A Study of Ixekizumab in Participants With Nonradiographic Axial Spondyloarthritis (COAST-X)

This study is being done to see how safe an investigational drug is and how well it will work to help people with nonradiographic axial spondyloarthritis. Nonradiographic axial spondyloarthritis is a form of arthritis primarily affecting the spine and sacroiliac [SI] joints, but with no definite changes on x-rays. SI joints are next to the bottom of the spine on each side and above the tailbone.

Study phase: III

Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.

Presence of sacroiliitis on MRI
have a history of back pain ?3 months with age at onset <45 years
Have active nonrad-axSpA
have had an inadequate response to 2 or more NSAIDs

Primary disease category: Arthritis

Sponsor: Eli Lilly

Protocol number: I1F-MC-RHBX

Projected enrollment dates: May 2016 to June 2017

Official study title: A 52-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ixekizumab (LY2439821) in bDMARD Naive Patients with Nonradiographic Axial Spondyloarthritis