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 ≥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.

Condition

Eligibility

Eligible Ages
Over 40 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.
  • 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BG00011
Participants will receive BG00011 56 mg once weekly by subcutaneous (SC) injection for 52 weeks.
  • Drug: BG00011
    Administered as specified in the treatment arm.
Placebo Comparator
Placebo
Participants will receive placebo once weekly by (SC) injection for 52 weeks.
  • Drug: Placebo
    Administered as specified in the treatment arm.

Recruiting Locations

Trials Today and nearby locations

Research Site
Pittsburgh, Pennsylvania 15213

Research Site
Providence, Rhode Island 02903

Research Site
Cleveland, Ohio 44195

Research Site
New York, New York 10029

Research Site
Lebanon, New Hampshire 03756

Research Site
Charleston, South Carolina 29425

Research Site
Nashville, Tennessee 37232

Research Site
Madison, Wisconsin 53792

Research Site
Seattle, Washington 98195

Research Site
Falls Church, Virginia 22042

Reserach Site
Houston, Texas 77030

Research Site
Kansas City, Missouri 66160

Research Site
Chesterfield, Missouri 63017

Research Site
New Haven, Connecticut 06510-3221

Research Site
Miami, Florida 33125

Research Site
Los Angeles, California 90048

Research Site
Phoenix, Arizona 85013

Research Site
Phoenix, Arizona 85006

Research Site
Atlanta, Georgia 30322

Research Site
Iowa City, Iowa 52242

Research Site
Rochester, Minnesota 55905

Research Site
Minneapolis, Minnesota 55407

Research Site
Boston, Massachusetts 02115

Research Site
Boston, Massachusetts 02114

Research Site
Birmingham, Alabama 35294

More Details

NCT ID
NCT03573505
Status
Recruiting
Sponsor
Biogen

Study Contact

US Biogen Clinical Trial Center
866-633-4636
clinicaltrials@biogen.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.