A randomized, controlled, safety and tolerability study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in participants with thyroid eye disease (TED)
This study is a research project looking into a new medicine called VRDN-001 for people who have thyroid eye disease. Thyroid eye disease can cause problems with your eyes, like bulging. The main goal of this study is to find out how safe VRDN-001 is and if it causes any unwanted side effects over the first 15 weeks of treatment. Researchers will also be checking if the medicine helps with eye bulging and will continue to track side effects for a longer period, up to 52 weeks. It’s part of a larger phase of testing new medicines to make sure they are safe and work well.
At a glance
What is this study about?
This research study is about a new medicine called VRDN-001, which is being tested for people who have a condition called thyroid eye disease (TED). Thyroid eye disease happens when your immune system (your body’s defense system) mistakenly attacks the tissues around your eyes. This can cause various problems like inflammation, swelling, and bulging of the eyes. This new medicine aims to help by blocking a specific signal in the body that is thought to play a role in TED.
The main purpose of this study is to see how safe the new medicine, VRDN-001, is. The researchers want to understand if people who take it experience any side effects, especially during the first 15 weeks of treatment. They will be carefully recording any new health problems or changes that happen during this time to make sure the medicine is well-tolerated. This is a very important step in developing any new medication.
After checking safety, the study will also look at whether VRDN-001 helps reduce how much the eyes bulge, which is a common symptom of thyroid eye disease. They will track this over 15 weeks and continue to monitor for any side effects for a longer period, up to 52 weeks. This type of study, called a Phase III study, is one of the final stages of testing a new medicine before it can potentially be made available to more people.
Key takeaways
- This study is testing a new medicine for thyroid eye disease.
- The main focus is to check how safe the medicine is over 15 weeks.
- It's a Phase III study, an advanced stage of medicine testing.
- Participants will be closely monitored for about a year.
- The study also looks at whether the medicine helps with eye bulging.
- You can stop participating at any time.
Who may be eligible?
To join this study, participants must be at least 18 years old. There is no upper age limit, meaning older adults can also take part. Both men and women are welcome to participate in this research.
While the basic requirements are flexible, there will be other specific health checks that the study doctors will need to do. These checks are important to make sure the study medicine is safe for you and that the results of the study are clear. These will likely include detailed assessments of your thyroid eye disease and your general health.
If you are interested, a study doctor would talk with you and carry out these checks to see if this study is a good fit for you and if you meet all the necessary medical criteria.
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 thyroid eye disease?
- Are you able to attend regular clinic visits?
- Are you comfortable with receiving an experimental medicine?
What does participation involve?
If you decide to participate in this study, you would receive the new medicine, VRDN-001. Throughout the study, you would have regular visits to the clinic where doctors and nurses would monitor your health very closely. They would conduct various tests and examinations to check for any side effects and to see how your thyroid eye disease is responding to the treatment. These visits are likely to involve physical examinations, blood tests, and eye measurements.
The main part of the study where they look for side effects will last for 15 weeks. However, you would be monitored for side effects for a longer period, up to 52 weeks in total. This means you would have regular follow-up appointments over nearly a year to ensure your well-being and to gather all necessary information about the medicine.
Potential risks and benefits
Locations (5)
- —UnverifiedGermany
- —UnverifiedNetherlands
- —UnverifiedPoland
- —UnverifiedFrance
- —UnverifiedSpain
Common questions
What exactly is VRDN-001?
VRDN-001 is a new medicine being tested. It's designed to block a specific signal in the body that is involved in thyroid eye disease.
What is 'Phase III' of a clinical study?
Phase III is a later stage of testing where a new medicine is given to a larger group of people to confirm its safety and how well it works, before it can be considered for wider use.
How long will I be involved in the study?
You'll be monitored for side effects for 15 weeks, and then followed for longer, up to a total of 52 weeks, to continue checking your health and the medicine's effects.
Will I definitely get the new medicine?
This is a 'randomized' study, which often means some participants might receive the new medicine while others might receive a placebo (a dummy medicine) or standard treatment. The study team will explain this to you.
What if I feel unwell during the study?
The study team will monitor you closely, and you should always tell them about any new health problems or changes you experience as soon as possible.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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