Idiopathic Pulmonary Fibrosis
Conditions
Brief summary
The primary objective of this study is to evaluate the efficacy of BG00011 compared with placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). The secondary objectives of this study are: to evaluate the efficacy of BG00011 compared with placebo in participants with IPF as determined by change in percent predicted forced (expiratory) vital capacity (FVC); to assess progression-free survival in participants who receive BG00011 compared with placebo; to assess the occurrence of IPF exacerbation in participants who receive BG00011 compared with placebo; to assess the incidence of absolute decline in FVC ≥10% in participants who receive BG00011 compared with placebo; to assess the time to death or lung transplantation in participants who receive BG00011 compared with placebo, and the transplant-free survival rate at Week 26 and Week 52; to assess the time to non-elective hospitalizations in participants who receive BG00011 compared with placebo; to assess additional pulmonary function test (PFT) findings in participants who receive BG00011 compared with placebo; To assess performance on the 6 minute walk test (6MWT) in participants who receive BG00011 compared with placebo; to evaluate the safety and tolerability of BG00011; and to evaluate the serum concentration of BG00011.
Interventions
DRUGBG00011
Administered as specified in the treatment arm.
DRUGPlacebo
Administered as specified in the treatment arm.
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Female subjects must be surgically sterile, postmenopausal (minimum 1 year without menses), or agree to use 1 or more forms of highly effective contraception from the time of signing of the informed consent form (ICF) until 3 months after the last injection of study medication. Male subjects must also agree to use 1 or more forms of highly effective contraception for either themselves or their partners from signing of ICF until 4 months after last injection of study medication. * IPF diagnosed based on modified ATS/ERS/JRS/ALAT IPF guideline for diagnosis and management, within 3 years of Screening. * Combination of high-resolution computed tomography (HRCT) pattern and, if one has been obtained, surgical lung biopsy pattern, consistent with diagnosis of IPF. * Carbon monoxide diffusion capacity (DLco) (corrected for hemoglobin): 30% to 79% predicted of normal at Screening, with no clinically significant deterioration between the Screening Visit and randomization, as determined by the Investigator. * Forced (expiratory) vital capacity (FVC) ≥50% predicted of normal at Screening, with no clinically significant deterioration between the Screening Visit and randomization, as determined by the Investigator. * If a subject is taking nintedanib or pirfenidone, they must be on a stable dose for at least 8 weeks prior to randomization. Key
Exclusion criteria
* Unable to perform pulmonary functional tests (PFTs) or undergo HRCT procedure. * Peripheral capillary oxygen saturation (SpO2) \<90% at rest (if on oxygen supplementation, must be ≤2 L/min at rest). * Airway obstruction (i.e., prebronchodilator FEV1/FVC \<0.7) or evidence of a bronchodilator response as defined by an absolute increase of ≥12% and an increase of ≥200 milliliters (mL) in FEV1 or FVC, or both, after bronchodilator use, compared with the values before bronchodilator use at Screening. * End-stage fibrotic disease likely requiring organ transplantation within 12 months, or if the subject has initiated active evaluation for organ transplantation. * The extent of emphysema in the lungs exceeds fibrosis, based on central review of HRCT scans. * Body weight \<60 kg at Screening. * History of or ongoing malignant disease, including solid tumors and hematologic malignancies, with the exception of basal cell carcinomas, squamous cell carcinomas, and carcinoma in situ of the cervix that have been completely excised and considered cured \>2 years prior to Screening. * Significant cardiac disease (e.g., New York Heart Association Class 3 or 4; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty or coronary artery bypass graft within the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias; or pulmonary hypertension requiring pharmacologic treatment). * Clinical diagnosis of any connective tissue disease (including but not limited to scleroderma, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis) or a diagnosis of interstitial pneumonia with autoimmune features as determined by the Investigator. * Other disease that may interfere with testing procedures or, in the judgment of the Investigator, may interfere with study participation or may put the patient at risk when participating in this study. * Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the subject unsuitable for enrollment. NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Forced (Expiratory) Vital Capacity (FVC) at Week 52 | Baseline, Week 52 | FVC is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Progression | Up to Week 60 (End of Study) | Time to progression is defined by a composite endpoint, including any of the following events: Absolute decline of 10% predicted in FVC (FVC percent predicted (baseline) - FVC percent predicted (progression) ≥10%); Non-elective hospitalization for respiratory events; Lung transplantation or death. The earliest time to meet at least 1 composite criterion was calculated. |
| Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation | Up to Early Termination Visit (Up to Week 52) | Time to first acute IPF exacerbation is defined as time from randomization to the first occurrence of acute IPF exacerbation. Acute IPF exacerbation is defined as a clinically significant deterioration of unidentifiable cause in a participant with underlying IPF. The diagnostic criteria for IPF used in this study were derived from evidence-based guidelines developed by the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) joint task force for the diagnosis and management of IPF. Participants were assessed according to the modified 2007 diagnostic criteria for acute IPF exacerbation. |
| Number of Participants With at Least One Acute IPF Exacerbation | Up to Early Termination Visit (Up to Week 52) | Acute IPF exacerbation is defined as a clinically significant deterioration of unidentifiable cause in a participant with underlying IPF. The diagnostic criteria for IPF used in this study were derived from evidence-based guidelines developed by the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) joint task force for the diagnosis and management of IPF. Participants were assessed according to the modified 2007 diagnostic criteria for acute IPF exacerbation. |
| Number of IPF Exacerbations | Up to Early Termination Visit (Up to Week 52) | The IPF exacerbation is defined as a clinically significant deterioration of unidentifiable cause in a participant with underlying IPF. The diagnostic criteria for IPF used in this study were derived from evidence-based guidelines developed by the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) joint task force for the diagnosis and management of IPF. Participants were assessed according to the modified 2007 diagnostic criteria for acute IPF exacerbation. |
| Number of Participants With Absolute Decline of 10% Predicted in FVC | Up to Early Termination Visit (Up to Week 52) | FVC is the is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs after taking an inhaled bronchodilator medicine which is used to dilate participant's bronchial (breathing) tubes. Absolute Decline of 10% = FVC percent predicted (baseline) - FVC percent predicted (progression) ≥10%. |
| Time to Death or Lung Transplantation | Up to Week 60 (End of Study) | Time to Death or Lung Transplantation is defined as the time from randomization to the first occurrence of any one of the event (death or lung transplantation). |
| Time to All Non-elective Hospitalizations | Up to Week 60 (End of Study) | Time to all non-elective hospitalizations is defined as the time from randomization to the first occurrence of hospitalization which was not elected by the participant. |
| Time to All Non-Elective Respiratory Hospitalizations | Up to Week 60 (End of Study) | Time to all non-elective respiratory hospitalizations is defined as the time from randomization to the first occurrence of hospitalization due to respiratory problems, which was not elected by the participant. |
| Change From Baseline in Absolute FVC | Up to Week 44 | FVC is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs after taking an inhaled bronchodilator medicine which is used to dilate participant's bronchial (breathing) tubes. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline. |
| Change From Baseline in FVC, Expressed in Percent Predicted at Week 52 | Baseline, Week 52 | FVC is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs after taking an inhaled bronchodilator medicine which is used to dilate participant's bronchial (breathing) tubes. Percent predicted FVC (in %, here FVC was measured in litres) = \[(observed FVC)/(predicted FVC)\]\*100. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline. |
| Change From Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco) | Up to Early Termination Visit (Up to Week 52) | DLCO is a measurement of the ability of the lungs to transfer gases from the air to the blood. Evaluation of DLco was be performed by single-breath carbon monoxide diffusing capacity. DLCO was assessed in milliliters per minute per millimeter of mercury (mL/min/mmHg). Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline. |
| Change From Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco) | Up to Early Termination Visit (Up to Week 52) | DLCO is a measurement of the ability of the lungs to transfer gases from the air to the blood. Evaluation of DLco was be performed by single-breath carbon monoxide diffusing capacity. Percent of predicted DLco (in %) = \[(observed DLco)/(predicted DLco)\]\*100. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline. |
| Change From Baseline in Absolute Total Lung Capacity (TLC) | Up to Early Termination Visit (Up to Week 52) | Total lung capacity is the measure of lung volume was measured by full-body plethysmography. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline. |
| Change From Baseline in Percent Predicted TLC | Up to Early Termination Visit (Up to Week 52) | Total lung capacity is the measure of lung volume was measured by full-body plethysmography. Percent predicted TLC (in %) = \[(observed TLC)/(predicted TLC)\]\*100. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline. |
| Change From Baseline in 6 Minute Walk Test (6MWT) Parameters | Baseline, Week 26 and Week 52 | The 6MWT measures the distance (in meters), a participant is able to walk in 6 minutes. This test measures the distance a person can walk quickly on a flat, hard surface in 6 minutes and reflects an individual's ability to perform daily physical activities. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Week 60 (End of Study) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, requires inpatient hospitalization, results in persistent or significant disability and/or results in a congenital anomaly. |
| Number of Participants With Anti-BG00011 Antibodies in the Serum | Up to Week 60 (End of Study) | — |
| Concentration of BG00011 in the Serum | Predose on Day 0, Day 5, Week 4, Week 8, Week 12, Week 26, Week 38, Week 52, and Safety Follow-up Visit (Up to Week 60) | — |
| Change From Baseline in Percent Predicted FVC | Up to Week 44 | FVC is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs after taking an inhaled bronchodilator medicine which is used to dilate participant's bronchial (breathing) tubes. Percent predicted FVC (in %) = \[(observed FVC)/(predicted FVC)\]\*100. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline. |
Countries
Argentina, Australia, Belgium, Chile, Czechia, Denmark, France, Greece, Israel, Italy, Netherlands, Poland, Russia, South Korea, Spain, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at 47 investigational sites in 16 countries from September 24, 2018 to November 14, 2019.
Pre-assignment details
A total of 109 participants with Idiopathic pulmonary fibrosis (IPF) were enrolled and randomized in this study. Of which, 106 participants received at least one dose of study drug. The maximum length of the dosing period was up to Week 46. Participants were then followed-up for safety for up to Week 60.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was 19.14 weeks. | 52 |
| BG00011 Participants received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was 17.14 weeks. | 54 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Consent withdrawn | 0 | 1 |
| Overall Study | Death | 0 | 4 |
| Overall Study | Disease progression | 0 | 1 |
| Overall Study | Reason not specified | 0 | 1 |
| Overall Study | Site Terminated by Sponsor | 1 | 1 |
| Overall Study | Study terminated by sponsor | 50 | 45 |
Baseline characteristics
| Characteristic | BG00011 | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 69.46 years STANDARD_DEVIATION 7.57 | 68.50 years STANDARD_DEVIATION 6.652 | 68.99 years STANDARD_DEVIATION 7.117 |
| Race/Ethnicity, Customized Asian | 5 Participants | 2 Participants | 7 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 5 Participants | 6 Participants | 11 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 49 Participants | 46 Participants | 95 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 47 Participants | 49 Participants | 96 Participants |
| Sex: Female, Male Female | 11 Participants | 12 Participants | 23 Participants |
| Sex: Female, Male Male | 43 Participants | 40 Participants | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 4 / 54 |
| other Total, other adverse events | 31 / 52 | 40 / 54 |
| serious Total, serious adverse events | 7 / 52 | 15 / 54 |
Outcome results
Primary
Change From Baseline in Forced (Expiratory) Vital Capacity (FVC) at Week 52
FVC is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.
Time frame: Baseline, Week 52
Population: MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo). 'Number analyzed' at Week 52, are a few participants whose early termination visit fell into the analysis visit window of the Week 52 visit. No participant received Week 52 dosing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Forced (Expiratory) Vital Capacity (FVC) at Week 52 | Baseline | 2.883 liters (L) | Standard Deviation 0.7037 |
| Placebo | Change From Baseline in Forced (Expiratory) Vital Capacity (FVC) at Week 52 | Change at Week 52 | -0.308 liters (L) | Standard Deviation 0.1768 |
| BG00011 | Change From Baseline in Forced (Expiratory) Vital Capacity (FVC) at Week 52 | Baseline | 2.867 liters (L) | Standard Deviation 0.8607 |
| BG00011 | Change From Baseline in Forced (Expiratory) Vital Capacity (FVC) at Week 52 | Change at Week 52 | -0.455 liters (L) | Standard Deviation 0.2849 |
Secondary
Change From Baseline in 6 Minute Walk Test (6MWT) Parameters
The 6MWT measures the distance (in meters), a participant is able to walk in 6 minutes. This test measures the distance a person can walk quickly on a flat, hard surface in 6 minutes and reflects an individual's ability to perform daily physical activities.
Time frame: Baseline, Week 26 and Week 52
Population: MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo). 'Number analyzed' are participants with data available for analyses at given timepoint. Participants at Week 52 are a few participants whose early termination visit fell into the analysis visit window of the Week 52 visit. No participant received Week 52 dosing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in 6 Minute Walk Test (6MWT) Parameters | Baseline | 458.4 meters | Standard Deviation 115.33 |
| Placebo | Change From Baseline in 6 Minute Walk Test (6MWT) Parameters | Change at Week 26 | -5.9 meters | Standard Deviation 38.79 |
| Placebo | Change From Baseline in 6 Minute Walk Test (6MWT) Parameters | Change at Week 52 | 44.8 meters | Standard Deviation 87.16 |
| BG00011 | Change From Baseline in 6 Minute Walk Test (6MWT) Parameters | Baseline | 404.0 meters | Standard Deviation 122.61 |
| BG00011 | Change From Baseline in 6 Minute Walk Test (6MWT) Parameters | Change at Week 26 | -28.6 meters | Standard Deviation 67.21 |
| BG00011 | Change From Baseline in 6 Minute Walk Test (6MWT) Parameters | Change at Week 52 | -40.0 meters | Standard Deviation 94.6 |
Secondary
Change From Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco)
DLCO is a measurement of the ability of the lungs to transfer gases from the air to the blood. Evaluation of DLco was be performed by single-breath carbon monoxide diffusing capacity. DLCO was assessed in milliliters per minute per millimeter of mercury (mL/min/mmHg). Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.
Time frame: Up to Early Termination Visit (Up to Week 52)
Population: MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo). 'Number Analyzed' are the participants who were assessed at the specified timepoint in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco) | Change at Week 8 | -0.108 mL/min/mmHg | Standard Deviation 0.5583 |
| Placebo | Change From Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco) | Change at Week 26 | -0.074 mL/min/mmHg | Standard Deviation 0.7756 |
| Placebo | Change From Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco) | Change at Week 4 | -0.094 mL/min/mmHg | Standard Deviation 0.4783 |
| Placebo | Change From Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco) | Change at Week 38 | -0.025 mL/min/mmHg | Standard Deviation 0.5611 |
| Placebo | Change From Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco) | Change at Week 16 | -0.205 mL/min/mmHg | Standard Deviation 0.6579 |
| Placebo | Change From Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco) | Change at Week 52 | -0.228 mL/min/mmHg | Standard Deviation 0.1839 |
| Placebo | Change From Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco) | Baseline | 4.397 mL/min/mmHg | Standard Deviation 1.1853 |
| BG00011 | Change From Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco) | Change at Week 52 | -0.400 mL/min/mmHg | Standard Deviation 0.7921 |
| BG00011 | Change From Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco) | Baseline | 4.036 mL/min/mmHg | Standard Deviation 1.1043 |
| BG00011 | Change From Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco) | Change at Week 4 | 0.019 mL/min/mmHg | Standard Deviation 0.4431 |
| BG00011 | Change From Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco) | Change at Week 8 | 0.028 mL/min/mmHg | Standard Deviation 0.6078 |
| BG00011 | Change From Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco) | Change at Week 16 | -0.263 mL/min/mmHg | Standard Deviation 0.5472 |
| BG00011 | Change From Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco) | Change at Week 26 | -0.383 mL/min/mmHg | Standard Deviation 0.7427 |
| BG00011 | Change From Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco) | Change at Week 38 | -0.445 mL/min/mmHg | Standard Deviation 0.6153 |
Secondary
Change From Baseline in Absolute FVC
FVC is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs after taking an inhaled bronchodilator medicine which is used to dilate participant's bronchial (breathing) tubes. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.
Time frame: Up to Week 44
Population: MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo). 'Number Analyzed' are the participants who were assessed at the specified timepoint in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Absolute FVC | Change at Week 16 | -0.046 liters | Standard Deviation 0.1819 |
| Placebo | Change From Baseline in Absolute FVC | Baseline | 2.883 liters | Standard Deviation 0.7037 |
| Placebo | Change From Baseline in Absolute FVC | Change at Week 26 | -0.079 liters | Standard Deviation 0.1949 |
| Placebo | Change From Baseline in Absolute FVC | Change at Week 8 | -0.030 liters | Standard Deviation 0.1575 |
| Placebo | Change From Baseline in Absolute FVC | Change at Week 32 | -0.078 liters | Standard Deviation 0.1979 |
| Placebo | Change From Baseline in Absolute FVC | Change at Week 20 | -0.086 liters | Standard Deviation 0.1921 |
| Placebo | Change From Baseline in Absolute FVC | Change at Week 38 | -0.131 liters | Standard Deviation 0.1847 |
| Placebo | Change From Baseline in Absolute FVC | Change at Week 12 | -0.020 liters | Standard Deviation 0.1846 |
| Placebo | Change From Baseline in Absolute FVC | Change at Week 44 | -0.200 liters | Standard Deviation 0.2153 |
| Placebo | Change From Baseline in Absolute FVC | Change at Week 4 | 0.006 liters | Standard Deviation 0.1544 |
| BG00011 | Change From Baseline in Absolute FVC | Change at Week 44 | -0.485 liters | Standard Deviation 0.3816 |
| BG00011 | Change From Baseline in Absolute FVC | Baseline | 2.867 liters | Standard Deviation 0.8607 |
| BG00011 | Change From Baseline in Absolute FVC | Change at Week 4 | 0.032 liters | Standard Deviation 0.1526 |
| BG00011 | Change From Baseline in Absolute FVC | Change at Week 8 | 0.007 liters | Standard Deviation 0.1513 |
| BG00011 | Change From Baseline in Absolute FVC | Change at Week 12 | 0.000 liters | Standard Deviation 0.2247 |
| BG00011 | Change From Baseline in Absolute FVC | Change at Week 16 | -0.042 liters | Standard Deviation 0.24 |
| BG00011 | Change From Baseline in Absolute FVC | Change at Week 26 | -0.069 liters | Standard Deviation 0.3045 |
| BG00011 | Change From Baseline in Absolute FVC | Change at Week 32 | -0.152 liters | Standard Deviation 0.3142 |
| BG00011 | Change From Baseline in Absolute FVC | Change at Week 38 | -0.275 liters | Standard Deviation 0.3436 |
| BG00011 | Change From Baseline in Absolute FVC | Change at Week 20 | -0.121 liters | Standard Deviation 0.3318 |
Secondary
Change From Baseline in Absolute Total Lung Capacity (TLC)
Total lung capacity is the measure of lung volume was measured by full-body plethysmography. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.
Time frame: Up to Early Termination Visit (Up to Week 52)
Population: MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo). 'Number Analyzed' are the participants who were assessed at the specified timepoint in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Absolute Total Lung Capacity (TLC) | Baseline | 4.472 liters | Standard Deviation 1.0497 |
| Placebo | Change From Baseline in Absolute Total Lung Capacity (TLC) | Change at Week 4 | 0.090 liters | — |
| Placebo | Change From Baseline in Absolute Total Lung Capacity (TLC) | Change at Week 8 | -0.010 liters | — |
| Placebo | Change From Baseline in Absolute Total Lung Capacity (TLC) | Change at Week 12 | -0.113 liters | Standard Deviation 0.3272 |
| Placebo | Change From Baseline in Absolute Total Lung Capacity (TLC) | Change at Week 16 | 0.060 liters | — |
| Placebo | Change From Baseline in Absolute Total Lung Capacity (TLC) | Change at Week 20 | -0.002 liters | Standard Deviation 0.2344 |
| Placebo | Change From Baseline in Absolute Total Lung Capacity (TLC) | Change at Week 26 | -0.103 liters | Standard Deviation 0.2293 |
| Placebo | Change From Baseline in Absolute Total Lung Capacity (TLC) | Change at Week 32 | -0.370 liters | — |
| Placebo | Change From Baseline in Absolute Total Lung Capacity (TLC) | Change at Week 38 | -0.090 liters | Standard Deviation 0.2263 |
| Placebo | Change From Baseline in Absolute Total Lung Capacity (TLC) | Change at Week 44 | -0.160 liters | Standard Deviation 0.0283 |
| Placebo | Change From Baseline in Absolute Total Lung Capacity (TLC) | Change at Week 52 | -0.197 liters | Standard Deviation 0.3075 |
| BG00011 | Change From Baseline in Absolute Total Lung Capacity (TLC) | Change at Week 4 | -0.080 liters | Standard Deviation 0.2276 |
| BG00011 | Change From Baseline in Absolute Total Lung Capacity (TLC) | Change at Week 26 | -0.214 liters | Standard Deviation 0.4403 |
| BG00011 | Change From Baseline in Absolute Total Lung Capacity (TLC) | Change at Week 52 | -0.695 liters | Standard Deviation 0.3465 |
| BG00011 | Change From Baseline in Absolute Total Lung Capacity (TLC) | Change at Week 12 | 0.380 liters | — |
| BG00011 | Change From Baseline in Absolute Total Lung Capacity (TLC) | Change at Week 32 | 0.140 liters | — |
| BG00011 | Change From Baseline in Absolute Total Lung Capacity (TLC) | Change at Week 16 | -0.350 liters | Standard Deviation 0.2131 |
| BG00011 | Change From Baseline in Absolute Total Lung Capacity (TLC) | Baseline | 4.413 liters | Standard Deviation 1.056 |
| BG00011 | Change From Baseline in Absolute Total Lung Capacity (TLC) | Change at Week 20 | -0.310 liters | Standard Deviation 0.3476 |
| BG00011 | Change From Baseline in Absolute Total Lung Capacity (TLC) | Change at Week 38 | -0.023 liters | Standard Deviation 0.4754 |
Secondary
Change From Baseline in FVC, Expressed in Percent Predicted at Week 52
FVC is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs after taking an inhaled bronchodilator medicine which is used to dilate participant's bronchial (breathing) tubes. Percent predicted FVC (in %, here FVC was measured in litres) = \[(observed FVC)/(predicted FVC)\]\*100. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.
Time frame: Baseline, Week 52
Population: MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo). 'Number analyzed' at Week 52, are a few participants whose early termination visit fell into the analysis visit window of the Week 52 visit. No participant received Week 52 dosing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in FVC, Expressed in Percent Predicted at Week 52 | Change at Week 52 | -7.6 percentage of predicted FVC | Standard Deviation 5.22 |
| Placebo | Change From Baseline in FVC, Expressed in Percent Predicted at Week 52 | Baseline | 76.1 percentage of predicted FVC | Standard Deviation 15.46 |
| BG00011 | Change From Baseline in FVC, Expressed in Percent Predicted at Week 52 | Baseline | 77.4 percentage of predicted FVC | Standard Deviation 17.07 |
| BG00011 | Change From Baseline in FVC, Expressed in Percent Predicted at Week 52 | Change at Week 52 | -11.5 percentage of predicted FVC | Standard Deviation 6.95 |
Secondary
Change From Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco)
DLCO is a measurement of the ability of the lungs to transfer gases from the air to the blood. Evaluation of DLco was be performed by single-breath carbon monoxide diffusing capacity. Percent of predicted DLco (in %) = \[(observed DLco)/(predicted DLco)\]\*100. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.
Time frame: Up to Early Termination Visit (Up to Week 52)
Population: MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo). 'Number Analyzed' are the participants who were assessed at the specified timepoint in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco) | Change at Week 8 | -1.5 percentage of predicted DLco | Standard Deviation 6.75 |
| Placebo | Change From Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco) | Change at Week 26 | -1.3 percentage of predicted DLco | Standard Deviation 9.1 |
| Placebo | Change From Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco) | Change at Week 4 | -1.1 percentage of predicted DLco | Standard Deviation 5.62 |
| Placebo | Change From Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco) | Change at Week 38 | -0.5 percentage of predicted DLco | Standard Deviation 6.42 |
| Placebo | Change From Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco) | Change at Week 16 | -2.4 percentage of predicted DLco | Standard Deviation 7.48 |
| Placebo | Change From Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco) | Change at Week 52 | -2.4 percentage of predicted DLco | Standard Deviation 1.82 |
| Placebo | Change From Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco) | Baseline | 52.6 percentage of predicted DLco | Standard Deviation 13.56 |
| BG00011 | Change From Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco) | Change at Week 52 | -4.0 percentage of predicted DLco | Standard Deviation 9.56 |
| BG00011 | Change From Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco) | Baseline | 49.1 percentage of predicted DLco | Standard Deviation 11.15 |
| BG00011 | Change From Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco) | Change at Week 4 | 0.4 percentage of predicted DLco | Standard Deviation 5.08 |
| BG00011 | Change From Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco) | Change at Week 8 | 0.5 percentage of predicted DLco | Standard Deviation 7.78 |
| BG00011 | Change From Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco) | Change at Week 16 | -3.1 percentage of predicted DLco | Standard Deviation 6.49 |
| BG00011 | Change From Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco) | Change at Week 26 | -4.8 percentage of predicted DLco | Standard Deviation 8.78 |
| BG00011 | Change From Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco) | Change at Week 38 | -5.5 percentage of predicted DLco | Standard Deviation 6.82 |
Secondary
Change From Baseline in Percent Predicted FVC
FVC is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs after taking an inhaled bronchodilator medicine which is used to dilate participant's bronchial (breathing) tubes. Percent predicted FVC (in %) = \[(observed FVC)/(predicted FVC)\]\*100. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.
Time frame: Up to Week 44
Population: MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo). 'Number Analyzed' are the participants who were assessed at the specified timepoint in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Percent Predicted FVC | Baseline | 76.1 percentage of predicted FVC | Standard Deviation 15.46 |
| Placebo | Change From Baseline in Percent Predicted FVC | Change at Week 4 | 0.1 percentage of predicted FVC | Standard Deviation 4.13 |
| Placebo | Change From Baseline in Percent Predicted FVC | Change at Week 8 | -0.7 percentage of predicted FVC | Standard Deviation 4.22 |
| Placebo | Change From Baseline in Percent Predicted FVC | Change at Week 12 | -0.4 percentage of predicted FVC | Standard Deviation 5.31 |
| Placebo | Change From Baseline in Percent Predicted FVC | Change at Week 16 | -1.1 percentage of predicted FVC | Standard Deviation 4.97 |
| Placebo | Change From Baseline in Percent Predicted FVC | Change at Week 20 | -2.3 percentage of predicted FVC | Standard Deviation 5.04 |
| Placebo | Change From Baseline in Percent Predicted FVC | Change at Week 26 | -2.0 percentage of predicted FVC | Standard Deviation 5.6 |
| Placebo | Change From Baseline in Percent Predicted FVC | Change at Week 32 | -1.9 percentage of predicted FVC | Standard Deviation 5.44 |
| Placebo | Change From Baseline in Percent Predicted FVC | Change at Week 38 | -3.4 percentage of predicted FVC | Standard Deviation 5.43 |
| Placebo | Change From Baseline in Percent Predicted FVC | Change at Week 44 | -5.1 percentage of predicted FVC | Standard Deviation 6.08 |
| BG00011 | Change From Baseline in Percent Predicted FVC | Change at Week 32 | -3.7 percentage of predicted FVC | Standard Deviation 8.66 |
| BG00011 | Change From Baseline in Percent Predicted FVC | Baseline | 77.4 percentage of predicted FVC | Standard Deviation 17.07 |
| BG00011 | Change From Baseline in Percent Predicted FVC | Change at Week 20 | -3.0 percentage of predicted FVC | Standard Deviation 8.08 |
| BG00011 | Change From Baseline in Percent Predicted FVC | Change at Week 4 | 1.1 percentage of predicted FVC | Standard Deviation 4.52 |
| BG00011 | Change From Baseline in Percent Predicted FVC | Change at Week 44 | -12.5 percentage of predicted FVC | Standard Deviation 9.26 |
| BG00011 | Change From Baseline in Percent Predicted FVC | Change at Week 8 | 0.4 percentage of predicted FVC | Standard Deviation 4.12 |
| BG00011 | Change From Baseline in Percent Predicted FVC | Change at Week 26 | -1.6 percentage of predicted FVC | Standard Deviation 8.19 |
| BG00011 | Change From Baseline in Percent Predicted FVC | Change at Week 12 | 0.1 percentage of predicted FVC | Standard Deviation 5.79 |
| BG00011 | Change From Baseline in Percent Predicted FVC | Change at Week 38 | -7.4 percentage of predicted FVC | Standard Deviation 8.44 |
| BG00011 | Change From Baseline in Percent Predicted FVC | Change at Week 16 | -0.8 percentage of predicted FVC | Standard Deviation 6.24 |
Secondary
Change From Baseline in Percent Predicted TLC
Total lung capacity is the measure of lung volume was measured by full-body plethysmography. Percent predicted TLC (in %) = \[(observed TLC)/(predicted TLC)\]\*100. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.
Time frame: Up to Early Termination Visit (Up to Week 52)
Population: MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo). 'Number Analyzed' are the participants who were assessed at the specified timepoint in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Percent Predicted TLC | Change at Week 26 | -1.6 percentage of predicted TLC | Standard Deviation 3.78 |
| Placebo | Change From Baseline in Percent Predicted TLC | Change at Week 4 | 2.0 percentage of predicted TLC | — |
| Placebo | Change From Baseline in Percent Predicted TLC | Change at Week 32 | -5.0 percentage of predicted TLC | — |
| Placebo | Change From Baseline in Percent Predicted TLC | Change at Week 16 | 1.0 percentage of predicted TLC | — |
| Placebo | Change From Baseline in Percent Predicted TLC | Change at Week 38 | -2.0 percentage of predicted TLC | Standard Deviation 4.24 |
| Placebo | Change From Baseline in Percent Predicted TLC | Change at Week 8 | 0.0 percentage of predicted TLC | — |
| Placebo | Change From Baseline in Percent Predicted TLC | Change at Week 44 | -2.0 percentage of predicted TLC | Standard Deviation 0 |
| Placebo | Change From Baseline in Percent Predicted TLC | Change at Week 52 | -2.7 percentage of predicted TLC | Standard Deviation 3.79 |
| Placebo | Change From Baseline in Percent Predicted TLC | Baseline | 69.6 percentage of predicted TLC | Standard Deviation 14.67 |
| Placebo | Change From Baseline in Percent Predicted TLC | Change at Week 20 | 0.0 percentage of predicted TLC | Standard Deviation 3.81 |
| Placebo | Change From Baseline in Percent Predicted TLC | Change at Week 12 | -1.3 percentage of predicted TLC | Standard Deviation 4.93 |
| BG00011 | Change From Baseline in Percent Predicted TLC | Change at Week 52 | -10.5 percentage of predicted TLC | Standard Deviation 3.54 |
| BG00011 | Change From Baseline in Percent Predicted TLC | Baseline | 67.7 percentage of predicted TLC | Standard Deviation 12.74 |
| BG00011 | Change From Baseline in Percent Predicted TLC | Change at Week 4 | -1.3 percentage of predicted TLC | Standard Deviation 3.5 |
| BG00011 | Change From Baseline in Percent Predicted TLC | Change at Week 12 | 5.0 percentage of predicted TLC | — |
| BG00011 | Change From Baseline in Percent Predicted TLC | Change at Week 16 | -4.8 percentage of predicted TLC | Standard Deviation 2.75 |
| BG00011 | Change From Baseline in Percent Predicted TLC | Change at Week 20 | -5.8 percentage of predicted TLC | Standard Deviation 5.76 |
| BG00011 | Change From Baseline in Percent Predicted TLC | Change at Week 26 | -3.0 percentage of predicted TLC | Standard Deviation 6.12 |
| BG00011 | Change From Baseline in Percent Predicted TLC | Change at Week 32 | 3.0 percentage of predicted TLC | — |
| BG00011 | Change From Baseline in Percent Predicted TLC | Change at Week 38 | -0.3 percentage of predicted TLC | Standard Deviation 6.51 |
Secondary
Concentration of BG00011 in the Serum
Time frame: Predose on Day 0, Day 5, Week 4, Week 8, Week 12, Week 26, Week 38, Week 52, and Safety Follow-up Visit (Up to Week 60)
Population: Pharmacokinetics (PK) population included all participants who received at least 1 dose of study treatment and had at least one PK concentration measurement. Participants at Week 52 are a few participants whose early termination visit fell into the analysis visit window of the Week 52 visit. No participant received Week 52 dosing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Concentration of BG00011 in the Serum | Baseline | 0 nanograms (ng)/mL | Standard Deviation 0 |
| Placebo | Concentration of BG00011 in the Serum | Day 5 | 2292.83 nanograms (ng)/mL | Standard Deviation 1778.376 |
| Placebo | Concentration of BG00011 in the Serum | Week 4 | 5323.08 nanograms (ng)/mL | Standard Deviation 3058.436 |
| Placebo | Concentration of BG00011 in the Serum | Week 8 | 7971.05 nanograms (ng)/mL | Standard Deviation 4912.091 |
| Placebo | Concentration of BG00011 in the Serum | Week 12 | 7768.33 nanograms (ng)/mL | Standard Deviation 5139.179 |
| Placebo | Concentration of BG00011 in the Serum | Week 16 | 6934.86 nanograms (ng)/mL | Standard Deviation 4288.642 |
| Placebo | Concentration of BG00011 in the Serum | Week 20 | 6614.24 nanograms (ng)/mL | Standard Deviation 4203.02 |
| Placebo | Concentration of BG00011 in the Serum | Week 26 | 8579.42 nanograms (ng)/mL | Standard Deviation 9754.642 |
| Placebo | Concentration of BG00011 in the Serum | Week 38 | 3560.00 nanograms (ng)/mL | Standard Deviation 2771.63 |
| Placebo | Concentration of BG00011 in the Serum | Week 52 | 1085.33 nanograms (ng)/mL | Standard Deviation 455.978 |
| Placebo | Concentration of BG00011 in the Serum | Safety Follow-up Visit | 344.64 nanograms (ng)/mL | Standard Deviation 701.639 |
Secondary
Number of IPF Exacerbations
The IPF exacerbation is defined as a clinically significant deterioration of unidentifiable cause in a participant with underlying IPF. The diagnostic criteria for IPF used in this study were derived from evidence-based guidelines developed by the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) joint task force for the diagnosis and management of IPF. Participants were assessed according to the modified 2007 diagnostic criteria for acute IPF exacerbation.
Time frame: Up to Early Termination Visit (Up to Week 52)
Population: MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of IPF Exacerbations | 0 exacerbations |
| BG00011 | Number of IPF Exacerbations | 8 exacerbations |
Secondary
Number of Participants With Absolute Decline of 10% Predicted in FVC
FVC is the is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs after taking an inhaled bronchodilator medicine which is used to dilate participant's bronchial (breathing) tubes. Absolute Decline of 10% = FVC percent predicted (baseline) - FVC percent predicted (progression) ≥10%.
Time frame: Up to Early Termination Visit (Up to Week 52)
Population: MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Absolute Decline of 10% Predicted in FVC | 6 Participants |
| BG00011 | Number of Participants With Absolute Decline of 10% Predicted in FVC | 9 Participants |
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, requires inpatient hospitalization, results in persistent or significant disability and/or results in a congenital anomaly.
Time frame: Up to Week 60 (End of Study)
Population: The safety population included all participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 39 Participants |
| Placebo | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 7 Participants |
| BG00011 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 47 Participants |
| BG00011 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 15 Participants |
Secondary
Number of Participants With Anti-BG00011 Antibodies in the Serum
Time frame: Up to Week 60 (End of Study)
Population: The immunogenicity population defined as participants from mITT population who have at least 1 postdose immunogenicity sample evaluated for anti-BG00011 antibodies. 'Number of participants analyzed' are those who were assessed in this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Anti-BG00011 Antibodies in the Serum | 1 Participants |
| BG00011 | Number of Participants With Anti-BG00011 Antibodies in the Serum | 0 Participants |
Secondary
Number of Participants With at Least One Acute IPF Exacerbation
Acute IPF exacerbation is defined as a clinically significant deterioration of unidentifiable cause in a participant with underlying IPF. The diagnostic criteria for IPF used in this study were derived from evidence-based guidelines developed by the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) joint task force for the diagnosis and management of IPF. Participants were assessed according to the modified 2007 diagnostic criteria for acute IPF exacerbation.
Time frame: Up to Early Termination Visit (Up to Week 52)
Population: MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With at Least One Acute IPF Exacerbation | 0 Participants |
| BG00011 | Number of Participants With at Least One Acute IPF Exacerbation | 7 Participants |
Secondary
Time to All Non-elective Hospitalizations
Time to all non-elective hospitalizations is defined as the time from randomization to the first occurrence of hospitalization which was not elected by the participant.
Time frame: Up to Week 60 (End of Study)
Population: The MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or Placebo). 'Overall number of participants analyzed' are the participants who had at least one episode of non-elective hospitalization.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to All Non-elective Hospitalizations | 133.0 days |
| BG00011 | Time to All Non-elective Hospitalizations | 119.0 days |
Secondary
Time to All Non-Elective Respiratory Hospitalizations
Time to all non-elective respiratory hospitalizations is defined as the time from randomization to the first occurrence of hospitalization due to respiratory problems, which was not elected by the participant.
Time frame: Up to Week 60 (End of Study)
Population: The MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or Placebo). 'Overall number of participants analyzed' are the participants who had at least one episode of non-elective respiratory hospitalization.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to All Non-Elective Respiratory Hospitalizations | 205.0 days |
| BG00011 | Time to All Non-Elective Respiratory Hospitalizations | 119.0 days |
Secondary
Time to Death or Lung Transplantation
Time to Death or Lung Transplantation is defined as the time from randomization to the first occurrence of any one of the event (death or lung transplantation).
Time frame: Up to Week 60 (End of Study)
Population: MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or Placebo).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| BG00011 | Time to Death or Lung Transplantation | Time to Death | 83.0 days |
| BG00011 | Time to Death or Lung Transplantation | Time to Lung Transplantation | 155.0 days |
Secondary
Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation
Time to first acute IPF exacerbation is defined as time from randomization to the first occurrence of acute IPF exacerbation. Acute IPF exacerbation is defined as a clinically significant deterioration of unidentifiable cause in a participant with underlying IPF. The diagnostic criteria for IPF used in this study were derived from evidence-based guidelines developed by the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) joint task force for the diagnosis and management of IPF. Participants were assessed according to the modified 2007 diagnostic criteria for acute IPF exacerbation.
Time frame: Up to Early Termination Visit (Up to Week 52)
Population: MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo). 'Overall number of participants analyzed' are participants who had at least one acute IPF exacerbation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BG00011 | Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation | 114.0 days |
Secondary
Time to Progression
Time to progression is defined by a composite endpoint, including any of the following events: Absolute decline of 10% predicted in FVC (FVC percent predicted (baseline) - FVC percent predicted (progression) ≥10%); Non-elective hospitalization for respiratory events; Lung transplantation or death. The earliest time to meet at least 1 composite criterion was calculated.
Time frame: Up to Week 60 (End of Study)
Population: MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo). 'Overall number of participants analyzed' are the participants who were assessed in this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Progression | 127.5 days |
| BG00011 | Time to Progression | 119.0 days |
Comparison: A cox proportional hazards model with terms for treatment (BG00011 vs. placebo) and randomization stratification factor is used. A stratified log-rank test is used to compare the 2 treatment groups using randomization stratus as the stratification factor. An HR (Hazard Ratio) \< 1 indicates lower risk of event for the BG00011 group where HR is based on Cox proportional hazard model with treatment (Placebo, BG00011) as the categorical covariate.p-value: 0.11295% CI: [0.85, 4.73]Log Rank