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

• Status: Withdrawn
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Adalimumab; Ixekizumab

Criteria

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