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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 in individuals with Moderate-to-Severe Thyroid Eye Disease. Thyroid Eye Disease is a condition that affects the eyes, often causing them to bulge or become swollen. The purpose of this study is to evaluate how effective and safe Satralizumab is in treating this condition. Satralizumab is administered as a solution for injection under the skin, known as a subcutaneous injection.

Participants in the study will be randomly assigned to receive either Satralizumab or a placebo, which is a substance with no active medication. The study will last for a period of 48 weeks, during which participants will receive regular injections and attend scheduled visits to monitor their progress. The main goal is to see if there is a reduction in the bulging of the eyes, known as proptosis, after 24 weeks of treatment. The study will also look at other factors, such as changes in eye appearance and quality of life, as well as any side effects that may occur.

Throughout the study, participants will be closely monitored by healthcare professionals to ensure their safety and to gather information on how Satralizumab affects their condition. This research aims to provide valuable insights into the treatment of Thyroid Eye Disease and potentially improve the quality of life for those affected by this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria related to thyroid eye disease (TED).

    Participants must be 18 years or older and have a clinical diagnosis of either active or chronic inactive TED.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline measurements. This includes evaluating the severity of TED symptoms such as proptosis (eye bulging) and diplopia (double vision).

    The clinical activity score (CAS) is used to assess the activity level of TED.

  3. Step 3

    Treatment phase

    Participants receive the medication satralizumab as a subcutaneous injection. The dosage is 120 mg, administered at specified intervals.

    The treatment aims to reduce symptoms of TED, such as proptosis and inflammation.

  4. Step 4

    Monitoring and follow-up

    Regular follow-up visits are scheduled to monitor the response to treatment. This includes measuring changes in proptosis and CAS.

    Participants are observed for any side effects or adverse events related to the treatment.

  5. Step 5

    Evaluation at week 24

    At week 24, a comprehensive evaluation is conducted to assess the effectiveness of the treatment.

    The primary goal is to achieve a reduction in proptosis and improvement in other TED symptoms without worsening in the other eye.

  6. Step 6

    End of study

    The study concludes with a final assessment to determine the overall impact of the treatment on TED symptoms.

    Participants may receive guidance on managing TED after the study ends.

Who can join the trial?

9 criteria

  • You must be **18 years or older** at the time you sign the consent form.
  • If you have **active thyroid eye disease (TED)**, you need a clinical diagnosis showing a **clinical activity score (CAS)** of **3 or more** in the affected eye at the start of the study. The CAS is a way to measure how active the disease is.
  • If you have **chronic inactive TED**, your medical records should show a CAS of **less than 3** in both eyes for at least **6 months** before the study starts. This means the disease has been stable and not active.
  • For **chronic inactive TED**, you should not have had any new symptoms or worsening of symptoms like **proptosis** (bulging of the eye) or **diplopia** (double vision) for at least **6 months** before the study.
  • If you have **active TED**, your eye should show **proptosis** of **3 mm or more** above normal for your race and gender. You should also have one or more of the following: **lid retraction** (eyelid pulled back) of **2 mm or more**, moderate or severe soft tissue changes, or **diplopia**.
  • If you have **chronic inactive TED**, your eye should have a history of **proptosis** of **3 mm or more** above normal for your race and gender, along with one or more of the following: **lid retraction** of **2 mm or more**, moderate or severe soft tissue changes, or **diplopia**.
  • If you have **active TED**, the symptoms should have started in the affected eye **12 months or less** before the study begins.
  • If you have **chronic inactive TED**, your initial diagnosis should have been made **more than 12 months but less than 10 years** before the study.
  • Your thyroid levels should be normal (**euthyroid**) or you should have mild **hypothyroidism** (low thyroid function) or **hyperthyroidism** (high thyroid function) that is under control.

Who cannot join the trial?

3 criteria

  • Patients who do not have Moderate-to-Severe Thyroid Eye Disease cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, meaning they may need special protection or care, cannot participate.
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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 reduction of eye bulging, which is a common symptom. The study also looks at the safety of the medication and how it behaves in the body.

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 severity of symptoms can vary, with some individuals experiencing mild discomfort while others face significant vision problems. Over time, the disease may stabilize, but the changes in appearance and vision can persist.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503309-13-00Protocol codeGP44467Estimated enrolment160 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).