Biogen (BG00011)

Condition: Idiopathic pulmonary fibrosis

Eligibility

Key Inclusion Criteria

  • At least 40 years old
  • Women must be surgically sterile, postmenopausal or agree to use contraception; male subjects must agree to use one or more forms of birth control.
  • Diagnosis of IPF

Key Exclusion Criteria

  • Unable to perform pulmonary function tests or undergo high-resolution computed tomography procedure
  • Airway obstruction or evidence of a bronchodilator response
  • Findings that are diagnostic of a condition other than usual interstitial pneumonia

Full Study Name

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis (IRB no. 51771)

Summary

The purpose of this study is to evaluate the investigational use of a drug called BG00011 in patients with idiopathic pulmonary fibrosis (IPF) who are at least 40 years old. The study aims to determine the safety and effectiveness of the drug compared to placebo (inactive substance) in these patients. BG00011 is a laboratory-made antibody that is being developed to treat IPF. An antibody is a type of protein that is made by the body to help protect it from harmful substances. Participants will be randomly assigned to receive either BG00011 or placebo. Researchers also aim to learn whether a biomarker test will help determine the effects of BG00011 on the patient’s IPF. A biomarker is a biological molecule found in blood, other body fluids, or tissues that may be a sign of a condition or disease.

Phase

Phase IIb

Principal Investigator

Jeremy Falk, MD

Contact
Susan Jackman
Phone: 310-423-4765
Email: susan.jackman@cshs.org