Study Condition(s): Nonradiographic Axial Spondyloarthritis

A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis (COAST-X)

Study Alias: RHBX

Study Identifier(s): Tool Tip Icon {{ defaultRegistry.registryAnchorText }} NCT02757352 {{ currentLocaleObject.registryAnchorText }}

Recruiting Recruiting

Study Purpose

The main purpose of this study is to evaluate the safety and efficacy of the study drug known as ixekizumab in biologic disease modifying antirheumatic drug (bDMARD) naïve participants with nonradiographic axial spondyloarthritis (nonrad-axSpA).

Key Participation Requirements Tool Tip Icon

All clinical trials have rules about who can participate. This section outlines some of those rules. Please contact a study center to discuss the full set of criteria

Gender

Male Female

Age

18+ years

Time Commitment

Your participation could last up to 1 ½ years and include 15 visits to the study center. After this study, you may be eligible to enter another study that could last up to 2 more years.
  • Participant must have diagnosis of nonradiographic axial spondyloarthritis (nr-axSpA)

  • Participant must be able to walk

  • Participant must have a history of back pain for ≥3 months that started before 45 years of age

  • Participants must have had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDS) for duration of 4 weeks or cannot tolerate NSAIDS.

  • Participants that are taking NSAIDS must be on a stable dose for at least 2 weeks prior to randomization

  • Participants must have a history of prior therapy for axSpA for at least 12 weeks prior to screening for the study

  • Participants must not have radiographic sacroiliitis

  • Participants must not have received any prior, or are currently receiving treatment with biologics, tumor necrosis factor inhibitors or other immunomodulatory agents

  • Female participants must not be pregnant or breastfeeding

Where to Participate

96 locations are currently available of 109 planned
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