Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase III, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants with Moderate-to-Severe Thyroid Eye Disease

This research study, called a Phase III trial, is investigating a new medication, Satralizumab, for individuals with moderate to severe Thyroid Eye Disease. The main goal is to find out if Satralizumab can effectively reduce eye bulging (proptosis) and other symptoms of the condition at 24 weeks, compared to a dummy medicine (placebo). Researchers will also be checking how safe the medicine is and how the body handles it. This type of study is an important step in determining if new treatments are safe and effective enough to be used more widely. Participants will be carefully monitored throughout the study.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

Start

10 Oct 2023

Moderate-to-Severe Thyroid Eye Disease

What is this study about?

This study is a clinical trial looking into a new treatment for Thyroid Eye Disease, a condition where your immune system affects the tissues around your eyes. This can cause symptoms like bulging eyes (which doctors call proptosis), double vision, and eye discomfort.

The new treatment being tested is a medicine called Satralizumab. This study is in 'Phase III', which means it's a key stage where the medicine has already been studied in smaller groups and now they need to confirm if it works well and is safe in a larger group of people. Participants will receive either the new medicine or a dummy medicine (placebo) without knowing which one they are getting. This helps researchers to accurately see the effects of the new treatment.

The main thing the researchers want to find out is if Satralizumab can reduce the bulging of the eyes by a certain amount (at least 2mm) over 24 weeks. They will also be looking at other important aspects, such as how it affects eye inflammation, vision, and your overall quality of life, alongside closely monitoring for any side effects.

Key takeaways

This study is testing a new medicine for moderate to severe Thyroid Eye Disease.
It aims to reduce eye bulging and other symptoms safely.
Participants will receive either the new medicine or a dummy treatment.
Close monitoring of health and eye changes will happen throughout.
It's a Phase III study, a key step for new treatments.

Who may be eligible?

To join this study, people must be at least 18 years old. Gender does not matter; both men and women can take part.

More detailed specific requirements would be checked by the study doctor to make sure the trial is right and safe for you. These might include how active your Thyroid Eye Disease is, and other health conditions or medications you might be taking.

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 18 years old or older?
Do you have moderate to severe Thyroid Eye Disease?
Are you able to attend regular clinic appointments?
Are you comfortable potentially receiving a placebo (dummy treatment)?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be regularly seen by the study team. This will involve several visits to the study clinic over a number of months. At these visits, you'll have various assessments to check your eye condition, overall health, and any side effects. You will receive either the study medication or a placebo (inactive substance) as part of the trial. The total duration of your active participation will involve several weeks and follow-up, and the specific schedule of visits and treatments will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as gaining access to a new treatment before it's widely available and receiving close medical attention for your condition. However, there are also potential risks, like experiencing side effects from the study medication or the treatment not working for you. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

—
Unverified
Germany
—
Unverified
Italy
—
Unverified
Austria
—
Unverified
Hungary
—
Unverified
Czechia

Common questions

What is 'Thyroid Eye Disease'?

It's an autoimmune condition affecting the eyes, often linked to an overactive thyroid, causing symptoms like bulging eyes and double vision.

What does 'Phase III' mean for a trial?

It means the medicine has been tested before and is now being studied in a larger group to confirm if it works well and is safe.

Will I definitely get the new medicine?

No, this study is 'placebo-controlled', meaning some participants will receive the new medicine and others will receive a dummy medicine.

What is 'proptosis'?

Proptosis is the medical term for bulging eyes, a common symptom of Thyroid Eye Disease.

How long will the study last?

The main part of the study measures effects at 24 weeks, but the full participation might involve follow-up beyond that time.