Spondylitis, Ankylosing
Conditions
Brief summary
This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active AS.
Interventions
DRUGIxekizumab
Administered SC
DRUGPlacebo
Administered SC
DRUGAdalimumab
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of Ixekizumab in Participants with Ankylosing Spondylitis (AS). Measure: Assessment of SpondyloArthritis International Society Criteria (ASAS20) | 16 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of Ixekizumab in Participants with AS. Measure: Peripheral Joint Counts | 16 Weeks |
| Efficacy of Ixekizumab in Participants with AS. Measure: Spinal Mobility | Baseline through 16 Weeks |
| Efficacy of Ixekizumab in Participants with AS. Measure: Non-Arthritic Disease Assessments | Baseline through 16 Weeks |
| Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Baseline through 16 Weeks |
| Efficacy of Ixekizumab in Participants with AS. Measure: modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) | Baseline through 108 Weeks |
| Efficacy of Ixekizumab in Participants with AS. Measure: ASAS | 16 Weeks |
Countries
Argentina, Belgium, Canada, Czechia, France, Germany, Hungary, Mexico, Netherlands, Poland, Russia, Spain, Ukraine, United Kingdom, United States
Outcome results
None listed