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

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 - SPIRIT-A1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002325-22-GB

Enrollment

408

Registered

2013-06-18

Start date

2013-09-26

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spondylitis, Ankylosing MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: Ixekizumab Product Code: LY2439821 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Ixekizumab

Eligibility

Sex/Gender

All

Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 388 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: ? Participants with a total ankylosis of the spine ? Prior or current treatment with adalimumab ? Patients 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active ankylosing spondylitis based on ASAS20 at 16 Weeks; Secondary Objective: Efficacy of either ixekizumab compared to placebo in patients with active AS based on the following measures at Week 16: -Proportion of biologic naïve patients who achieve an ASAS40 response. -peripheral tender or swollen joint counts -Change from baseline in patient-reported quality of life and other outcomes assessments -Change from baseline in non-arthritic aisease assessments -spinal mobility Efficacy of either ixekizumab compared to placebo in patients with active AS based on the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) change from baseline at Week 108. ; Primary end point(s): Efficacy of ixekizumab in participants with Ankylosing Spondylitis (AS). Measure: Assessment of Spondyloarthritis International Society (ASAS) 20 Response ;Timepoint(s) of evaluation of this end point: At 16 Weeks	—

Measure

Time frame

Main Objective: Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active ankylosing spondylitis based on ASAS20 at 16 Weeks; Secondary Objective: Efficacy of either ixekizumab compared to placebo in patients with active AS based on the following measures at Week 16: -Proportion of biologic naïve patients who achieve an ASAS40 response. -peripheral tender or swollen joint counts -Change from baseline in patient-reported quality of life and other outcomes assessments -Change from baseline in non-arthritic aisease assessments -spinal mobility Efficacy of either ixekizumab compared to placebo in patients with active AS based on the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) change from baseline at Week 108. ; Primary end point(s): Efficacy of ixekizumab in participants with Ankylosing Spondylitis (AS). Measure: Assessment of Spondyloarthritis International Society (ASAS) 20 Response ;Timepoint(s) of evaluation of this end point: At 16 Weeks

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Secondary

Measure	Time frame
Secondary end point(s): 1) Efficacy of ixekizumab in participants with AS. Measure: ASAS 2) Quality of life and outcome assessments. Measures: Patient Reported Outcomes (PRO) 3) Efficacy of ixekizumab in participants with AS. Measure: Non-Arthritic Disease Assessments 4) Efficacy of ixekizumab in participants with AS. Measure: Peripheral Joint Counts 5) Efficacy of ixekizumab in participants with AS. Measure: Spinal Mobility 6) Efficacy of ixekizumab in participants with Ankylosing Spondylitis (AS). Measure: modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) ; Timepoint(s) of evaluation of this end point: 1) 16 Weeks 2) Baseline through 16 Weeks 3) Baseline through 16 Weeks 4) 16 Weeks 5) Baseline through 16 Weeks 6) Baseline through 108 Weeks	—

Measure

Time frame

Secondary end point(s): 1) Efficacy of ixekizumab in participants with AS. Measure: ASAS 2) Quality of life and outcome assessments. Measures: Patient Reported Outcomes (PRO) 3) Efficacy of ixekizumab in participants with AS. Measure: Non-Arthritic Disease Assessments 4) Efficacy of ixekizumab in participants with AS. Measure: Peripheral Joint Counts 5) Efficacy of ixekizumab in participants with AS. Measure: Spinal Mobility 6) Efficacy of ixekizumab in participants with Ankylosing Spondylitis (AS). Measure: modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) ; Timepoint(s) of evaluation of this end point: 1) 16 Weeks 2) Baseline through 16 Weeks 3) Baseline through 16 Weeks 4) 16 Weeks 5) Baseline through 16 Weeks 6) Baseline through 108 Weeks

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Countries

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

Contacts

Public ContactClinical Trial Information

Eli Lilly

EU_Lilly_clinical_Trials@Lilly.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026