Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A randomized, double-masked, placebo-controlled safety, tolerability, and efficacy study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in participants with chronic thyroid eye disease (TED)

This study is looking into a new treatment for Thyroid Eye Disease (TED), a condition that affects the eyes. The new medicine, called VRDN-001, is a special antibody designed to block a certain signal in the body that can contribute to TED. Researchers are comparing it to a dummy treatment (placebo) to find out if VRDN-001 is safe, well-tolerated, and effective in improving symptoms like eye bulging (proptosis) and other changes in the eye. They will be closely monitoring how participants' eyes respond and also watching for any side effects throughout the study, which is in a late stage of testing (Phase III) before potential approval.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Viridian Therapeutics Inc.

Enrolment target

170

Start

02 Apr 2024

Thyroid eye disease

What is this study about?

This research is specifically for people living with Thyroid Eye Disease (TED). TED is an autoimmune condition often linked to an overactive thyroid, where your immune system mistakenly attacks healthy tissues around your eyes. This can lead to various symptoms like bulging eyes, double vision, pain, and redness.

The study is testing a new medicine called VRDN-001. This medicine is a 'monoclonal antibody' – think of it like a specially designed key that fits a very specific lock in your body. In this case, it's designed to block a signal called IGF-1R, which is thought to play a role in developing TED. By blocking this signal, the hope is to reduce the inflammation and swelling around the eyes that cause the symptoms. Some participants will receive VRDN-001, while others will receive a 'placebo', which looks exactly like the study medicine but contains no active drug. This helps researchers understand if any improvements are truly due to the new medicine.

The main goals of the study are to see how safe VRDN-001 is, how well people tolerate it (meaning, how many side effects they experience), and most importantly, if it improves the symptoms of TED. Researchers will be especially interested in changes to eye bulging (which doctors call proptosis) and other signs of eye disease. They will also look at whether improvements last and if participants experience less double vision.

Key takeaways

This study is testing a new medicine for Thyroid Eye Disease (TED).
It aims to see if the medicine, VRDN-001, is safe and helps improve eye symptoms.
Participants will receive either the new medicine or a dummy treatment (placebo).
Researchers will closely monitor eye changes and any side effects.
The study is for adults aged 18 and over, of any gender.

Who may be eligible?

To join this study, you must be at least 18 years old, and the study is open to both men and women. The specific details of your Thyroid Eye Disease will be important, as there might be certain criteria about how long you've had the condition or how severe your symptoms are at the start.

There will also be other health conditions that might prevent someone from joining, to ensure the study is as safe as possible for everyone involved. For example, if you have certain other medical problems or are taking particular medications, you might not be able to take part.

A doctor involved with the study will carefully check your health and medical history against a full list of requirements to determine if this study is right for you. It's important to discuss any health concerns or medications you're taking with them.

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?
Have you been diagnosed with Thyroid Eye Disease (TED)?
Are you comfortable with receiving study medication through an IV drip?
Are you able to attend regular clinic appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to make sure you meet all the requirements. If you qualify, you would receive the study medicine (either VRDN-001 or a placebo) through a drip into your arm (intravenous infusion), likely over several visits. These infusions would be given periodically over a period of time. You would also have regular check-ups and assessments, which include eye examinations, blood tests, and discussions about how you're feeling and any symptoms or side effects you might be experiencing.

The study will involve several visits to the clinic or hospital, and the total duration of your participation, including follow-up appointments after your last dose, will be explained in detail by the study team. You would be closely monitored throughout this time to ensure your safety and track your progress.

Potential risks and benefits

Taking part in a clinical study means you might receive a new treatment that could potentially improve your symptoms, though there's no guarantee it will work for everyone, or at all. There is also no guarantee you will receive the active treatment as some participants get a placebo. As with any new medicine, there's a risk of side effects, ranging from mild to more serious; the study team will carefully monitor you for these. You will be given full information about all known and potential risks before you decide to join. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

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

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Unverified
Spain
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Unverified
Hungary
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Unverified
Poland
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Unverified
France
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Unverified
Italy
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Unverified
Germany

Common questions

What is Thyroid Eye Disease (TED)?

TED is an autoimmune condition where your body's immune system affects the tissues around your eyes, leading to symptoms like bulging eyes, double vision, and discomfort.

What is VRDN-001?

VRDN-001 is a new medicine being tested. It's a special antibody designed to block a certain signal in your body that is thought to contribute to TED.

What is a 'placebo'?

A placebo is a dummy treatment that looks exactly like the study medicine but contains no active drug. It helps researchers fairly compare the new medicine's effects.

Am I guaranteed to get the new medicine?

No, because this is a 'randomized' study, you will be randomly assigned to either receive VRDN-001 or the placebo. You won't know which one you're getting.

How long does the study last?

The exact duration of participation will be discussed with you by the study team, but it involves several visits for treatment and follow-up over a period of time.