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Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS) (SPIRIT A1)

This study has been withdrawn prior to enrollment.
(Due to unexpected operational issues outside of Lilly's control the study has been closed)
Information provided by (Responsible Party):
Eli Lilly and Company Identifier:
First received: June 3, 2013
Last updated: September 15, 2014
Last verified: September 2014
This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active AS.

Condition Intervention Phase
Spondylitis, Ankylosing
Drug: Ixekizumab
Drug: Placebo
Drug: Adalimumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:

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

Secondary Outcome Measures:
  • Efficacy of Ixekizumab in Participants with AS. Measure: ASAS [ Time Frame: 16 Weeks ]
  • 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: Spinal Mobility [ Time Frame: Baseline through 16 Weeks ]
  • Efficacy of Ixekizumab in Participants with AS. Measure: modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) [ Time Frame: Baseline through 108 Weeks ]

Enrollment: 0
Study Start Date: July 2014
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ixekizumab Dosing Regimen 1
Administered by 80 milligram (mg) subcutaneous (SC) injection
Drug: Ixekizumab
Administered SC
Other Name: LY2439821
Experimental: Ixekizumab Dosing Regimen 2
Administered by 80 mg SC Injection
Drug: Ixekizumab
Administered SC
Other Name: LY2439821
Placebo Comparator: Placebo
Placebo for ixekizumab and placebo for adalimumab administered by SC injection
Drug: Placebo
Administered SC
Active Comparator: Adalimumab
Administered by 40 mg SC injection
Drug: Adalimumab
Administered SC


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01870284

  Show 126 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Study Director: 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) Eli Lilly and Company
  More Information

Responsible Party: Eli Lilly and Company Identifier: NCT01870284     History of Changes
Other Study ID Numbers: 13650
I1F-MC-RHAO ( Other Identifier: Eli Lilly and Company )
Study First Received: June 3, 2013
Last Updated: September 15, 2014

Additional relevant MeSH terms:
Spondylitis, Ankylosing
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Joint Diseases
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on May 25, 2017