Clinical Trial Results:
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis
Summary
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EudraCT number |
2017-003158-18 |
Trial protocol |
CZ GB DK NL GR BE ES DE PL IT |
Global end of trial date |
14 Nov 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
14 Nov 2020
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First version publication date |
14 Nov 2020
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
203PF203
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03573505 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Biogen
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Sponsor organisation address |
250 Binney Street, Cambridge, United States, 02142
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Public contact |
Biogen Study Medical Director, Biogen, clinicaltrials@biogen.com
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Scientific contact |
Biogen Study Medical Director, Biogen, clinicaltrials@biogen.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
14 Nov 2019
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
14 Nov 2019
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
The primary objective of this study is to evaluate the efficacy of BG00011 compared with placebo in subjects with Idiopathic Pulmonary Fibrosis (IPF).
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Protection of trial subjects |
Written informed consent was obtained from each subject or subject’s legally authorized representative (e.g., parent or legal guardian), as applicable, prior to evaluations performed for eligibility. Subjects or the subject’s legally authorized representative were given adequate time to review the information in the informed consent/assent and were allowed to ask, and have answered, questions concerning all portions of the conduct of the study.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
24 Sep 2018
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety, Efficacy | ||
Long term follow-up duration |
2 Months | ||
Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 29
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Country: Number of subjects enrolled |
Australia: 28
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Country: Number of subjects enrolled |
Netherlands: 8
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Country: Number of subjects enrolled |
Korea, Republic of: 7
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Country: Number of subjects enrolled |
United Kingdom: 6
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Country: Number of subjects enrolled |
Chile: 6
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Country: Number of subjects enrolled |
Czech Republic: 6
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Country: Number of subjects enrolled |
Greece: 3
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Country: Number of subjects enrolled |
Italy: 3
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Country: Number of subjects enrolled |
Argentina: 2
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Country: Number of subjects enrolled |
Denmark: 2
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Country: Number of subjects enrolled |
Poland: 2
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Country: Number of subjects enrolled |
France: 1
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Country: Number of subjects enrolled |
Israel: 1
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Country: Number of subjects enrolled |
Russian Federation: 1
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Country: Number of subjects enrolled |
Spain: 1
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Worldwide total number of subjects |
106
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EEA total number of subjects |
32
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
30
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From 65 to 84 years |
76
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects were enrolled at 47 investigational sites in 16 countries from September 24, 2018 to November 14, 2019. Out of 109 enrolled subjects, 106 were treated (mITT population) and 3 were not treated. Data for subject number per country and age-group breakdown is provided for 106 subjects as data for age for one of the subjects was not collected. | |||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
A total of 109 subjects with Idiopathic pulmonary fibrosis (IPF) were enrolled and randomized in this study. Of which, 106 subjects received at least one dose of study drug (mITT). The maximum length of the dosing period was up to Week 46. Subjects were then followed-up for safety for up to Week 60. | |||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Carer, Assessor | |||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo | |||||||||||||||||||||||||||||||||
Arm description |
Subjects received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was for 19.14 weeks. | |||||||||||||||||||||||||||||||||
Arm type |
Placebo | |||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection in pre-filled syringe
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Subcutaneous (SC) injection, once weekly.
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Arm title
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BG00011 | |||||||||||||||||||||||||||||||||
Arm description |
Subjects received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was for 17.14 weeks. | |||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||
Investigational medicinal product name |
BG00011
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection in pre-filled syringe
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
SC injection, once weekly.
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Baseline characteristics reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Subjects received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was for 19.14 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
BG00011
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Reporting group description |
Subjects received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was for 17.14 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Subjects received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was for 19.14 weeks. | ||
Reporting group title |
BG00011
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Reporting group description |
Subjects received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was for 17.14 weeks. |
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End point title |
Change from Baseline in Forced (Expiratory) Vital Capacity (FVC) at Week 52 [1] | ||||||||||||||||||
End point description |
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 subject 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 subjects who were randomised and received at least 1 dose of study treatment (BG00011 or placebo). 'n’ are the subjects who were assessed at the specified timepoint in this endpoint. 'n' at Week 52, are a few subjects whose early termination visit fell into the analysis visit window of the Week 52 visit. No subject received Week 52 dosing.
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End point type |
Primary
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End point timeframe |
Baseline, Week 52
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical analysis was not performed for this endpoint. |
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No statistical analyses for this end point |
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End point title |
Change from Baseline in FVC, Expressed in Percent Predicted at Week 52 | ||||||||||||||||||
End point description |
FVC is the total amount of air exhaled during the forced expiratory volume test measured during spirometry and is the most important measurement of lung function. It requires subject 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 subject'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 subjects who were randomised and received at least 1 dose of study treatment (BG00011 or placebo). 'n’ are the subjects who were assessed at the specified timepoint. 'n' at Week 52, are a few subjects whose early termination visit fell into the analysis visit window of the Week 52 visit. No subject received Week 52 dosing.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 52
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No statistical analyses for this end point |
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End point title |
Time to Progression | ||||||||||||
End point description |
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 subjects who were randomised and received at least 1 dose of study treatment (BG00011 or placebo). 'Number of subjects analysed' are the subjects who were assessed in this outcome measure.
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End point type |
Secondary
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End point timeframe |
Up to Week 60 (End of Study)
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Statistical analysis title |
Placebo vs BG00011 | ||||||||||||
Statistical analysis description |
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.
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Comparison groups |
Placebo v BG00011
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Number of subjects included in analysis |
23
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Analysis specification |
Pre-specified
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Analysis type |
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P-value |
= 0.112 | ||||||||||||
Method |
Logrank | ||||||||||||
Parameter type |
Hazard ratio (HR) | ||||||||||||
Point estimate |
2.01
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
0.85 | ||||||||||||
upper limit |
4.73 |
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End point title |
Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation | ||||||||||||
End point description |
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 subject 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 subjects who were randomised and received at least 1 dose of study treatment (BG00011 or placebo). 'Number of subjects analysed' are the subjects who had at least one acute IPF exacerbation.
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End point type |
Secondary
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End point timeframe |
Up to Early Termination Visit (Up to Week 52)
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Notes [2] - No subjects had at least one acute IPF exacerbation in Placebo arm. |
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No statistical analyses for this end point |
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End point title |
Number of Subjects with at Least One Acute IPF Exacerbation | |||||||||
End point description |
Acute IPF exacerbation is defined as a clinically significant deterioration of unidentifiable cause in a subject 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 subjects who were randomised and received at least 1 dose of study treatment (BG00011 or placebo).
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End point type |
Secondary
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End point timeframe |
Up to Early Termination Visit (Up to Week 52)
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No statistical analyses for this end point |
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End point title |
Number of IPF Exacerbations | |||||||||
End point description |
The IPF exacerbation is defined as a clinically significant deterioration of unidentifiable cause in a subject 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 subjects who were randomised and received at least 1 dose of study treatment (BG00011 or placebo).
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End point type |
Secondary
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End point timeframe |
Up to Early Termination Visit (Up to Week 52)
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No statistical analyses for this end point |
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End point title |
Number of Subjects with Absolute Decline of 10% Predicted in FVC | |||||||||
End point description |
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 subject 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 subject's bronchial (breathing) tubes. Absolute Decline of 10% = FVC percent predicted (baseline) - FVC percent predicted (progression) ≥10%. MITT population included all subjects who were randomised and received at least 1 dose of study treatment (BG00011 or placebo).
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End point type |
Secondary
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End point timeframe |
Up to Early Termination Visit (Up to Week 52)
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No statistical analyses for this end point |
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End point title |
Time to Death or Lung Transplantation | ||||||||||||||||||
End point description |
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 subjects who were randomised and received at least 1 dose of study treatment (BG00011 or Placebo).
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End point type |
Secondary
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End point timeframe |
Up to Week 60 (End of Study)
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Notes [3] - No subjects were analysed for this endpoint in the Placebo arm. |
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No statistical analyses for this end point |
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End point title |
Time to All Non-elective Hospitalizations | ||||||||||||
End point description |
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 subjects who were randomised and received at least 1 dose of study treatment (BG00011 or Placebo). 'Number of subjects analysed' are the subjects who had at least one episode of non-elective hospitalization.
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End point type |
Secondary
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End point timeframe |
Up to Week 60 (End of Study)
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No statistical analyses for this end point |
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End point title |
Time to All Non-Elective Respiratory Hospitalizations | ||||||||||||
End point description |
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 subjects who were randomised and received at least 1 dose of study treatment (BG00011 or Placebo). 'Number of subjects analysed' are the subjects who had at least one episode of non-elective respiratory hospitalization.
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End point type |
Secondary
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End point timeframe |
Up to Week 60 (End of Study)
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No statistical analyses for this end point |
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End point title |
Change from Baseline in Absolute FVC | ||||||||||||||||||||||||||||||||||||||||||
End point description |
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 subject 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 subject'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 subjects who were randomised and received at least 1 dose of study treatment (BG00011 or placebo). ‘n’ are the subjects who were assessed at the specified timepoint in this endpoint.
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End point type |
Secondary
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End point timeframe |
Up to Week 44
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No statistical analyses for this end point |
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End point title |
Change from Baseline in Percent Predicted FVC | ||||||||||||||||||||||||||||||||||||||||||
End point description |
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 subject 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 subject'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 subjects who were randomised and received at least 1 dose of study treatment (BG00011 or placebo). 'n’ are the subjects who were assessed at the specified timepoint in this endpoint.
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End point type |
Secondary
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End point timeframe |
Up to Week 44
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No statistical analyses for this end point |
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End point title |
Change from Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco) | |||||||||||||||||||||||||||||||||
End point description |
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 subjects who were randomised and received at least 1 dose of study treatment (BG00011 or placebo). 'n’ are the subjects who were assessed at the specified timepoint in this endpoint.
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End point type |
Secondary
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End point timeframe |
Up to Early Termination Visit (Up to Week 52)
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No statistical analyses for this end point |
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End point title |
Change from Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco) | |||||||||||||||||||||||||||||||||
End point description |
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 subjects who were randomised and received at least 1 dose of study treatment (BG00011 or placebo). 'n’ are the subjects who were assessed at the specified timepoint in this endpoint.
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End point type |
Secondary
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End point timeframe |
Up to Early Termination Visit (Up to Week 52)
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No statistical analyses for this end point |
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End point title |
Change from Baseline in Absolute Total Lung Capacity (TLC) | |||||||||||||||||||||||||||||||||||||||||||||
End point description |
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 subjects who were randomised and received at least 1 dose of study treatment (BG00011 or placebo). 'n’ are the subjects who were assessed at the specified timepoint in this endpoint. 9999 indicates that the data was not reported as no subjects were evaluated at the given time point.
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End point type |
Secondary
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End point timeframe |
Up to Early Termination Visit (Up to Week 52)
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No statistical analyses for this end point |
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End point title |
Change from Baseline in Percent Predicted TLC | |||||||||||||||||||||||||||||||||||||||||||||
End point description |
Total lung capacity is the measure of lung volume was measured by full-body plethysmography. Percent of 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). 'n’ are the subjects who were assessed at the specified time point in this endpoint. 99999 indicates that SD was not calculable as there was only 1 subject. 9999 indicates that the data was not reported as no subjects were evaluated at the given time point.
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End point type |
Secondary
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End point timeframe |
Up to Early Termination Visit (Up to Week 52)
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No statistical analyses for this end point |
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End point title |
Change from Baseline in 6 Minute Walk Test (6MWT) Parameters | |||||||||||||||||||||
End point description |
The 6MWT measures the distance (in meters), a subject 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 subjects who were randomised and received at least 1 dose of study treatment (BG00011 or placebo). 'n' are subjects with data available for analyses at given timepoint. Subjects at Week 52, are a few subjects whose early termination visit fell into the analysis visit window of the Week 52 visit. No subjects received Week 52 dosing.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 26 and Week 52
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No statistical analyses for this end point |
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End point title |
Number of Subjects with Adverse Events (AEs) and Serious Adverse Events (SAEs) | |||||||||||||||
End point description |
An AE is any untoward medical occurrence in a subject 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 subjects who were randomised and receive at least 1 dose of study treatment (BG00011 or placebo).
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End point type |
Secondary
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End point timeframe |
Up to Week 60 (End of Study)
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No statistical analyses for this end point |
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End point title |
Number of Subjects With Anti-BG00011 Antibodies in the Serum | |||||||||
End point description |
The immunogenicity population defined as subjects from mITT population who have at least 1 postdose immunogenicity sample evaluated for anti-BG00011 antibodies. 'n' are the subjects who were assessed in this endpoint.
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End point type |
Secondary
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End point timeframe |
Up to Week 60 (End of Study)
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No statistical analyses for this end point |
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End point title |
Concentration of BG00011 in the Serum [4] | ||||||||||||||||||||||||||||||
End point description |
Pharmacokinetics (PK) population included all subjects who received at least 1 dose of study treatment and had at least one PK concentration measurement. "n" indicates number of subjects analysed at the give time point. Subjects at Week 52 are a few subjects whose early termination visit fell into the analysis visit window of the Week 52 visit. No participant received Week 52 dosing.
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End point type |
Secondary
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End point 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).
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Notes [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The serum concentration of BG00011 is measured in subjects in BG00011 arm. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Up to 60 Weeks (End of Study)
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Adverse event reporting additional description |
The safety population included all the subjects who were randomised and receive at least 1 dose of study treatment (BG00011 or placebo).
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
22.0
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Reporting groups
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Reporting group title |
Placebo
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
BG00011
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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02 Jul 2019 |
The primary reason for this amendment to Protocol 203PF203 is to reflect current modified (2018) American Thoracic Society (ATS) guidelines for idiopathic pulmonary fibrosis (IPF) diagnosis. • The stratification of subjects on background therapy was clarified. • Text was added to clarify that the Investigator should attempt to complete the Investigator’s determination of IPF exacerbation as soon as possible. • The exclusion criteria due to current hepatitis C or hepatitis B infection was clarified. • Liver chemistry threshold discontinuation criteria were added. • Dosing can be performed 2 days from the dose schedule. • A subject may continue in the study on their assigned study treatment if background therapy is initiated or adjusted. • The interim analysis when approximately 50% of subjects completed the week 52 visit was removed. A potential interim database lock and its associated interim analysis for efficacy and safety data is added. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
The study was terminated early due to safety findings |