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Secukinumab in active ankylosing spondylitis
NCT01649375Phase 3
Key facts
- Status
- Completed
- Start
- Oct 2012
- Primary completion
- Aug 2014
- Countries
- 13
- Sponsor
- Novartis
- Modality
- Monoclonal Antibodies
- Drugs
- secukinumab
- Conditions
- ankylosing spondylitis (AS)
01
Overview
Phase 3, randomised, double-blind trial of secukinumab in ankylosing spondylitis (AS) (3 arms), sponsored by Novartis. Primary endpoint: Assessment of SpondyloArthritis International Society 20 Response at 16 weeks. Started Oct 2012; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Secukinumab 75 mg
Secukinumab 75 mg s.c. weekly for 4 weeks then every 4 weeks
Secukinumab 150 mg
Secukinumab 150 mg s.c. weekly for 4 weeks then every 4 weeks
Placebo
Placebo s.c. weekly for 4 weeks then every 4 weeks
03
Who it enrols
Adult patients with moderate to severe active ankylosing spondylitis who have had an inadequate response to NSAIDs or TNF inhibitors.
04
Endpoints
Primary
Assessment of SpondyloArthritis International Society 20 Response
Secondary
Assessment of SpondyloArthritis International Society 40 Response
High Sensitivity C-Reactive Protein
Assessment of SpondyloArthritis International Society 5/6 Response
Bath Ankylosing Spondylitis Disease Activity Index
Short Form-36 Physical Component Summary
Ankylosing Spondylitis Quality of Life
ASAS Partial Remission
05
Results
Primary endpoints met
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