Status:
COMPLETED
An Efficacy, Safety, and Tolerability Study of Veligrotug (VRDN-001), in Participants With Chronic Thyroid Eye Disease (TED) (THRIVE-2)
Lead Sponsor:
Viridian Therapeutics, Inc.
Conditions:
Thyroid Eye Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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).
Detailed Description
This is a randomized (meaning participants will be assigned to study arms by chance), double-masked (meaning study doctor and participant will not know which study arm participant is assigned to), pla...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
November 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2025
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT06021054
Start Date
November 14 2023
End Date
July 25 2025
Last Update
October 23 2025
Active Locations (57)
Enter a location and click search to find clinical trials sorted by distance.
1
Advancing Research International, LLC
Los Angeles, California, United States, 90023
2
USC Roski Eye Institute
Los Angeles, California, United States, 90089
3
Amy Patel Jain, MD
Newport Beach, California, United States, 92660
4
Stanford Byers Eye Institute
Palo Alto, California, United States, 94303