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
- Conditions
- Axial spondyloarthritis
- Registration Number
- JPRN-jRCT2080223206
- Lead Sponsor
- Eli Lilly Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- recruiting
- Sex
- All
- Target Recruitment
- Not specified
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.
-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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method