A Phase 2 interventional study of BIBF 1120 and BIBF 1120 in Pulmonary Fibrosis, sponsored by Boehringer Ingelheim. Completed at 58 sites in 21 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2019-06-06.
Sponsored by Boehringer Ingelheim · Phase 2, Interventional, and Treatment
The aim of this trial is to offer continuation of BIBF 1120 treatment for patients with Idiopathic Pulmonary Fibrosis (IPF) who have completed a prior clinical trial with that drug.
The primary objective will be to establish the long term tolerability and safety profile of BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF).
As a secondary objective the effects of long term treatment with BIBF 1120 on survival as well as safety and efficacy parameters will be investigated in an open-label, not randomized, un-controlled design.
680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.
This study's enrollment of 198 is above the median of 50 across 419 interventional studies indexed under Pulmonary Fibrosis.
Browse Pulmonary Fibrosis studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
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 inclusion and at least 10 weeks after end of active therapy.
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 Intra Uterine Devices (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.
Low dose BIBF 1120 once daily
Drug: BIBF 1120
Low dose BIBF 1120 twice daily
Drug: BIBF 1120
Intermediate dose BIBF 1120 twice daily
Drug: BIBF 1120
High dose BIBF 1120 twice daily
Drug: BIBF 1120
Intermediate dose BIBF 1120 twice daily
High dose BIBF 1120 twice daily
Low dose BIBF 1120 twice daily
Low dose BIBF 1120 once daily
Annual Rate of Decline in Forced Vital Capacity (FVC)
Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test. For this endpoint reported means represent the adjusted rate.
Time frame: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Overall Survival
Overall survival is defined as the time from the first intake of nintedanib in trial 1199.35 to death. For presentation of overall survival results, Kaplan-Meier estimates and confidence intervals (using Greenwood variance formula) for the overall on-treatment survival is calculated within each treatment arm.
Time frame: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Progression-Free Survival
Progression-free survival was defined as the time from the first nintedanib intake in trial 1199.35 to disease progression. For presentation of progression-free survival results, Kaplan-Meier estimates and confidence intervals (using Greenwood variance formula) for the overall on-treatment progression-free survival is calculated within each treatment arm.
Time frame: From first trial drug intake in 1199.35 to disease progression; up to 61.8 months
Annual Rate of Decline in Haemoglobin Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Decrease
Haemoglobin corrected DLCO decrease was a secondary endpoint for the trial. It was considered important that all investigators used the same method of testing and recording data at each visit for each patient. Haemoglobin corrected DLCO was calculated for each patient using the following formulae: Males: Hb corrected DLCO = measured DLCO x (10.22 + Hb concentration) / (1.7 x Hb concentration) Females: Hb corrected DLCO = measured DLCO x (9.38 + Hb concentration) / (1.7 x Hb concentration). Annual rate of decline in haemoglobin corrected diffusing capacity of the lung for carbon monoxide (DLCO) decrease is presented.
Time frame: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Percentage of Patients With at Least One Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation
Percentage of patients with at least one acute idiopathic pulmonary fibrosis (IPF) exacerbation are presented. An exacerbation was defined as otherwise unexplained clinical features occurring within 1 month including all of the following: * Progression of dyspnoea over several days to 4 weeks * New diffuse pulmonary infiltrates on chest X-ray and/or high-resolution computerised tomography (HRCT) Parenchymal abnormalities with no pneumothorax or pleural effusion (new ground-glass opacities) since the last visit * A decrease in arterial oxygen partial pressure (PaO2) of ≥10 mmHg or PaO2/fraction of inspired oxygen (FiO2) of \<225 mmHg since the last visit * Exclusion of infection based on routine clinical practice and microbiological studies * Absence of other contributory causes such as congestive heart failure, pulmonary embolism, etc.
Time frame: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Incidence of Patients With at Least One Acute IPF Exacerbation Over Time
Incidence rate = (Patients with at least one acute IPF exacerbation / Total number of years at risk) x 100
Time frame: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Time to First Acute IPF Exacerbation
Due to rare events, the median of time to event is not calculable, thus Kaplan-Meier estimates (providing the percentage of patients without acute IPF exacerbation for a certain amount of time after treatment) and confidence intervals (using Greenwood variance formula) are reported and presented within each treatment arm as secondary endpoint.
Time frame: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Percentage of Patients With at Least One Adverse Events (AEs), With Investigator Defined Drug-Related AEs, AEs Leading to Discontinuation of Trial Drug, Serious AEs
Percentage of patients with at least one Adverse events (AEs), with investigator defined drug-related AEs, AEs leading to discontinuation of trial drug, serious AEs are presented
Time frame: From the first nintedanib intake in trial 1199.35 to the last nintedanib intake + 28 days; up to 61.8 months + 28 days
Treatment groups are displayed according to dose at randomisation in 1199.30 (NCT00514683).
| Milestone | Placebo | Nintedanib 50 mg- 100 mg | Nintedanib 150 mg |
|---|---|---|---|
| Started | 37 | 126 | 35 |
| Completed | 9 | 34 | 9 |
| Not completed | 28 | 92 | 26 |
| Withdrew: Adverse event | 17 | 50 | 10 |
| Withdrew: Lost to follow-up | 1 | 4 | 1 |
| Withdrew: Consent withdrawn, not due to ae | 2 | 4 | 2 |
| Withdrew: Reason other than specified | 3 | 8 | 3 |
| Withdrew: Ongoing after planned observation time | 5 | 26 | 10 |
Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test. For this endpoint reported means represent the adjusted rate.
| milliliters per year (mL/ yr) | Placebo | Nintedanib 50 mg- 100 mg | Nintedanib 150 mg |
|---|---|---|---|
| Annual Rate of Decline in Forced Vital Capacity (FVC) | -129.0 ± 29.47 | -137.5 ± 14.60 | -132.9 ± 28.22 |
Overall survival is defined as the time from the first intake of nintedanib in trial 1199.35 to death. For presentation of overall survival results, Kaplan-Meier estimates and confidence intervals (using Greenwood variance formula) for the overall on-treatment survival is calculated within each treatment arm.
| percentage of participants | Placebo | Nintedanib 50 mg- 100 mg | Nintedanib 150 mg |
|---|---|---|---|
| Overall Survival | 37.4 ± 29.47 | 46.8 ± 14.60 | 66.2 ± 28.22 |
Progression-free survival was defined as the time from the first nintedanib intake in trial 1199.35 to disease progression. For presentation of progression-free survival results, Kaplan-Meier estimates and confidence intervals (using Greenwood variance formula) for the overall on-treatment progression-free survival is calculated within each treatment arm.
| percentage of participants | Placebo | Nintedanib 50 mg- 100 mg | Nintedanib 150 mg |
|---|---|---|---|
| Progression-Free Survival | 9.6 ± 29.47 | 3.5 ± 14.60 | 12.2 ± 28.22 |
Haemoglobin corrected DLCO decrease was a secondary endpoint for the trial. It was considered important that all investigators used the same method of testing and recording data at each visit for each patient. Haemoglobin corrected DLCO was calculated for each patient using the following formulae: Males: Hb corrected DLCO = measured DLCO x (10.22 + Hb concentration) / (1.7 x Hb concentration) Females: Hb corrected DLCO = measured DLCO x (9.38 + Hb concentration) / (1.7 x Hb concentration). Annual rate of decline in haemoglobin corrected diffusing capacity of the lung for carbon monoxide (DLCO) decrease is presented.
| mmol/min/kPa/yr | Placebo | Nintedanib 50 mg- 100 mg | Nintedanib 150 mg |
|---|---|---|---|
| Annual Rate of Decline in Haemoglobin Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Decrease | -0.4 ± 0.08 | -0.3 ± 0.04 | -0.2 ± 0.07 |
Percentage of patients with at least one acute idiopathic pulmonary fibrosis (IPF) exacerbation are presented. An exacerbation was defined as otherwise unexplained clinical features occurring within 1 month including all of the following: * Progression of dyspnoea over several days to 4 weeks * New diffuse pulmonary infiltrates on chest X-ray and/or high-resolution computerised tomography (HRCT) Parenchymal abnormalities with no pneumothorax or pleural effusion (new ground-glass opacities) since the last visit * A decrease in arterial oxygen partial pressure (PaO2) of ≥10 mmHg or PaO2/fraction of inspired oxygen (FiO2) of \<225 mmHg since the last visit * Exclusion of infection based on routine clinical practice and microbiological studies * Absence of other contributory causes such as congestive heart failure, pulmonary embolism, etc.
| Percentage of participants | Placebo | Nintedanib 50 mg- 100 mg | Nintedanib 150 mg |
|---|---|---|---|
| Percentage of Patients With at Least One Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation | 13.5 ± 0.08 | 19.8 ± 0.04 | 20.0 ± 0.07 |
Incidence rate = (Patients with at least one acute IPF exacerbation / Total number of years at risk) x 100
| Exacerbations Per Year | Placebo | Nintedanib 50 mg- 100 mg | Nintedanib 150 mg |
|---|---|---|---|
| Incidence of Patients With at Least One Acute IPF Exacerbation Over Time | 6.1 ± 0.08 | 7.6 ± 0.04 | 7.8 ± 0.07 |
Due to rare events, the median of time to event is not calculable, thus Kaplan-Meier estimates (providing the percentage of patients without acute IPF exacerbation for a certain amount of time after treatment) and confidence intervals (using Greenwood variance formula) are reported and presented within each treatment arm as secondary endpoint.
| percentage of participants | Placebo | Nintedanib 50 mg- 100 mg | Nintedanib 150 mg |
|---|---|---|---|
| Time to First Acute IPF Exacerbation | 67.7 ± 29.47 | 68.6 ± 14.60 | 73.5 ± 28.22 |
Percentage of patients with at least one Adverse events (AEs), with investigator defined drug-related AEs, AEs leading to discontinuation of trial drug, serious AEs are presented
| Percentage of participants | Placebo | Nintedanib 50 mg- 100 mg | Nintedanib 150 mg |
|---|---|---|---|
| AEs | 100.0 ± 0.08 | 99.2 ± 0.04 | 97.1 ± 0.07 |
| Investigator defined drug-related AEs | 70.3 | 65.9 | 54.3 |
| AEs leading to discontinuation of trial drug | 48.6 | 41.3 | 34.3 |
| Serious AE | 67.6 | 74.6 | 62.9 |
Collected over From the first nintedanib intake in trial 1199.35 to the last nintedanib intake + 28 days; up to 61.8 months + 28 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 25/37 (67.6%) | 34/37 (91.9%) |
| Nintedanib 50 mg- 100 mg | — | 94/126 (74.6%) | 111/126 (88.1%) |
| Nintedanib 150 mg | — | 22/35 (62.9%) | 32/35 (91.4%) |
| Event | Placebo | Nintedanib 50 mg- 100 mg | Nintedanib 150 mg |
|---|---|---|---|
| Idiopathic pulmonary fibrosisRespiratory, thoracic and mediastinal disorders | 11/37 | 41/126 | 10/35 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 2/37 | 11/126 | 0/35 |
| Lung infectionInfections and infestations | 1/37 | 5/126 | 3/35 |
| DiarrhoeaGastrointestinal disorders | 3/37 | 2/126 | 1/35 |
| PneumoniaInfections and infestations | 3/37 | 6/126 | 2/35 |
| FallInjury, poisoning and procedural complications | 3/37 | 2/126 | 1/35 |
| Cardiac disorderCardiac disorders | 0/37 | 0/126 | 2/35 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/37 | 7/126 | 1/35 |
| Cardiac arrestCardiac disorders | 2/37 | 1/126 | 0/35 |
| HaemorrhoidsGastrointestinal disorders | 2/37 | 1/126 | 0/35 |
| Event | Placebo | Nintedanib 50 mg- 100 mg | Nintedanib 150 mg |
|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 19/37 | 68/126 | 22/35 |
| BronchitisInfections and infestations | 12/37 | 27/126 | 6/35 |
| Weight decreasedInvestigations | 10/37 | 29/126 | 7/35 |
| NauseaGastrointestinal disorders | 9/37 | 22/126 | 2/35 |
| NasopharyngitisInfections and infestations | 8/37 | 24/126 | 6/35 |
| CoughRespiratory, thoracic and mediastinal disorders | 3/37 | 27/126 | 4/35 |
| VomitingGastrointestinal disorders | 7/37 | 17/126 | 3/35 |
| Idiopathic pulmonary fibrosisRespiratory, thoracic and mediastinal disorders | 0/37 | 22/126 | 3/35 |
| InfluenzaInfections and infestations | 1/37 | 9/126 | 6/35 |
| Decreased appetiteMetabolism and nutrition disorders | 6/37 | 17/126 | 2/35 |
Treated set (TS): The treated set which included all patients who received at least 1 dose of open-label study medication in trial 1199.35
| Age, Continuous(years) | Placebo | Nintedanib 50 mg- 100 mg | Nintedanib 150 mg | Total |
|---|---|---|---|---|
| Mean | 64.2 ± 7.3 | 65.4 ± 8.6 | 65.2 ± 7.2 | 65.2 ± 8.1 |
| Sex: Female, Male(Participants) | Placebo | Nintedanib 50 mg- 100 mg | Nintedanib 150 mg | Total |
|---|---|---|---|---|
| Female | 14 | 36 | 7 | 57 |
| Male | 23 | 90 | 28 | 141 |
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Boehringer Ingelheim