Phase 3
N=458
Study of Efficacy and Safety of Secukinumab in Patients With Ankylosing Spondylitis
Ankylosing Spondyloarthritis
Bottom Line
View on ClinicalTrials.gov: NCT02896127 ↗Enrolled (actual)
458
Serious AEs
5.9%
Results posted
Dec 2020
Primary outcome: Primary: The Proportion of Participants Who Achieve an ASAS 20 Response (Assessment of SpondyloArthritis International Society Criteria) — 178; 56 Participants — p=<.0001
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
- May 2018
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 | — |
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.
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in total and a minimum of 2 weeks for each NSAID prior to randomization, or less than 4 weeks if therapy had to be withdrawn due to intolerance, toxicity or contraindications Patients who are regularly taking NSAIDs (including COX-1 or COX-2 inhibitors) as part of their AS therapy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). 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.