Study of VRDN-001 compared to placebo to evaluate safety and effectiveness in adults with chronic thyroid eye disease

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What is this study about?

This study focuses on Thyroid Eye Disease (TED), a condition where the eyes become swollen and may bulge forward. The study will test a new medication called VRDN-001, which is a type of antibody that targets a specific receptor in the body called IGF-1 receptor. The purpose is to determine if this treatment is safe and effective for people who have had TED for a long period (chronic form of the disease).

The treatment involves receiving five intravenous infusions of either VRDN-001 or placebo over several weeks. The medication will be given through a vein using a solution that contains sodium chloride (normal saline). Each infusion will be carefully prepared to contain the correct amount of medication based on the person’s weight.

During the study, doctors will measure changes in eye bulging (also called proptosis) and other eye-related symptoms. They will also monitor how well participants tolerate the treatment and track any side effects that may occur. The total duration of participation in the study will be approximately 12 weeks, during which participants will need to attend regular check-ups at the clinic.

1 Initial assessment

Your eye condition (thyroid eye disease) will be evaluated, including measurements of eye bulging (proptosis).

Basic health checks and tests will be performed to confirm your eligibility for the study.

2 Treatment assignment

You will be randomly assigned to receive either VRDN-001 or a placebo treatment.

Neither you nor your doctor will know which treatment you are receiving during the study.

3 Treatment period

You will receive 5 intravenous infusions of either VRDN-001 (10 mg/kg) or placebo.

The medication will be given through a vein in your arm (intravenous infusion).

Your eye measurements and symptoms will be monitored throughout the treatment period.

4 Follow-up evaluation

Three weeks after your fifth infusion, your eye measurements will be taken again.

Your eye symptoms will be evaluated, including any improvements in double vision (diplopia).

The medical team will assess your overall response to the treatment at week 15.

Any side effects or health changes will be recorded throughout the study period.

5 Final assessment

Your final eye measurements will be taken to compare with your initial measurements.

The medical team will evaluate the overall effectiveness of the treatment.

All health changes and side effects will be documented for final safety assessment.

Who Can Join the Study?

Age between 18 and 75 years old
Must have been diagnosed with thyroid eye disease (TED) of any severity level, as measured by a special scoring system called CAS scale
Must have moderate to severe chronic thyroid eye disease with eye bulging (proptosis) of at least 3 millimeters and more than 17 millimeters when measured before starting treatment
Eye-related symptoms or signs must have started more than 15 months before the study screening
Must agree to use reliable birth control methods as detailed in the study protocol
Female participants must have a negative pregnancy test during the screening visit
Both men and women can participate in the study

Who Cannot Join the Study?

Age under 18 or over 65 years old
Currently pregnant or breastfeeding women
Previous treatment with orbital radiotherapy (radiation therapy directed at the eye area)
Active eye infection or severe eye inflammation
History of orbital decompression surgery (surgery to reduce pressure in the eye socket) in the past 3 months
Uncontrolled thyroid function (too high or too low thyroid hormone levels)
Severe heart, liver, or kidney disease
Active or recent cancer within the past 5 years
Current smoking or tobacco use
Use of other investigational drugs within 30 days before starting the study
History of substance abuse in the past 2 years
Severe psychiatric conditions that could interfere with study participation
Known allergies to study medication or its components
Inability to provide informed consent
Participation in another clinical trial

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
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari	Italy
Universitaetsmedizin Goettingen	Goettingen	Germany
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Clinica De Oftalmologia De Cordoba S.L.	Cordoba	Spain
Nozologen Kft.	Pecs	Hungary
Centro De Oftalmologia Barraquer S.A.	Barcelona	Spain
Centrum Medyczne Piasta 47	Walbrzych	Poland
Uniwersytecki Szpital Kliniczny W Bialymstoku	Bialystok	Poland
Virgen del Rocío University Hospital	Sevilla	Spain
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Universita’ Di Pisa	Pisa	Italy
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Nice	Nice	France
University Of Pecs	Pecs	Hungary
Budapest Retina Associates	Budapest	Hungary
Utwpwxgiliboqdgmkcvcf Eivwi Aic	Essen	Germany
Cvtmtul Myckqftm Peuimnsn Suq z oqhg	Piaseczno	Poland
Owcaaywrwxt Sok z oazv	Bydgoszcz	Poland
Polnasidfniv Cszuora Mdravzag Sws z ojwt	Gdansk	Poland
Cphoao Hjkuasjriwi Ruqbnvvq Dmzjgoeddrhumc	Angers	France
Ianrw Ofhlljwf Aboinhphuy Smg Lflv	Milan	Italy

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.04.2024
Germany	Not recruiting	01.04.2024
Hungary	Not recruiting	01.04.2024
Italy	Not recruiting	01.04.2024
Poland	Not recruiting	01.04.2024
Spain	Not recruiting	01.04.2024

Trial locations

Investigated drugs:

VRDN-001 is a humanized monoclonal antibody that targets the IGF-1 receptor. This medication is given through infusions and is being studied for treating chronic thyroid eye disease (TED). It works by binding to specific receptors that are involved in the eye inflammation and swelling associated with thyroid eye disease. This targeted approach aims to reduce the symptoms and progression of the condition.

Placebo is an inactive substance that contains no medication. It is used as a comparison to determine if VRDN-001 is effective in treating thyroid eye disease.

Investigated diseases:

Endocrine ophthalmopathy

Thyroid Eye Disease – A condition that affects the eyes and surrounding tissues, typically associated with thyroid disorders. The disease causes inflammation and swelling of the muscles and fatty tissues around the eyes, leading to various eye symptoms. The affected tissues behind the eyes become inflamed and enlarged, which can push the eyeballs forward, causing bulging eyes (proptosis). As the disease progresses, patients may experience eye irritation, pressure sensation, and problems with eye movement. In some cases, the condition can cause double vision (diplopia) due to the affected eye muscles not working properly together.

Trial ID:

2023-507217-10-00

Protocol code:

VRDN-001-301

NCT ID:

NCT06021054

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of VRDN-001 compared to placebo to evaluate safety and effectiveness in adults with chronic thyroid eye disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?