Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF)

• Status: Terminated
• Trial end date: 2016-02-23
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives of this study are to determine the effect of simtuzumab (GS-6624) on progression-free survival (PFS) as determined by either a categorical decline in forced vital capacity (FVC) or all-cause mortality, in all participants enrolled or in a subset of participants who are classified as lysyl oxidase-like-2 (LOXL2) high based on a prespecified level in serum at baseline.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences

Criteria

Key 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

Key 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.