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 is investigating a new medication called Efgartigimod for people living with Thyroid Eye Disease (TED). The main aim is to understand how effective this drug is at treating the condition, particularly focusing on whether it can reduce eye bulging. Researchers will also be checking if the treatment is safe and well-tolerated, meaning it doesn't cause too many unwanted side effects. This study is designed as a 'Phase 3' trial, which means it's one of the final stages of testing before a new medicine might become available to everyone. It's a 'double-masked' study, so neither the participants nor the doctors will know who is receiving the new drug and who is getting a placebo (a dummy treatment). This helps make sure the results are as fair and accurate as possible.

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 all about a condition called Thyroid Eye Disease, often shortened to TED. TED is an autoimmune condition where the body's immune system mistakenly attacks the tissues around the eyes. This can lead to a variety of symptoms, including swollen eyelids, double vision, and eyes that bulge forward, a symptom doctors call proptosis.

The main purpose of this research is to see if a new drug, Efgartigimod, can help people with TED. Specifically, the researchers want to find out how well Efgartigimod can reduce eye bulging and improve overall eye health and quality of life for those affected. They will also be carefully monitoring for any side effects to make sure the treatment is safe.

This is a 'Phase 3' study, which means it's a large and important step in developing new medicines. It's set up in a way that is designed to give very clear results: some people will receive the new drug, while others will receive a 'placebo', which looks exactly like the drug but contains no active medicine. This helps researchers compare the effects accurately. Neither you nor your study doctor will know which treatment you are receiving, which helps ensure the study is fair and unbiased.

Key takeaways

This study investigates a new drug (Efgartigimod) for Thyroid Eye Disease (TED).
It aims to see if the drug can reduce eye bulging and improve TED symptoms.
The study compares the new drug with a dummy treatment (placebo).
You won't know if you're getting the active drug or the placebo.
Participation involves regular clinic visits for about 6 months, plus follow-up.
All study-related care and medication are free.

Who may be eligible?

This study is looking for adults who have been diagnosed with Thyroid Eye Disease. You must be at least 18 years old to be considered for this research. There's no upper age limit, meaning older adults are also welcome to participate if they meet the other criteria.

Both men and women are invited to take part in this study. The researchers want to include a wide range of people to understand how the treatment might work for different individuals.

Before you can join, the study team will ask you some questions and do some checks to make sure your health and specific situation with TED match what they need for the study. There will be other requirements, so it's important to talk to the study team to see if this study is right 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.

Are you 18 years old or older?
Have you been diagnosed with Thyroid Eye Disease (TED)?
Are you able to attend regular clinic appointments?
Are you comfortable with 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 given either the new treatment, Efgartigimod, or a placebo (a dummy treatment) through injections. These injections will be given with a prefilled syringe, making them easier to administer. You won't know whether you are receiving the active drug or the placebo, and neither will your study doctor.

Over a period of 24 weeks (about 6 months), you will have regular visits to the study clinic. During these visits, the study team will carefully check your eyes, measure things like eye bulging, and ask you questions about your symptoms and how you are feeling. They will also perform other medical tests to monitor your health and any potential side effects.

After the initial 24-week treatment period, there will be further visits to follow up on your progress and health. The total time you would be involved in the study, including follow-up, could extend beyond the 24 weeks of active treatment. All medicines and study-related care will be provided at no cost.

Potential risks and benefits

Participating in a clinical trial like this could potentially offer a benefit by giving you access to a new treatment for Thyroid Eye Disease that isn't yet widely available. If Efgartigimod proves effective, it might help improve your TED symptoms, such as reducing eye bulging or improving your vision. However, there's no guarantee that you will receive the active drug or that it will help your condition. Like all medications, Efgartigimod might have side effects, which the study team will explain in detail. There could also be discomfort from injections or study procedures. It's very important to remember that you are free to withdraw from the study at any time, for any reason, without 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
Estonia
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Unverified
Czechia
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Unverified
Germany
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Unverified
Spain
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Unverified
Greece
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Unverified
Hungary
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Unverified
Bulgaria
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Unverified
Belgium
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Unverified
Romania
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Unverified
Italy

Common questions

What is Thyroid Eye Disease (TED)?

TED is a condition where your immune system affects the tissues around your eyes, causing symptoms like swelling, double vision, or eyes that bulge forward.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the real medicine but doesn't contain any active drug. It helps researchers compare how well the new medicine works.

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

No, this is a 'masked' study, meaning neither you nor your study doctor will know which treatment you are receiving. This helps keep the study fair.

How long will I be in the study?

The main treatment period is 24 weeks (about 6 months), but there will be follow-up visits, so your total time in the study could be longer.

What does a 'Phase 3' study mean?

Phase 3 means this is one of the final stages of testing a new medicine in a large group of people to confirm its effectiveness and safety before it can be approved for wider use.