Study on the Safety and Effectiveness of VRDN-001 for Patients with 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), which affects the eyes and can cause symptoms like bulging eyes, discomfort, and vision problems. The study is testing a new treatment 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 play a role in the development of TED.

The purpose of the study is to evaluate the safety, tolerability, and effectiveness of VRDN-001 in both healthy volunteers and individuals with TED. Participants will receive the medication through an intravenous infusion, which means it will be administered directly into the bloodstream. The study will last for a period of up to 56 days, during which participants will receive multiple doses of the medication. Throughout the study, researchers will monitor participants closely to assess how well the medication is working and to identify any potential side effects.

In addition to VRDN-001, some participants may receive a solution of Sodium Chloride, which is commonly used in medical settings. The study aims to gather important information about how VRDN-001 affects the body and its potential as a treatment for Thyroid Eye Disease. This research could lead to new insights and advancements in the management of this condition.

1 initial visit and consent

Upon joining the study, you will have an initial visit where the study procedures and potential risks will be explained to you. You will be asked to provide written informed consent, confirming your understanding and willingness to participate.

2 screening and eligibility confirmation

You will undergo a series of tests to confirm your eligibility for the study. This includes a medical examination and, if you are a woman of childbearing potential, a pregnancy test. You must agree to use effective contraception during the study and for 100 days after the last dose of the study medication.

3 first infusion

You will receive your first dose of the study medication, VRDN-001, through an intravenous infusion. The dosage will be determined based on the study protocol, ranging from 3.0 to 20.0 mg/kg.

4 subsequent infusions

You will receive additional infusions of VRDN-001 at scheduled intervals. The total number of infusions and the exact schedule will be explained to you during the study.

5 monitoring and assessments

Throughout the study, you will be monitored for any side effects or changes in your condition. Regular assessments will be conducted to evaluate the safety and effectiveness of the treatment. This includes measuring changes in eye symptoms and overall health.

6 final assessment

At the end of the study period, a final assessment will be conducted to evaluate the overall impact of the treatment. This will include a review of your health status and any changes in your condition.

Who Can Join the Study?

Must be an adult, at least 18 years old.
Must have a clinical diagnosis of Thyroid Eye Disease (TED).
Must have a Clinical Activity Score (CAS) of 3 or higher on a 7-item scale for the study eye. This score helps measure the activity of the disease.
Must have moderate to severe active TED, which means it significantly affects daily life. This includes eye bulging (proptosis) of 3 mm or more above normal values for race and gender, and at least one of the following:
- Eyelid retraction of 2 mm or more
- Moderate or severe soft tissue involvement
- Double vision (diplopia), either occasional or constant
- Spontaneous pain behind the eye or pain when moving the eye
- Swelling or redness of the conjunctiva (the clear tissue covering the white part of the eye), eyelids, or plica (a fold of tissue in the eye)
Must have documented evidence of eye symptoms or signs associated with active TED that began within 15 months before the study screening.
If female and capable of having children, must have a negative pregnancy test and agree to use effective birth control methods during the study and for 100 days after the last dose of study medication.
If male, must be surgically sterile or agree to use effective birth control methods during the study and for 100 days after the last dose of study medication.
Must not require immediate eye surgery for any reason in the study eye.
If diabetic, must have a glycated hemoglobin (HbA1c) level of less than 8.5% and be monitored by a healthcare professional.
Must be willing and able to follow all study requirements for the entire duration of the study.
Must be able to understand the study procedures and risks and be willing to provide written informed consent before participating in the study.

Who Cannot Join the Study?

Patients with any other serious health condition that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients with a history of allergic reactions to similar medications.
Patients who are unable to comply with the study procedures.
Patients with uncontrolled high blood pressure.
Patients with severe liver or kidney disease.
Patients with a history of drug or alcohol abuse within the past year.
Patients with active infections that require treatment.
Patients with a history of cancer within the last 5 years, except for certain skin cancers.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Universitaetsmedizin Goettingen	Goettingen	Germany
Hospital Clinico San Carlos	Madrid	Spain
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Hospital Universitario Ramon Y Cajal	Madrid	Spain
Hospital Unviersitario Miguel Servet	Zaragoza	Spain
Hospital Universitario Virgen Macarena	Sevilla	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Metavision Arruzafa S.L.	Cordoba	Spain
Akwjqmndr Uao	Amsterdam	The Netherlands
Enhgprl Uahoppwobxuc Myahvjl Cdcajgq Rhmifxkyh (jruzpnv Mzp	Rotterdam	The Netherlands
Cilrlm Hvtxsrouzuu Rfmqcbcv Doxbkkicrjbbey	Angers	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.08.2023
Germany	Not recruiting	01.08.2023
Spain	Not recruiting	01.08.2023
The Netherlands	Not recruiting	01.08.2023

Trial locations

Investigated drugs:

VRDN-001 is a humanized monoclonal antibody designed to target the IGF-1 receptor. This medication is being studied to see if it can help people with thyroid eye disease, a condition that can cause the eyes to bulge and lead to discomfort or vision problems. By blocking the IGF-1 receptor, VRDN-001 may help reduce inflammation and other symptoms associated with this condition. The study aims to understand how safe and effective VRDN-001 is for patients, as well as how the body processes the medication. This information will help determine if VRDN-001 could be a useful treatment for thyroid eye disease in the future.

Thyroid Eye Disease – Thyroid Eye Disease (TED) is an autoimmune condition that affects the muscles and other tissues around the eyes. It is often associated with an overactive thyroid gland, known as Graves’ disease. The disease progresses through an active phase, where inflammation and swelling occur, leading to symptoms such as bulging eyes (proptosis), double vision (diplopia), and eyelid retraction. Over time, the inflammation may subside, entering a chronic phase where the changes become more stable. The severity and duration of symptoms can vary widely among individuals. TED can impact vision and eye appearance, affecting the quality of life.

Trial ID:

2024-512244-36-00

Protocol code:

VRDN-001-101

NCT ID:

NCT05176639

Trial Phase:

Therapeutic use (Phase IV)

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

What is this study about?

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