A randomized, parallel-group, 24 week, double-blind, placebo-controlled, multicenter Phase 3 study to assess the efficacy and safety of secukinumab compared to placebo in adult patients with active rotator cuff tendinopathy
This research study is looking at a new medicine called secukinumab for adults who have pain and difficulty moving their shoulder due to a condition called rotator cuff tendinopathy. This is when the tendons in your shoulder, which connect muscles to bone, become inflamed or damaged. The study will last 24 weeks and will compare secukinumab to a placebo, which is a treatment that looks like the real medicine but contains no active drug. We want to see if secukinumab can reduce pain and improve how well people can use their shoulder. We will also carefully check for any side effects to make sure the medicine is safe. The main aim is to see how much people's shoulder symptoms improve after 16 weeks.
At a glance
What is this study about?
This study is about understanding if a new medicine, called secukinumab, can help adults who are suffering from moderate to severe rotator cuff tendinopathy. This condition causes ongoing pain and weakness in the shoulder, making it hard to do everyday tasks like lifting your arm or reaching for things. The 'rotator cuff' is a group of muscles and tendons that surround the shoulder joint, helping it to move.
The study will compare secukinumab with a placebo. A placebo is like a dummy medicine; it looks exactly the same as the real medicine but doesn't contain any active drug. This is a common and important way to test new medicines, as it helps researchers see if the real medicine is actually making a difference, or if improvements might be due to other factors. Participants won't know if they are receiving the active medicine or the placebo, and neither will their study doctor. This is called a 'double-blind' study.
The main goal is to measure how much better people's shoulder symptoms – like pain and stiffness – become after 16 weeks when using secukinumab, compared to the placebo. We’ll use a special questionnaire called the Western Ontario Rotator Cuff Index (WORC) to track these changes. We'll also be closely monitoring any side effects and overall safety of the medicine throughout the 24 weeks.
Key takeaways
- This study is for adults with ongoing shoulder pain from rotator cuff problems.
- It tests a new medicine, secukinumab, against a dummy treatment (placebo).
- The main goal is to see if secukinumab improves shoulder pain and movement after 16 weeks.
- The study lasts 24 weeks, with regular check-ups and injections.
- Both safety and effectiveness of the new medicine will be carefully watched.
Who may be eligible?
This study is looking for adult volunteers, aged 18 or older, who have been diagnosed with moderate to severe rotator cuff tendinopathy. This means you have significant ongoing pain and problems with shoulder movement due to inflammation or damage to the tendons in your shoulder.
Both men and women can take part in this study. The research team will need to check your medical history and carry out some tests to make sure that the study is right for you and that taking part would be safe.
There might be other reasons why you wouldn't be able to join the study, for example, if you are currently taking certain other medications or have certain other health conditions. It's important to discuss all your health details with the study team.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with moderate to severe rotator cuff tendinopathy?
- Are you able to attend regular clinic appointments for 24 weeks?
- Are you willing to potentially receive a placebo instead of the active medicine?
What does participation involve?
If you decide to join this study, it would involve several visits to the clinic over a period of 24 weeks. You would receive injections of either the study medicine (secukinumab) or the placebo. These injections look the same and are given in the same way. You wouldn't know which one you are getting.
During your visits, you would have check-ups, which include assessments of your shoulder pain and movement using questionnaires like the WORC Index. The study team would also take blood samples to check levels of the medicine, if you are receiving it, and to monitor your general health. Your vital signs (like blood pressure and heart rate) would also be checked regularly. Throughout the study, the team would ask you about any side effects you might experience. After the 24-week treatment period, there will be follow-up appointments to continue monitoring your health and well-being.
Potential risks and benefits
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Common questions
What is rotator cuff tendinopathy?
It's a condition where the tendons in your shoulder, which help you move your arm, become inflamed or damaged, leading to pain and difficulty with movement.
What is a placebo?
A placebo is a treatment that looks like the real medicine but contains no active drug. It helps researchers see if the actual medicine is truly effective.
Will I know if I'm getting the real medicine?
No, this is a 'double-blind' study, meaning neither you nor your study doctor will know if you're receiving secukinumab or the placebo.
How long will the study last?
The main treatment and assessment period of the study will last for 24 weeks, though follow-ups may extend beyond that.
What is the main thing the study wants to find out?
The study primarily aims to see if secukinumab can significantly reduce shoulder pain and improve movement after 16 weeks compared to the placebo.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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