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Study on the Effects of VRDN-003 for Patients with Active Thyroid Eye Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Thyroid Eye Disease (TED). This is a condition where the muscles and fatty tissues around the eyes become inflamed, leading to symptoms such as bulging eyes, discomfort, and vision problems. The study is testing a new treatment called VRDN-003, which is an injection designed to target and inhibit a specific receptor involved in the disease process. The goal is to see if VRDN-003 can effectively reduce the signs and symptoms of TED, while also being safe and well-tolerated by the body.

Participants in the study will receive either the VRDN-003 injection or a placebo. The injections will be administered under the skin, either every four weeks or every eight weeks. The study will last for several months, during which the effects of the treatment on eye symptoms and overall health will be closely monitored. The main focus is to determine if there is a significant reduction in eye bulging and other symptoms by the end of the study period.

The study will also look at any side effects that may occur and how the body responds to the treatment. The aim is to gather comprehensive data on the effectiveness and safety of VRDN-003 for people with active TED. This information will help in understanding whether VRDN-003 could be a viable treatment option for managing the symptoms of Thyroid Eye Disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, clinical diagnosis of thyroid eye disease (TED), and other criteria such as eye bulging and symptoms.

    A negative pregnancy test is required for female participants at the first study visit.

  2. Step 2

    Treatment administration

    Participants receive VRDN-003 or a placebo through subcutaneous injections. These injections are administered either every 4 weeks or every 8 weeks.

    The treatment involves injecting the substance into the layer of fat between the skin and muscle.

  3. Step 3

    Monitoring and evaluation

    Throughout the study, participants are monitored for changes in eye bulging, disease severity, and symptoms.

    The primary endpoint is assessed at Week 24, focusing on the percentage of participants achieving a significant reduction in eye bulging and improvement in the Clinical Activity Score (CAS).

  4. Step 4

    Safety assessment

    Safety is evaluated by monitoring any side effects and the body's response to VRDN-003 throughout the study.

    The study aims to ensure that the treatment is both safe and tolerable for participants.

  5. Step 5

    Final evaluation

    At the end of the study, a final evaluation is conducted to assess the overall effectiveness of the treatment.

    The study concludes with an analysis of the primary and secondary endpoints, including changes in eye bulging, disease severity, and resolution of double vision.

Who can join the trial?

6 criteria

  • Participants must be adults, either male or female, aged between 18 and 75 years.
  • Participants must have a clinical diagnosis of **Thyroid Eye Disease (TED)**, with a score of 3 or higher on the **CAS scale**. The CAS scale is a tool used by doctors to measure the activity of TED.
  • Participants must have moderate to severe active TED, with noticeable eye bulging in the study eye before the first dose, as defined in the study guidelines, and at least one other sign or symptom as described in the study guidelines.
  • Participants must have experienced eye-related signs or symptoms that started within 15 months before the first study visit.
  • Participants must agree to use highly effective birth control methods as specified in the study guidelines.
  • Female participants must have a negative pregnancy test at the first study visit.

Who cannot join the trial?

7 criteria

  • Patients who do not have **Thyroid eye disease** cannot participate. This is a condition that affects the eyes and is related to thyroid problems.
  • Patients who are not within the specified age range cannot participate. The trial is open to certain age groups only.
  • Patients who are not willing to receive **subcutaneous injections** cannot participate. These are injections given into the layer of fat between the skin and muscle.
  • Patients who are not comfortable with the possibility of receiving a **placebo** cannot participate. A placebo is a substance with no active drug ingredients used for comparison.
  • Patients who are not part of the specified clinical trial groups cannot participate. The trial is designed for specific groups of people.
  • Both **male and female** patients are eligible, so those who do not identify as either may not be able to participate.
  • Patients who are considered part of a **vulnerable population** may not be eligible. This refers to groups of people who might need special protection or care.
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Investigated drugs

VRDN-003 is an investigational medication being studied for its potential to treat active thyroid eye disease (TED). This medication is administered through injections under the skin, either every 4 weeks or every 8 weeks. The study aims to determine if VRDN-003 can effectively reduce the signs and symptoms of TED and if it is safe and well-tolerated by the body.

What is already known about the treatment

VRDN-003 – This medication is administered through subcutaneous injections, which means it is injected into the layer of fat between the skin and muscle. It is currently being studied in a phase 3 clinical trial to evaluate its effectiveness, safety, and tolerability for treating thyroid eye disease. The main therapeutic indication for VRDN-003 is to alleviate the signs and symptoms associated with active thyroid eye disease. At the molecular level, VRDN-003 works by targeting specific pathways involved in the inflammation and tissue changes seen in this condition. It is classified pharmacologically as a treatment for thyroid-related disorders.

Investigated diseases

Thyroid Eye Disease – This condition is an autoimmune disorder that affects the muscles and tissues around the eyes. It often occurs in people with thyroid problems, particularly Graves' disease. The disease can cause symptoms such as bulging eyes, redness, swelling, and discomfort. As it progresses, individuals may experience double vision and difficulty moving the eyes. The severity of symptoms can vary, and the condition may go through active and inactive phases. Over time, the inflammation may decrease, but some changes, like eye bulging, can become permanent.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514972-42-00Protocol codeVRDN-003-301Estimated enrolment142 patientsSponsorViridian Therapeutics Inc.

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