RECRUITING

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

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Conditions

Thyroid Eye Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

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

Quick Facts

Study Start:2025-07-01
Study Completion:2026-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07155668

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Not require immediate ophthalmological or orbital surgery in the study eye for any reason
  3. * Must agree to use highly effective contraception as specified in the protocol
  4. * Female TED participants must have a negative serum pregnancy test at screening
  1. * Must not have received prior treatment with another anti-IGF-1R therapy
  2. * Must not have received systemic corticosteroids for any condition, including TED, or selenium within 2 weeks prior to first dose.
  3. * 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
  4. * 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
  5. * Must not have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose
  6. * Must not have had previous orbital irradiation or decompression surgery for TED to the study eye's orbit
  7. * 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
  8. * Must not have abnormal hearing test before first dose or history of ear conditions considered significant by study doctor
  9. * Must not have a history of inflammatory bowel disease
  10. * Female TED participants must not be pregnant or breastfeeding

Contacts and Locations

Study Locations (Sites)

United Medical Research Institute
Inglewood, California, 90301
United States
Ilumina Medical Research
Kissimmee, Florida, 34744
United States
Hype Clinical Research, LLC
Miami, Florida, 33145
United States
Fraser Eye Center
Fraser, Michigan, 48026
United States

Collaborators and Investigators

Sponsor: Viridian Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-01
Study Completion Date2026-11

Study Record Updates

Study Start Date2025-07-01
Study Completion Date2026-11

Terms related to this study

Additional Relevant MeSH Terms

  • Thyroid Eye Disease