Trial Outcomes & Findings for An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis (NCT NCT03573505)
NCT ID: NCT03573505
Last Updated: 2020-12-11
Results Overview
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.
TERMINATED
PHASE2
109 participants
Baseline, Week 52
2020-12-11
Participant Flow
Participants were enrolled at 47 investigational sites in 16 countries from September 24, 2018 to November 14, 2019.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
54
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
52
|
54
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Consent withdrawn
|
0
|
1
|
|
Overall Study
Disease progression
|
0
|
1
|
|
Overall Study
Site Terminated by Sponsor
|
1
|
1
|
|
Overall Study
Study terminated by sponsor
|
50
|
45
|
|
Overall Study
Reason not specified
|
0
|
1
|
|
Overall Study
Death
|
0
|
4
|
Baseline Characteristics
An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis
Baseline characteristics by cohort
| Measure |
Placebo
n=52 Participants
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.
|
BG00011
n=54 Participants
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.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.50 years
STANDARD_DEVIATION 6.652 • n=5 Participants
|
69.46 years
STANDARD_DEVIATION 7.570 • n=7 Participants
|
68.99 years
STANDARD_DEVIATION 7.117 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
46 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
49 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 52Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=52 Participants
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.
|
BG00011
n=54 Participants
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.
|
|---|---|---|
|
Change From Baseline in Forced (Expiratory) Vital Capacity (FVC) at Week 52
Baseline
|
2.883 liters (L)
Standard Deviation 0.7037
|
2.867 liters (L)
Standard Deviation 0.8607
|
|
Change From Baseline in Forced (Expiratory) Vital Capacity (FVC) at Week 52
Change at Week 52
|
-0.308 liters (L)
Standard Deviation 0.1768
|
-0.455 liters (L)
Standard Deviation 0.2849
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=52 Participants
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.
|
BG00011
n=54 Participants
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.
|
|---|---|---|
|
Change From Baseline in FVC, Expressed in Percent Predicted at Week 52
Baseline
|
76.1 percentage of predicted FVC
Standard Deviation 15.46
|
77.4 percentage of predicted FVC
Standard Deviation 17.07
|
|
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
|
-11.5 percentage of predicted FVC
Standard Deviation 6.95
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=8 Participants
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.
|
BG00011
n=15 Participants
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.
|
|---|---|---|
|
Time to Progression
|
127.5 days
Interval 29.0 to 235.0
|
119.0 days
Interval 28.0 to 302.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
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.
|
BG00011
n=7 Participants
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.
|
|---|---|---|
|
Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation
|
—
|
114.0 days
Interval 42.0 to 223.0
|
SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Placebo
n=52 Participants
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.
|
BG00011
n=54 Participants
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.
|
|---|---|---|
|
Number of Participants With at Least One Acute IPF Exacerbation
|
0 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Placebo
n=52 Participants
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.
|
BG00011
n=54 Participants
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.
|
|---|---|---|
|
Number of IPF Exacerbations
|
0 exacerbations
|
8 exacerbations
|
SECONDARY outcome
Timeframe: 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).
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%.
Outcome measures
| Measure |
Placebo
n=52 Participants
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.
|
BG00011
n=54 Participants
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.
|
|---|---|---|
|
Number of Participants With Absolute Decline of 10% Predicted in FVC
|
6 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 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).
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).
Outcome measures
| Measure |
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.
|
BG00011
n=54 Participants
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.
|
|---|---|---|
|
Time to Death or Lung Transplantation
Time to Death
|
—
|
83.0 days
Interval 60.0 to 137.0
|
|
Time to Death or Lung Transplantation
Time to Lung Transplantation
|
—
|
155.0 days
Interval 155.0 to 155.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=5 Participants
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.
|
BG00011
n=11 Participants
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.
|
|---|---|---|
|
Time to All Non-elective Hospitalizations
|
133.0 days
Interval 61.0 to 235.0
|
119.0 days
Interval 42.0 to 302.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=2 Participants
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.
|
BG00011
n=9 Participants
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.
|
|---|---|---|
|
Time to All Non-Elective Respiratory Hospitalizations
|
205.0 days
Interval 175.0 to 235.0
|
119.0 days
Interval 42.0 to 223.0
|
SECONDARY outcome
Timeframe: Up to Week 44Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=52 Participants
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.
|
BG00011
n=54 Participants
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.
|
|---|---|---|
|
Change From Baseline in Absolute FVC
Change at Week 8
|
-0.030 liters
Standard Deviation 0.1575
|
0.007 liters
Standard Deviation 0.1513
|
|
Change From Baseline in Absolute FVC
Change at Week 26
|
-0.079 liters
Standard Deviation 0.1949
|
-0.069 liters
Standard Deviation 0.3045
|
|
Change From Baseline in Absolute FVC
Change at Week 44
|
-0.200 liters
Standard Deviation 0.2153
|
-0.485 liters
Standard Deviation 0.3816
|
|
Change From Baseline in Absolute FVC
Baseline
|
2.883 liters
Standard Deviation 0.7037
|
2.867 liters
Standard Deviation 0.8607
|
|
Change From Baseline in Absolute FVC
Change at Week 4
|
0.006 liters
Standard Deviation 0.1544
|
0.032 liters
Standard Deviation 0.1526
|
|
Change From Baseline in Absolute FVC
Change at Week 12
|
-0.020 liters
Standard Deviation 0.1846
|
0.000 liters
Standard Deviation 0.2247
|
|
Change From Baseline in Absolute FVC
Change at Week 16
|
-0.046 liters
Standard Deviation 0.1819
|
-0.042 liters
Standard Deviation 0.2400
|
|
Change From Baseline in Absolute FVC
Change at Week 20
|
-0.086 liters
Standard Deviation 0.1921
|
-0.121 liters
Standard Deviation 0.3318
|
|
Change From Baseline in Absolute FVC
Change at Week 32
|
-0.078 liters
Standard Deviation 0.1979
|
-0.152 liters
Standard Deviation 0.3142
|
|
Change From Baseline in Absolute FVC
Change at Week 38
|
-0.131 liters
Standard Deviation 0.1847
|
-0.275 liters
Standard Deviation 0.3436
|
SECONDARY outcome
Timeframe: Up to Week 44Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=52 Participants
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.
|
BG00011
n=54 Participants
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.
|
|---|---|---|
|
Change From Baseline in Percent Predicted FVC
Baseline
|
76.1 percentage of predicted FVC
Standard Deviation 15.46
|
77.4 percentage of predicted FVC
Standard Deviation 17.07
|
|
Change From Baseline in Percent Predicted FVC
Change at Week 8
|
-0.7 percentage of predicted FVC
Standard Deviation 4.22
|
0.4 percentage of predicted FVC
Standard Deviation 4.12
|
|
Change From Baseline in Percent Predicted FVC
Change at Week 38
|
-3.4 percentage of predicted FVC
Standard Deviation 5.43
|
-7.4 percentage of predicted FVC
Standard Deviation 8.44
|
|
Change From Baseline in Percent Predicted FVC
Change at Week 4
|
0.1 percentage of predicted FVC
Standard Deviation 4.13
|
1.1 percentage of predicted FVC
Standard Deviation 4.52
|
|
Change From Baseline in Percent Predicted FVC
Change at Week 12
|
-0.4 percentage of predicted FVC
Standard Deviation 5.31
|
0.1 percentage of predicted FVC
Standard Deviation 5.79
|
|
Change From Baseline in Percent Predicted FVC
Change at Week 16
|
-1.1 percentage of predicted FVC
Standard Deviation 4.97
|
-0.8 percentage of predicted FVC
Standard Deviation 6.24
|
|
Change From Baseline in Percent Predicted FVC
Change at Week 20
|
-2.3 percentage of predicted FVC
Standard Deviation 5.04
|
-3.0 percentage of predicted FVC
Standard Deviation 8.08
|
|
Change From Baseline in Percent Predicted FVC
Change at Week 26
|
-2.0 percentage of predicted FVC
Standard Deviation 5.60
|
-1.6 percentage of predicted FVC
Standard Deviation 8.19
|
|
Change From Baseline in Percent Predicted FVC
Change at Week 32
|
-1.9 percentage of predicted FVC
Standard Deviation 5.44
|
-3.7 percentage of predicted FVC
Standard Deviation 8.66
|
|
Change From Baseline in Percent Predicted FVC
Change at Week 44
|
-5.1 percentage of predicted FVC
Standard Deviation 6.08
|
-12.5 percentage of predicted FVC
Standard Deviation 9.26
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=52 Participants
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.
|
BG00011
n=54 Participants
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.
|
|---|---|---|
|
Change From Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco)
Baseline
|
4.397 mL/min/mmHg
Standard Deviation 1.1853
|
4.036 mL/min/mmHg
Standard Deviation 1.1043
|
|
Change From Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco)
Change at Week 4
|
-0.094 mL/min/mmHg
Standard Deviation 0.4783
|
0.019 mL/min/mmHg
Standard Deviation 0.4431
|
|
Change From Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco)
Change at Week 8
|
-0.108 mL/min/mmHg
Standard Deviation 0.5583
|
0.028 mL/min/mmHg
Standard Deviation 0.6078
|
|
Change From Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco)
Change at Week 16
|
-0.205 mL/min/mmHg
Standard Deviation 0.6579
|
-0.263 mL/min/mmHg
Standard Deviation 0.5472
|
|
Change From Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco)
Change at Week 26
|
-0.074 mL/min/mmHg
Standard Deviation 0.7756
|
-0.383 mL/min/mmHg
Standard Deviation 0.7427
|
|
Change From Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco)
Change at Week 38
|
-0.025 mL/min/mmHg
Standard Deviation 0.5611
|
-0.445 mL/min/mmHg
Standard Deviation 0.6153
|
|
Change From Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco)
Change at Week 52
|
-0.228 mL/min/mmHg
Standard Deviation 0.1839
|
-0.400 mL/min/mmHg
Standard Deviation 0.7921
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=52 Participants
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.
|
BG00011
n=54 Participants
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.
|
|---|---|---|
|
Change From Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco)
Baseline
|
52.6 percentage of predicted DLco
Standard Deviation 13.56
|
49.1 percentage of predicted DLco
Standard Deviation 11.15
|
|
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
|
0.4 percentage of predicted DLco
Standard Deviation 5.08
|
|
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
|
0.5 percentage of predicted DLco
Standard Deviation 7.78
|
|
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
|
-3.1 percentage of predicted DLco
Standard Deviation 6.49
|
|
Change From Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco)
Change at Week 26
|
-1.3 percentage of predicted DLco
Standard Deviation 9.10
|
-4.8 percentage of predicted DLco
Standard Deviation 8.78
|
|
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
|
-5.5 percentage of predicted DLco
Standard Deviation 6.82
|
|
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
|
-4.0 percentage of predicted DLco
Standard Deviation 9.56
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=52 Participants
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.
|
BG00011
n=54 Participants
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.
|
|---|---|---|
|
Change From Baseline in Absolute Total Lung Capacity (TLC)
Baseline
|
4.472 liters
Standard Deviation 1.0497
|
4.413 liters
Standard Deviation 1.0560
|
|
Change From Baseline in Absolute Total Lung Capacity (TLC)
Change at Week 4
|
0.090 liters
Standard Deviation NA
NA indicates that SD was not calculable as there was only 1 participant.
|
-0.080 liters
Standard Deviation 0.2276
|
|
Change From Baseline in Absolute Total Lung Capacity (TLC)
Change at Week 8
|
-0.010 liters
Standard Deviation NA
NA indicates that SD was not calculable as there was only 1 participant.
|
—
|
|
Change From Baseline in Absolute Total Lung Capacity (TLC)
Change at Week 12
|
-0.113 liters
Standard Deviation 0.3272
|
0.380 liters
Standard Deviation NA
NA indicates that SD was not calculable as there was only 1 participant.
|
|
Change From Baseline in Absolute Total Lung Capacity (TLC)
Change at Week 16
|
0.060 liters
Standard Deviation NA
NA indicates that SD was not calculable as there was only 1 participant.
|
-0.350 liters
Standard Deviation 0.2131
|
|
Change From Baseline in Absolute Total Lung Capacity (TLC)
Change at Week 20
|
-0.002 liters
Standard Deviation 0.2344
|
-0.310 liters
Standard Deviation 0.3476
|
|
Change From Baseline in Absolute Total Lung Capacity (TLC)
Change at Week 26
|
-0.103 liters
Standard Deviation 0.2293
|
-0.214 liters
Standard Deviation 0.4403
|
|
Change From Baseline in Absolute Total Lung Capacity (TLC)
Change at Week 32
|
-0.370 liters
Standard Deviation NA
NA indicates that SD was not calculable as there was only 1 participant.
|
0.140 liters
Standard Deviation NA
NA indicates that SD was not calculable as there was only 1 participant.
|
|
Change From Baseline in Absolute Total Lung Capacity (TLC)
Change at Week 38
|
-0.090 liters
Standard Deviation 0.2263
|
-0.023 liters
Standard Deviation 0.4754
|
|
Change From Baseline in Absolute Total Lung Capacity (TLC)
Change at Week 44
|
-0.160 liters
Standard Deviation 0.0283
|
—
|
|
Change From Baseline in Absolute Total Lung Capacity (TLC)
Change at Week 52
|
-0.197 liters
Standard Deviation 0.3075
|
-0.695 liters
Standard Deviation 0.3465
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=52 Participants
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.
|
BG00011
n=54 Participants
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.
|
|---|---|---|
|
Change From Baseline in Percent Predicted TLC
Change at Week 20
|
0.0 percentage of predicted TLC
Standard Deviation 3.81
|
-5.8 percentage of predicted TLC
Standard Deviation 5.76
|
|
Change From Baseline in Percent Predicted TLC
Change at Week 26
|
-1.6 percentage of predicted TLC
Standard Deviation 3.78
|
-3.0 percentage of predicted TLC
Standard Deviation 6.12
|
|
Change From Baseline in Percent Predicted TLC
Change at Week 38
|
-2.0 percentage of predicted TLC
Standard Deviation 4.24
|
-0.3 percentage of predicted TLC
Standard Deviation 6.51
|
|
Change From Baseline in Percent Predicted TLC
Change at Week 44
|
-2.0 percentage of predicted TLC
Standard Deviation 0.00
|
—
|
|
Change From Baseline in Percent Predicted TLC
Baseline
|
69.6 percentage of predicted TLC
Standard Deviation 14.67
|
67.7 percentage of predicted TLC
Standard Deviation 12.74
|
|
Change From Baseline in Percent Predicted TLC
Change at Week 4
|
2.0 percentage of predicted TLC
Standard Deviation NA
NA indicates that SD was not calculable as there was only 1 participant.
|
-1.3 percentage of predicted TLC
Standard Deviation 3.50
|
|
Change From Baseline in Percent Predicted TLC
Change at Week 8
|
0.0 percentage of predicted TLC
Standard Deviation NA
NA indicates that SD was not calculable as there was only 1 participant.
|
—
|
|
Change From Baseline in Percent Predicted TLC
Change at Week 12
|
-1.3 percentage of predicted TLC
Standard Deviation 4.93
|
5.0 percentage of predicted TLC
Standard Deviation NA
NA indicates that SD was not calculable as there was only 1 participant.
|
|
Change From Baseline in Percent Predicted TLC
Change at Week 16
|
1.0 percentage of predicted TLC
Standard Deviation NA
NA indicates that SD was not calculable as there was only 1 participant.
|
-4.8 percentage of predicted TLC
Standard Deviation 2.75
|
|
Change From Baseline in Percent Predicted TLC
Change at Week 32
|
-5.0 percentage of predicted TLC
Standard Deviation NA
NA indicates that SD was not calculable as there was only 1 participant.
|
3.0 percentage of predicted TLC
Standard Deviation NA
NA indicates that SD was not calculable as there was only 1 participant.
|
|
Change From Baseline in Percent Predicted TLC
Change at Week 52
|
-2.7 percentage of predicted TLC
Standard Deviation 3.79
|
-10.5 percentage of predicted TLC
Standard Deviation 3.54
|
SECONDARY outcome
Timeframe: Baseline, Week 26 and Week 52Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=52 Participants
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.
|
BG00011
n=54 Participants
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.
|
|---|---|---|
|
Change From Baseline in 6 Minute Walk Test (6MWT) Parameters
Change at Week 26
|
-5.9 meters
Standard Deviation 38.79
|
-28.6 meters
Standard Deviation 67.21
|
|
Change From Baseline in 6 Minute Walk Test (6MWT) Parameters
Baseline
|
458.4 meters
Standard Deviation 115.33
|
404.0 meters
Standard Deviation 122.61
|
|
Change From Baseline in 6 Minute Walk Test (6MWT) Parameters
Change at Week 52
|
44.8 meters
Standard Deviation 87.16
|
-40.0 meters
Standard Deviation 94.60
|
SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Placebo
n=52 Participants
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.
|
BG00011
n=54 Participants
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.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
39 Participants
|
47 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
7 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Placebo
n=46 Participants
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.
|
BG00011
n=42 Participants
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.
|
|---|---|---|
|
Number of Participants With Anti-BG00011 Antibodies in the Serum
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Placebo
n=54 Participants
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.
|
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.
|
|---|---|---|
|
Concentration of BG00011 in the Serum
Baseline
|
0 nanograms (ng)/mL
Standard Deviation 0
|
—
|
|
Concentration of BG00011 in the Serum
Day 5
|
2292.83 nanograms (ng)/mL
Standard Deviation 1778.376
|
—
|
|
Concentration of BG00011 in the Serum
Week 4
|
5323.08 nanograms (ng)/mL
Standard Deviation 3058.436
|
—
|
|
Concentration of BG00011 in the Serum
Week 8
|
7971.05 nanograms (ng)/mL
Standard Deviation 4912.091
|
—
|
|
Concentration of BG00011 in the Serum
Week 12
|
7768.33 nanograms (ng)/mL
Standard Deviation 5139.179
|
—
|
|
Concentration of BG00011 in the Serum
Week 16
|
6934.86 nanograms (ng)/mL
Standard Deviation 4288.642
|
—
|
|
Concentration of BG00011 in the Serum
Week 20
|
6614.24 nanograms (ng)/mL
Standard Deviation 4203.020
|
—
|
|
Concentration of BG00011 in the Serum
Week 26
|
8579.42 nanograms (ng)/mL
Standard Deviation 9754.642
|
—
|
|
Concentration of BG00011 in the Serum
Week 38
|
3560.00 nanograms (ng)/mL
Standard Deviation 2771.630
|
—
|
|
Concentration of BG00011 in the Serum
Week 52
|
1085.33 nanograms (ng)/mL
Standard Deviation 455.978
|
—
|
|
Concentration of BG00011 in the Serum
Safety Follow-up Visit
|
344.64 nanograms (ng)/mL
Standard Deviation 701.639
|
—
|
Adverse Events
Placebo
BG00011
Serious adverse events
| Measure |
Placebo
n=52 participants at risk
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.
|
BG00011
n=54 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
1.9%
1/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
1.9%
1/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Infections and infestations
Influenza
|
1.9%
1/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
0.00%
0/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
3.7%
2/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
3.7%
2/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
1.9%
1/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
0.00%
0/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
1/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
0.00%
0/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Musculoskeletal and connective tissue disorders
Hip deformity
|
1.9%
1/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
0.00%
0/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.9%
1/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
0.00%
0/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
1.9%
1/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
0.00%
0/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
1.9%
1/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
1.9%
1/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Nervous system disorders
Cerebrovascular accident
|
1.9%
1/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
0.00%
0/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
1.9%
1/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Reproductive system and breast disorders
Fallopian tube cyst
|
1.9%
1/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
0.00%
0/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Reproductive system and breast disorders
Ovarian cyst
|
1.9%
1/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
0.00%
0/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
1.9%
1/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
1.9%
1/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
14.8%
8/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
1.9%
1/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
0.00%
0/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Vascular disorders
Steal syndrome
|
1.9%
1/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
0.00%
0/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
Other adverse events
| Measure |
Placebo
n=52 participants at risk
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.
|
BG00011
n=54 participants at risk
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.
|
|---|---|---|
|
Eye disorders
Cataract
|
0.00%
0/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
5.6%
3/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Gastrointestinal disorders
Diarrhoea
|
9.6%
5/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
24.1%
13/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Gastrointestinal disorders
Nausea
|
9.6%
5/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
9.3%
5/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
General disorders
Fatigue
|
15.4%
8/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
7.4%
4/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
General disorders
Injection site bruising
|
7.7%
4/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
3.7%
2/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
General disorders
Injection site pain
|
0.00%
0/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
7.4%
4/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
5.6%
3/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Infections and infestations
Lower respiratory tract infection
|
1.9%
1/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
5.6%
3/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Infections and infestations
Nasopharyngitis
|
5.8%
3/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
13.0%
7/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Infections and infestations
Upper respiratory tract infection
|
11.5%
6/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
9.3%
5/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
5.6%
3/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Injury, poisoning and procedural complications
Fall
|
1.9%
1/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
7.4%
4/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.8%
3/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
5.6%
3/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
2/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
5.6%
3/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Nervous system disorders
Headache
|
9.6%
5/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
1.9%
1/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Renal and urinary disorders
Nephrolithiasis
|
5.8%
3/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
0.00%
0/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.8%
15/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
20.4%
11/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.2%
10/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
16.7%
9/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.9%
1/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
5.6%
3/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/52 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
11.1%
6/54 • Up to 60 Weeks (End of Study)
The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER