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An Efficacy, Safety, and Tolerability Study of Veligrotug (VRDN-001), in Participants With Chronic Thyroid Eye Disease (TED)
An Efficacy, Safety, and Tolerability Study of Veligrotug (VRDN-001), in Participants With Chronic Thyroid Eye Disease (TED)

NCT06021054

CompletedPhase 3

Sponsor: Viridian Therapeutics, Inc.

Conditions: Thyroid Eye Disease

Interventions: Veligrotug, Placebo

Countries: United States, Australia, France, Germany, Hungary, Poland, Spain, Turkey (Türkiye)

This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, veligrotug (VRDN-001), in participants with chronic thyroid eye disease (TED).

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria:

* Must have moderate to severe chronic TED with documented evidence of ocular symptoms or signs that began greater than 15 months prior to screening
* Must have had a clinical diagnosis of TED, with any CAS (0-7)
* 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 or another investigational agent for any condition, including TED, or any other therapy for 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 a pre-existing ophthalmic condition in the study eye that in the opinion of the study doctor would confound interpretation of the study results
* Must not have had previous orbital irradiation or decompression surgery for TED to the study eye's orbit
* Must not have inflammatory bowel disease
* Must not have abnormal baseline audiometry Pure Tone Average (PTA) assessment or history of significant (as determined by the Investigator) ear pathology, relevant ear surgery or hearing loss.
* Female TED participants must not be pregnant or lactating
Locations (57)
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Newport Beach, California, United States
  • Palo Alto, California, United States
  • San Diego, California, United States
  • Miami, Florida, United States
  • Sarasota, Florida, United States
  • Chicago, Illinois, United States
  • Oak Lawn, Illinois, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • East Lansing, Michigan, United States
  • Livonia, Michigan, United States
  • St Louis, Missouri, United States
  • Las Vegas, Nevada, United States
  • Newark, New Jersey, United States
  • Somerset, New Jersey, United States
  • Philadelphia, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Houston, Texas, United States
  • Houston, Texas, United States
  • Burlington, Vermont, United States
  • Seattle, Washington, United States
  • Saint Leonards, New South Wales, Australia
  • Angers, France
  • Bordeaux, France
  • Nantes, France
  • Nice, France
  • Berlin, Germany
  • Essen, Germany
  • + 27 more on CT.gov