Active not recruitingPHASE3INTERVENTIONAL

A Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)

This research study is testing a new medicine, VRDN-003, for a condition called Thyroid Eye Disease (TED). We want to find out if this medicine is safe and if people can take it without too many problems. This is a Phase 3 study, which means it's a later stage of research before a medicine might be approved. Everyone in the study will either receive the new medicine or a dummy treatment, chosen by chance. Neither you nor your doctor will know which one you are getting. The medicine is given as a jab under the skin every 4 or 8 weeks. We're looking for adults aged 18 to 75 who have TED to take part.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Viridian Therapeutics, Inc.

Enrolment target

320

Start

03 Feb 2025

Estimated completion

01 Oct 2026

Thyroid Eye Disease (TED)

What is this study about?

This clinical trial is designed to investigate a new treatment, VRDN-003, for Thyroid Eye Disease (TED). TED is a condition where the immune system mistakenly attacks the tissues around the eyes, which can cause symptoms like bulging eyes, double vision, and eye dryness or irritation. The main goal of this study is to see if VRDN-003 is safe for people with TED and how well their bodies cope with the medicine. We also want to understand if it has any noticeable effects on the condition.

This study is in Phase 3, which is a key step in developing new medicines. It's a 'randomised' study, meaning that whether you receive the new medicine (VRDN-003) or a 'placebo' (a dummy treatment with no active medicine) will be decided by chance, like flipping a coin. It's also 'double-masked,' which means neither you nor your study doctor will know whether you are receiving VRDN-003 or the placebo. This helps ensure the study results are as fair and unbiased as possible.

VRDN-003 will be given as a series of injections just under the skin. Study participants will receive these injections either every 4 weeks or every 8 weeks. The study aims to gather important information about how the medicine works, its safety, and how often it might need to be given to be effective for people living with TED.

Key takeaways

This study is testing a promising new medicine (VRDN-003) for Thyroid Eye Disease (TED).
It aims to check if the medicine is safe and well-tolerated.
You'll either receive the new medicine or a dummy treatment, assigned by chance.
The medicine is given by injection under the skin every 4 or 8 weeks.
Close medical monitoring and regular hospital visits will be part of taking part.
You can stop participating in the study at any time.

Who may be eligible?

To join this study, you need to be an adult between 18 and 75 years old and have been diagnosed with Thyroid Eye Disease (TED). Your study doctor will need to feel that VRDN-003 might be helpful for you. Importantly, you shouldn't need immediate eye surgery for any reason during the study.

There are also some important reasons why you might not be able to join. For instance, you can't have received certain other treatments for TED or other conditions recently, such as strong steroid medicines or other investigative treatments. If you've had certain eye procedures like orbital irradiation or decompression surgery for TED in the eye being studied, you also wouldn't be able to participate. Women who are pregnant or breastfeeding, or who could become pregnant and are not using effective birth control, cannot take part.

In addition, you shouldn't have specific health problems like inflammatory bowel disease or certain hearing issues. The study doctors will carefully check your medical history to make sure taking part is safe for you and that the study results will be clear.

Quick self-check

Are you between 18 and 75 years old?
Have you been diagnosed with Thyroid Eye Disease (TED)?
Have you avoided other TED treatments (like strong steroids or experimental drugs) recently?
Are you generally healthy, without conditions like inflammatory bowel disease or significant hearing problems?
Are you not pregnant or breastfeeding, and willing to use effective birth control if needed?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will be assigned by chance to either receive the new medicine, VRDN-003, or a dummy medicine called a placebo. You won't know which one you're getting, and neither will your study doctor. The medicine or placebo will be given as injections under your skin, either every 4 weeks or every 8 weeks, depending on which group you're in. This means you will need to attend regular clinic visits for your injections and for the study team to carry out checks.

During these visits, the study team will perform various tests and assessments to monitor your health, how the medicine is affecting your TED, and to check for any side effects. These assessments might include eye exams, blood tests, and other physical checks. You'll need to follow the study schedule closely and attend all your appointments. The total length of your participation in the study will be explained in detail by the study team, but it will involve a series of injections and follow-up over several months.

Potential risks and benefits

Taking part in a clinical trial can have potential benefits, though these are not guaranteed. You might receive a new treatment for your Thyroid Eye Disease that isn't yet available to everyone. You’ll also receive close medical attention and monitoring from the study team. However, there are also potential risks. The new medicine, VRDN-003, might cause side effects, some of which we might not fully know yet. There's also a chance you might receive the placebo (dummy medicine) and not the active drug. Your participation is always voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (64)

Catalina Eye Care
Tuscon, United States
United Medical Research Institute
Inglewood, United States
Orbital Plastics
Newport Beach, United States
California Eye Specialists Medical Group INC
Pasadena, United States
FOMAT Medical Research
Pismo Beach, United States
Pacific Neuroscience Institute
Santa Monica, United States
Pacific Neuroscience Institute at Saint John's Physician Partners
Torrance, United States
C A Clinical Trial Corp.
Cape Coral, United States
Herco Medical and Research Center
Coral Gables, United States
Alfa Medical Research
Davie, United States
D H Doral Research Center
Doral, United States
Eye Centers of Florida
Fort Myers, United States

+52 more sites — see the official record for the full list.

Common questions

What is Thyroid Eye Disease (TED)?

TED is an autoimmune condition where your body's immune system attacks the tissues around your eyes, potentially causing swelling, bulging eyes, double vision, and discomfort.

What does 'randomised' and 'double-masked' mean?

Randomised means who gets the new medicine or the dummy treatment is chosen by chance. Double-masked means neither you nor your doctor will know which one you are receiving, making the study fairer.

How will the medicine be given?

The medicine (VRDN-003 or placebo) will be given as injections just under your skin, either every 4 weeks or every 8 weeks.

Can I still get other treatments for my TED while in the study?

Generally, no. You cannot have received certain other treatments like strong steroids or other experimental drugs for TED shortly before or during the study, as this could affect the results.

What if I change my mind about being in the study?

You can leave the study at any time, for any reason, without having to explain why. This won't affect your future medical care.