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Study on the Effects of TOUR006 for Adults with Thyroid Eye Disease

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What is this study about?

This clinical trial is focused on studying a condition known as Thyroid Eye Disease, which is often associated with Graves’ disease. This condition can cause the eyes to bulge and lead to discomfort and vision problems. The study will test a new treatment called TOUR006, which is a type of medication known as a human IgG2 monoclonal antibody against IL-6. This medication is designed to be injected under the skin and aims to reduce the bulging of the eyes, also known as proptosis.

The purpose of the study is to evaluate how effective and safe TOUR006 is in treating people with Thyroid Eye Disease. Participants in the study will receive either the new treatment or a placebo, which is a substance with no active medication. The study will last for several weeks, and participants will receive regular injections and attend follow-up visits to monitor their progress. The main goal is to see if the treatment can reduce the eye bulging by at least 2 millimeters without worsening the condition in the other eye.

Throughout the study, participants will be monitored for any changes in their condition, including improvements in eye bulging and other symptoms like double vision. The study will also track any side effects or adverse events that may occur. The results will help determine if TOUR006 is a viable treatment option for people with Thyroid Eye Disease.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a clinical diagnosis of Graves’ disease with moderate to severe active thyroid eye disease (TED).

The onset of active TED symptoms should be within approximately 15 months, and proptosis (eye bulging) should be 3 mm or more above the normal range for the study eye.

A clinical activity score (CAS) of 4 or more on a 7-item scale for the study eye is required.

Presence of thyroid-stimulating immunoglobulin (TSI) greater than 130% of the normal reference standard or greater than 0.55 IU/L is necessary.

2 treatment administration

Participants receive a subcutaneous injection of the study medication, TOUR006, which is a human IgG2 monoclonal antibody against IL-6.

The solution for injection contains L-Histidine, L-Histidine monohydrochloride monohydrate, Mannitol, Sucrose, Disodium EDTA dihydrate, Polysorbate 80, and Water for injection.

The frequency and dosage of the injections are determined by the study protocol and are administered over a specified period.

3 monitoring and follow-up

Participants are monitored for proptosis response, defined as a 2 mm reduction from baseline in the study eye without deterioration in the fellow eye, at Week 20.

Secondary assessments occur at Weeks 8, 16, 24, 32, 40, 44, 48, 56, 64, and 72, evaluating changes in proptosis, CAS, and diplopia (double vision).

The study also tracks the incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 72.

4 completion of study

The study is estimated to conclude by June 30, 2026.

Final assessments are conducted to evaluate the overall efficacy and safety of the treatment.

Who Can Join the Study?

  • Must have a clinical diagnosis of Graves’ disease linked with moderate to severe active Thyroid Eye Disease (TED). This means the patient has a specific thyroid condition affecting the eyes.
  • The symptoms of active TED must have started within the last 15 months.
  • Must have proptosis (also known as exophthalmos), which is when the eyes bulge out more than 3 mm beyond the normal range. This is determined by the study doctor based on race and gender.
  • Must have a Clinical Activity Score (CAS) of 4 or higher on a 7-item scale for the study eye. CAS is a way to measure how active the eye disease is.
  • Must have a Thyroid Stimulating Immunoglobulin (TSI) level greater than 130% of the normal reference standard or more than 0.55 IU/L, depending on the test method used. TSI is a type of antibody related to thyroid function.
  • Both male and female participants are eligible.
  • Participants must be within certain age ranges, which are typically adults.
  • Vulnerable populations, which may include groups like children or the elderly, are considered for participation.

Who Cannot Join the Study?

  • Patients who do not have Thyroid Eye Disease cannot participate. This is a condition affecting the eyes, often related to thyroid problems.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
  • Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for specific types of participants.
  • Both male and female patients can participate, so gender is not a reason for exclusion.
  • Patients who are considered part of a vulnerable population may not be eligible. This refers to groups who might need special protection in research studies.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Gyncentrum Sp. z o.o. Katowice Poland

Other Sites

Site Name City Country Status
Hospital Universitario Ramon Y Cajal Madrid Spain
University Hospital Bratislava Bratislava Slovakia
Santa Sp. z o.o. Lodz Poland
Eb Group Sp. z o.o. Warsaw Poland
Clinica De Oftalmologia De Cordoba S.L. Cordoba Spain
Hospital Universitario Virgen Macarena Sevilla Spain
Universita’ Di Pisa Pisa Italy
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Centre Hospitalier Universitaire De Nantes Nantes France
Zfccykltijputo rkqgbvsvf sbtnexrz Sac Ventspils Latvia
Ccaztv Hegngfwiuvu Rjxmbvzl Dywntgsqepfwaf Angers France
Rccun Avowpkft kusakspn unkaaclsgdhgo srvnktkl Sqs Riga Latvia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
07.01.2025
Italy Italy
Not recruiting
07.01.2025
Latvia Latvia
Not recruiting
07.01.2025
Poland Poland
Not yet recruiting
07.01.2025
Slovakia Slovakia
Not recruiting
07.01.2025
Spain Spain
Not recruiting
07.01.2025

Trial locations

Investigated drugs:

TOUR006 is an investigational medication being studied for its potential to help reduce the symptoms of Thyroid Eye Disease, specifically focusing on reducing the bulging of the eyes, known as proptosis. This medication is being tested to see how effective it is in managing this condition.

Thyroid Eye Disease – This condition is an autoimmune disorder that affects the muscles and other tissues around the eyes. It is often associated with an overactive thyroid gland, known as hyperthyroidism. The disease can cause the eyes to bulge or protrude, a condition known as proptosis. Patients may experience symptoms such as redness, swelling, and discomfort in the eyes. Double vision, or diplopia, can also occur as the muscles around the eyes become inflamed. Over time, the disease can lead to changes in vision and appearance due to the altered position of the eyes.

Trial ID:
2024-514801-69-00
Protocol code:
TOUR006-T01
NCT ID:
NCT06088979
Trial Phase:
Therapeutic exploratory (Phase II)

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