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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Universitaetsmedizin Goettingen	Goettingen	Germany
Hospital Clinico San Carlos	Madrid	Spain
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Santa Sp. z o.o.	Lodz	Poland
Clinica De Oftalmologia De Cordoba S.L.	Cordoba	Spain
Warszawski Szpital Okulistyczny Sp. z o.o.	Warsaw	Poland
University Teaching Hospital Markusovszky	Szombathely	Hungary
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
University Of Pecs	Pecs	Hungary
Budapest Retina Associates	Budapest	Hungary
Cnyahja Mehylauz Piwaotlh Srq z onrf	Piaseczno	Poland
Efydgww Pptkzocdi Sxn z ovwh	Pabianice	Poland
Ahxkcidek Ube	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	17.01.2025
Hungary	Not recruiting	17.01.2025
Poland	Not yet recruiting	17.01.2025
Spain	Not recruiting	17.01.2025
The Netherlands	Not recruiting	17.01.2025

Trial locations

Investigated drugs:

VRDN-003

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.

Investigated diseases:

Endocrine ophthalmopathy

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 ID:

2024-514972-42-00

Protocol code:

VRDN-003-301

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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