Active not recruitingPHASE3INTERVENTIONAL

A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease

This study is looking into a new treatment called teprotumumab for people who have active Thyroid Eye Disease, a condition where the immune system attacks the tissues around the eyes. We want to find out if this medicine, given as an injection under the skin, can help reduce eye bulging (proptosis) more effectively than a placebo, which is a dummy medicine with no active ingredients. Participants will be adults aged between 18 and 80 years old who have moderate to severe active TED. The study will compare two groups: one receiving teprotumumab and another receiving the placebo, to understand how well the new treatment works and if it's safe.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Amgen

Enrolment target

Start

05 Jul 2024

Estimated completion

02 Sep 2026

Thyroid Eye Disease

What is this study about?

This study is about a condition called Thyroid Eye Disease, often shortened to TED. If you have TED, your immune system mistakenly attacks the tissues around your eyes, which can cause them to become red, swollen, and sometimes bulge outwards. This bulging is called proptosis. We are testing a new medicine called teprotumumab, given as an injection under the skin, to see if it can help reduce this bulging.

We need to compare the new medicine to a 'placebo', which is like a dummy medicine with no active ingredients. This helps us understand if any improvements are truly due to the medicine or if they might happen naturally. You won't know if you're getting the active medicine or the placebo, and neither will your study doctor – this is called 'double-masked'. This approach is the best way to get clear and reliable results.

The main goal of the study is to see how many people experience a significant improvement in their eye bulging after 24 weeks. Specifically, we'll be looking for a reduction of at least 2mm in the bulging of your more affected eye, without the other eye getting worse. After the main part of the study, there might be an option for those who received the placebo and whose proptosis didn't improve to receive the active medicine.

Key takeaways

New study for active Thyroid Eye Disease (TED).
Testing teprotumumab to reduce eye bulging (proptosis).
Compares medicine to a dummy treatment (placebo).
Participants aged 18-80 with moderate to severe TED.
Study lasts about 6 months with regular clinic visits.
Aims to find new ways to treat TED symptoms.

Who may be eligible?

To join this study, you need to be an adult between 18 and 80 years old, male or female. You must have been diagnosed with Graves' disease and have active Thyroid Eye Disease (TED) that affects your eyes moderately to severely. This means you might have problems like bulging eyes (proptosis), your eyelids pulled back, or double vision.

Your TED symptoms should have started within the last 15 months, and your eyes should be bulging at least 3mm more than they were before you had TED, or at least 3mm more than what's considered normal for your gender and background. It's important that your thyroid hormone levels are mostly stable and under control.

You can't join if you need eye surgery right away or are planning to have surgery or radiation for your eyes during the study. If you're a woman who could become pregnant, you'll need to have negative pregnancy tests before and during the study.

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 between 18 and 80 years old?
Do you have a diagnosis of Graves' disease linked with active Thyroid Eye Disease?
Did your TED symptoms start within the last 15 months?
Are your eyes bulging (proptosis) at least 3mm more than normal?
Are your thyroid hormone levels mostly stable and under control?
Are you able to attend regular appointments for about 6 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first go through a screening process to check if you're suitable for the study. This will involve appointments where doctors will examine your eyes, take measurements, and possibly perform blood tests. You will be assigned randomly to either receive the study medicine (teprotumumab) or a placebo, which looks like the real medicine but contains no active ingredients. You won't know which one you're getting.

The study medicine or placebo will be given as injections under the skin. You'll have regular appointments at the study clinic over several months to monitor your eye condition, check for any improvements or side effects, and make sure you're feeling well. These visits will involve eye exams, measurements of your eye bulging, and possibly more blood tests or other checks. The main part of the study will last about 24 weeks. After that, there might be an option for some participants to receive the active medicine if their condition didn't improve in the first phase. You'll need to be able to attend all scheduled appointments.

Potential risks and benefits

Participating in this study might offer some potential benefits. You could receive a new treatment that might help improve your Thyroid Eye Disease, especially the bulging of your eyes, which could improve your daily life. You'll also be closely monitored by medical professionals, and your participation will help doctors learn more about TED, potentially helping others in the future. However, like all medical treatments, teprotumumab can have side effects, and some people might experience discomfort from the injections. There's also a chance you might receive the placebo, which means your TED symptoms might not improve during the main part of the study. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (38)

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

Catalina Eye Care - NVISION - PPDS
Verified postcode
Tucson, United States
Advanced Quality Medical Research
Verified postcode
Orland Park, United States
W Kellogg Eye Center
Verified postcode
Ann Arbor, United States
Las Vegas Endocrinology
Verified postcode
Henderson, United States
The Center for Eye and Facial Plastic Surgery
Verified postcode
Somerset, United States
Casey Eye Institute -515 SW Campus Dr
Verified postcode
Portland, United States
Scheie Eye Institute
Verified postcode
Philadelphia, United States
University of Tennessee Health Science Center - 848 Adams Ave
Verified postcode
Memphis, United States
Baylor College of Medicine-1977 Butler Blvd
Verified postcode
Houston, United States
University of Washington Eye Institute
Verified postcode
Seattle, United States
West Virginia University Eye Institute
Verified postcode
Morgantown, United States
Hospital Universitario Austral
Verified postcode
Pilar, Argentina

Common questions

What is Thyroid Eye Disease (TED)?

TED is an eye condition linked to an overactive thyroid, where your immune system attacks the tissues around your eyes, causing symptoms like bulging, redness, and swelling.

What is teprotumumab?

Teprotumumab is a medicine being tested to see if it can help reduce the eye bulging ('proptosis') caused by Thyroid Eye Disease.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks like the real medicine but contains no active ingredients. It helps doctors see if the real medicine is truly effective.

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 if you're receiving the active medicine or the placebo. This is called 'double-masked'.

How long will the study last for me?

The main part of the study where you receive the treatment will last around 24 weeks (about 6 months), with regular check-ups.