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Lebrikizumab In Patients With Idiopathic Pulmonary Fibrosis


Title

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study To Assess The Efficacy And Safety Of Lebrikizumab In Patients With Idiopathic Pulmonary Fibrosis

Therapeutic Area Pulmonary Fibrosis
Principal Investigator Nicholas Hill, MD
Min Age 40 Years
Gender Both
Contact Karen Visnaw, RN
617-636-1334
More Information http://clinicaltrials.gov/ct2/show/study/NCT01872689

Overview

This study is to evaluate the efficacy and safety of simtuzumab (GS-6624) in adults with idiopathic pulmonary fibrosis

Study Details

Inclusion Criteria

  • Adult patient, >/= 40 years of age
  • Have a diagnosis of IPF within the previous 5 years from time of screening and confirmed at baseline
  • Forced vital capacity (FVC) >/= 40% and </= 100% predicted at screening

Exclusion Criteria

  • Evidence of other known causes of interstitial lung disease (ILD)
  • Lung transplant expected within 12 months of screening
  • Known current malignancy or current evaluation for potential malignancy
  • Past use of any anti-IL-13 or anti-IL-14/IL-13 therapy, including lebrikizumab

Study Requirements

At most visits the following testing will be performed:

  • Recording of your demographic information, including your age, sex, and race/ethnicity
  • A physical examination will be performed
  • Your medical history and current illnesses will be reviewed
  • Your current medications will be reviewed
  • Your blood pressure, heart rate, breathing rate, temperature, oxygen level, height, and weight
  • be measured and recorded
  • You will be asked whether you have participated in other clinical trials with antibody type
  • medications, including any studies with medications that block IL 13.
  • 15 ml_ (approximately 1 tablespoon) of blood will be drawn for hematology and clinical chemistry
  • testing
  • 15 ml_ (approximately 1 tablespoon) of blood will be drawn for testing of proteins and other
  • substances called biomarkers in your blood
  • A urine sample will be collected for routine testing
  • A serum pregnancy test will be done (only for female subjects with childbearing potential). The
  • results of the pregnancy testing must be negative in order for you to be in the study
  • You will perform a 6 minute walk test and rate your level of tiredness at the end of the six minute
  • walk test
  • An electrocardiogram (ECG) will be performed to measure your heart's electrical activity
  • Lung Function tests will be performed
  • A high resolution computed tomography (HRCT - a computerized series of detailed pictures)
  • scan of your lungs will be performed if you have not had one in the last 12 months prior to this
  • visit