Study of VRDN-001 for Patients with Thyroid Eye Disease Who Did Not Respond to Previous Treatment

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What is this study about?

This clinical trial is focused on studying a condition known as Thyroid Eye Disease. This condition can cause the eyes to bulge and become red, swollen, and painful. The study will use a treatment called VRDN-001, which is an experimental medication designed to block a specific protein that may be involved in the disease. The study will also use Sodium Chloride 0.9% Intravenous Infusion, commonly known as normal saline, which is a standard fluid used in medical treatments.

The purpose of this study is to provide access to VRDN-001 for participants who did not respond to previous treatments in earlier studies. The study will assess the safety and effectiveness of VRDN-001 in these participants. Participants will receive the treatment through an intravenous infusion, which means the medication will be given directly into a vein. The study will last for a period of 12 weeks, during which participants will receive several doses of the medication.

Throughout the study, participants will be monitored for any changes in their condition, as well as any side effects they may experience. The study aims to determine if VRDN-001 can help reduce the symptoms of Thyroid Eye Disease in those who have not responded to other treatments. Participants will be closely observed to ensure their safety and to gather information on how well the treatment works.

1 joining the study

Upon joining the study, ensure understanding of the procedures and risks involved. Written consent is required before any study-related activities begin.

Eligibility includes having completed at least 5 intravenous infusions in previous studies and being identified as a non-responder.

2 initial assessment

An initial assessment will be conducted to confirm eligibility and establish baseline measurements for the study.

3 treatment administration

Receive VRDN-001, an insulin-like growth factor-1 receptor inhibitor, through intravenous infusion. This is a concentrate for solution for infusion.

The treatment involves a series of infusions, with the frequency and duration determined by the study protocol.

4 monitoring and follow-up

Regular monitoring will occur to assess the safety and effectiveness of the treatment. This includes tracking any adverse events.

Assessments will focus on changes in eye protrusion and clinical activity in the most affected eye.

5 final assessment

A final assessment will be conducted to evaluate the overall response to the treatment.

The primary focus will be on the reduction of eye protrusion and any changes in clinical activity.

Who Can Join the Study?

  • Must be able to understand the study procedures and the risks involved and must provide written informed consent before the first study-related activity.
  • Must have completed at least 5 intravenous (IV) infusions and assessments required to determine proptosis responder status 3 weeks after the fifth IV infusion. Proptosis means the bulging of the eye.
  • Must have been a participant in either the VRDN-001-101 or VRDN-001-301 studies and found to be a non-responder, meaning the treatment did not work as expected.
  • Must not require immediate eye or eye socket surgery in the study eye for any reason.
  • If female, must have a negative urine pregnancy test at the start and before each dose of study medication, and agree to use an acceptable method of contraception, such as a condom and another highly effective method, during the study and for 100 days after the last dose.
  • If male and not surgically sterile, must agree to use an acceptable method of contraception, such as a condom and another highly effective method, during the study and for 100 days after the last dose.
  • Must be willing and able to follow all the study requirements for the entire duration of the study.

Who Cannot Join the Study?

  • Participants who have not previously been treated with the study medication or a placebo in the related studies.
  • Participants who have not shown a lack of response to the treatment after the specified period in the related studies.
  • Participants who have any other medical conditions that might interfere with the study or its results.
  • Participants who are unable to comply with the study requirements or follow-up procedures.
  • Participants who are pregnant or breastfeeding, as the effects on the baby are unknown.
  • Participants who are currently participating in another clinical trial that might interfere with this study.
  • Participants who have a history of allergic reactions to the study medication or similar drugs.
  • Participants who have any serious health conditions that could pose a risk during the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Bari Italy
Universitaetsmedizin Goettingen Goettingen Germany
Technische Universitaet Dresden Dresden Germany

Other Sites

Site Name City Country Status
Clinica De Oftalmologia De Cordoba S.L. Cordoba Spain
Nozologen Kft. Pecs Hungary
Hospital Universitario Ramon Y Cajal Madrid Spain
Centrum Medyczne Piasta 47 Walbrzych Poland
Hospital Unviersitario Miguel Servet Zaragoza Spain
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Hospital Universitario Virgen Macarena Sevilla Spain
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Universita’ Di Pisa Pisa Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
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
University Hospital Olomouc Olomouc Czechia
University Of Pecs Pecs Hungary
Budapest Retina Associates Budapest Hungary
Uoybglbckpxpispvxxmlg Eluqu Agd Essen Germany
Crunkfd Mwzgukps Pucclcpf Sly z omwt Piaseczno Poland
Pdvgbxqjxfnj Cjczoag Mjuzjmsk Sai z okro Gdansk Poland
Afmxilyqg Uch Amsterdam The Netherlands
Cslztr Hnmzujvokwp Rtuxvvgm Dznftddagygrqe Angers France
Inlol Ormrsxrg Abpcisrtiy Spt Ldrg Milan Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
01.03.2024
France France
Not recruiting
01.03.2024
Germany Germany
Not recruiting
01.03.2024
Hungary Hungary
Not recruiting
01.03.2024
Italy Italy
Not recruiting
01.03.2024
Poland Poland
Not recruiting
01.03.2024
Spain Spain
Not recruiting
01.03.2024
The Netherlands The Netherlands
Not recruiting
01.03.2024

Trial locations

Investigated drugs:

VRDN-001 is a medication being studied to help people who did not respond to previous treatments in earlier studies. It is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. The goal of this study is to see if VRDN-001 is safe and effective for these participants.

Investigated diseases:

Thyroid eye disease – This condition is an autoimmune disorder that affects the muscles and other tissues around the eyes. It is often associated with an overactive thyroid gland, known as hyperthyroidism. The disease can cause the eyes to bulge or protrude, a condition known as proptosis. Patients may experience symptoms such as redness, swelling, and discomfort in the eyes. As the disease progresses, it can lead to double vision and difficulty moving the eyes. The severity of symptoms can vary, and they may fluctuate over time.

Trial ID:
2023-507350-33-00
Protocol code:
VRDN-001-302
Trial Phase:
Therapeutic confirmatory (Phase III)

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