A Phase 2 Study to See if Simtuzumab (GS-6624) is Safe and Works in Idiopathic Pulmonary Fibrosis (IPF) (RAINIER)

A Phase 2 Study to See if Simtuzumab (GS-6624) is Safe and Works in Idiopathic Pulmonary Fibrosis (IPF) (RAINIER)

Full Study Title: A Phase 2 Study to See if Simtuzumab (GS-6624) is Safe and Works in Idiopathic Pulmonary Fibrosis (IPF) (RAINIER)

Summary

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

Participant Eligibility

Inclusion Criteria:

  • Male or female subjects from 45 to 85 years of age
  • Definite IPF within 3 years prior to screening
  • Be able to walk at least 50 meters

Exclusion Criteria:

  • Significant diseases other than IPF
  • Obstructive lung disease
  • Aortic aneurysm greater than or equal to 3.5 cm in diameter
  • Treatment with immunosuppressive, cytotoxic, or antifibrotic drugs < 28 days prior to randomization are not permitted.
    • N-acetylcysteine is permitted provided the individual has been on a stable dose for > 4 weeks prior to screening
    • Concomitant use of pirfenidone or nintedanib must be in accordance with the approved prescribing instructions in the country where the site is located
  • Individuals actively listed for lung transplant are excluded. However individuals at transplant centers with long waiting times (greater than 1 year) may be permitted to enter the study after discussion with Medical Monitor.

Study ID: NCT01769196

Study Sites
Medical College of Wisconsin

Principal Investigator(s)
Randolph Lipchik

Contact
Rachel Harris
414-955-7030
racharris@mcw.edu