Trial · NCT03573505
An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis
NCT03573505, Phase 2, Terminated, Biogen; results first posted 2020-11-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis. Trials, record NCT03573505. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03573505
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis
- NCT number
- NCT03573505
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 109 participants, actual
- Lead sponsor
- Biogen
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- BG00011, Placebo
- First posted
- 2018-06-29
- Last updated
- 2020-12-11
- Other registries' IDs
- eudract:2017-003158-18
- Results first posted
- 2020-11-20
- Limitations and caveats
- The study was terminated early due to safety findings.
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Forced (Expiratory) Vital Capacity (FVC) at Week 52 | Baseline, Week 52 | FVC is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline. |
| Secondary | Change From Baseline in FVC, Expressed in Percent Predicted at Week 52 | Baseline, Week 52 | FVC is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs after taking an inhaled bronchodilator medicine which is used to dilate participant's bronchial (breathing) tubes. Percent predicted FVC (in %, here FVC was measured in litres) = \[(observed FVC)/(predicted FVC)\]\*100. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline. |
| Secondary | Time to Progression | Up to Week 60 (End of Study) | Time to progression is defined by a composite endpoint, including any of the following events: Absolute decline of 10% predicted in FVC (FVC percent predicted (baseline) - FVC percent predicted (progression) ≥10%); Non-elective hospitalization for respiratory events; Lung transplantation or death. The earliest time to meet at least 1 composite criterion was calculated. |
| Secondary | Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation | Up to Early Termination Visit (Up to Week 52) | Time to first acute IPF exacerbation is defined as time from randomization to the first occurrence of acute IPF exacerbation. Acute IPF exacerbation is defined as a clinically significant deterioration of unidentifiable cause in a participant with underlying IPF. The diagnostic criteria for IPF used in this study were derived from evidence-based guidelines developed by the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) joint task force for the diagnosis and management of IPF. Participants were assessed according to the modified 2007 diagnostic criteria for acute IPF exacerbation. |
| Secondary | Number of Participants With at Least One Acute IPF Exacerbation | Up to Early Termination Visit (Up to Week 52) | Acute IPF exacerbation is defined as a clinically significant deterioration of unidentifiable cause in a participant with underlying IPF. The diagnostic criteria for IPF used in this study were derived from evidence-based guidelines developed by the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) joint task force for the diagnosis and management of IPF. Participants were assessed according to the modified 2007 diagnostic criteria for acute IPF exacerbation. |
| Secondary | Number of IPF Exacerbations | Up to Early Termination Visit (Up to Week 52) | The IPF exacerbation is defined as a clinically significant deterioration of unidentifiable cause in a participant with underlying IPF. The diagnostic criteria for IPF used in this study were derived from evidence-based guidelines developed by the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) joint task force for the diagnosis and management of IPF. Participants were assessed according to the modified 2007 diagnostic criteria for acute IPF exacerbation. |
| Secondary | Number of Participants With Absolute Decline of 10% Predicted in FVC | Up to Early Termination Visit (Up to Week 52) | FVC is the is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs after taking an inhaled bronchodilator medicine which is used to dilate participant's bronchial (breathing) tubes. Absolute Decline of 10% = FVC percent predicted (baseline) - FVC percent predicted (progression) ≥10%. |
| Secondary | Time to Death or Lung Transplantation | Up to Week 60 (End of Study) | Time to Death or Lung Transplantation is defined as the time from randomization to the first occurrence of any one of the event (death or lung transplantation). |
| Secondary | Time to All Non-elective Hospitalizations | Up to Week 60 (End of Study) | Time to all non-elective hospitalizations is defined as the time from randomization to the first occurrence of hospitalization which was not elected by the participant. |
| Secondary | Time to All Non-Elective Respiratory Hospitalizations | Up to Week 60 (End of Study) | Time to all non-elective respiratory hospitalizations is defined as the time from randomization to the first occurrence of hospitalization due to respiratory problems, which was not elected by the participant. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Forced (Expiratory) Vital Capacity (FVC) at Week 52 | Baseline, Week 52 | 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. | liters (L) | MEAN |
| SECONDARY | Change From Baseline in FVC, Expressed in Percent Predicted at Week 52 | Baseline, Week 52 | 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. | percentage of predicted FVC | MEAN |
| SECONDARY | Time to Progression | Up to Week 60 (End of Study) | 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. | days | MEDIAN |
| SECONDARY | Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation | Up to Early Termination Visit (Up to Week 52) | 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. | days | MEDIAN |
| SECONDARY | Number of Participants With at Least One Acute IPF Exacerbation | Up to Early Termination Visit (Up to Week 52) | MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of IPF Exacerbations | Up to Early Termination Visit (Up to Week 52) | MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo). | exacerbations | NUMBER |
| SECONDARY | Number of Participants With Absolute Decline of 10% Predicted in FVC | Up to Early Termination Visit (Up to Week 52) | MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Death or Lung Transplantation | Up to Week 60 (End of Study) | MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or Placebo). | days | MEDIAN |
| SECONDARY | Time to All Non-elective Hospitalizations | Up to Week 60 (End of Study) | 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. | days | MEDIAN |
| SECONDARY | Time to All Non-Elective Respiratory Hospitalizations | Up to Week 60 (End of Study) | 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. | days | MEDIAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group154
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Forced (Expiratory) Vital Capacity (FVC) at Week 52 | Placebo | Baseline | 2.883 | Standard Deviation 0.7037 | liters (L) |
| Change From Baseline in Forced (Expiratory) Vital Capacity (FVC) at Week 52 | BG00011 | Baseline | 2.867 | Standard Deviation 0.8607 | liters (L) |
| Change From Baseline in Forced (Expiratory) Vital Capacity (FVC) at Week 52 | Placebo | Change at Week 52 | -0.308 | Standard Deviation 0.1768 | liters (L) |
| Change From Baseline in Forced (Expiratory) Vital Capacity (FVC) at Week 52 | BG00011 | Change at Week 52 | -0.455 | Standard Deviation 0.2849 | liters (L) |
| Change From Baseline in FVC, Expressed in Percent Predicted at Week 52 | Placebo | Baseline | 76.1 | Standard Deviation 15.46 | percentage of predicted FVC |
| Change From Baseline in FVC, Expressed in Percent Predicted at Week 52 | BG00011 | Baseline | 77.4 | Standard Deviation 17.07 | percentage of predicted FVC |
| Change From Baseline in FVC, Expressed in Percent Predicted at Week 52 | Placebo | Change at Week 52 | -7.6 | Standard Deviation 5.22 | percentage of predicted FVC |
| Change From Baseline in FVC, Expressed in Percent Predicted at Week 52 | BG00011 | Change at Week 52 | -11.5 | Standard Deviation 6.95 | percentage of predicted FVC |
| Time to Progression | Placebo | 127.5 | Full Range 29 to 235 | days | |
| Time to Progression | BG00011 | 119.0 | Full Range 28 to 302 | days |
1 to 10 of 154Source ClinicalTrials.gov
See all 154 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 52 | |
| Overall Study | STARTED | BG00011 | 54 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | COMPLETED | BG00011 | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 52 | |
| Overall Study | NOT COMPLETED | BG00011 | 54 |
Source ClinicalTrials.gov
Adverse events82
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cataract | Eye disorders | Placebo | 0 | 52 | |
| other | Cataract | Eye disorders | BG00011 | 3 | 54 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 5 | 52 | |
| other | Diarrhoea | Gastrointestinal disorders | BG00011 | 13 | 54 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 5 | 52 | |
| other | Nausea | Gastrointestinal disorders | BG00011 | 5 | 54 | |
| other | Fatigue | General disorders | Placebo | 8 | 52 | |
| other | Fatigue | General disorders | BG00011 | 4 | 54 | |
| other | Injection site bruising | General disorders | Placebo | 4 | 52 | |
| other | Injection site bruising | General disorders | BG00011 | 2 | 54 |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 52 |
| Total, all-cause mortality | BG00011 | 4 | 54 |
| Total, other adverse events | Placebo | 31 | 52 |
| Total, other adverse events | BG00011 | 40 | 54 |
| Total, serious adverse events | Placebo | 7 | 52 |
| Total, serious adverse events | BG00011 | 15 | 54 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| BG00011 vs Placebo: Number of Participants With at Least One Acute IPF Exacerbation | Trial comparisons |
| BG00011 vs Placebo: Number of Participants With Anti-BG00011 Antibodies in the Serum | Trial comparisons |
| BG00011 vs Placebo: Number of Participants With Absolute Decline of 10% Predicted in FVC | Trial comparisons |
| BG00011 vs Placebo: deaths from any cause | Trial comparisons |
| BG00011 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
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