Phase 3
N=137
Efficacy and Safety Study of Secukinumab in Chinese Participants With Non-radiographic Axial Spondyloarthritis
Non-radiographic Axial Spondyloarthritis
Bottom Line
View on ClinicalTrials.gov: NCT04732117 ↗Enrolled (actual)
137
Serious AEs
3.5%
Results posted
Jan 2026
Primary outcome: Primary: Assessment of SpondyloArthritis International Society 40 (ASAS40) Response Rate in TNF-alpha-inhibitor-naive Participants at Week 16 — 58.72; 26.03 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Secukinumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of SpondyloArthritis International Society 40 (ASAS40) Response Rate in TNF-alpha-inhibitor-naive Participants at Week 16 |
58.72; 26.03 | — |
| SECONDARY ASAS40 Response Rate in All Participants at Week 16 |
60.10; 24.78 | — |
| SECONDARY ASAS 5/6 Response Rate at Week 16. |
61.97; 25.89 | — |
| SECONDARY Change From Baseline in Total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Week 16 |
-3.70; -2.15 | — |
| SECONDARY BASDAI 50 Rate at Week 16 |
64.04; 25.77 | — |
| SECONDARY Change From Baseline of High Sensitivity C-Reactive Protein (hsCRP) at Week 16 |
0.38; 0.74 | — |
| SECONDARY Change From Baseline in Total Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16 |
-2.04; -0.93 | — |
| SECONDARY Change From Baseline in Sacroiliac Joint (SIJ) Edema Score on Magentic Resonance Imaging (MRI) at Week 16 |
-3.09; -0.84 | — |
| SECONDARY ASAS20 Response Rate at Week 16 |
78.10; 47.60 | — |
| SECONDARY Change From Baseline in Short Form-36 Physical Component Summary (SF-36 PCS) at Week 16 |
9.35; 4.34 | — |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 16 |
-4.90; -3.07 | — |
| SECONDARY ASAS Partial Remission Rate at Week 16 |
30.83; 14.52 | — |
Summary
The purpose of this study was to evaluate the efficacy, safety, and tolerability of secukinumab in Chinese patients with active non-radiographic axial spondyloarthritis (nr-axSpA).
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 TNFα 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
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04732117). 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.