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