|E.1 Medical condition or disease under investigation
|Medical condition(s) being investigated
|mild to moderate Idiopathic Pulmonary Fibrosis
|Medical condition in easily understood language
|mild to moderate scarring of lung tissue
|Diseases [C] - Respiratory Tract Diseases [C08]
|E.1.2 Medical condition or disease under investigation
|Idiopathic pulmonary fibrosis
|System Organ Class
|10038738 - Respiratory, thoracic and mediastinal disorders
|Condition being studied is a rare disease
|E.2 Objective of the trial
|Main objective of the trial
|To evaluate the efficacy of BG00011 compared with placebo in subjects with Idiopathic pulmonary fibrosis (IPF).
|Secondary objectives of the trial
-The efficacy of BG00011 compared with placebo in subjects with IPF as determined by change in percent predicted FVC
-The safety and tolerability of BG00011; and to evaluate the serum concentration of BG00011
-Progression-free survival in subjects who receive BG00011 compared with placebo.
-The occurrence of IPF exacerbation in participants who receive BG00011 compared with placebo
-The incidence of absolute decline in FVC ≥10% in subjects who receive BG00011 compared with placebo.
-The time to death or lung transplantation in subjects who receive BG00011 compared with placebo, and the transplant-free survival rate at Week 26 and Week 52
-The time to nonselective hospitalizations in subjects who receive BG00011 compared with placebo.
-Additional PFT findings in subjects who receive BG00011 compared with placebo
- Performance on the 6MWT in participants who receive BG00011 compared with placebo
Please refer to protocol for further secondary objectives
|Trial contains a sub-study
|Principal inclusion criteria
|- Female subjects must be surgically sterile,
postmenopausal (minimum 1 year without menses), or
agree to use 1 or more forms of highly effective
contraception from the time of signing of the informed
consent form (ICF) until 3 months after the last injection
of study medication. Male subjects must also agree to
use 1 or more forms of highly effective contraception for
either themselves or their partners from signing of ICF
until 4 months after last injection of study medication.
- Diagnosed with Idiopathic pulmonary fibrosis (IPF).
- Combination of high-resolution computed tomography
(HRCT) pattern and, if one has been obtained, surgical
lung biopsy pattern, consistent with diagnosis of IPF.
- Carbon monoxide diffusion capacity (DLco) (corrected
for hemoglobin): 30% to 79% predicted of normal at
Screening, with no clinically significant deterioration
between the Screening Visit and randomization, as
determined by the Investigator.
- Forced (expiratory) vital capacity (FVC) ≥50%
predicted of normal at Screening, with no clinically
significant deterioration between the Screening Visit and
randomization, as determined by the Investigator.
- If a subject is taking nintedanib or pirfenidone, they
must be on a stable dose for at least 8 weeks prior to
NOTE: Other protocol defined inclusion criteria may apply.
|Principal exclusion criteria
|- Unable to perform pulmonary functional tests (PFTs) or
undergo HRCT procedure.
- Peripheral capillary oxygen saturation (SpO2) <90% at
rest (if on oxygen supplementation, must be ≤2 L/min at
- Airway obstruction (i.e., prebronchodilator FEV1/FVC
<0.7) or evidence of a bronchodilator response as
defined by an absolute increase of ≥12% and an
increase of ≥200 milliliters (mL) in FEV1 or FVC, or both,
after bronchodilator use, compared with the values
before bronchodilator use at Screening.
- End-stage fibrotic disease likely requiring organ
transplantation within 12 months, or if the subject has
initiated active evaluation for organ transplantation.
- The extent of emphysema in the lungs exceeds
fibrosis, based on central review of HRCT
- Body weight <60 kg at Screening.
- History of or ongoing malignant disease, including solid
tumors and hematologic malignancies, with the
exception of basal cell carcinomas, squamous cell
carcinomas, and carcinoma in situ of the cervix that
have been completely excised and considered cured >2
years prior to Screening.
- Significant cardiac disease (e.g., New York Heart
Association Class 3 or 4; myocardial
infarction within the past 6 months; unstable angina;
coronary angioplasty or coronary artery bypass graft
within the past 6 months; uncontrolled atrial or
ventricular cardiac arrhythmias; or pulmonary
hypertension requiring pharmacologic treatment).
- Clinical diagnosis of any connective tissue disease
(including but not limited to scleroderma,
polymyositis/dermatomyositis, systemic lupus
erythematosus, and rheumatoid arthritis) or a diagnosis
of interstitial pneumonia with autoimmune features as
determined by the Investigator.
- Other disease that may interfere with testing
procedures or, in the judgment of the Investigator, may
interfere with study participation or may put the patient
at risk when participating in this study.
- Other unspecified reasons that, in the opinion of the
Investigator or Biogen, make the subject unsuitable for
NOTE: Other protocol defined exclusion criteria may apply.
|E.5 End points
|Primary end point(s)
|Yearly Rate of Change in Forced (Expiratory) Vital Capacity (FVC)
|Timepoint(s) of evaluation of this end point
|various time point assessments throughout the study
|Secondary end point(s)
|- Percent Predicted Yearly Rate of Change in FVC
- Time to Progression
- Time to First Acute Exacerbation
- Percentage of Participants with at least 1 Acute Exacerbation
- Number of Exacerbations
- Number of Participants with Absolute Decline of 10% Predicted in FVC
- Time to Death or Lung Transplantation
- Time to All Non-Elective Hospitalizations
- Time to All Non-Elective Respiratory Hospitalizations
- Change from Baseline in Absolute Predicted FVC
- Change from Baseline in Percent Predicted FVC
- Change from Baseline in Absolute Predicted Carbon Monoxide Diffusion Capacity (DLco)
- Change from Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco)
- Change from Baseline in Absolute Predicted Total Lung Capacity
- Change from Baseline in Percent Predicted Total Lung Capacity
- Change from Baseline in 6 Minute Walk Test (6MWT) Parameters
- Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Percentage of Participants With Anti-BG00011 Antibodies in the Serum
- Concentration of BG00011 in the Serum
|Timepoint(s) of evaluation of this end point
|Change to baseline, weeks 26 and 52
|E.6 and E.7 Scope of the trial
|Scope of the trial
|Trial type and phase
|Human pharmacology (Phase I)
|First administration to humans
|Other trial type description
|Therapeutic exploratory (Phase II)
|Therapeutic confirmatory (Phase III)
|Therapeutic use (Phase IV)
|E.8 Design of the trial
| Comparator of controlled trial
|Other medicinal product(s)
|Number of treatment arms in the trial
The trial involves single site in the Member State concerned
| The trial involves multiple sites in the Member State concerned
|Number of sites anticipated in Member State concerned
|The trial involves multiple Member States
|Number of sites anticipated in the EEA
|E.8.6 Trial involving sites outside the EEA
|Trial being conducted both within and outside the EEA
|Trial being conducted completely outside of the EEA
|If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
|Korea, Republic of
|Trial has a data monitoring committee
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|The end of study is last subject, last visit.
|E.8.9 Initial estimate of the duration of the trial
|In the Member State concerned years
|In the Member State concerned months
|In the Member State concerned days
|In all countries concerned by the trial years
|In all countries concerned by the trial months
|In all countries concerned by the trial days