Phase 3
N=350
16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing Spondylitis
Spondylitis, Ankylosing
Bottom Line
View on ClinicalTrials.gov: NCT02159053 ↗Enrolled (actual)
350
Serious AEs
10.9%
Results posted
Apr 2019
Primary outcome: Primary: Percentage of Participants Responded for Assessment of Spondyloarthritis International Society 20 Criteria (ASAS20) at 16 Weeks — 60.5; 65.5; 49.1 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Secukinumab (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Responded for Assessment of Spondyloarthritis International Society 20 Criteria (ASAS20) at 16 Weeks |
60.5; 65.5; 49.1 | — |
| SECONDARY Percentage of Participants Responded for ASAS 40 Response at 16 Weeks |
39.5; 38.2; 29.5 | — |
| SECONDARY Change From Baseline in Serum High Sensitivity C-reactive Protein (hsCRP) at 16 Weeks |
-4.23; -6.57; 0.62 | — |
| SECONDARY Percentage of Participants Responded for ASAS 5/6 Response at 16 Weeks |
37.7; 45.5; 30.4 | — |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 16 Weeks |
-2.405; -2.533; -1.917 | — |
| SECONDARY Change From Baseline in Physical Function Component Summary (PCS) of the Medical Outcomes Study Questionnaire Short-form Health Survey (SF-36) |
6.754; 7.242; 4.700 | — |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at 16 Weeks |
-4.2; -4.7; -3.0 | — |
| SECONDARY Number of Participants With Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs) and Related Discontinuations at 104 Weeks |
100; 98; 65; 289; 16; 11 | — |
| SECONDARY Percentage of Participants Responded for ASAS 20 at Week 4 |
49.1; 55.3; 40.0 | — |
| SECONDARY Percentage of Participants Responded for ASAS 40 Response at Week 4 |
29.3; 27.2; 18.3 | — |
Summary
The purpose of this study is to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with active AS despite current or previous NSAID, non-biologic DMARD, or biologic anti-TNFα therapy.
Eligibility Criteria
Inclusion criteria: moderate to severe AS, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response to NSAIDs.
Exclusion criteria: pregnancy or lactation, on-going infectious or malignant process on a chest X-ray or MRI, previous exposure to IL-17 or IL-17R targeting therapies, previous exposure to any biological immunomodulating agent excluding TNF antagonists, previous cell depleting therapy.
Other protocol-defined inclusion/exclusion criteria do apply.
Data sourced from ClinicalTrials.gov (NCT02159053). 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.