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

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

Official Title
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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

Conditions
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Spondylitis, Ankylosing

Intervention / Treatment
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* Drug: Ixekizumab
* Drug: Placebo
* Drug: Adalimumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ixekizumab Dosing Regimen 1<br>Administered by 80 milligram (mg) subcutaneous (SC) injection | Drug: Ixekizumab<br>* Administered SC<br>* Other names: LY2439821;|
| Experimental: Ixekizumab Dosing Regimen 2<br>Administered by 80 mg SC Injection | Drug: Ixekizumab<br>* Administered SC<br>* Other names: LY2439821;|
| Placebo Comparator: Placebo<br>Placebo for ixekizumab and placebo for adalimumab administered by SC injection | Drug: Placebo<br>* Administered SC<br>|
| Active Comparator: Adalimumab<br>Administered by 40 mg SC injection | Drug: Adalimumab<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Ixekizumab in Participants with Ankylosing Spondylitis (AS). Measure: Assessment of SpondyloArthritis International Society Criteria (ASAS20) |  | 16 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Ixekizumab in Participants with AS. Measure: ASAS |  | 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: Non-Arthritic Disease Assessments |  | Baseline through 16 Weeks | 
| 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: modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) |  | Baseline through 108 Weeks |