Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efgartigimod PH20 SC Administered by Prefilled Syringe in Adult Participants With Thyroid Eye Disease

This research study, called a Phase 3 trial, is looking into a new treatment named Vyvgart for adults who have Thyroid Eye Disease (TED). TED can cause problems like bulging eyes (proptosis) and double vision. The study wants to find out if Vyvgart is safe and effective in improving these symptoms and overall eye health. Participants will either receive Vyvgart or a dummy medicine (placebo) given as an injection. Researchers will then compare how both groups feel over a 24-week period. This type of study helps doctors understand if a new medicine works better than no treatment, and if it's safe for people to use.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Argenx

Enrolment target

Start

23 Sep 2024

Thyroid Eye Disease (TED)

What is this study about?

This study is designed to test a new medicine, called Vyvgart, for people who have a condition called Thyroid Eye Disease (TED). TED is when your immune system, which normally fights off germs, mistakenly attacks the tissues around your eyes. This can cause various problems, including your eyes bulging outwards (this is called proptosis), double vision, pain, and discomfort. Currently, there aren't many specific treatments for TED, so finding new options is really important.

The main goal of this particular study is to see if Vyvgart can help reduce the bulging of the eyes in people with TED. For some people, proptosis can be quite noticeable and affect their vision and how they feel about their appearance. The study will also look at whether Vyvgart can help improve other symptoms, such as double vision, and how people feel about their quality of life with TED overall. They will compare Vyvgart to a dummy medicine (placebo) to make sure any improvements are truly due to the new treatment.

This is a `Phase 3` study, which means it's one of the final steps before a new medicine might be approved for wider use. It involves a larger number of people and helps researchers confirm the effects and safety of the treatment that were seen in earlier, smaller studies. By taking part, you could be helping to find a new way to treat Thyroid Eye Disease for many others in the future.

Key takeaways

This study tests a new medicine, Vyvgart, for Thyroid Eye Disease (TED).
It aims to see if Vyvgart can reduce bulging eyes (proptosis) and improve other TED symptoms.
Participants will receive either Vyvgart or a dummy medicine (placebo) by injection.
The study lasts for 24 weeks, with follow-up appointments.
It's a 'Phase 3' study, meaning it's a key step towards potential new treatments.
You will receive close medical monitoring throughout your participation.

Who may be eligible?

To be considered for this study, you need to be an adult, meaning 18 years old or older. Both men and women are welcome to participate. The study is specifically for people who have been diagnosed with Thyroid Eye Disease (TED).

There will be other specific health requirements and medical checks to make sure the study medicine is right and safe for you. For example, the study team will need to review your current health conditions and any other medicines you are taking. These checks are important to ensure your safety and that the study results are clear.

It's important to understand that not everyone with Thyroid Eye Disease will be able to join this study. The research team will review everyone's medical history carefully. If you're interested, the doctors and nurses involved in the study will explain all the requirements in detail and help you understand if you might be a good fit.

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 Thyroid Eye Disease (TED)?
Are you able to attend regular clinic visits?
Are you comfortable receiving injections?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned by chance to receive either the study medicine, Vyvgart, or a dummy medicine called a placebo. You won't know which one you're getting, and neither will the study doctors or nurses – this is called 'double-masked' and helps make sure the results are fair. Both the Vyvgart and the placebo will be given as an injection using a pre-filled syringe.

Over the course of 24 weeks, you will have several visits to the clinic. During these visits, the study team will carry out various assessments. This includes regular checks of your eye health, measuring how much your eyes might be bulging, and asking you questions about your vision and how you're feeling overall. They will also take blood samples to understand how your body reacts to the medicine and to monitor your general health.

After the initial 24-week treatment period, there will be further follow-up visits to continue monitoring your health and the long-term effects of the treatment. The total duration of your involvement in the study will be explained to you by the study team before you make a decision to participate.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new investigational treatment for your Thyroid Eye Disease, which could improve your symptoms. You will also receive very close medical supervision throughout the study. However, like all medicines, Vyvgart might have side effects, and some are still unknown. There's also a chance you might receive the placebo (dummy medicine) and not experience any direct treatment benefit from the study drug. All potential risks and side effects will be explained in detail by the study team. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (10)

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

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Unverified
Latvia
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Unverified
Austria
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Unverified
Italy
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Unverified
Spain
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Unverified
Sweden
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Unverified
France
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Unverified
Germany
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Unverified
Poland
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Unverified
Bulgaria
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Unverified
Slovenia

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 and symptoms like bulging eyes, double vision, and discomfort.

What does 'Phase 3' mean for a study?

Phase 3 is a late-stage study that involves a larger group of people. It helps confirm if a new medicine is safe and effective before it can be considered for approval for wider use.

What are the main things the study wants to find out?

The study mainly wants to see if the new medicine, Vyvgart, can reduce eye bulging and improve other eye symptoms like double vision, as well as your overall eye health and quality of life, over 24 weeks.

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

No, you won't know, and neither will your study doctor. This is to ensure the study results are fair and unbiased.

How will the medicine be given?

The medicine or placebo will be given as an injection using a pre-filled syringe.