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Study on the Effects of Satralizumab for Patients with Moderate-to-Severe Thyroid Eye Disease

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Satralizumab on individuals with Moderate-to-Severe Thyroid Eye Disease. Thyroid Eye Disease is a condition where the muscles and tissues around the eyes become inflamed, leading to symptoms such as bulging eyes, discomfort, and vision problems. The purpose of this study is to evaluate how effective and safe Satralizumab is in treating this condition.

Participants in the study will receive either Satralizumab or a placebo. Satralizumab is administered as a subcutaneous injection, which means it is injected under the skin. The study will last for a period of 48 weeks, during which participants will be monitored for changes in their symptoms, such as a reduction in eye bulging and improvements in eye function and appearance. The study will also assess the safety of Satralizumab by monitoring any side effects that may occur.

In addition to Satralizumab, the study will also involve other medications, including Azathioprine, Mycophenolate Mofetil, Tocilizumab, Rituximab, Ciclosporin, and Glucocorticoids. These medications are commonly used to manage immune system activity and inflammation. The study aims to provide valuable information on the potential benefits and risks of using Satralizumab for treating Moderate-to-Severe Thyroid Eye Disease, helping to improve the quality of life for those affected by this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria related to thyroid eye disease.
Participants must be 18 years or older and have a clinical diagnosis of either active or chronic inactive thyroid eye disease.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline measurements, including proptosis (eye bulging) and clinical activity score (CAS).
This assessment helps determine the severity of the condition and sets a reference point for future evaluations.
Step 3
Treatment administration
Participants receive satralizumab as a subcutaneous injection. The dosage is 120 mg, administered at specified intervals.
The treatment aims to evaluate the efficacy and safety of satralizumab in reducing symptoms of thyroid eye disease.
Step 4
Ongoing monitoring
Regular monitoring occurs throughout the study to track changes in symptoms and any side effects.
Participants undergo assessments at various time points to measure proptosis, CAS, and other health indicators.
Step 5
Final evaluation
At the end of the study period, a final evaluation is conducted to assess the overall response to the treatment.
The primary focus is on the reduction of proptosis and improvement in quality of life related to visual functioning and appearance.

Who can join the trial?

9 criteria

Must be **18 years or older** at the time of signing the consent form.
For patients with **active thyroid eye disease (TED)**: Must have a clinical diagnosis of active TED with a **clinical activity score (CAS)** of 3 or higher in the study eye at the start of the study. The CAS is a measure of how active the disease is.
For patients with **chronic inactive TED**: Must have a stable, chronic TED with a CAS of less than 3 in both eyes for at least 6 months before the study starts. This means the disease has not been active recently.
For patients with **active TED**: Must have a diagnosis of moderate-to-severe TED, often with **proptosis** (bulging of the eye) of 3 mm or more above normal for their race and gender in the study eye. They should also have one or more of the following: **lid retraction** (eyelid pulled back) of 2 mm or more, moderate or severe soft tissue involvement, or **diplopia** (double vision) that comes and goes or is constant.
For patients with **chronic inactive TED**: Must have a history and current presence of chronic TED with proptosis of 3 mm or more above normal for their race and gender in the study eye. They should also have one or more of the following: lid retraction of 2 mm or more, moderate or severe soft tissue involvement, or diplopia that comes and goes or is constant.
For patients with **active TED**: The symptoms must have started in the study eye within 12 months before the study begins.
For patients with **chronic inactive TED**: The initial TED diagnosis must have been made more than 12 months but less than 10 years before the study starts.
Must have a **euthyroid** state, meaning their thyroid function is normal, or have mild **hypothyroidism** (underactive thyroid) or **hyperthyroidism** (overactive thyroid) that is under control.
For patients with **chronic inactive TED**: Must have a CAS of less than 3 in both eyes at the start of the study.

Who cannot join the trial?

9 criteria

Patients with other serious eye conditions that are not related to **Thyroid Eye Disease**.
Patients who have had recent eye surgery or are planning to have eye surgery during the study period.
Patients who are currently using certain medications that might interfere with the study treatment.
Patients with a history of severe allergic reactions to medications similar to the study treatment.
Patients with uncontrolled medical conditions that could affect their participation in the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within a certain time frame before this study.
Patients who have a history of substance abuse that could interfere with the study.
Patients who are unable to comply with the study procedures and follow-up visits.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Bellvitge University Hospital
L'hospitalet De Llobregat, Spain
Verified
Centre Hospitalier Universitaire De Nantes
Nantes, France
Verified
Fondation A De Rothschild
Paris, France

Trial locations

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Investigated drugs

Satralizumab is a medication being studied for its effectiveness in treating moderate-to-severe thyroid eye disease. It is administered through an injection under the skin. The trial aims to see how well this medication works in reducing the symptoms of the disease, particularly focusing on the improvement of eye bulging, which is a common issue in thyroid eye disease.

What is already known about the treatment

Satralizumab – Satralizumab is administered as a subcutaneous injection, meaning it is given under the skin. It is currently being studied in clinical trials for its effectiveness in treating moderate-to-severe thyroid eye disease. The medication works by targeting and inhibiting a specific protein involved in the inflammatory process, which helps reduce symptoms associated with the disease. Satralizumab is classified as a monoclonal antibody, a type of medication designed to interact with specific molecules in the body to modulate immune responses.

Investigated diseases

Thyroid Eye Disease – Thyroid Eye Disease, also known as Graves' orbitopathy, is an autoimmune condition where the immune system mistakenly attacks the tissues around the eyes. This leads to inflammation and swelling, causing symptoms such as bulging eyes, redness, and discomfort. As the disease progresses, it can result in increased pressure within the eye socket, affecting eye movement and vision. Patients may experience double vision and difficulty closing their eyes completely. The condition can vary in severity, with some individuals experiencing mild symptoms while others have more pronounced effects. Over time, the inflammation may subside, but changes in appearance and vision can persist.