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NCT Number: NCT07155668

A Safety, Tolerability and Pharmacokinetics Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)

This is a clinical trial assessing the safety, tolerability and pharmacokinetics (PK) of an investigational drug, VRDN-003, in participants with TED (Thyroid Eye Disease)

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Key information

Conditions

Thyroid Eye Disease Autoimmune Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine System Diseases Exophthalmos Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Goiter Graves Disease Graves Ophthalmopathy Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

United Medical Research Institute, Inglewood, California, United States

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About this study

This is a randomized (meaning participants will be assigned to study arms by chance), open-label (meaning study doctor, participant and the sponsor will know which study arm participant is assigned to), parallel-group study that will enroll participants with TED of any duration. The key objectives of this study are to determine if VRDN-003 is safe and tolerable and to see how the body reacts to VRDN-003 when administered as a series of subcutaneous (SC) injections every 4 weeks or every 8 weeks in participants with TED either via autoinjector or via vial and syringe.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have a clinical diagnosis of TED with or without proptosis, with any CAS (0-7) and in the opinion of the Investigator may benefit from VRDN-003
  • Not require immediate ophthalmological or orbital surgery in the study eye for any reason
  • Must agree to use highly effective contraception as specified in the protocol
  • Female TED participants must have a negative serum pregnancy test at screening

Key Exclusion Criteria:

  • Must not have received prior treatment with another anti-IGF-1R therapy
  • Must not have received systemic corticosteroids for any condition, including TED, or selenium within 2 weeks prior to first dose.
  • Must not have received other immunosuppressive drugs for any condition, including TED, or any other therapy for TED, within 12 weeks prior to first dose
  • Must not have received an investigational agent/device for any condition, including TED, within 8 weeks or longer (depending on the type of agent/device) prior to first dose
  • Must not have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose
  • Must not have had previous orbital irradiation or decompression surgery for TED to the study eye's orbit
  • Must not have a pre-existing ophthalmic condition in the study eye which in the study doctor's opinion, would interfere with interpretation of study results
  • Must not have abnormal hearing test before first dose or history of ear conditions considered significant by study doctor
  • Must not have a history of inflammatory bowel disease
  • Female TED participants must not be pregnant or breastfeeding

Treatment and study plan

VRDN-003

Drug

VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R).

Autoinjector

Device

The autoinjector is a single-dose, disposable, ready-to-use delivery device

Primary outcomes

  1. Treatment Emergent Adverse Event (TEAE) incidence rate

    Time frame: Through Week 24

    Treatment Emergent Adverse Event (TEAE) incidence rate

Secondary outcomes

  1. Pharmacokinetic outcome measures

    Time frame: Through Week 24

    Time of maximum serum concentration (Tmax) of VRDN-003

  2. Pharmacokinetic outcome measures

    Time frame: Through Week 24

    Maximum serum concentration (Cmax) of VRDN-003

Sponsors and collaborators

Lead sponsor

Viridian Therapeutics, Inc.

Industry

Registry information

Official study title

A Randomized, Open-label Study Evaluating the Safety, Tolerability and Pharmacokinetics of VRDN-003 Administered Subcutaneously in Participants With Thyroid Eye Disease (TED)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2025
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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