An Open-label Extension Study for Participants who Completed Study IMVT-1401-3201 or Study IMVT-1401-3202 to Assess the Efficacy and Safety of Batoclimab for the Treatment of Thyroid Eye Disease (TED)
This study is a follow-up for people who have previously taken part in studies testing a new medicine called batoclimab for Thyroid Eye Disease (TED). The main aim is to understand how long the improvements in bulging eyes (proptosis) last after people stop taking batoclimab, especially if they responded well to it before. We also want to see if batoclimab can help people whose bulging eyes didn't improve in the previous studies, whether they received batoclimab or a dummy treatment (placebo) initially. This is a Phase 3 study, meaning it's one of the final steps before a new medicine might become widely available. It helps doctors understand the long-term effects and if the medicine can benefit more people with TED.
At a glance
What is this study about?
This research study is about a new medicine called batoclimab for a condition known as Thyroid Eye Disease, or TED. TED can cause problems like bulging eyes, double vision, and discomfort. This specific study is a continuation for people who have already participated in earlier studies looking at batoclimab. It's like going to the next chapter to learn more.
The main goal of this follow-up study is to see how long the improvements in bulging eyes (which doctors call proptosis) last after someone stops taking batoclimab. For example, if someone's eyes got better during a previous study, we want to know if those improvements continue for a long time even without the medicine. We also want to find out if batoclimab can help people whose eyes didn't improve much in the earlier studies, whether they received the actual medicine or a placebo (a treatment that looks like medicine but has no active drug).
Understanding these things is really important. It helps doctors know more about how well batoclimab works in the long term and who might benefit most from it. This information brings us closer to potentially having a new treatment option for people living with TED.
Key takeaways
- This is a follow-up study for people who previously participated in batoclimab trials for TED.
- It aims to see how long improvements in bulging eyes (proptosis) last after stopping the medicine.
- The study also checks if batoclimab can help those who didn't respond well in earlier studies.
- All participants in this part of the study will receive the batoclimab medicine.
- This is a Phase 3 study, getting closer to potential new treatments for TED.
- Participants must be 18 years or older.
Who may be eligible?
To be able to join this study, you must have already taken part in one of two specific earlier studies about batoclimab for Thyroid Eye Disease (these were called Study IMVT-1401-3201 or Study IMVT-1401-3202). This means it's not a study for people who are completely new to this medicine research.
You need to be an adult, 18 years old or older. There is no upper age limit, so people of all adult ages can be considered. The study is open to everyone, whether you are a man or a woman.
Basically, if you were in the previous batoclimab studies for TED at your doctor's office, and you are 18 or over, you might be eligible to continue with this new phase of the research.
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.
- Have you already completed Study IMVT-1401-3201 or Study IMVT-1401-3202?
- Are you 18 years old or older?
- Are you able to attend regular clinic appointments?
- Are you willing to receive the study medicine, batoclimab?
What does participation involve?
If you decide to take part in this study, you'll continue to be looked after by the study team. You'll likely have regular visits to the clinic where doctors and nurses will check your health and how your Thyroid Eye Disease (TED) is progressing. These check-ups will probably involve eye examinations, taking measurements of your eyes (like how much they bulge), and possibly blood tests.
Since this is an "open-label" study, all participants will receive the batoclimab medicine. You won't be getting a placebo this time. The study team will explain how and when to take the medicine. You will be closely monitored for any changes or side effects. The total length of the follow-up and treatment will be clearly explained by the study team, including how often you'll need to visit and for how long after you stop the medicine.
Potential risks and benefits
Locations (7)
- —UnverifiedSlovakia
- —UnverifiedHungary
- —UnverifiedBelgium
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- —UnverifiedPoland
Common questions
What is Thyroid Eye Disease (TED)?
TED is a condition linked to an overactive thyroid that can cause inflammation and swelling around the eyes, leading to symptoms like bulging eyes, dryness, or double vision.
What is batoclimab?
Batoclimab is a new medicine being studied to see if it can help treat Thyroid Eye Disease by reducing the inflammation and swelling around the eyes.
I was in a previous batoclimab study. Can I join this one?
Yes, this study is specifically for people who have already completed Study IMVT-1401-3201 or Study IMVT-1401-3202, and are 18 years or older.
What does 'open-label' mean?
Open-label means that both you and your study doctor will know that you are receiving the batoclimab medicine during the study, rather than a placebo.
What does 'proptosis' mean?
Proptosis is the medical term for bulging eyes, a common symptom of Thyroid Eye Disease.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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