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

Active Not RecruitingPhase 3

Sponsor: Viridian Therapeutics, Inc.

Conditions: Thyroid Eye Disease

Interventions: VRDN-003, Placebo

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

This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, VRDN-003, 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 any CAS (0-7) on the 7-item scale, and with documented evidence of ocular symptoms or signs that began greater than 15 months prior to screening
* 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

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 (60)

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
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
Boston, Massachusetts, 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
Philadelphia, Pennsylvania, United States
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