, Germany, India, Ireland, Israel, Italy, Japan, United Kingdom, United States

Contacts

Public Contactclintriage.rdg@boehringer-ingelheim

Boehringer Ingelheim Pharma GmbH & Co. KG

clintriage.rdg@boehringer-ingelheim.com001800243 0127

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026