A Phase 2b, Randomized, Double-Mask, Placebo-Controlled, Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Linsitinib in Subjects with Active, Moderate to Severe Thyroid Eye Disease (TED)
This research study is looking at a new tablet called linsitinib for adults with active, moderate to severe Thyroid Eye Disease (TED). The study aims to understand how safe linsitinib is and if it can help improve symptoms like bulging eyes. Some participants will receive the active medicine, while others will get a 'dummy' tablet (placebo) that looks exactly the same. We'll be carefully comparing how people's bulging eyes change over 24 weeks. We'll also check if it helps with other symptoms and how it affects quality of life. The study helps doctors learn if this new treatment could be a good option for people with TED.
At a glance
What is this study about?
This clinical trial is designed to investigate a new tablet medicine, called linsitinib, for people who have Thyroid Eye Disease (TED). TED is an autoimmune condition where the immune system mistakenly attacks the tissues around the eyes, leading to symptoms like bulging eyes, redness, swelling, and sometimes double vision. This particular study focuses on people whose TED is active and falls into the moderate to severe category.
The main goal of this study is to see if linsitinib can reduce the bulging of the eyes (often called proptosis) after 24 weeks of treatment. The researchers will also be closely monitoring how safe the medicine is and if people have any side effects. To make sure the results are fair and accurate, some participants will receive the active medicine, linsitinib, while others will receive a 'placebo' – this is an inactive tablet that looks exactly like the real medicine but contains no active ingredients. Neither the participants nor their doctors will know who is getting which tablet until the study ends. This helps prevent bias.
Besides measuring eye bulging, the study will also look at other important things. For example, they'll check if the medicine helps improve other signs of TED activity, like inflammation, and how it affects a person's overall quality of life. Quality of life includes things like how TED impacts daily activities, emotions, and overall well-being. By gathering all this information, doctors hope to understand if linsitinib could become a helpful new treatment option for people living with TED.
Key takeaways
- This study is testing a new tablet for moderate to severe Thyroid Eye Disease (TED).
- It aims to see if linsitinib can reduce eye bulging and is safe to use.
- Participants will receive either the new medicine or a dummy tablet, without knowing which one.
- The study lasts 24 weeks, with regular clinic visits to monitor your eyes and overall health.
- It could help find a new treatment option for people with TED.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be an adult, at least 18 years old, and have a confirmed diagnosis of Thyroid Eye Disease (TED). Your TED should be currently active and considered moderate to severe by the study doctors.
Both men and women can take part in this research. The study team will carefully review your medical history and conduct several tests to make sure that the study is safe and appropriate for you.
There might be other specific health requirements or conditions that would prevent someone from joining, even if they meet the basic age and diagnosis criteria. These detailed checks help ensure the study is suitable for everyone involved and that the results will be meaningful.
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 a diagnosis of Thyroid Eye Disease (TED)?
- Is your TED currently active and considered moderate to severe?
- Are you comfortable potentially receiving a placebo (dummy tablet)?
- Are you able to attend regular study clinic visits for 24 weeks and beyond?
What does participation involve?
If you decide to take part in this study, you will be given tablets to take regularly. Some people will receive the new medicine, linsitinib, and others will receive a dummy tablet (placebo). You won't know which one you're getting, and neither will your study doctor, until the study is over. The tablets are designed to look identical.
You will have several scheduled visits to the study clinic over a total of 24 weeks. During these visits, the study team will measure your eye bulging, check for any changes in your symptoms, and ask you to complete questionnaires about your quality of life. They will also perform physical examinations and take blood samples to monitor your health and how your body is reacting to the treatment.
After the 24 weeks of treatment, there will likely be follow-up visits to ensure your safety and track any long-term effects. The study team will explain the full schedule of visits, tests, and how long your participation will last if you're interested.
Potential risks and benefits
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Common questions
What is Thyroid Eye Disease (TED)?
TED is an eye condition linked to an overactive thyroid, where your immune system affects the tissues around your eyes, causing symptoms like bulging.
What is a 'placebo' in a study?
A placebo is a 'dummy' tablet that looks identical to the active medicine but contains no active ingredients. It helps researchers fairly compare the new medicine's effects.
Why don't I know if I'm getting the real medicine or the placebo?
This 'double-masking' helps make sure the study results are accurate and fair, as neither you nor your doctor knows which pill you're taking.
How long does the study last?
The main treatment part of the study lasts for 24 weeks, with additional follow-up visits afterwards.
What does 'proptosis responder rate' mean?
It refers to the percentage of people whose bulging eyes improve by a certain amount according to the study's specific criteria.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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