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NCT Number: NCT06812325

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Thyroid Eye Disease (TED) 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

Servicde d'Endocrinologie, Diabetologieet Nutrition Centre Hospitalier Universitaire d'Angers, Angers, France

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About this study

This is a randomized (meaning participants will be assigned to study arms by chance), double-masked (meaning study doctor and participant will not know which study arm participant is assigned to), controlled study that will include participants with TED of any duration. The key objectives of this study are to determine if VRDN-003 is safe and tolerable when administered as a series of subcutaneous (SC) injections every 4 weeks or every 8 weeks in participants with TED.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Have a clinical diagnosis of TED with or without proptosis and 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 or steroid eye drops 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 for any condition, including TED, within 8 weeks or longer duration (depending on the type of investigational agent) 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. Must also not have a 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).

Placebo

Drug

Placebo injections that appear identical to VRDN-003 injections but have no active drug.

Primary outcomes

  1. Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24

    Time frame: Week 24

    Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24

Secondary outcomes

  1. Change from baseline in proptosis in the study eye at Week 24 as measured by exophthalmometer

    Time frame: Week 24

    Change from baseline in proptosis in the study eye

  2. TEAE incident rate through study completion

    Time frame: Week 52

    Treatment Emergent Adverse Event (TEAE) incidence rate measurement through study completion

Sponsors and collaborators

Lead sponsor

Viridian Therapeutics, Inc.

Industry

Registry information

Official study title

A Randomized, Double-masked, Controlled, Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2025
Registry last updated
May 22, 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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