A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Location:

Rochester, Minn., Jacksonville, Fla., Phoenix/Scottsdale, Ariz.

Trial status:

Open for Enrollment

Why is this study being done?

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

Who is eligible to participate?

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.

Last updated:

10/21/2014

NCT ID:

NCT01769196

IRB Number:

13-000529