Status:
WITHDRAWN
Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)
Lead Sponsor:
Eli Lilly and Company
Conditions:
Spondylitis, Ankylosing
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active AS.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01870284
Start Date
July 1 2014
End Date
April 1 2018
Last Update
September 16 2014
Active Locations (125)
Enter a location and click search to find clinical trials sorted by distance.
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.
Birmingham, Alabama, United States, 35205
2
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.
Little Rock, Arkansas, United States, 72205
3
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.
Upland, California, United States, 91786
4
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.
Denver, Colorado, United States, 80230