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Study on the Safety and Tolerability of VRDN-003 for Patients with 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 will test a new treatment called VRDN-003, which is an Insulin-like growth factor-1 receptor (IGF-1R) inhibitor. This treatment is designed to help manage the symptoms of TED by being injected under the skin, either every four weeks or every eight weeks.

The purpose of the study is to determine if VRDN-003 is safe and tolerable for people with TED. Participants will receive the treatment as a series of injections, and the study will monitor how their bodies react to the medication. The study will also look at changes in the bulging of the eyes over time. A comparison will be made between the eye condition before starting the treatment and after 24 weeks of receiving the injections.

The study will last for a period of time, with the primary focus on observing any safety events that occur after starting treatment with VRDN-003. These observations will continue through Week 24, and further safety assessments will be made up to Week 52. The goal is to ensure that the treatment is not only effective but also safe for long-term use in managing Thyroid Eye Disease.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, an initial visit is conducted. During this visit, eligibility is confirmed, including age and diagnosis of thyroid eye disease (TED). A pregnancy test is required for female participants.

    Participants must agree to use highly effective contraception throughout the study.

  2. Step 2

    First injection

    The first dose of the study medication, VRDN-003, is administered as a subcutaneous injection. This means the injection is given into the layer of fat between the skin and muscle.

    The purpose of this medication is to evaluate its safety and tolerability in treating TED.

  3. Step 3

    Follow-up injections

    Subsequent injections are scheduled every 4 weeks or every 8 weeks, depending on the study group assignment.

    Each injection visit includes monitoring for any side effects and assessing the body's response to the medication.

  4. Step 4

    Safety monitoring

    Throughout the study, safety is closely monitored. This involves regular check-ups to identify any adverse events, which are any unwanted effects that occur after starting the treatment.

    The primary focus is on the rate of these events through Week 24, with continued monitoring through Week 52.

  5. Step 5

    Assessment of eye condition

    At Week 24, an assessment is conducted to measure changes in eye bulging compared to measurements taken before the first dose.

    This helps determine the effectiveness of the treatment in managing symptoms of TED.

  6. Step 6

    Study completion

    The study is expected to continue until January 31, 2027. Participants will have regular visits and assessments throughout this period.

    Upon completion, participants may receive information about the study's findings and any potential next steps.

Who can join the trial?

4 criteria

  • Adult males or females, 18 to 75 years of age
  • Have a clinical diagnosis of Thyroid Eye Disease (TED) of any duration and, in the opinion of the study doctor, may benefit from the study treatment
  • Must agree to use highly effective contraception as specified in the study plan
  • Female participants must have a negative pregnancy test at the first study visit

Who cannot join the trial?

10 criteria

  • Participants cannot have any other serious health conditions that might interfere with the study.
  • Participants should not have had any recent surgeries or medical procedures that could affect the study results.
  • Participants must not be pregnant or planning to become pregnant during the study.
  • Participants should not be breastfeeding.
  • Participants must not have a history of allergic reactions to similar medications.
  • Participants should not be using other medications that might interfere with the study drug.
  • Participants must not have participated in another clinical trial recently.
  • Participants should not have any mental health conditions that could affect their ability to participate in the study.
  • Participants must not have any substance abuse issues.
  • Participants should not have any infections or illnesses that could affect the study.
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Investigated drugs

VRDN-003 is a medication being studied for its safety and how well people can tolerate it when used to treat thyroid eye disease (TED). TED is a condition that affects the eyes, often causing them to bulge or become red and swollen. This medication is given as an injection under the skin, which is a method that allows it to enter the body slowly. The study is testing how the body reacts to this medication when it is given every four weeks or every eight weeks. The goal is to see if it is safe for people to use and if their bodies can handle it without significant side effects. This could potentially help manage the symptoms of TED and improve the quality of life for those affected by the condition.

What is already known about the treatment

VRDN-003 – VRDN-003 is administered through subcutaneous injections, which means it is injected into the layer of fat between the skin and muscle. This medication is currently being studied in clinical trials to determine its safety and how well it is tolerated by the body, specifically for treating thyroid eye disease (TED). The main goal of VRDN-003 is to help manage symptoms of TED, a condition that affects the eyes and surrounding tissues. At the molecular level, VRDN-003 works by targeting specific pathways involved in the inflammation and swelling associated with TED. It is classified pharmacologically as a therapeutic agent for thyroid eye disease.

Investigated diseases

Thyroid eye disease – Thyroid eye disease is an autoimmune condition where the immune system mistakenly attacks the tissues around the eyes. This leads to inflammation and swelling, causing the eyes to bulge outward, a condition known as exophthalmos. As the disease progresses, individuals may experience redness, discomfort, and a gritty sensation in the eyes. The eyelids can retract, making it difficult to close the eyes completely. Double vision and vision impairment can occur if the muscles controlling eye movement are affected. Over time, the inflammation may subside, but changes in the appearance and function of the eyes can persist.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519417-57-00Protocol codeVRDN-003-303Estimated enrolment322 patientsSponsorViridian Therapeutics Inc.

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