Phase 3
N=303
A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis
Axial Spondyloarthritis
Bottom Line
View on ClinicalTrials.gov: NCT02757352 ↗Enrolled (actual)
303
Serious AEs
1.6%
Results posted
Mar 2020
Primary outcome: Primary: Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response — 19.0; 35.4; 40.2 percentage of participants — p=0.009
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ixekizumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response |
19.0; 35.4; 40.2 | 0.009 sig |
| PRIMARY Percentage of Participants Achieving an ASAS40 Response |
13.3; 30.2; 31.4 | 0.004 sig |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) |
-0.78; -1.39; -1.47 | <0.001 sig |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) |
-0.78; -1.39; -1.47 | <0.001 sig |
| SECONDARY Number of Participants Without Clinically Meaningful Changes in Background Therapy |
98; 90; 100 | — |
| SECONDARY Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score |
4.7210; 8.9211; 9.3291 | 0.012 sig |
| SECONDARY Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score |
4.7210; 8.9211; 9.3291 | 0.012 sig |
| SECONDARY Percentage of Participants Achieving ASDAS Low Disease Activity |
8.6; 29.8; 27.5 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving ASDAS Low Disease Activity |
8.6; 29.8; 27.5 | <0.001 sig |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) |
-1.76; -2.89; -3.04 | 0.006 sig |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) |
-1.76; -2.89; -3.04 | 0.006 sig |
| SECONDARY Change From Baseline in Magnetic Resonance Imaging (MRI) of the Sacroiliac Joint (SIJ) Spondyloarthritis Research Consortium of Canada (SPARCC) Score |
-0.31; -3.38; -4.52 | <0.001 sig |
| SECONDARY Change From Baseline in SPARCC Enthesitis Score |
-2.87; -2.99; -3.14 | 0.849 |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) |
-1.57; -2.63; -2.75 | 0.018 sig |
| SECONDARY Percentage of Participants Achieving ASDAS Inactive Disease |
2.9; 13.5; 10.8 | 0.0011 sig |
| SECONDARY Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP) |
-4.804; -8.611; -7.547 | 0.183 |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) |
-0.17; -0.56; -0.48 | 0.008 sig |
| SECONDARY Change From Baseline in Chest Expansion |
0.57; 0.62; 0.91 | 0.871 |
| SECONDARY Change From Baseline in Occiput to Wall Distance |
0.04; -0.42; -0.73 | 0.257 |
| SECONDARY Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) |
-2.34; -3.21; -3.19 | 0.082 |
| SECONDARY Change From Baseline in Severity of Peripheral Arthritis by Tender (TJC) and Swollen Joint Count (SJC) Scores of 44 Joints |
-0.59; -2.38; -4.12; -3.66; -4.63; -4.41 | 0.219 |
| SECONDARY Number of Participants With Anterior Uveitis |
2; 1; 2 | — |
| SECONDARY Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score |
-2.1; -2.6; -2.7 | 0.325 |
| SECONDARY Change From Baseline in ASAS Health Index (ASAS HI) |
-2.57; -3.16; -3.54 | 0.330 |
| SECONDARY Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ) |
-2.9; -3.6; -3.6 | 0.348 |
| SECONDARY Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores |
-13.20; -26.96; -19.49; -3.11; -9.01; -7.26 | 0.005 sig |
| SECONDARY Change From Baseline in ASAS-Nonsteroidal Anti-Inflammatory Drug (NSAID) Score |
-8.89; -7.91; -5.33 | — |
| SECONDARY Number of Participants With Treatment Emergent (TE) Anti-Ixekizumab Antibodies |
14; 5; 8; 2 | — |
| SECONDARY Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough ss) |
7.88; 9.56; 10.3; 10.4; 2.88; 6.45 | — |
Summary
The main purpose of this study is to evaluate the safety and efficacy of the study drug known as ixekizumab in biologic disease modifying antirheumatic drug (bDMARD) naïve participants with nonradiographic axial spondyloarthritis (nonrad-axSpA).
Eligibility Criteria
Inclusion Criteria
- Are ambulatory.
- Diagnosis of nonradiographic axial spondyloarthritis (nr-axSpA) and fulfilling the 2009 Assessment of Spondyloarthritis International Society (ASAS) classification criteria.
- Have a history of back pain ≥3 months with age at onset <45 years.
- Have active nr-axSpA defined as BASDAI ≥4 and total back pain ≥4 on a numeric rating scale (NRS) at screening and baseline.
- Have objective signs of inflammation by presence of sacroiliitis on MRI and/or presence of elevated C-reactive protein (CRP).
- In the past had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDS) for duration of 4 weeks or cannot tolerate NSAIDS.
- If taking NSAIDS be on 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 radiographic sacroiliitis fulfilling the 1984 modified New York criteria.
- Have received any prior, or are currently receiving treatment with biologics, tumor necrosis factor inhibitors or other immunomodulatory agents.
- Have 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.
- Have evidence of active anterior uveitis (an acute episode) within the last 42 days prior to baseline randomization.
Data sourced from ClinicalTrials.gov (NCT02757352). 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.