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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis

General Information

Age Group

Adult

Status

Active

Protocol Number

203PF203

Background Information

The purpose of this research study is to evaluate the benefit and safety of the study drug BG00011 compared with placebo in subjects with IPF. BG00011 is an investigation medication which would be self-administered once weekly via subcutaneous injection. Study duration would last for 52 weeks (1 year).

Offered At

Inova Heart and Vascular Institute
Advanced Lung Disease and Transplant Clinic
3300 Gallows Road
Falls Church, VA 22042

Principal Investigator

Steven Nathan, MD

Eligibility Information

  • Written informed consent signed prior to entry into study
  • ≥ 40 years of age
  • Female subjects of childbearing potential must agree to use one or more form of highly effective contraception from the time of signing the informed consent until 3 months after the last study injection
  • IPF diagnosis within 3 years of screening for study
  • Combination of HRCT pattern and, if one has been obtained previously, surgical lung biopsy consistent with diagnosis of IPF
  • DLCO (corrected for hemoglobin) 30-79% of predicted normal
  • FVC≥50% predicted of normal
  • If patient is taking nintedanib or pirfenidone, they must be on a stable dose for at least 8 weeks prior to entering study

Ineligibility Information

  • Unable to perform PFTs or undergo HRCT procedure
  • Peripheral capillary oxygen saturation (SpO2) <90% at rest (if on oxygen supplementation, must be ≤2L/min at rest)
  • Findings that are diagnostic of a condition other than UIP based on combination of testing including but not limited to surgical lung biopsy and HRCT
  • Airway obstruction or evidence of bronchodilator response on pulmonary function testing
  • End-stage fibrotic disease likely requiring transplantation within 12 months
  • The extent of emphysema in the lungs exceeds fibrosis
  • Body weight <60kg
  • History of ongoing malignant disease (such as 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 >2 year ago)
  • Significant cardiac disease
  • Clinical diagnosis of connective tissue disease or interstitial pneumonia with autoimmune features
  • History of organ transplant
  • Female who is pregnant or breastfeeding
  • Serious local infection or systemic infection within 3 months prior
  • Fever or symptomatic viral or bacterial infection within 2 weeks prior
  • History or positive test result of HIV
  • Patient has a disease other than IPF with a life expectancy < 2 years based on investigator assessment