A study testing teprotumumab compared to placebo in adult patients with moderate-to-severe active thyroid eye disease

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What is this study about?

This study examines moderate-to-severe active thyroid eye disease, which is a condition associated with Graves’ disease where the eyes become inflamed and may bulge forward. The condition can affect the soft tissues around the eyes, cause double vision, and impact daily life. The study will compare teprotumumab, which is given as an injection under the skin, with placebo. Teprotumumab is also known by the code names AMG 632 and HZN-001.

The purpose of the study is to evaluate how well teprotumumab works compared to placebo in reducing eye bulging in people with this condition, and to assess its safety and how well it is tolerated. The study will measure whether the eyes move back into a more normal position by at least 2 millimeters without the other eye getting worse. The study will also look at other aspects of the disease, including signs of inflammation, double vision, and how the condition affects quality of life.

Participants in this study will be randomly assigned to receive either teprotumumab or placebo through injections under the skin. The study will follow participants over a period of time to monitor changes in eye bulging, inflammation scores, double vision, and overall well-being. Participants must have active disease with significant eye bulging and symptoms that started within 15 months before joining the study. Their thyroid hormone levels should be controlled or only mildly abnormal during the study.

1 Initial assessment and treatment assignment

At the beginning of the trial, your condition will be assessed. This includes measuring the bulging of your eyes, called proptosis, which will be measured in millimeters.

Your Clinical Activity Score, abbreviated as CAS, will be evaluated. This is a score from 0 to 7 that measures how active your thyroid eye disease is. Higher scores indicate more active disease.

Your thyroid hormone levels will be checked to ensure they are controlled. Specifically, free thyroxine (FT4) and free triiodothyronine (FT3) will be measured.

If you experience double vision, called diplopia, this will be assessed and graded.

You will be randomly assigned to receive either teprotumumab or placebo. A placebo is an inactive substance that looks like the actual medication but contains no active ingredient.

Neither you nor your doctor will know which treatment you are receiving. This is called a double-masked trial.

2 Treatment period with injections

You will receive injections under the skin, called subcutaneous injections.

The injections will contain either teprotumumab or placebo for teprotumumab.

Before each injection, a urine pregnancy test will be performed if you are a woman of childbearing potential.

The injections will be administered at regular intervals throughout the treatment period.

3 Regular monitoring visits

Throughout the trial, you will attend scheduled visits for monitoring.

At these visits, measurements of your eye bulging will be taken to track any changes.

Your Clinical Activity Score will be assessed repeatedly to monitor the activity level of your thyroid eye disease.

If you have double vision, the severity will be evaluated at each visit.

Your thyroid hormone levels will be checked to ensure they remain stable. Efforts will be made to keep you in a euthyroid state, which means your thyroid hormone levels are normal.

Any side effects or changes in your condition will be recorded.

4 Quality of life assessment

You will be asked to complete a questionnaire called the Graves’ Ophthalmopathy Quality of Life questionnaire, abbreviated as GO-QoL.

This questionnaire measures how thyroid eye disease affects your daily life and well-being.

You will complete this questionnaire at baseline and at scheduled time points during the trial.

5 Final assessment

At the end of the treatment period, a comprehensive assessment will be conducted.

The bulging of your eyes will be measured again to determine if there has been a reduction of at least 2 millimeters in the study eye.

Your Clinical Activity Score will be evaluated to see if it has decreased.

If you had double vision at the start, it will be assessed to determine if there has been any improvement or resolution.

The GO-QoL questionnaire will be completed again to evaluate changes in your quality of life.

All findings will be compared to your baseline measurements taken at the beginning of the trial.

Who Can Join the Study?

You must provide written permission to join the study.
You must be willing and able to follow all study requirements for the entire duration.
You must be between 18 and 80 years old.
You must have a confirmed diagnosis of Graves’ disease, which is a condition affecting the thyroid gland, along with active thyroid eye disease. Your most severely affected eye must have a Clinical Activity Score of 3 or higher on a 7-point scale. This score measures how active and inflamed your eye disease is.
You must have moderate-to-severe active thyroid eye disease that affects your daily life but is not threatening your vision. This usually includes one or more of the following: upper eyelid pulled back by 2 millimeters or more, moderate or severe swelling and inflammation of the tissues around the eye, or double vision that occurs sometimes or all the time.
You must have proptosis, which means your eyeball is pushed forward. This should be at least 3 millimeters more than before your thyroid eye disease started, or at least 3 millimeters more than what is normal for your race and gender.
Your active thyroid eye disease symptoms must have started within 15 months before joining the study.
Your thyroid hormone levels must be normal or only slightly abnormal. If your levels of free thyroxine and free triiodothyronine, which are thyroid hormones, are too high or too low, they must be less than 50% away from normal limits. Efforts should be made to correct any imbalance and keep your thyroid levels normal throughout the study.
You must not need immediate eye surgery and must not be planning any corrective eye surgery or radiation treatment during the study period.
If you are a woman who can become pregnant, you must have a negative pregnancy test before starting the study and negative urine pregnancy tests before each treatment dose and throughout your participation.

Who Cannot Join the Study?

The study does not list specific reasons why patients cannot participate
General exclusion information has not been provided in the available study documents
If you are interested in this study, your doctor will need to review the complete study requirements to determine if you are eligible to participate

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach	Katowice	Poland
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Dc-Med Michal Kowalski sp.k.	Swidnica	Poland
Hospital Provincial De Conxo	Santiago De Compostela	Spain
Hospital Universitario Ramon Y Cajal	Madrid	Spain
Hospital Universitario Virgen Macarena	Sevilla	Spain
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Quinze-Vingts National Ophthalmology Hospital	Paris	France
Universita’ Di Pisa	Pisa	Italy
Ufipmnocoovpmtkyvsrly Ekexr Aex	Essen	Germany
Pygrzbbgoybx Cjcvfcv Mifewcsp Shl z ojas	Gdansk	Poland
Acjhemsccr Phnugxmd Hvtzjlwu Df Munjggppg	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.12.2024
Germany	Not recruiting	01.12.2024
Italy	Not recruiting	01.12.2024
Poland	Not yet recruiting	01.12.2024
Spain	Not recruiting	01.12.2024

Trial locations

Investigated drugs:

Teprotumumab

Teprotumumab is a medication given as an injection under the skin that is being tested to see if it can help reduce eye bulging in people with thyroid eye disease. This medication works by targeting specific proteins in the body that may be causing the eye problems associated with an overactive or underactive thyroid gland.

Placebo is an inactive substance that looks like the real medication but contains no active medicine. It is used in this study to compare against teprotumumab to help determine if the actual medication is working better than no treatment at all.

Thyroid Eye Disease – Thyroid Eye Disease is an inflammatory condition that affects the tissues and muscles around the eyes. It occurs when the immune system mistakenly attacks the fatty tissue and muscles behind the eyeballs, causing them to swell and become inflamed. This swelling pushes the eyes forward, causing them to bulge outward from their sockets, a condition called proptosis. The disease can also affect eye movement, leading to double vision when the muscles that control eye movement become stiff and swollen. Patients may experience redness, pain, excessive tearing, and sensitivity to light. The condition is often associated with thyroid gland disorders and can affect one or both eyes, with symptoms that may worsen over time during the active phase of the disease.

Trial ID:

2024-515702-63-00

Protocol code:

HZNP-TEP-305

NCT ID:

NCT06248619

Trial Phase:

Therapeutic confirmatory (Phase III)

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A study testing teprotumumab compared to placebo in adult patients with moderate-to-severe active thyroid eye disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?