A 52-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ixekizumab (LY2439821) in bDMARD Naive Patients with Nonradiographic Axial Spondyloarthritis (I1F-MC-RHBX)
- Conditions
- Axial spondyloarthritis
- Registration Number
- JPRN-jRCT2080223291
- 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 nonradiographic axial spondyloarthritis (nr-axSpA) and fulfilling the 2009 ASAS classification criteria.
-Have a history of back pain >= months with age at onset <45 years.
-Have active nr-axSpA defined as >=4 and total back pain >=4 on a NRS at screening and baseline.
-Have objective signs of inflammation by presence of sacroiliitis on MRI and/or presence of elevated CRP.
-In the past had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDS) for duration of 4 weeks or cannot tolerate NSAIDS.
-If taking NSAIDS be on 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 radiographic sacroiliitis fulfilling the 1984 modified New York criteria.
-Have received any prior, or are currently receiving treatment with biologics, tumor necrosis factor inhibitors or other immunomodulatory agents.
-Have 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.
-Have evidence of active anterior uveitis (an acute episode) within the last 42 days prior to baseline randomization.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method