| 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. | 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. | Posted | | Mean | Standard Deviation | liters (L) | | Baseline, Week 52 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
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| Baseline | - ParticipantsOG00052
- ParticipantsOG00154
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| 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. | 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. | Posted | | Mean | Standard Deviation | percentage of predicted FVC | | Baseline, Week 52 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Median | Full Range | days | | Up to Week 60 (End of Study) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Median | Full Range | days | | Up to Early Termination Visit (Up to Week 52) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo). | Posted | | Count of Participants | | Participants | | Up to Early Termination Visit (Up to Week 52) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo). | Posted | | Number | | exacerbations | | Up to Early Termination Visit (Up to Week 52) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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%. | MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo). | Posted | | Count of Participants | | Participants | | Up to Early Termination Visit (Up to Week 52) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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). | MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or Placebo). | Posted | | Median | Full Range | days | | Up to Week 60 (End of Study) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Median | Full Range | days | | Up to Week 60 (End of Study) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Median | Full Range | days | | Up to Week 60 (End of Study) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | liters | | Up to Week 44 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | percentage of predicted FVC | | Up to Week 44 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | mL/min/mmHg | | Up to Early Termination Visit (Up to Week 52) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | percentage of predicted DLco | | Up to Early Termination Visit (Up to Week 52) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | liters | | Up to Early Termination Visit (Up to Week 52) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | percentage of predicted TLC | | Up to Early Termination Visit (Up to Week 52) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | meters | | Baseline, Week 26 and Week 52 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | The safety population included all participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo). | Posted | | Count of Participants | | Participants | | Up to Week 60 (End of Study) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Number of Participants With Anti-BG00011 Antibodies in the Serum | | 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. | Posted | | Count of Participants | | Participants | | Up to Week 60 (End of Study) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Concentration of BG00011 in the Serum | | 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. | Posted | | Mean | Standard Deviation | nanograms (ng)/mL | | 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) | | | | ID | Title | Description |
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| OG000 | 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. |
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