A Study of Ixekizumab (LY2439821) in Chinese Participants With Radiographic Axial Spondyloarthritis

  • STATUS
    Recruiting
  • participants needed
    140
  • sponsor
    Eli Lilly and Company
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Updated on 16 February 2024
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NSAID
tumor necrosis factor
back pain
ixekizumab
axial spondyloarthritis
spondyloarthropathy
sacroiliitis

Summary

The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in Chinese participants with radiographic axial spondyloarthritis (r-axSpA).

Details
Condition Spondylarthritis
Age 18years - 100years
Treatment Placebo, Ixekizumab
Clinical Study IdentifierNCT04285229
SponsorEli Lilly and Company
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Have an established diagnosis of radiographic axial spondyloarthritis (r-xSpA) with sacroiliitis defined radiographically according to the modified New York criteria
Participants have a history of back pain 3 months with age at onset <45 years
Biologic nave or have had prior treatment with 1 tumor necrosis factor (TNF) inhibitor
Must have had an inadequate response to 2 or more NSAIDs at the therapeutic dose range for a total duration of at least 4 weeks OR have a history of intolerance to NSAIDs
Have a history of prior therapy for axSpa for at least 12 weeks prior to screening

Exclusion Criteria

Have total ankylosis of the spine
Have recently received a live vaccine within 12 weeks or have had a vaccination with Bacillus Calmette-Guerin (BCG) within the past year
Have an ongoing or serious infection within the last 12 weeks
Have a compromised immune system
Have any other serious and/or uncontrolled diseases
Have either a current diagnosis or a recent history of malignant disease
Have had major surgery within 8 weeks of baseline, or will require surgery during the study
Are pregnant or breastfeeding
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