SKIPPAIN ( SecuKinumab-Induced relief from Pain in AxSpA)
Research type
Research Study
Full title
SKIPPAIN (Speed of onset of SecuKinumab-Induced relief from Pain in Patients with AxIal SpoNdyloarthritis) A 24-week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of secukinumab in controlling spinal pain in patients with axial spondyloarthritis
IRAS ID
225233
Contact name
Mark Tomlinson
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2017-000401-21
Duration of Study in the UK
1 years, 6 months, 23 days
Research summary
Axial Spondyloarthritis (axSpA) is a chronic inflammatory disease predominantly affecting the axial skeleton (sacroiliac joints and spine). The main symptoms are back pain and spinal inflammation. axSpA is among the most common chronic inflammatory joint disorders. Recently biologic drugs have proven effective at treating axSpA. Biologics are protein based drugs which can target particular elements of the overactive immune system. The most commonly used biologic treatments for axSpA are drugs which block a particular chemical messenger called TNFalpha. Secukinumab is a new class of biologic which blocks the activity of one of the chemical messengers which is involved in the immune system and is implicated in axSpA. This is a 24 week long study to evaluate the efficacy and safety of secukinumab 150 mg compared to placebo in the early management (Baseline to Week 8) of spinal pain, disease activity, fatigue and predictability of disease flares in patients with axial Spondyloarthritis (axSpA) who have an inadequate response to prior NSAIDs. This study will also assess the efficacy and safety of secukinumab 300 mg compared to secukinumab 150 mg from Week 8 to Week 24 in order to assess the potential additional benefits of dose escalation in patients with axSpA. Approximately 352 patients will be randomised across the participating countries, with approximately 15 in the UK at approximately 5 sites.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
17/LO/1116
Date of REC Opinion
6 Sep 2017
REC opinion
Further Information Favourable Opinion