A Study of Ixekizumab (LY2439821) in TNF Inhibitor Experienced Participants With Radiographic Axial Spondyloarthritis

• Status: Completed
• Trial end date: 2019-05-03
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in tumor necrosis factor (TNF) inhibitor-experienced participants with radiographic axial spondyloarthritis (rad-axSpA).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Ixekizumab

Criteria

Inclusion Criteria:

• Are ambulatory.

• Have an established diagnosis of radiographic axial spondyloarthritis (rad-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.

• Have had prior treatment with at least 1 and not more than 2 TNF inhibitors.

• 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 never taken a TNF inhibitor medication or have taken more than 2.

• 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 or evidence of active tuberculosis.

• 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.