Study of efficacy and safety of secukinumab in participants with moderate-severe rotator cuff
Research type
Research Study
Full title
A randomised, parallel-group, 24 week, double-blind, placebo-controlled, multicentre Phase 3 study to assess the efficacy and safety of secukinumab compared to placebo in adult patients with active rotator cuff tendinopathy
IRAS ID
1007495
Contact name
Maria Pang
Contact email
Sponsor organisation
Novartis Pharma AG
Clinicaltrials.gov Identifier
Research summary
The purpose of the study is to investigate the effectiveness and safety of injections with secukinumab 300 mg compared to placebo (dummy treatment) in participants with Rotator Cuff Tendinopathy (a problem with the tendon [a tissue which connects muscle to bone] in the shoulder caused by overuse or injury leading to pain, weakness, swelling or stiffness of the shoulder), with no effective relief when using other commonly used therapies. Approximately 234 people with Rotator Cuff Tendinopathy (RCT) between the ages of 18 and 65 years will be invited to take part in this study globally.
Secukinumab (AIN457) is a drug that recognises and binds to certain unique proteins that the body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin-17A (IL-17A). IL-17A is believed to be partly responsible for inflammation (pain, swelling, redness), and research shows it contributes to symptoms of RCT. A drug such as secukinumab that blocks the actions of IL-17A therefore may help to relieve these symptoms.
Participants will be allocated to one of the following study treatments by chance which will be given by two injections subcutaneously (through the skin) every week for the first 4 weeks and then every 4 weeks up to week 12: Secukinumab 300mg (2 x 150 mg) or placebo.
Participants will be in the study for up to 32 weeks and during that time will visit the Study Doctor about 11 times (possibly less if they are able to inject the study drug at home). Participants will receive the study drug seven times during the study. At the study visits, the following assessments will be performed: an examination of general health, blood tests, blood pressure and pulse rate, images of the shoulder taken (before starting study drug) and several questionnaires. Participants will need to complete an electronic diary to monitor pain and sleep disturbance and record their use of pain relief medicines and physiotherapy.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
23/SC/0200
Date of REC Opinion
14 Sep 2023
REC opinion
Further Information Favourable Opinion