Interventional, open-label, single-group, long-term follow-up trial of Lu AG22515 in patients with moderate-to-severe Thyroid Eye Disease
Thyroid Eye Disease (TED) is an autoimmune condition that causes inflammation, swelling, and bulging of the eyes. This clinical trial is testing a new experimental medicine, known as Lu AG22515, in adults who have active, moderate-to-severe TED. Because this is an 'open-label' study, all participants will receive the study medicine, and there is no dummy drug (placebo). The main aim is to find out if the treatment helps reduce eye bulging after 24 weeks of care. Doctors will also check how the body handles the medicine, whether it causes any unwanted side effects, and how safe it is over a longer period. Taking part involves regular hospital visits for eye measurements, blood tests, and health checks. This research could help scientists understand if Lu AG22515 could become a useful new treatment option in the future.
At a glance
What is this study about?
Thyroid Eye Disease (often called TED) is an eye condition usually linked to an overactive thyroid gland. In TED, the body's immune system mistakenly attacks the fatty tissue and muscles behind the eyes. This causes redness, swelling, and a pushing forward of the eyeballs, which doctors call eye bulging or proptosis. It can feel uncomfortable, cause double vision, and significantly affect a person's quality of life and appearance.
This early-stage study is testing a potential new treatment called Lu AG22515. The main goal is to measure how much the medicine can reduce eye bulging over a 24-week period. To check this, doctors use a simple, painless handheld ruler called an exophthalmometer that rests gently on the cheekbone to measure how far the eye rests forward.
Beyond measuring eye changes, the study closely checks participant safety. The trial team will run regular blood tests and heart tracings to see how the body breaks down the medicine and whether any side effects develop. Finding new, effective treatments is vital because current therapies do not work well for everyone with this challenging condition.
Key takeaways
- The trial tests an experimental medicine called Lu AG22515 for Thyroid Eye Disease.
- It is open to adults aged 18 and over with moderate-to-severe, active symptoms.
- The main goal is to measure changes in eye bulging over 24 weeks.
- All participants receive the study drug; there is no dummy treatment (placebo).
- Safety, heart health, and blood levels of the drug will be closely monitored throughout.
Who may be eligible?
This trial is open to adults aged 18 and older of any sex who have been diagnosed with active, moderate-to-severe Thyroid Eye Disease. 'Active' means your eye symptoms are currently inflamed, red, or changing, rather than having settled down into a stable, inactive state.
Because the study focuses specifically on eye bulging, participants will need to have noticeable swelling or bulging in at least one eye that the study team can measure.
People with other serious eye conditions, unstable medical problems, or those who have recently had certain other medical treatments for TED may not be eligible to take part. The study team will carry out detailed health checks to make sure joining is safe for 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.
- I am aged 18 or older.
- I have been diagnosed with Thyroid Eye Disease (TED).
- My eye symptoms are currently active (e.g. red, swollen, or changing).
- I have moderate-to-severe eye bulging in at least one eye.
- I am able to attend regular hospital appointments for tests and follow-up.
What does participation involve?
If you join the trial, you will receive the experimental medicine Lu AG22515. Since this is an open-label study, both you and the trial doctors will know that you are receiving the real treatment.
You will need to attend regular clinic visits over at least 24 weeks, followed by a long-term follow-up period to check on your ongoing health. During these visits, doctors will measure your eyes, test your vision, take blood samples, check your blood pressure, and carry out heart traces (ECGs). These tests help researchers see how much medicine stays in your bloodstream and whether your body makes any antibodies against it. The study team will explain the exact visit schedule and how long your participation will last before you agree to join.
Potential risks and benefits
Locations (4)
- —UnverifiedPoland
- —UnverifiedBulgaria
- —UnverifiedGermany
- —UnverifiedSpain
Common questions
What does 'open-label' mean?
It means there is no placebo (dummy treatment). Everyone who joins the trial will receive the experimental medicine, and both you and the doctors will know this.
How do doctors measure eye bulging?
Doctors use a small, painless instrument called an exophthalmometer. It rests gently against the bone on the side of your eye to measure how far forward your eye sits.
Will taking part cure my Thyroid Eye Disease?
This study is an early research trial, so doctors cannot promise a cure. The aim is to see if the medicine is safe and if it can reduce symptoms.
Do I have to pay to take part?
No, clinical trial medicines and study-related tests are provided free of charge, and travel expenses are often covered.
Can I leave the trial if I change my mind?
Yes, you can leave the study at any time. Your normal medical care and relationship with your doctors will carry on as usual.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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