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

Description

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

Conditions

Thyroid Eye Disease (TED)

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Thyroid Eye Disease (TED)
Intervention / Treatment

-

Contacts and Locations

East Weymouth

VRDN-003-303 Investigational Site, East Weymouth, Massachusetts, United States, 02189

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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 8 weeks prior to first dose
  • * Must not have received an investigational agent for any condition, including TED, within 8 weeks 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Viridian Therapeutics, Inc.,

Study Record Dates

2026-12