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 study is looking into a new medicine called secukinumab for adults experiencing moderate to severe pain in their shoulder due to a condition called rotator cuff tendinopathy. This is when the tendons around your shoulder become painful and inflamed. The study aims to find out if secukinumab is safe and effective at reducing pain and improving how well people can use their shoulder, compared to a placebo (a dummy medicine with no active ingredients). This is a 'Phase 3' study, meaning it's a larger trial to confirm the findings from earlier research. Participants will receive either the active medicine or the placebo by injection and will be followed for 24 weeks.
At a glance
What is this study about?
This study is about a common problem many adults face: painful shoulders due to something called rotator cuff tendinopathy. Your rotator cuff is a group of muscles and tendons that help you lift and rotate your arm. When these tendons become irritated or damaged, it can lead to ongoing pain and difficulty moving your arm, making everyday tasks challenging.
Researchers are investigating whether a medicine called secukinumab could be a helpful new treatment. This medicine is already used for other conditions, and scientists believe it might also reduce the inflammation and pain associated with rotator cuff tendinopathy. The study will carefully compare secukinumab to a 'placebo', which looks exactly like the real medicine but contains no active ingredients. This helps scientists truly understand if any improvements are due to the medicine itself and not just other factors.
The main goal is to see if secukinumab can significantly reduce your shoulder pain and make it easier for you to use your arm after 16 weeks. They will also look at how you feel further down the line, and carefully monitor for any side effects, ensuring the treatment is as safe as possible.
Key takeaways
- This study is for adults with ongoing shoulder pain from rotator cuff tendinopathy.
- It tests a new medicine, secukinumab, against a dummy medicine (placebo).
- The main goals are to reduce pain and improve shoulder function.
- Participation involves regular clinic visits, injections, and health checks for 24 weeks.
- Your health will be closely monitored, and you can withdraw at any time.
Who may be eligible?
This study is looking for adult volunteers, aged 18 and over, who are currently experiencing moderate to severe pain in their shoulder due to rotator cuff tendinopathy. This means your shoulder pain should be significant enough to affect your daily life.
While the general requirements are broad, there will be other medical checks to make sure the study is right and safe for you. For example, your doctor will likely review your full medical history and current medications to ensure you meet all the specific criteria.
Both men and women are welcome to participate. If you're interested, the study team will provide all the detailed information and perform tests to confirm if you're a good fit.
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?
- Do you have moderate to severe shoulder pain from rotator cuff tendinopathy?
- Are you able to attend regular clinic visits for injections and assessments?
- Are you willing to potentially receive a placebo instead of the active medicine?
What does participation involve?
If you decide to take part, you would be involved for 24 weeks. Throughout this time, you would receive regular injections of either secukinumab or the placebo. Neither you nor your study doctor would know which one you are receiving – this is called 'double-blind' and helps ensure the results are fair.
Your participation would involve several visits to the study clinic. During these visits, the study team would give you your injections, perform physical examinations, and ask you to fill out questionnaires about your shoulder pain and ability to move your arm. They would also take blood samples to check drug levels and monitor your health carefully. We would continuously look for any side effects.
Potential risks and benefits
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Common questions
What is rotator cuff tendinopathy?
It's a common condition where the tendons around your shoulder become painful and inflamed, making it hard to move your arm.
What is secukinumab?
It's a medicine that researchers believe might help reduce the inflammation and pain in your shoulder.
Will I definitely get the active medicine?
No, because it’s a 'blind' study, you have an equal chance of receiving either the active medicine or a placebo (dummy medicine).
How long does the study last?
The study will last for 24 weeks, which is about 5 and a half months.
What is a 'Phase 3' study?
It's a larger study designed to confirm if a medicine is safe and effective in many patients, after it has shown promise in earlier, smaller studies.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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