A Multicenter, Extension Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Two Doses of Linsitinib in Subjects with Active, Moderate to Severe Thyroid Eye Disease (TED)
This research is an extension of a previous study investigating a potential new medicine, linsitinib, for individuals living with Thyroid Eye Disease (TED). TED is an autoimmune condition that can cause the eyes to bulge. The main goal of this study is to see how effective and safe two different doses of linsitinib are over a longer period. Researchers will be checking if the medicine helps reduce the bulging of the eyes, which is called proptosis, and how this changes over 24 weeks. They will also look at other measures of the disease's activity. Participants will receive either the medicine or a 'dummy' tablet that looks identical, and the study aims to understand the long-term effects of linsitinib.
At a glance
What is this study about?
This study is a follow-up to an earlier research project looking into a new medicine called linsitinib for people with Thyroid Eye Disease, often shortened to TED. TED is a condition where the immune system mistakenly attacks the tissues around the eyes. This can cause various problems, including the eyes pushing forward or bulging, a symptom doctors call 'proptosis'.
The main aim of this extended study is to carefully watch how well linsitinib works and if it's safe when taken over a longer period. Specifically, the researchers want to see if the medicine helps reduce the bulging of the eyes over 24 weeks. They will be measuring this carefully and also looking at other signs of TED activity. The insights gained from this study are very important because they help us understand if linsitinib could be a useful long-term treatment option for people with TED.
Participants in the study will receive either one of two doses of linsitinib or a 'placebo'. A placebo is a 'dummy' tablet that looks exactly like the real medicine but contains no active drug. This helps researchers compare the effects of the actual medicine against no medicine, giving them a clear picture of how well linsitinib is really working. This is a "Phase II" study, which means it's an earlier stage of drug development, designed to explore how effective the treatment might be and to learn more about its safety.
Key takeaways
- This study evaluates a potential new medicine, linsitinib, for Thyroid Eye Disease (TED).
- It's an extension of a previous study, focusing on long-term safety and effectiveness.
- The main goal is to see if linsitinib reduces eye bulging (proptosis) over 24 weeks.
- Participants will receive either linsitinib or a matching 'dummy' tablet (placebo).
- It's a 'Phase II' study, aimed at exploring effectiveness and learning more about safety.
Who may be eligible?
To be considered for this study, you must be at least 18 years old. There is no upper age limit, meaning older adults may also be able to join. Both men and women are welcome to participate.
This study is specifically for people who have active, moderate to severe Thyroid Eye Disease. This means your condition should be causing noticeable issues and not just be very mild. Your doctor will be able to tell you if your TED falls into the 'moderate to severe' category.
Since this is an 'extension study', it's likely that participants would have already taken part in the previous study (VGN-TED-301). The study team will check against a full list of criteria to make sure it's safe and appropriate for you to join.
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 active Thyroid Eye Disease (TED)?
- Has your doctor described your TED as 'moderate to severe'?
- Have you potentially participated in a previous study called VGN-TED-301?
- Are you able to attend regular clinic appointments for 24 weeks?
What does participation involve?
If you decide to take part in this study, you will be given either the study medicine, linsitinib, or a 'dummy' tablet called a placebo. The placebo looks exactly like the real medicine but doesn't contain any active drug. You will receive your assigned tablets to take as instructed. The study will last for 24 weeks, which is about 6 months.
Over these 24 weeks, you will need to attend several appointments at the study clinic. During these visits, the study team will carry out various tests and checks. These will likely include measuring how much your eyes are bulging, checking your general health and vision, and possibly taking blood samples. They will also ask you about any changes you notice in your health or any side effects you might experience. These regular check-ups help the researchers understand how the medicine is affecting you and if it's safe.
Potential risks and benefits
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Common questions
What is Thyroid Eye Disease (TED)?
TED is an illness where your body's immune system mistakenly attacks the tissues around your eyes, causing symptoms like bulging eyes, irritation, or blurry vision.
What is 'proptosis'?
Proptosis is the medical term for when your eyes appear to push forward or bulge out from their sockets due to the condition.
What is a 'placebo'?
A placebo is a 'dummy' tablet that looks exactly like the real medicine but contains no active drug. It helps researchers compare the effects of the actual medicine.
How long will the study last?
This part of the study will last for 24 weeks, which is about 6 months, after which your progress will be assessed.
Will I get the actual medicine?
You will be given either the study medicine (linsitinib) or a placebo, but you won't know which one you're receiving. This is a common way to test new medicines fairly.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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