Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)
Phase 3
Withdrawn
- Conditions
- Spondylitis, Ankylosing
- Interventions
- Registration Number
- NCT01870284
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active AS.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo for ixekizumab and placebo for adalimumab administered by SC injection Ixekizumab Dosing Regimen 1 Ixekizumab Administered by 80 milligram (mg) subcutaneous (SC) injection Ixekizumab Dosing Regimen 2 Ixekizumab Administered by 80 mg SC Injection Adalimumab Adalimumab Administered by 40 mg SC injection
- Primary Outcome Measures
Name Time Method Efficacy of Ixekizumab in Participants with Ankylosing Spondylitis (AS). Measure: Assessment of SpondyloArthritis International Society Criteria (ASAS20) 16 Weeks
- Secondary Outcome Measures
Name Time Method Efficacy of Ixekizumab in Participants with AS. Measure: ASAS 16 Weeks Efficacy of Ixekizumab in Participants with AS. Measure: Peripheral Joint Counts 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: 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 Efficacy of Ixekizumab in Participants with AS. Measure: Non-Arthritic Disease Assessments Baseline through 16 Weeks
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇬🇧Leeds, West Yorkshire, United Kingdom