A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease
This research is looking into a new medicine, satralizumab, for people who have Thyroid Eye Disease (TED). TED is a condition that affects the eyes, often causing them to bulge or become inflamed. Satralizumab is a special type of antibody designed to block a specific protein in the body that might be involved in TED. The study aims to find out if this medicine can improve the symptoms of TED, how safe it is to use, and how it behaves in the body. Participants will either receive the new medicine or a placebo (a dummy medicine) to compare their effects. This is a Phase 3 study, meaning it's one of the final stages of testing before a medicine might become widely available.
At a glance
What is this study about?
This study is focused on a new medicine called satralizumab, which is being tested to help people who have a condition called Thyroid Eye Disease (TED). TED is an autoimmune condition where the body's immune system mistakenly attacks the tissues around the eyes. This can lead to symptoms like eye bulging, double vision, pain, and redness.
Satralizumab is a type of medicine known as a monoclonal antibody. Think of it as a specially designed key that can only fit one specific lock in your body. In this case, it's designed to block a protein called interleukin-6 (IL-6), which scientists believe plays a role in causing the inflammation and changes seen in TED. By blocking this protein, the hope is to reduce the effects of the disease.
The main goals of this study are to see if satralizumab can effectively reduce the symptoms of TED, how safe it is for people to use, and how it travels through and affects the body. This is a 'Phase 3' study, which means it's a large, important step in testing a new medicine. If the results are positive, it could lead to a new treatment option for people living with TED.
Key takeaways
- This study is testing a new medicine (satralizumab) for Thyroid Eye Disease (TED).
- It aims to see if the medicine is safe and helps improve TED symptoms.
- Participants will receive either the new medicine or a dummy medicine (placebo).
- Regular clinic visits, eye exams, and blood tests will be part of taking part.
- You must be 18 or older and not pregnant or breastfeeding to join.
- You can stop participating at any time if you change your mind.
Who may be eligible?
To join this study, doctors will first need to confirm you have Thyroid Eye Disease (TED) based on a common assessment method. You'll need to be at least 18 years old.
There are also some reasons why you might not be able to join. For example, if your eye condition has improved significantly on its own between your initial check-up and the start of the study, or if you need eye surgery or radiation treatment very soon. Also, if you have other serious eye conditions that might make it difficult to understand the study results, or any other serious health issue that your doctor believes would make taking part unsafe, you wouldn't be able to participate.
Finally, if you are pregnant, breastfeeding, or planning to become pregnant during the study or for three months after your last dose of the study medicine, you would not be able to join. This is a common precaution in many medical studies to protect mothers and babies.
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 I have a confirmed diagnosis of Thyroid Eye Disease?
- Am I 18 years old or older?
- Is my TED stable, without recent significant improvement?
- Do I need any eye surgery or radiation soon?
- Do I have any other serious health conditions that might make taking part unsafe?
- Am I pregnant, breastfeeding, or planning to become pregnant in the next few months?
What does participation involve?
If you decide to take part in this study, you would receive the study medicine, satralizumab, or a placebo (a dummy medicine that looks the same but contains no active drug), typically given as an injection under the skin. You wouldn't know which one you are receiving – this helps ensure the study results are fair.
Throughout the study, you would have regular visits to the clinic. These visits will involve various checks to see how you are doing, including eye examinations, blood tests, and discussions about any symptoms you're experiencing. These assessments help the doctors monitor your health, how the medicine is affecting you, and if your TED is improving. The total time you would be involved in the study would depend on the study's design, including how long the treatment period is and any follow-up appointments after your last dose of medication.
Potential risks and benefits
Locations (40)
- Plastics-Orbit-NeuroVerified postcodeSan Diego, United States
- Connecticut Eye Consultants, P.C.Verified postcodeDanbury, United States
- University of Illinois Eye and Ear InfirmaryVerified postcodeChicago, United States
- Scheie Eye InstituteVerified postcodePhiladelphia, United States
- Vanderbilt Eye InstituteVerified postcodeNashville, United States
- Retina Consultants of TexasVerified postcodeSan Antonio, United States
- University of AlbertaVerified postcodeEdmonton, Canada
- Toronto Retina InstituteVerified postcodeToronto, Canada
- Universite de Montreal - Hopital Maisonneuve-RosemontVerified postcodeMontreal, Canada
- Peking Union Medical College HospitalVerified postcodeBeijing, China
- Peking University Third HospitalVerified postcodeBeijing, China
- Beijing Tongren Hospital, Capital Medical UniversityVerified postcodeBeijing, China
Common questions
What is Thyroid Eye Disease (TED)?
TED is a condition where the body's immune system attacks the tissues around the eyes, leading to symptoms like bulging eyes, pain, or double vision.
What is satralizumab?
Satralizumab is a new medicine being tested. It's designed to block a specific protein (IL-6) in the body that's thought to be involved in TED.
Will I get the real medicine or a placebo?
Participants will either receive satralizumab or a placebo (a dummy medicine). You won't know which one you are getting to keep the study fair.
How is the medicine given?
The study medicine is given as an injection under the skin.
What is a Phase 3 study?
Phase 3 is an advanced stage of testing a new medicine, involving a larger group of people to confirm its effectiveness and safety.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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