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)

Eli Lilly Japan K.K.0 个研究点开始时间: 2016年8月16日最近更新: 2023年10月17日

适应症

试验速览

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•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.

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