A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis
Overview
- Phase
- Phase 2
- Intervention
- BG00011
- Conditions
- Idiopathic Pulmonary Fibrosis
- Sponsor
- Biogen
- Enrollment
- 109
- Locations
- 2
- Primary Endpoint
- Change From Baseline in Forced (Expiratory) Vital Capacity (FVC) at Week 52
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
The primary objective of this study is to evaluate the efficacy of BG00011 compared with placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). The secondary objectives of this study are: to evaluate the efficacy of BG00011 compared with placebo in participants with IPF as determined by change in percent predicted forced (expiratory) vital capacity (FVC); to assess progression-free survival in participants who receive BG00011 compared with placebo; to assess the occurrence of IPF exacerbation in participants who receive BG00011 compared with placebo; to assess the incidence of absolute decline in FVC ≥10% in participants who receive BG00011 compared with placebo; to assess the time to death or lung transplantation in participants who receive BG00011 compared with placebo, and the transplant-free survival rate at Week 26 and Week 52; to assess the time to non-elective hospitalizations in participants who receive BG00011 compared with placebo; to assess additional pulmonary function test (PFT) findings in participants who receive BG00011 compared with placebo; To assess performance on the 6 minute walk test (6MWT) in participants who receive BG00011 compared with placebo; to evaluate the safety and tolerability of BG00011; and to evaluate the serum concentration of BG00011.
Investigators
Eligibility Criteria
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.
- •IPF diagnosed based on modified ATS/ERS/JRS/ALAT IPF guideline for diagnosis and management, within 3 years of Screening.
- •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 randomization.
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 rest).
- •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 scans.
- •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.
Arms & Interventions
BG00011
Participants will receive BG00011 56 mg once weekly by subcutaneous (SC) injection for 52 weeks.
Intervention: BG00011
Placebo
Participants will receive placebo once weekly by (SC) injection for 52 weeks.
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in Forced (Expiratory) Vital Capacity (FVC) at Week 52
Time Frame: 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 Outcomes
- Time to Progression(Up to Week 60 (End of Study))
- Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation(Up to Early Termination Visit (Up to Week 52))
- Time to All Non-Elective Respiratory Hospitalizations(Up to Week 60 (End of Study))
- Change From Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco)(Up to Early Termination Visit (Up to Week 52))
- Change From Baseline in Absolute Total Lung Capacity (TLC)(Up to Early Termination Visit (Up to Week 52))
- Change From Baseline in FVC, Expressed in Percent Predicted at Week 52(Baseline, Week 52)
- Number of Participants With at Least One Acute IPF Exacerbation(Up to Early Termination Visit (Up to Week 52))
- Change From Baseline in Percent Predicted FVC(Up to Week 44)
- Number of IPF Exacerbations(Up to Early Termination Visit (Up to Week 52))
- Time to All Non-elective Hospitalizations(Up to Week 60 (End of Study))
- Change From Baseline in Absolute FVC(Up to Week 44)
- Number of Participants With Anti-BG00011 Antibodies in the Serum(Up to Week 60 (End of Study))
- Number of Participants With Absolute Decline of 10% Predicted in FVC(Up to Early Termination Visit (Up to Week 52))
- Time to Death or Lung Transplantation(Up to Week 60 (End of Study))
- Change From Baseline in Percent Predicted TLC(Up to Early Termination Visit (Up to Week 52))
- Change From Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco)(Up to Early Termination Visit (Up to Week 52))
- Change From Baseline in 6 Minute Walk Test (6MWT) Parameters(Baseline, Week 26 and Week 52)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to Week 60 (End of Study))
- Concentration of BG00011 in the Serum(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))