Phase 3
Completed N=316
A Study of Ixekizumab (LY2439821) in TNF Inhibitor Experienced Participants With Radiographic Axial Spondyloarthritis
Source: ClinicalTrials.gov NCT02696798 ↗Enrolled (actual)
316
Serious AEs
3.7%
Results posted
Oct 2019
Primary outcomePrimary: Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response — 12.5; 25.4; 30.6 Percentage of participants — p=0.017
◆ Published Evidence
Emerging
14citations · ~5 / year
Long-Term Safety and Efficacy of Ixekizumab in Patients With Axial Spondyloarthritis: 3-year Data From the COAST Program.
Summary
The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in tumor necrosis factor (TNF) inhibitor-experienced participants with radiographic axial spondyloarthritis (rad-axSpA).
Linked Publications (5)
-
Long-Term Safety and Efficacy of Ixekizumab in Patients With Axial Spondyloarthritis: 3-year Data From the COAST Program.
-
Baseline Characteristics and Treatment Response to Ixekizumab Categorised by Sex in Radiographic and Non-radiographic Axial Spondylarthritis Through 52 Weeks: Data from Three Phase III Randomised Controlled Trials.
-
Does HLA-B27 Status Influence Ixekizumab Efficacy in Axial Spondyloarthritis? Results From the COAST-V, COAST-W, and COAST-X Trials.
-
Ixekizumab Improves Signs, Symptoms, and Quality of Life in Patients with Axial Spondyloarthritis Irrespective of Symptom Duration.
-
External validation of the alternative Ankylosing Spondylitis Disease Activity Score in three randomized clinical trials of ixekizumab.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response |
12.5; 25.4; 30.6 | 0.017 sig |
| SECONDARY Percentage of Participants Achieving an ASAS20 Response |
29.8; 48.2; 46.9 | 0.006 sig |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) |
-0.11; -1.16; -1.13 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response |
9.6; 21.9; 23.5 | 0.015 sig |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) |
-0.92; -2.17; -2.09 | <0.001 sig |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) |
-0.64; -1.69; -1.92 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving ASDAS Inactive Disease |
1.0; 3.5; 5.1 | 0.242 |
| SECONDARY Percentage of Participants Achieving ASDAS <2.1 |
4.8; 17.5; 16.3 | 0.006 sig |
| SECONDARY Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores |
2.7410; 3.5099; 3.6514; 1.3638; 6.5785; 6.1223 | 0.550 |
| SECONDARY Change From Baseline in ASAS Health Index (ASAS HI) |
-0.89; -1.92; -1.58 | 0.026 sig |
| SECONDARY Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Ankylosing Spondylitis Spinal Magnetic Resonance Imaging [ASSpiMRI] - Berlin Score) |
1.03; -0.92; -1.14 | <0.001 sig |
| SECONDARY Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) |
3.29; -2.99; -3.97 | 0.001 sig |
| SECONDARY Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP) |
9.719; -11.096; -8.121 | <0.001 sig |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) |
-0.046; -0.349; -0.217 | 0.018 sig |
| SECONDARY Change From Baseline in Chest Expansion |
0.04; 1.27; 0.27 | 0.170 |
| SECONDARY Change From Baseline in Occiput to Wall Distance |
0.35; 0.03; -0.65 | 0.547 |
| SECONDARY Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) |
-1.9; -1.8; -2.2 | 0.861 |
| SECONDARY Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score |
-1.9; -2.3; -1.8 | 0.504 |
| SECONDARY Change From Baseline in Severity of Peripheral Arthritis by Tender Joint Count (TJC) Scores |
-3.9; -4.8; -5.0 | 0.362 |
| SECONDARY Change From Baseline in Severity of Peripheral Arthritis by Swollen Joint Count (SJC) Scores |
-2.4; -2.6; -3.0 | 0.813 |
| SECONDARY Percentage of Participants With Anterior Uveitis |
0; 1.8; 3.1 | — |
| SECONDARY Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score |
-0.7; -2.0; -1.7 | <0.001 sig |
| SECONDARY Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ) |
-1.8; -3.0; -2.4 | 0.088 |
| SECONDARY Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores |
-9.84; -20.97; -23.50; -10.1; -16.5; -18.4 | 0.038 sig |
| SECONDARY Change From Baseline in ASAS-Nonsteroidal Anti-Inflammatory Drug (NSAID) Score |
-9.84; -5.52; -2.33 | — |
| SECONDARY Percentage of Participants With Anti-Ixekizumab Antibodies |
2.9; 7.1; 4.1 | — |
| SECONDARY Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss) |
2.10; 2.47; 6.27; 8.52 | — |
Eligibility Criteria
Inclusion Criteria
- Are ambulatory.
- Have an established 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.
- Have had prior treatment with at least 1 and not more than 2 TNF inhibitors.
- Must have had an inadequate response to 2 or more NSAIDs at the therapeutic dose range for a total duration of at least 4 weeks OR have a history of intolerance to NSAIDs.
- 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 never taken a TNF inhibitor medication or have taken more than 2.
- 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 (NCT02696798) 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.