Phase 3
Completed N=555
Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis
Non-radiographic Spondyloarthritis
Source: ClinicalTrials.gov NCT02696031 ↗
Enrolled (actual)
555
Serious AEs
8.2%
Results posted
Aug 2020
Primary outcomePrimary: The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response at Week 16 — 68; 70; 50 Participants — p=0.0197
◆ Published Evidence
Highly cited
161citations · ~32 / year
Improvement of Signs and Symptoms of Nonradiographic Axial Spondyloarthritis in Patients Treated With Secukinumab: Primary Results of a Randomized, Placebo-Controlled Phase III Study.
Summary
The purpose of this study was to demonstrate the clinical efficacy, safety and tolerability of secukinumab compared to placebo in patients with nr-axSpA at Week 16 as well as Week 52 and long term efficacy and safety up to Week 104 (core phase) followed by an optional extension phase consisting of a 16-week randomized dose escalation treatment period and a continuous treatment period for up to Week 208
Linked Publications (5)
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Improvement of Signs and Symptoms of Nonradiographic Axial Spondyloarthritis in Patients Treated With Secukinumab: Primary Results of a Randomized, Placebo-Controlled Phase III Study.
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Secukinumab in non-radiographic axial spondyloarthritis: subgroup analysis based on key baseline characteristics from a randomized phase III study, PREVENT.
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Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications.
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Two-year imaging outcomes from a phase 3 randomized trial of secukinumab in patients with non-radiographic axial spondyloarthritis.
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Automated detection of spinal bone marrow oedema in axial spondyloarthritis: training and validation using two large phase 3 trial datasets.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response at Week 16 |
68; 70; 50 | 0.0197 sig |
| PRIMARY The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 52 |
58; 66; 34 | 0.0017 sig |
| SECONDARY The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response |
74; 75; 52; 62; 70; 36 | 0.0108 sig |
| SECONDARY The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 20 Response |
105; 107; 85 | 0.0260 sig |
| SECONDARY The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response |
74; 66; 44 | 0.0005 sig |
| SECONDARY The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society Partial Remission (ASAS PR) |
40; 39; 13 | <.0001 sig |
| SECONDARY Change in Bath Ankylosing Spondylitis Functional Index (BASFI) |
-1.75; -1.64; -1.01 | 0.0041 sig |
| SECONDARY The Number and Percentage of Patients to Achieve a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response |
69; 69; 39; 57; 65; 37 | 0.0001 sig |
| SECONDARY Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) |
-2.35; -2.43; -1.46 | 0.0006 sig |
| SECONDARY Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 16 |
-3.45; -3.62; -1.84 | 0.0008 sig |
| SECONDARY Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 52 |
-7.1; -7.6; -6.4 | 0.0012 sig |
| SECONDARY The Number and Percentage of Patients Who Achieved an Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Inactive Disease |
29; 44; 19 | 0.0577 |
| SECONDARY Change in High Sensitivity C-reactive Protein |
0.64; 0.64; 0.91 | 0.0002 sig |
| SECONDARY Change in Short Form-36 Physical Component Summary (SF-36 PCS) |
5.71; 5.57; 2.93 | 0.0006 sig |
| SECONDARY Change in Sacroiliac Joint Edema - Week 16 |
-1.68; -1.03; -0.39 | <0.0001 sig |
| SECONDARY Change in Sacroiliac Joint Edema - Week 52 |
-2.9; -1.9; -0.1 | <.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Male or non-pregnant, non-nursing female patients at least 18 years of age
- Diagnosis of axial spondyloarthritis according to Ankylosing SpondyloArthritis International Society (ASAS) axial spondyloarthritis criteria
- objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal C-reactive protein)
- active axial spondyloarthritis as assessed by total Bath Ankylosing Spondylitis Disease Activity Index >=4 cm
- Spinal pain as measured by Bath Ankylosing Spondylitis Disease Activity Index question #2 ≥ 4 cm (0-10 cm) at baseline
- Total back pain as measured by Visual Analogue scale ≥ 40 mm (0-100 mm) at baseline
- Patients should have been on at least 2 different non-steroidal anti-inflammatory drugs with an inadequate response
- Patients who have been on a Tumor Necrosis Factor (TNF) α inhibitor (not more than one) must have experienced an inadequate response
Exclusion Criteria
- Patients with radiographic evidence for sacroiliitis, grade ≥ 2 bilaterally or grade ≥ 3 unilaterally
- Inability or unwillingness to undergo MRI
- Chest X-ray or MRI with evidence of ongoing infectious or malignant process
- Patients taking high potency opioid analgesics
- Previous exposure to secukinumab or any other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor
- Pregnant or nursing (lactating) women
Data sourced from ClinicalTrials.gov (NCT02696031) 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.