Study on the Effectiveness and Safety of VRDN-003 for Patients with Chronic 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 and double vision. 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 signs and symptoms of TED. Participants in the study will receive VRDN-003 through injections under the skin, either every 4 weeks or every 8 weeks. Some participants will receive a placebo instead, which is a substance with no active drug ingredients.

The purpose of the study is to determine if VRDN-003 is effective, safe, and tolerable for people with chronic TED. The study will last for several months, and participants will be monitored to see if there is a reduction in eye bulging and if their symptoms improve without worsening. The study will also look at any side effects that may occur and how the body responds to the treatment.

Throughout the study, researchers will assess the percentage of participants who show improvement in their condition by Week 24. This includes a reduction in eye bulging and no worsening of their disease severity. The study will also evaluate changes in symptoms like double vision and overall safety. The results will help determine if VRDN-003 can be a beneficial treatment option for those living with chronic TED.

1 initial visit

Upon joining the study, participants will attend an initial visit. During this visit, eligibility will be confirmed, including a clinical diagnosis of thyroid eye disease (TED) and other criteria such as age and health status.

Female participants will undergo a pregnancy test to ensure eligibility. Participants must agree to use effective contraception as specified in the study protocol.

2 first dose administration

Participants will receive their first dose of the study medication. The medication, VRDN-003, is administered as a subcutaneous injection, which means it is injected into the layer of fat between the skin and muscle.

The dosage and frequency of the injections will be determined by the study protocol, with injections given every 4 weeks or every 8 weeks.

3 follow-up visits

Participants will attend regular follow-up visits to monitor their response to the treatment. These visits will include assessments of eye bulging and other symptoms of TED.

The study will evaluate the safety and tolerability of VRDN-003, monitoring for any side effects or adverse reactions.

4 week 24 assessment

At week 24, a primary assessment will be conducted to determine the effectiveness of the treatment. This includes measuring the reduction in eye bulging and ensuring there is no worsening in the Clinical Activity Score (CAS), which estimates disease severity.

Secondary assessments will also be conducted to evaluate changes in disease symptoms and the resolution of double vision.

5 end of study

The study is estimated to conclude by December 2026. Participants will have a final visit to assess their overall response to the treatment and any long-term effects.

The study aims to determine if VRDN-003 is effective, safe, and tolerable for individuals with chronic TED.

Who Can Join the Study?

Adult males or females, aged 18 to 75 years, who have been diagnosed with Thyroid Eye Disease (TED).
Must have moderate to severe chronic TED with noticeable eye bulging in the study eye before the first dose.
Have experienced eye-related signs or symptoms that started more than 15 months before the first study visit.
Must agree to use highly effective contraception 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.
Patients who are not within the specified age range cannot participate.
Patients who are not willing to receive subcutaneous injections (injections into the layer of fat between the skin and muscle) cannot participate.
Patients who are not willing to receive a placebo (a substance with no active drug ingredients) cannot participate.
Patients who are part of a vulnerable population that is not selected for this study cannot participate.

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
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Hospital Clinico San Carlos	Madrid	Spain

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
Nozologen Kft.	Pecs	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
Pkmgdaumsx Ctgvdsf Bxnil Pfqxcyduatxk I Ljbyiqos Swu z oqgk	Warsaw	Poland
Edkxpog Pmqurykhk Sib z oaya	Pabianice	Poland
Plydagl Mqdjmf Smy z Ojsi Ezw Pekyoudcv	Poniatowa	Poland
Avkqlcbxz Ujs	Amsterdam	The Netherlands
Eyylyht Udgojbxlovzp Mhlpelj Czzjnfv Rgvcjrqcz (pwsybzb Mii	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	14.02.2025
Hungary	Not recruiting	14.02.2025
Poland	Not recruiting	14.02.2025
Spain	Not recruiting	14.02.2025
The Netherlands	Not recruiting	14.02.2025

Trial locations

Investigated drugs:

VRDN-003

VRDN-003 is a medication being studied to see if it can help people with chronic thyroid eye disease, which is a condition that affects the eyes and can cause them to bulge or become irritated. This medication is given as an injection under the skin, either every four weeks or every eight weeks. The study is looking at whether VRDN-003 can improve the symptoms of this eye condition and whether it is safe and well-tolerated by the body, meaning it doesn’t cause too many unwanted side effects.

Investigated diseases:

Endocrine ophthalmopathy

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 proptosis. As the disease progresses, it can cause redness, discomfort, and irritation in the eyes. Patients may experience double vision due to the misalignment of the eyes. The condition can also lead to a reduction in the ability to move the eyes and, in severe cases, compression of the optic nerve. Over time, the inflammation may subside, but changes in the appearance and function of the eyes can persist.

Trial ID:

2024-514973-23-00

Protocol code:

VRDN-003-302

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of VRDN-003 for Patients with Chronic Thyroid Eye Disease

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