IMVT-1401-3201: A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants with Active Thyroid Eye Disease (TED)
This research is a Phase 3 study, which means it’s one of the final steps in testing a new medicine called batoclimab for people with active Thyroid Eye Disease (TED). We want to find out if batoclimab can effectively reduce eye bulging (proptosis) and improve other common symptoms of TED, like eye inflammation, double vision, and how people feel about their quality of life. Participants will receive either batoclimab or a placebo (a dummy medicine that looks the same but has no active ingredient). This is a 'quadruple-masked' study, meaning neither the patient, the doctor, the research staff, nor the study sponsor will know who is getting which treatment until the study is over. This helps ensure fair and accurate results. Adult men and women with TED can take part.
At a glance
What is this study about?
Thyroid Eye Disease (TED) is a condition linked to an overactive thyroid, where your immune system mistakenly attacks tissues around your eyes. This can lead to symptoms like bulging eyes (known as proptosis), swelling, redness, double vision, and discomfort. In some cases, it can affect vision.
This study is investigating a new medication called batoclimab to see if it can help improve these symptoms in people who have active TED. 'Active' means your symptoms are still changing or getting worse. Batoclimab is designed to work on the immune system to try and calm down the attack on the eye tissues. If successful, it could offer a new treatment option for this challenging condition.
The main goal of this study is to see if batoclimab can reduce eye bulging. We will measure how many participants have a significant decrease in how much their eyes stick out. We'll also be looking at other important aspects like reducing eye inflammation, improving double vision, and checking how the treatment might improve a person's overall quality of life related to their eye condition.
Key takeaways
- This study is testing a new medication, batoclimab, for active Thyroid Eye Disease (TED).
- Its main aim is to see if it can reduce eye bulging (proptosis) and improve other TED symptoms.
- Participants will receive either batoclimab or a placebo (dummy medicine).
- The study involves regular clinic visits for eye checks and general health monitoring.
- Participation is for adults aged 18 and over who have active TED.
Who may be eligible?
This study is looking for adults aged 18 and over who have active Thyroid Eye Disease (TED). Both men and women are welcome to take part in this research.
To be considered for the study, your doctor will need to confirm that you have active TED, which means your eye symptoms are still causing problems or changing. They will also check if you meet certain health criteria to ensure it's safe for you to participate and that the study results will be clear.
Although not specifically mentioned in the brief details, typically, studies like this would exclude people with other serious health conditions or those taking certain medications that might interfere with the study drug or the results. Your doctor will discuss all the specific requirements with you.
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 Thyroid Eye Disease (TED)?
- Are your TED symptoms currently active (e.g., still changing or causing problems)?
- Are you able to attend regular clinic appointments for checks and assessments?
What does participation involve?
If you decide to join this study, you will first go through a screening process to make sure you meet all the necessary health requirements. If you qualify, you will be randomly assigned to receive either batoclimab or a placebo (a dummy medicine) for a period of 24 weeks. Neither you, your doctor, nor the study team will know which one you are receiving until the study is finished. This is standard practice in clinical trials to ensure unbiased results.
Throughout the 24 weeks, you will have several visits to the clinic for assessments. These visits will involve various tests and measurements of your eyes, such as checking your eye bulging, inflammation, vision, and how your eyes move. You'll also likely provide blood samples and fill out questionnaires about how you are feeling and how your eye condition is affecting your daily life. After the main treatment period, there will be follow-up visits to continue monitoring your health and any long-term effects. The total duration of your participation, including screening and follow-up, will be longer than 24 weeks.
Potential risks and benefits
Locations (3)
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- —UnverifiedGermany
Common questions
What is Thyroid Eye Disease (TED)?
TED is an autoimmune condition where your body’s immune system mistakenly attacks the tissues around your eyes, causing symptoms like bulging, swelling, and redness.
What is 'proptosis'?
Proptosis is the medical term for bulging or protruding eyes, which is a common symptom in people with Thyroid Eye Disease.
What does 'quadruple-masked' mean?
It means that no one involved in the study – not you, your doctor, the nurses, or the company sponsoring the trial – knows whether you're getting the active medicine or the dummy one. This helps keep the study fair.
What is a 'placebo'?
A placebo is a 'dummy' treatment that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the real drug's effects.
Will I have to pay to be in the study?
No, you will not have to pay for the study medication, study visits, or related tests. Some studies may even reimburse you for travel expenses.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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