Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

A Phase 3b/4, Double-masked, Randomized, International, Parallel-assignment, Multicenter Trial in Patients with Thyroid Eye Disease to Evaluate the Safety and Tolerability of Different Dosing Durations of Teprotumumab

This research is investigating a medicine called teprotumumab for a condition known as Thyroid Eye Disease. The main goal is to understand how safe this treatment is and if taking it for different lengths of time changes anything for patients. Researchers will also be checking if patients might need further treatment after their initial course. A group of patients will receive the actual treatment, while another group will receive a 'dummy' treatment (placebo) that looks the same but contains no medicine. This helps researchers fairly compare the results. The study will also look at how the treatment affects eye bulging, double vision, and overall quality of life for people with Thyroid Eye Disease.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

Horizon Therapeutics USA Inc.

Enrolment target

214

Start

03 Jul 2024

Thyroid Eye Disease

What is this study about?

This study is about a medical condition called Thyroid Eye Disease, sometimes known as TED. This condition can cause problems with the eyes, such as bulging, redness, and double vision. Researchers are looking into a treatment called teprotumumab to see how well it works and how safe it is for people with TED.

The main idea behind this study is to deliver the treatment in different ways to see what works best. Some people in the study will get the actual medicine (teprotumumab), while others will get a 'dummy' treatment, called a placebo. This placebo looks just like the real medicine but doesn't have any active ingredients. This is a common and important step in medical research – it helps the researchers compare the effects of the new medicine fairly, to make sure any improvements are really due to the treatment itself and not just chance.

During the study, the medical team will be closely checking how patients respond. They'll be looking at things like whether patients experience any side effects, how their eye bulging (proptosis) changes, and if their double vision improves. They'll also be asking about general well-being and visual function using questionnaires. All of this information helps decide the best way to use this treatment in the future to help people with Thyroid Eye Disease.

Key takeaways

This study is testing a new treatment called teprotumumab for Thyroid Eye Disease.
It aims to see how safe the treatment is and if different treatment lengths work better.
Some patients will receive the actual medicine, others a 'dummy' treatment (placebo).
Doctors will closely monitor eye changes, side effects, and overall well-being.
All participants must be at least 18 years old, with no upper age limit.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. There's no upper age limit, meaning older adults can also take part if they meet the other requirements. Both men and women are welcome to join the study.

Beyond age and sex, there will be other specific health checks to make sure the study is a safe and suitable option for you. These checks are important to ensure the research is conducted safely and that the results are meaningful for people with Thyroid Eye Disease.

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 a diagnosis of Thyroid Eye Disease?
Are you willing to potentially receive either the study drug or a placebo?
Are you able to attend regular appointments for infusions and check-ups?

Answer every question to see your result.

What does participation involve?

If you join this study, you will likely receive treatment through an infusion, which means the medicine or placebo will be given slowly into your vein. The study is designed to look at different lengths of treatment, so you might have infusions for a particular number of weeks or months. You will have regular appointments to check your eye health, measure any changes in your eyes (like bulging or double vision), and talk about how you are feeling generally. Doctors will also check for any side effects. You will continue to be monitored for a period after your main treatment ends to see how well the effects last. The total time you'd be involved in the study – from the initial checks to the final follow-up – will be explained fully by the study team.

Potential risks and benefits

Participating in a clinical trial might offer potential benefits, such as access to a new treatment before it's widely available, and your health will be closely monitored by medical professionals. This can also provide valuable information to help others with Thyroid Eye Disease in the future. However, like all medicines, teprotumumab may have side effects, and some people may get the placebo and not the active treatment. You will be told about all known or potential risks in detail before you decide to join. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France
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Unverified
Italy
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Unverified
Germany
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Unverified
Spain

Common questions

What is Thyroid Eye Disease?

It's an autoimmune condition where the immune system attacks the tissues around the eyes, leading to symptoms like bulging eyes, double vision, and redness.

What is teprotumumab?

Teprotumumab is a medicine being studied for Thyroid Eye Disease. It's given through an infusion (into a vein).

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It helps researchers compare the real medicine's effects accurately.

Will I know if I'm getting the real medicine or the placebo?

This is a 'double-masked' study, meaning neither you nor your study doctor will know if you're getting the active medicine or the placebo. This helps keep the study fair and unbiased.

How long will I be in the study?

The study involves an initial treatment period and then a follow-up period. The exact duration will be explained by the study team if you are eligible.