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Study on the Safety and Tolerability of VRDN-001 for Patients with Thyroid Eye Disease

Verified siteInvestigationalNo placebo
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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 tissues around the eyes become inflamed, which can lead to symptoms like bulging eyes, discomfort, and vision problems. The treatment being tested in this study is called VRDN-001, which is a type of medication known as an Insulin-like Growth Factor-1 Receptor (IGF-1R) inhibitor. This medication is designed to target specific proteins in the body that may be involved in the development of TED.

The purpose of this study is to confirm the safety and tolerability of VRDN-001 in people with TED. Participants in the study will receive five doses of VRDN-001 through an intravenous infusion, which means the medication is given directly into a vein. Each dose will be administered every three weeks. The study will monitor participants for any side effects and changes in their condition over a period of time.

Throughout the study, researchers will be looking at how participants respond to the treatment, including any changes in the symptoms of TED, such as the degree of eye bulging. The study aims to gather important information about the safety of VRDN-001 and how well it is tolerated by people with TED. This information will help in understanding the potential benefits and risks of using VRDN-001 as a treatment for this condition.

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 visit

    Upon joining the study, you will attend an initial visit where your eligibility will be confirmed. This includes a review of your medical history and a physical examination.

    If you are female, a blood test will be conducted to ensure you are not pregnant. This test will be repeated before each dose of the study medication and after the last dose.

  2. Step 2

    First infusion

    You will receive the first dose of the study medication, VRDN-001, through an intravenous infusion. This means the medication will be administered directly into your vein.

    The dosage will be 10 mg per kilogram of your body weight.

  3. Step 3

    Subsequent infusions

    You will receive a total of five infusions of VRDN-001, each given every three weeks.

    Each infusion will be administered in the same manner and dosage as the first.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, you will be monitored for any side effects or changes in your condition. This includes regular check-ups and assessments.

    The primary focus is to observe any treatment-emergent adverse events up to week 15, and changes in your eye condition will be measured at week 15.

  5. Step 5

    Extended monitoring

    After the initial 15 weeks, you will continue to be monitored for any adverse events up to week 52.

    This extended period ensures the long-term safety and tolerability of the treatment.

Who can join the trial?

4 criteria

  • Be an adult male or female participant, older than 18 years and up to 75 years of age.
  • Have a clinical diagnosis of Thyroid Eye Disease (TED), which is a condition affecting the eyes, with or without proptosis (bulging of the eyes), and any Clinical Activity Score (CAS) between 0 and 7. The investigator should believe that the participant may benefit from treatment.
  • If female, have a negative blood pregnancy test at the start of the study and further negative urine tests before each dose of the study medication and after the last dose.
  • If male, be surgically sterile for at least 6 weeks before the first dose of the study medication, or agree to use an acceptable method of contraception, such as a condom, along with a second highly effective method of contraception.

Who cannot join the trial?

10 criteria

  • Patients with any other serious health condition that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a known allergy to the study medication or any of its ingredients.
  • Patients with a history of drug or alcohol abuse.
  • Patients who have received certain medications that might interfere with the study results.
  • Patients with uncontrolled high blood pressure or diabetes.
  • Patients with a history of certain eye diseases other than thyroid eye disease.
  • Patients who have had a recent infection or are currently experiencing an infection.
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Investigated drugs

VRDN-001 is a humanized monoclonal antibody designed to target the IGF-1 receptor. This medication is being studied for its potential to help people with thyroid eye disease (TED). In this trial, participants receive VRDN-001 through a series of intravenous infusions. The main goal is to see if the medication is safe and well-tolerated by the participants. By targeting the IGF-1 receptor, VRDN-001 may help reduce inflammation and other symptoms associated with TED, potentially improving the quality of life for those affected by this condition.

What is already known about the treatment

VRDN-001 – VRDN-001 is administered through an intravenous (IV) infusion, meaning it is delivered directly into the bloodstream through a vein. It is currently being studied in clinical trials for its safety and tolerability in treating thyroid eye disease, a condition that affects the eyes. The medication works by targeting and blocking the IGF-1 receptor, which plays a role in the development of this eye condition. VRDN-001 is classified as a humanized monoclonal antibody, a type of drug designed to specifically target certain proteins in the body.

Investigated diseases

Thyroid eye disease – This condition, also known as Graves' ophthalmopathy, is an autoimmune disorder that affects the muscles and other tissues around the eyes. It is often associated with hyperthyroidism, where the immune system mistakenly attacks the tissues behind the eyes. The disease progresses with symptoms such as bulging eyes, redness, swelling, and discomfort. Over time, it can lead to double vision and difficulty moving the eyes. The severity of symptoms can vary, and they may fluctuate over time. The disease can cause changes in appearance and vision, impacting daily activities.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507563-19-00Protocol codeVRDN-001-303Estimated enrolment297 patientsSponsorViridian Therapeutics Inc.

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