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 study is looking at a new treatment called Batoclimab for adults who have Thyroid Eye Disease (TED). TED can cause the eyes to bulge. We want to find out if Batoclimab can help reduce this bulging and improve other eye problems linked to TED, like pain or double vision. Participants will either receive Batoclimab or a placebo, which looks identical but contains no active medicine. Researchers will compare the results to see if Batoclimab is effective and safe. This is a large study (Phase 3) to confirm earlier findings and support possible future use of this medicine.
At a glance
What is this study about?
This study is focused on a health condition called Thyroid Eye Disease, often shortened to TED. If you have TED, your immune system can mistakenly attack the tissues around your eyes, leading to swelling, inflammation, and sometimes causing your eyes to bulge out more than usual. This can also lead to other uncomfortable symptoms like double vision, pain, or changes in how your eyes look and feel.
The main goal of this particular study is to test a new medicine called Batoclimab. We want to see if this medicine can help reduce the bulging of the eyes in people with TED. Researchers will be carefully measuring the eyes to see if the bulging goes down by a certain amount. They'll also be looking at other important aspects, such as whether the medicine helps reduce inflammation, improve double vision, or generally enhance a person's quality of life.
To make sure the results are fair and accurate, some participants will receive the new medicine, Batoclimab, while others will receive a placebo. A placebo looks exactly like the real medicine but doesn't contain any active ingredient. Neither the participants nor the doctors will know who is getting which treatment. This helps us objectively measure the true effects of Batoclimab.
Key takeaways
- This study tests a new medicine for Thyroid Eye Disease (TED).
- It aims to see if Batoclimab can reduce eye bulging and improve other TED symptoms.
- Participants will get either Batoclimab or a dummy medicine (placebo).
- The study measures changes over 24 weeks and is for adults aged 18 and older with active TED.
- Your doctors won't know if you're getting the active drug or placebo to keep results fair.
Who may be eligible?
To be part of this study, you need to be an adult, 18 years old or older. Both men and women can take part. The study is specifically for people who currently have active Thyroid Eye Disease.
Your eye doctor will check your medical history and do some examinations to make sure the study is right for you. They will confirm that your Thyroid Eye Disease is currently active, meaning you are experiencing ongoing symptoms that the study medicine aims to help.
There might be other specific health requirements or conditions that could prevent someone from joining, even if they have TED. These are put in place to ensure the safety of all participants and the reliability of the study results.
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)?
- Are you comfortable with the possibility of receiving a placebo?
- Are you able to attend regular clinic visits and assessments?
What does participation involve?
If you decide to join this study, you would be randomly assigned to receive either the new medicine, Batoclimab, or a placebo. The placebo looks just like the study medicine but doesn't have an active ingredient. You, your study doctors, and nurses won't know which one you are receiving during the main part of the study.
Your involvement would include regular visits to the clinic for check-ups. During these visits, you'll have various assessments of your eyes, including measurements of how much your eyes bulge, checks for inflammation, and assessments of your vision and eye movement. You'll also likely provide blood samples for tests and answer questionnaires about how you're feeling and how your symptoms are affecting your daily life. The study aims to measure changes in your eyes over 24 weeks, but the total duration of your participation, including follow-up, could be longer.
Potential risks and benefits
Locations (6)
- —UnverifiedSlovakia
- —UnverifiedSpain
- —UnverifiedHungary
- —UnverifiedGermany
- —UnverifiedBelgium
- —UnverifiedLatvia
Common questions
What is Thyroid Eye Disease (TED)?
TED is an autoimmune condition where your immune system attacks the tissues around your eyes, causing inflammation, swelling, and sometimes bulging eyes.
What is Batoclimab?
Batoclimab is the name of the new medicine being tested in this study for people with active Thyroid Eye Disease.
What is a placebo?
A placebo is a 'dummy' treatment that looks exactly like the study medicine but contains no active ingredients. It's used to compare against the real medicine.
Will I know if I'm getting the real medicine or the placebo?
No, during the main part of the study, neither you nor your doctors will know whether you are receiving Batoclimab or the placebo. This is to ensure fair and accurate results.
How long will the study last?
The main part of the study measures effects over 24 weeks, but your total involvement, including follow-up, might be longer.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.