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An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Active Thyroid Eye Disease (TED)
An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Active Thyroid Eye Disease (TED)

NCT06625411

Active Not RecruitingPhase 3

Sponsor: Viridian Therapeutics, Inc.

Conditions: Thyroid Eye Disease

Interventions: VRDN-003, Placebo

Countries: United States, Germany, Hungary, Netherlands, Spain

This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, VRDN-003, in participants with active 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 active TED with documented evidence of ocular symptoms or signs that began within 15 months prior to screening
* Must have a Clinical Activity Score (CAS) of ≥ 3 on the 7-item scale for the study eye
* 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 who must not be pregnant or breastfeeding

NOTE: There are additional eligibility criteria for participants who do not have a meaningful response at Week 24 (irrespective of initial treatment arm) who may receive additional injections of VRDN-003. These are described in the protocol.
Locations (48)
  • Scottsdale, Arizona, United States
  • Canoga Park, California, United States
  • Huntington Beach, California, United States
  • Inglewood, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Lynwood, California, United States
  • Newport Beach, California, United States
  • Palo Alto, California, United States
  • Pasadena, California, United States
  • San Diego, California, United States
  • Cape Coral, Florida, United States
  • Kissimmee, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Sarasota, Florida, United States
  • Atlanta, Georgia, United States
  • Orland Park, Illinois, United States
  • East Weymouth, Massachusetts, United States
  • Fraser, Michigan, United States
  • Livonia, Michigan, United States
  • Kansas City, Missouri, United States
  • Las Vegas, Nevada, United States
  • Sparks, Nevada, United States
  • Newark, New Jersey, United States
  • Asheville, North Carolina, United States
  • Durham, North Carolina, United States
  • Houston, Texas, United States
  • + 18 more on CT.gov