Phase 3
Completed N=458
Study of Efficacy and Safety of Secukinumab in Patients With Ankylosing Spondylitis
Ankylosing Spondyloarthritis
Source: ClinicalTrials.gov NCT02896127 ↗
Enrolled (actual)
458
Serious AEs
5.9%
Results posted
Dec 2020
Primary outcomePrimary: The Proportion of Participants Who Achieve an ASAS 20 Response (Assessment of SpondyloArthritis International Society Criteria) — 178; 56 Participants — p=<.0001
◆ Published Evidence
Established
49citations · ~8 / year
Secukinumab provided significant and sustained improvement in the signs and symptoms of ankylosing spondylitis: results from the 52-week, Phase III China-centric study, MEASURE 5.
Summary
The purpose of this trial is to demonstrate the clinical efficacy at week 16; and to demonstrate safety and tolerability of secukinumab compared to placebo in patients with ankylosing spondylitis at week 16 and long term safety up to Week 52.
Linked Publications (3)
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Secukinumab provided significant and sustained improvement in the signs and symptoms of ankylosing spondylitis: results from the 52-week, Phase III China-centric study, MEASURE 5.
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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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A Pooled Analysis Reporting the Efficacy and Safety of Secukinumab in Male and Female Patients with Ankylosing Spondylitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Participants Who Achieve an ASAS 20 Response (Assessment of SpondyloArthritis International Society Criteria) |
178; 56 | <.0001 sig |
| SECONDARY The Proportion of Participants Who Achieve an ASAS40 Response |
138; 27 | — |
| SECONDARY Change in hsCRP Over Time |
-11.78; -0.79 | — |
| SECONDARY Percentage of Participants Who Achieve an ASAS 5/6 at Week 16 |
50.5; 19.2 | — |
| SECONDARY Participants With BASDAI Response at 16 Weeks |
41.7; 22.6 | — |
| SECONDARY Change in Short Form (36) - PCS Responders (Improvement of >= 2.5 Points) at Week 16 |
71.8; 61.1 | — |
| SECONDARY Change in ASQoL Score Over Time |
-4.6; -2.6 | — |
| SECONDARY The Proportion of Patients Who Achieve an ASAS Partial Remission |
17.7; 7.5 | — |
Eligibility Criteria
Inclusion Criteria
Male or non-pregnant, non-lactating female patients at least 18 years of age
Diagnosis of moderate to severe AS with prior documented radiologic evidence (x-ray or radiologist's report) fulfilling the Modified New York criteria for AS:
- Active AS assessed by BASDAI ≥4 (0-10) at Baseline
- Spinal pain as measured by BASDAI question #2 ≥ 4 cm (0-10 cm) at Baseline
- Total back pain as measured by VAS ≥ 40 mm (0-100 mm) at Baseline Patients should have had inadequate response or failure to respond to at least 2 NSAIDs at an approved dose for a minimum of 4 weeks in total and a minimum of 2 weeks for each NSAID prior to randomization, or less than 4 weeks if therapy had to be withdrawn due to intolerance, toxicity or contraindications Patients who are regularly taking NSAIDs (including COX-1 or COX-2 inhibitors) as part of their AS therapy are required to be on a stable dose for at least 2 weeks before randomisation Patients who have been on a TNFα inhibitor (not more than one) must have experienced an inadequate response to previous or current treatment given at an approved dose for at least 3 months prior to randomization or have been intolerant to at least one administration of an anti-TNFα agent
Exclusion Criteria
- 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 IL-17 or IL-17 receptor
- Pregnant or nursing (lactating) women
Data sourced from ClinicalTrials.gov (NCT02896127) 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.