Phase 3
Completed N=341
A Study of Ixekizumab (LY2439821) in bDMARD-Naive Participants With Radiographic Axial Spondyloarthritis
Source: ClinicalTrials.gov NCT02696785 ↗Enrolled (actual)
341
Serious AEs
2.9%
Results posted
Nov 2019
Primary outcomePrimary: Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response — 18.4; 35.6; 48.1; 51.8 percentage of participants — p=0.005
◆ Published Evidence
Emerging
7citations · ~7 / year
The effect of ixekizumab treatment on MRI sacroiliac joint structural lesions in patients with radiographic axial spondyloarthritis: post-hoc analysis of a 52-week, randomised, placebo-controlled trial with an active reference arm.
Summary
The main purpose of this study is to evaluate the safety and efficacy of the study drug known as ixekizumab in biological disease-modifying anti-rheumatic drugs (bDMARDs)-naive participants with radiographic axial spondyloarthritis (rad-axSpA).
Linked Publications (5)
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The effect of ixekizumab treatment on MRI sacroiliac joint structural lesions in patients with radiographic axial spondyloarthritis: post-hoc analysis of a 52-week, randomised, placebo-controlled trial with an active reference arm.
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Does HLA-B27 Status Influence Ixekizumab Efficacy in Axial Spondyloarthritis? Results From the COAST-V, COAST-W, and COAST-X Trials.
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Improvement in spinal pain at night and its impact on long-term outcomes in radiographic axial spondyloarthritis: Results from Ixekizumab COAST-V randomised trial.
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Efficacy of Ixekizumab in Radiographic Axial Spondyloarthritis by Baseline C-Reactive Protein Level: A Pooled Analysis of Phase III Trials.
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Ixekizumab Improves Signs, Symptoms, and Quality of Life in Patients with Axial Spondyloarthritis Irrespective of Symptom Duration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response |
18.4; 35.6; 48.1; 51.8 | 0.005 sig |
| SECONDARY Percentage of Participants Achieving an ASAS20 Response |
40.2; 58.9; 64.2; 68.7 | 0.007 sig |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) |
-0.46; -1.30; -1.43; -1.37 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response |
17.2; 32.2; 42.0; 43.4 | 0.012 sig |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) |
-1.16; -2.14; -2.39; -2.43 | 0.001 sig |
| SECONDARY Percentage of Participants Achieving ASDAS Inactive Disease |
2.3; 15.6; 16.0; 10.8 | 0.009 sig |
| SECONDARY Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Ankylosing Spondylitis Spinal Magnetic Resonance Imaging [ASSpiMRI] - Berlin Score) |
-0.15; -2.92; -2.77; -2.54 | <0.001 sig |
| SECONDARY Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores |
3.6432; 6.9005; 7.6952; 7.9686; 2.1229; 2.5550 | 0.002 sig |
| SECONDARY Change From Baseline in ASAS Health Index (ASAS HI) |
-1.25; -2.30; -2.36; -2.74 | 0.012 sig |
| SECONDARY Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP) |
1.426; -7.202; -5.209; -6.565 | 0.001 sig |
| SECONDARY Change From Baseline in Mobility on the Bath Ankylosing Spondylitis Metrology Index (BASMI) |
-0.080; -0.447; -0.502; -0.408 | 0.001 sig |
| SECONDARY Change From Baseline in Chest Expansion |
0.06; 0.70; 0.49; 0.67 | 0.003 sig |
| SECONDARY Change From Baseline in Occiput to Wall Distance |
-0.06; -0.72; -0.69; -0.73 | 0.039 sig |
| SECONDARY Change From Baseline in MRI Sacroiliac Joint(s) (SIJ) Spondyloarthritis Research Consortium of Canada (SPARCC) Score |
0.92; -4.21; -3.97; -4.25 | <0.001 sig |
| SECONDARY Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) |
-2.1; -2.6; -2.3; -2.4 | 0.317 |
| SECONDARY Change From Baseline in SPARCC Enthesitis Score |
-2.1; -2.9; -2.7; -2.6 | 0.154 |
| SECONDARY Change From Baseline in Severity of Peripheral Arthritis by Tender (TJC) |
-2.0; -2.2; -2.5; -3.3 | 0.783 |
| SECONDARY Number of Participants With Anterior Uveitis or Uveitis Flares |
0; 0; 1; 0 | — |
| SECONDARY Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score |
-1.4; -2.2; -2.5; -2.1 | 0.027 sig |
| SECONDARY Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ) |
-1.5; -2.7; -2.5; -3.0 | 0.041 sig |
| SECONDARY Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores |
-17.82; -21.44; -21.36; -24.06; -14.1; -21.1 | 0.989 |
| SECONDARY Change From Baseline in ASAS-Nonsteroidal Anti-Inflammatory Drug (NSAID) Score |
-10.28; -5.91; -7.62; -9.91 | — |
| SECONDARY Number of Participants With Anti Ixekizumab Antibodies |
2; 5; 2; 2 | — |
| SECONDARY Pharmacokinetics: Trough Ixekizumab Concentration at Steady State (Ctrough ss) |
3.56; 3.88; 11.6; 11.3 | — |
| SECONDARY Change From Baseline in Severity of Peripheral Arthritis by Swollen Joint Count (SJC) |
-1.7; -2.7; -3.6; -2.7 | 0.166 |
| SECONDARY Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) |
-1.51; -11.57; -11.02; -9.58 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Are ambulatory.
- Diagnosis of radiographic axial spondyloarthritis (rad-xSpA) with sacroiliitis defined radiographically according to the modified New York criteria.
- Participants have a history of back pain ≥3 months with age at onset <45 years.
- In the past had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (for duration 4 weeks) or cannot tolerate NSAIDS.
- If taking NSAIDS be on a stable dose for at least 2 weeks prior to randomization.
- Have a history of prior therapy for axSpa for at least 12 weeks prior to screening.
Exclusion Criteria
- Have total ankylosis of the spine.
- Have received any prior, or are currently receiving, treatment with biologics, tumor necrosis factor inhibitors or other immunomodulatory agents.
- Have recently received a live vaccine within 12 weeks or have had a vaccination with Bacillus Calmette-Guerin (BCG) within the past year.
- Have an ongoing or serious infection within the last 12 weeks or evidence of active tuberculosis.
- Have a compromised immune system.
- Have any other serious and/or uncontrolled diseases.
- Have either a current diagnosis or a recent history of malignant disease.
- Have had major surgery within 8 weeks of baseline, or will require surgery during the study.
- Are pregnant or breastfeeding.
Data sourced from ClinicalTrials.gov (NCT02696785) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.