An Efficacy, Safety, and Tolerability Study of Veligrotug (VRDN-001), in Participants With Chroni… (NCT06021054) | Clinical Trial Compass
CompletedPhase 3
An Efficacy, Safety, and Tolerability Study of Veligrotug (VRDN-001), in Participants With Chronic Thyroid Eye Disease (TED) (THRIVE-2)
United States188 participantsStarted 2023-11-14
Plain-language summary
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).
Who can participate
Age range18 Years – 75 Years
SexALL
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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
* 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
What they're measuring
1
Proptosis Responder Rate in the most proptotic eye