A multiple ascending dose (MAD) safety, tolerability and efficacy study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in normal healthy volunteers (NHVs) and subjects with thyroid eye disease (TED)
This research is looking into a new treatment called VRDN-001 for a condition called Thyroid Eye Disease (TED). TED can cause the eyes to bulge forward, among other symptoms. The study is split into two main parts. First, it checks how safe the new medicine is and if people can comfortably take different doses. This is done with both healthy volunteers and people who have TED. The second part focuses on how effective VRDN-001 is at reducing eye bulging and other signs of TED. Researchers will carefully watch for any side effects and measure if the treatment makes eyes bulge less and improves other symptoms, like redness and swelling. The main goal is to see if VRDN-001 can offer a new way to help people living with TED by reducing their symptoms.
At a glance
What is this study about?
This study is investigating a new medicine called VRDN-001 for Thyroid Eye Disease, often shortened to TED. TED is a condition where the immune system mistakenly attacks the tissues around the eyes, causing them to become inflamed. This can lead to various symptoms like eye bulging (called proptosis), pain, double vision, and redness.
The main purpose of this research is to see if VRDN-001 is a safe and effective treatment for TED. The medicine works by targeting a specific protein in the body that is thought to play a role in the development of TED. The study will first check how safe the medicine is and what different doses people can comfortably take. This important first step helps researchers understand how the medicine affects the body in general. Once safety and suitable doses are understood, the study will then look closely at whether VRDN-001 can actually improve the symptoms of TED, such as reducing the bulging of the eyes and other signs of inflammation.
Researchers will be carefully monitoring participants throughout the study. They will track any side effects, both minor and serious, to ensure the medicine is as safe as possible. They will also measure changes in eye bulging using a special tool and assess other symptoms of TED. The results of this study will help determine if VRDN-001 could become a valuable new treatment option for people living with Thyroid Eye Disease, potentially offering relief from challenging symptoms.
Key takeaways
- This study is testing a new medicine (VRDN-001) for Thyroid Eye Disease (TED).
- It aims to find out if VRDN-001 is safe and effective at reducing TED symptoms.
- The medicine targets a specific protein involved in TED.
- Participants will receive either the new medicine or a placebo by infusion.
- Researchers will monitor eye bulging (proptosis) and other symptoms.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be considered for this study, you must be 18 years old or older. The study is open to both men and women.
Beyond these basic requirements, there will be more specific details about your health and medical history that the study team will need to check. For example, if you have Thyroid Eye Disease, there will be certain criteria related to your condition that you'll need to meet.
It's important to discuss your full medical history with the study team to see if this particular study is suitable for you. They will guide you through all the specific requirements.
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 a diagnosis of Thyroid Eye Disease?
- Are you able to attend appointments regularly?
- Are you comfortable with receiving study medicine through an infusion?
What does participation involve?
If you decide to take part in this study, you will receive either the new study medicine, VRDN-001, or a 'dummy' medicine (placebo) – which looks the same but contains no active drug. This is given as an infusion, meaning it goes directly into your bloodstream, likely through a drip in your arm. The study involves a number of visits to the clinic where you will have various assessments.
These assessments will include regular checks of your general health, such as blood tests and physical examinations, to make sure you are tolerating the treatment well. Researchers will also specifically monitor your eye condition, including measuring eye bulging and other symptoms of Thyroid Eye Disease, to see if the treatment is having an effect. You will have several infusions of the medicine over a period of weeks. The study team will explain the exact schedule of these infusions and follow-up appointments, as well as the total length of time you'll be involved in the study.
Potential risks and benefits
Locations (4)
- —UnverifiedSpain
- —UnverifiedGermany
- —UnverifiedFrance
- —UnverifiedNetherlands
Common questions
What is Thyroid Eye Disease (TED)?
TED is an autoimmune condition where the immune system attacks eye tissues, causing inflammation and symptoms like bulging eyes, pain, or double vision.
What is the new medicine being tested?
The medicine is called VRDN-001. It's a type of treatment designed to target specific processes in the body linked to TED.
Will I definitely get the new medicine?
You might receive the new medicine or a placebo (a 'dummy' treatment with no active drug). This helps researchers fairly compare how well the new medicine works.
How will they know if the medicine is working?
Researchers will measure changes in your eye bulging and other TED symptoms, like redness and swelling, during your clinic visits.
How long does the study last?
The study involves a series of infusions and follow-up appointments. The study team will provide you with a detailed timeline of your participation.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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