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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01870284
• Date of registration: 03/06/2013
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS) SPIRIT A1
• Scientific title: 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
• Date of first enrolment: July 2014
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT01870284
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Argentina, Belgium, Canada, Czech Republic, France, Germany, Hungary, Mexico, Netherlands, Poland, Russian Federation, Spain, Ukraine, United Kingdom, United States

Contacts

• Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Spondylitis, Ankylosing

Intervention(s)

Drug: Adalimumab

Drug: Placebo

Drug: Ixekizumab

Primary Outcome(s)

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

Secondary Outcome(s)

Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) [Time Frame: Baseline through 16 Weeks]

Efficacy of Ixekizumab in Participants with AS. Measure: Non-Arthritic Disease Assessments [Time Frame: Baseline through 16 Weeks]

Efficacy of Ixekizumab in Participants with AS. Measure: Peripheral Joint Counts [Time Frame: 16 Weeks]

Efficacy of Ixekizumab in Participants with AS. Measure: modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) [Time Frame: Baseline through 108 Weeks]

Efficacy of Ixekizumab in Participants with AS. Measure: ASAS [Time Frame: 16 Weeks]

Efficacy of Ixekizumab in Participants with AS. Measure: Spinal Mobility [Time Frame: Baseline through 16 Weeks]

Secondary ID(s)

13650

I1F-MC-RHAO

Source(s) of Monetary Support

Please refer to primary and secondary sponsors