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A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16 Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in bDMARD-Naive Patients with Radiographic Axial Spondyloarthritis

A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16 Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in bDMARD-Naive Patients with Radiographic Axial Spondyloarthritis

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080223206
Enrollment
Unknown
Registered
2016-05-19
Start date
2016-05-19
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Axial spondyloarthritis

Interventions

Sponsors

Eli Lilly Japan K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion Criteria: -Are ambulatory. -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. -In the past had an inadequate response to at least 1 non-steroidal anti-inflammatory drug (for duration 12 weeks) or cannot tolerate NSAIDS. -If taking NSAIDS be on a stable dose for at least 2 weeks prior to randomization. -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 received any prior, or are currently receiving, treatment with biologics, tumor necrosis factor inhibitors or other immunomodulatory agents. -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.

Exclusion criteria

Exclusion criteria:

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026