Phase 3
Completed N=147
A Study of Ixekizumab (LY2439821) in Chinese Participants With Radiographic Axial Spondyloarthritis
Source: ClinicalTrials.gov NCT04285229 ↗Enrolled (actual)
147
Serious AEs
3.3%
Results posted
Jun 2022
Primary outcomePrimary: Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response in Biological Disease-modifying Antirheumatic Drug (bDMARD)-naïve Participants — 7.8; 40.9 Percentage of Participants — p=<0.001
◆ Published Evidence
Emerging
5citations · ~3 / year
Ixekizumab for Active Radiographic Axial Spondyloarthritis in Chinese Patients: 16- and 52-Week Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study.
Summary
The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in Chinese participants with radiographic axial spondyloarthritis (r-axSpA).
Linked Publications (5)
-
Ixekizumab for Active Radiographic Axial Spondyloarthritis in Chinese Patients: 16- and 52-Week Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study.
-
Efficacy of Ixekizumab in Chinese Patients with Radiographic Axial Spondyloarthritis by Baseline C-Reactive Protein Level.
-
Rapid and Sustained Effect of Ixekizumab on Patient Global, Spinal Pain, Stiffness, and Fatigue in Chinese Patients with Radiographic Axial Spondyloarthritis.
-
Efficacy of Ixekizumab in Radiographic Axial Spondyloarthritis by Baseline C-Reactive Protein Level: A Pooled Analysis of Phase III Trials.
-
Efficacy of Ixekizumab in Chinese Patients with Radiographic-Axial Spondyloarthritis by Baseline Inflammation Status on Magnetic Resonance Imaging.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response in Biological Disease-modifying Antirheumatic Drug (bDMARD)-naïve Participants |
7.8; 40.9 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving an ASAS40 Response |
8.2; 37.8 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving an ASAS20 Response |
35.6; 59.5 | 0.006 sig |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) |
-0.19; -1.33 | <0.001 sig |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Response |
-0.90; -2.39 | <0.001 sig |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) |
-0.49; -1.36 | 0.002 sig |
| SECONDARY Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) |
-0.93; -8.65 | <0.001 sig |
| SECONDARY Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score |
1.23; 3.85 | 0.001 sig |
| SECONDARY Change From Baseline in 36-Item SF-36 Mental Component Summary (MCS) Score |
-0.06; 0.45 | 0.660 |
| SECONDARY Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP) |
2.65; -10.10 | <0.001 sig |
| SECONDARY Change From Baseline in Mobility on the Bath Ankylosing Spondylitis Metrology Index (BASMI) |
0.06; -0.30 | <0.001 sig |
| SECONDARY Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) |
-1.06; -1.77 | 0.086 |
| SECONDARY Change From Baseline in MRI Sacroiliac Joint(s) (SIJ) Spondyloarthritis Research Consortium of Canada (SPARCC) Score |
-1.31; -6.98 | <0.001 sig |
| SECONDARY Number of Participants With Anterior Uveitis |
0; 0 | — |
| SECONDARY Change From Baseline in ASAS-Nonsteroidal Anti-Inflammatory Drug (NSAID) Score |
-30.71; -26.13 | — |
| SECONDARY Percentage of Participants With Anti-Ixekizumab Antibodies |
4.1; 13.5 | — |
| SECONDARY Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss) |
3.89 | — |
Eligibility Criteria
Inclusion Criteria
- Have an established diagnosis of radiographic axial spondyloarthritis (r-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.
- Biologic naïve or have had prior treatment with 1 tumor necrosis factor (TNF) inhibitor.
- 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 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.
- 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 (NCT04285229) 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.