AIN457 vs placebo in patients with active overuse tendinopathy
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, parallel group, Phase II, 24-week study investigating the efficacy, safety and tolerability of AIN457 in patients with active overuse tendinopathy refractory to oral NSAIDs/acetaminophen, physiotherapy or corticosteroid injections
IRAS ID
234908
Contact name
Neal Millar
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2017-003099-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 17 days
Research summary
Overuse tendinopathy is a complex disease of the tendon, clinically diagnosed
after gradual onset of activity-related pain, decreased function and sometimes with swelling of the tendon. Tendinopathy is a common overuse injury in the athletic and working populations. Per year, between 0.3% and 5.5% of the population are newly diagnosed with overuse rotator cuff tendinopathy, which is the specific type of tendinopathy being studied in this trial.
Current treatments for tendinopathy are rest, icepacks and physiotherapy (including therapeutic ultrasound and laser therapy). Non-steroidal anti-inflammatory drugs (NSAIDS), or local corticosteroid injections can give temporary pain relief, but the long term benefit is questionable.
Overall, overuse tendinopathy is a disease with high medical need without adequate treatment options.
AIN457 (secukinumab) is an antibody which neutralises (makes ineffective) a chemical messenger called IL-17A. IL-17A has been shown to cause inflammation, disrepair and cell death in tendon cells so it is believed that neutralising IL-17A will reduce inflammation in the tendon and allow the structure of the tendon to repair. AIN457 has already been shown to be effective in a number of other inflammatory diseases and is licensed for the treatment of psoriatic arthritis, psoriasis and ankylosing spondylitis.
In this study, the effectiveness and safety of AIN457 will be assessed and compared to placebo (‘dummy’ medicine with no active ingredient). Effectiveness will be assessed by a number of procedures and assessments including patient questionnaires, MRI scans, range of movement assessment, painful arc assessment, shoulder/arm strength and monitoring sleep quality. Additionally, at some sites, there will be use of a special type of ultrasound called shearwave elastopgraphy to measure the elasticity of the tendon. Safety of AIN457 will be monitored with ECGs, blood tests and the collection of adverse events (untoward signs and symptoms that occur).It is expected that there will be 1 site in the UK (Glasgow) and that 20 patients will be recruited.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
17/YH/0435
Date of REC Opinion
6 Feb 2018
REC opinion
Further Information Favourable Opinion