Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

An open-label study for participants who are non-responders at the end of treatment assessment on the VRDN-001-101 and VRDN-001-301 pivotal studies

This research study is looking at a new medicine called VRDN-001 for people with Thyroid Eye Disease (TED). Specifically, it's for those who have previously taken part in other studies for this medicine (VRDN-001-101 or VRDN-001-301) and whose symptoms, like bulging eyes, didn't get better enough, or completely, by the end of their treatment. The main goal is to see if this medicine can help reduce how much the eyes bulge out, and improve other signs of the disease. Researchers will also be carefully monitoring for any side effects. This study aims to find more effective treatments for people still affected by TED.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Viridian Therapeutics Inc.

Enrolment target

Start

16 Apr 2024

Thyroid eye disease

What is this study about?

This study is designed for individuals who have Thyroid Eye Disease (TED) and have previously participated in specific trials for a medicine called VRDN-001 (studies VRDN-001-101 or VRDN-001-301), but found that their condition didn't fully improve by the end of that earlier treatment. TED is an autoimmune condition where the body's immune system mistakenly attacks the tissues around the eyes, leading to symptoms like eye bulging, double vision, pain, and redness.

Researchers want to see if continuing with or receiving VRDN-001, which is a medicine that targets a specific protein involved in TED, can help improve these symptoms for people who haven't seen enough benefit from previous treatment. They are particularly interested in whether it can reduce how much the eyes bulge out and improve overall eye discomfort. The study will also keep a very close eye on the safety of the medicine, noting any side effects that might occur.

By carefully studying the effects of VRDN-001 in this group of patients, researchers hope to gain a better understanding of how to treat TED, especially for those who find their symptoms persistent. The ultimate goal is to find more effective ways to help people living with this challenging condition.

Key takeaways

This study is for adults with Thyroid Eye Disease (TED) whose symptoms weren't fully helped by previous VRDN-001 studies.
It aims to see if VRDN-001 can reduce eye bulging and improve other TED symptoms.
Researchers will very carefully watch for any side effects of the medicine.
Participation involves regular clinic visits and IV infusions.
You can stop participating at any time if you change your mind.

Who may be eligible?

To be considered for this study, you must be an adult, aged 18 or over. This study is open to both men and women.

A key requirement is that you must have previously taken part in one of two specific studies for the medicine VRDN-001 (either VRDN-001-101 or VRDN-001-301). Importantly, at the end of that earlier study, your Thyroid Eye Disease should not have improved enough. This means your symptoms were still bothering you.

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?
Have you previously taken part in the VRDN-001-101 or VRDN-001-301 studies?
Did your Thyroid Eye Disease not fully improve by the end of your previous VRDN-001 study?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve receiving infusions of either the study medicine (VRDN-001) or a saline solution directly into your vein. The researchers will be closely monitoring how your eyes respond, especially focusing on whether eye bulging reduces and if other symptoms improve. This will involve regular visits to the clinic for assessments.

During these visits, you'll have various checks and tests, including eye measurements to track changes in bulging eyes and general health checks. You will be asked about any side effects you might experience. The total duration of your participation, including follow-up, will be determined by the study's specific schedule.

Potential risks and benefits

Participating in research studies like this means there's a chance the study medicine might help improve your eye bulging and other symptoms of Thyroid Eye Disease, especially if previous treatments haven't fully worked for you. However, it's also possible that the medicine might not work, or you could experience side effects. All known and potential risks will be thoroughly explained to you, and your safety will be carefully monitored throughout the study. Remember, choosing to participate is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (8)

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

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Unverified
Czechia
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Unverified
Italy
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Unverified
Spain
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Unverified
France
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Unverified
Germany
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Unverified
Netherlands
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Unverified
Poland
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Unverified
Hungary

Common questions

What is Thyroid Eye Disease?

Thyroid Eye Disease (TED) is an autoimmune condition where your immune system affects the tissues around your eyes, causing symptoms like bulging or painful eyes.

What is VRDN-001?

VRDN-001 is a study medicine that aims to block a specific protein involved in the progression of Thyroid Eye Disease, hoping to reduce symptoms.

Who is this study for?

This study is for adults with Thyroid Eye Disease who were previously in VRDN-001 studies (101 or 301) and whose symptoms did not fully improve.

What will researchers be looking for?

Researchers will mainly be checking if the medicine reduces eye bulging and improves other signs of Thyroid Eye Disease, while also monitoring for safety.

Will I get the actual medicine?

Participants will receive either the study medicine (VRDN-001) or a saline solution (a salt water drip) through an IV during the study.