Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease
This research study is investigating a new medication, satralizumab, for people living with Thyroid Eye Disease (TED). Researchers want to find out how effective it is at treating the condition, how safe it is to use, and how it works within the body. Participants will either receive the new medicine or a dummy treatment (placebo) to help doctors compare the results. This is a Phase 3 trial, meaning the medicine has already been tested in smaller groups and is now being studied in a larger group of people to confirm its benefits and safety before potentially becoming widely available.
At a glance
What is this study about?
This study is all about a condition called Thyroid Eye Disease, sometimes known as TED. This is an autoimmune condition where your body's immune system mistakenly attacks healthy tissues around your eyes. This can lead to a number of symptoms, including bulging eyes, double vision, pain, and discomfort.
The researchers are testing a new medicine called satralizumab. This medicine is designed to block a specific protein in the body called interleukin-6 (IL-6). Experts believe that IL-6 plays a role in the inflammation and damage seen in TED. By blocking it, they hope to reduce the symptoms and progression of the disease.
In this study, some people will receive the new medicine, and others will receive a 'placebo', which looks like the medicine but doesn't contain any active drug. This is a common way to test new medicines, as it helps researchers see if the real medicine is more effective than no treatment at all. The aim is to understand if satralizumab can be a safe and helpful new treatment option for people with TED.
Key takeaways
- This study is testing a new medicine (satralizumab) for Thyroid Eye Disease.
- It aims to see if the medicine is safe and effective in reducing TED symptoms.
- Participants will receive either the new medicine or a dummy treatment (placebo).
- It's a Phase 3 study, meaning it's a larger trial following earlier tests.
- You must have a diagnosed case of TED and be at least 18 years old to consider joining.
- Participation involves regular clinic visits for checks and injections.
Who may be eligible?
To join this study, you must have a clear diagnosis of Thyroid Eye Disease (TED) from a doctor. You also need to be at least 18 years old.
There are some reasons why you might not be able to join. For example, if your eye condition has recently improved a lot on its own, or if you need eye surgery very soon. Also, if you have another eye disease that might make it hard to understand the results, or if you have any serious health problems that the study doctors think could make participation unsafe, you might not be eligible.
Finally, if you are pregnant, breastfeeding, or planning to become pregnant during the study or in the three months after receiving the last dose of the study medicine, you won't be able to take part.
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.
- Do you have a clear diagnosis of Thyroid Eye Disease (TED)?
- Are you 18 years old or older?
- Are you not currently pregnant or breastfeeding, or planning to become pregnant soon?
- Do you not need eye surgery (for TED) in the near future?
- Has your eye condition not significantly improved on its own very recently?
What does participation involve?
If you decide to take part in this study, you would receive either the new medicine (satralizumab) or a placebo, given as an injection under the skin. You would have regular visits to the study clinic for assessments. These visits would include checks of your eyes, general health checks, and possibly blood tests.
The study would involve a number of visits over a period of time, although the exact schedule would be explained in detail by the study team. You would be monitored closely throughout the study for any changes in your condition or any side effects from the treatment. There would also be a follow-up period after your last dose to ensure your continued well-being. The study team will provide all the detailed information before you decide to join.
Potential risks and benefits
Locations (46)
- Thrive Health Research LLCVerified postcodeBeverly Hills, United States
- UCSD Shiley Eye CenterVerified postcodeLa Jolla, United States
- Grene Vision Group, LLCVerified postcodeWichita, United States
- Johns Hopkins UniversityVerified postcodeBaltimore, United States
- University of Michigan, Kellogg Eye CenterVerified postcodeAnn Arbor, United States
- Great Lakes Eye CareVerified postcodeSaint Joseph, United States
- 'Northwell Health Physician Partners OphthalmologyVerified postcodeGreat Neck, United States
- EyeHealth NorthwestVerified postcodePortland, United States
- Austin Retina AssociatesVerified postcodeAustin, United States
- Eyelid Center of UtahVerified postcodeSalt Lake City, United States
- WVU Eye InstituteVerified postcodeMorgantown, United States
- Centro Medico Dra. Laura Maffei- Investigacion Clinica AplicadaVerified postcodeBuenos Aires, Argentina
Common questions
What is Thyroid Eye Disease (TED)?
TED is an eye condition linked to an overactive thyroid, where your immune system attacks tissues around your eyes, causing symptoms like bulging eyes or double vision.
What is satralizumab?
Satralizumab is the new medicine being tested. It's designed to block a specific protein (IL-6) thought to contribute to TED.
What is a placebo?
A placebo is a dummy treatment that looks just like the real medicine but contains no active drug. It helps doctors compare results.
How will I receive the study medicine?
The study medicine or placebo will be given as an injection under the skin.
Can I leave the study if I change my mind?
Yes, you can choose to stop participating in the study at any time, for any reason, without penalty or affecting your future care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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