Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)



Status:Not yet recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:1/1/2014
Start Date:July 2014
End Date:April 2018
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone:1-317-615-4559

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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 Patients With Active Ankylosing Spondylitis

This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo
in participants with active AS.


Inclusion Criteria:

- Diagnosis of moderate to severe AS with prior documented radiologic evidence (X-ray)
fulfilling the Modified New York criteria for AS (1984)

- Have active AS defined as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
≥4 and the spinal pain (back pain) score ≥4 on a numeric rating scale (NRS)

- Participants should have been on nonsteroidal anti-inflammatory drugs (NSAIDs) with
an inadequate response

- Participants who are regularly taking NSAIDs or cyclooxygenase-2 (COX-2) inhibitors
as part of their AS therapy are required to be on a stable dose

- Participants who have been on a tumor necrosis factor alpha (TNF) inhibitor (not more
than one) must have experienced an inadequate response

- Total duration of prior therapy (NSAIDs and/or adequate physical therapy) should be
at least 12 weeks

- Men must agree to use a reliable method of birth control or remain abstinent during
the study

- Women must agree to use reliable birth control or remain abstinent during the study
and for at least 12 weeks after stopping treatment

Exclusion Criteria:

- Participants with a total ankylosis of the spine

- Prior or current treatment with adalimumab

- Participants previously treated with any biological or other immunomodulating agents
except for those targeting TNF

- Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other
than ankylosing spondylitis

- Have participated in any study with interleukin 17 (IL-17) antagonists, including
ixekizumab

- Serious disorder or illness other than ankylosing spondylitis

- Serious infection within the last 3 months

- Breastfeeding or nursing (lactating) women
We found this trial at
34
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Brooklyn, NY
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Charleston, South Carolina 29412
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Charlotte, North Carolina 28207
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North Charleston, South Carolina 29406
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