Phase 3
N=341
A Study of Ixekizumab (LY2439821) in bDMARD-Naive Participants With Radiographic Axial Spondyloarthritis
Spondyloarthritis
Bottom Line
View on ClinicalTrials.gov: NCT02696785 ↗Enrolled (actual)
341
Serious AEs
2.9%
Results posted
Nov 2019
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ixekizumab (Drug); Placebo (Drug); Adalimumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Dec 2017
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 |
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).
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). 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.