Safety and Efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patients

• Register: EUCTR
• Last refreshed on: 3 February 2014
• Main ID: EUCTR2010-024251-87-DE
• Date of registration: 09/02/2011
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG
• Public title: Safety and Efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patients
• Scientific 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)
• Date of first enrolment: 12/04/2011
• Target sample size: 485
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-024251-87
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

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

Contacts

• Name: clintriage.rdg@boehringer-ingelheim
• Affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG

• Name: clintriage.rdg@boehringer-ingelheim
• Affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG

Key inclusion & exclusion 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:
Laboratory parameters (AST, ALT > 1.5 x ULN; Bilirubin > 1.5 x ULN);
Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC < 0.7);
Patient likely to have lung transplantation during study (being on transplantation list is acceptable for participation);
Myocardial infarction within 6 months;
Unstable angina within 1 month;
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);
Thrombotic risk (inherited predisposition; history of thrombotic event (including stroke and transient ischemic attacks) within 12 months; International normalised ratio (INR) > 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;


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

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: 150-
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use

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: 100-
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use

Primary Outcome(s)

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.

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).

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.

Secondary Outcome(s)

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.

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;

Secondary ID(s)

1199.32

Source(s) of Monetary Support

Boehringer Ingelheim Pharma GmbH & Co. KG