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An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis
Study Purpose
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 ā„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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
40 Years and Over
Gender
All
More Inclusion & Exclusion Criteria
Key
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) ā„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.
Key
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 ā¤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 ā„12% and an increase of
ā„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.
- Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the
subject unsuitable for enrollment.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Phase 2
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
Biogen
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
Medical Director
Principal Investigator Affiliation
Biogen
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Industry
Overall Status
Recruiting
Countries
Argentina, Australia, Belgium, Chile, Czechia, Denmark, France, Greece, Israel, Italy, Korea, Republic of, Netherlands, Poland, Russian Federation, Spain, United Kingdom, United States
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Idiopathic Pulmonary Fibrosis
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
