Status:
RECRUITING
A Safety, Tolerability and Pharmacokinetics Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)
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 safety, tolerability and pharmacokinetics (PK) of an investigational drug, VRDN-003, in participants with TED (Thyroid Eye Disease)
Detailed Description
This is a randomized (meaning participants will be assigned to study arms by chance), open-label (meaning study doctor, participant and the sponsor will know which study arm participant is assigned to...
Eligibility Criteria
Inclusion
- Have a clinical diagnosis of TED with or without proptosis, with any CAS (0-7) and in the opinion of the Investigator may benefit from VRDN-003
- Not require immediate ophthalmological or orbital surgery in the study eye for any reason
- 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 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/device for any condition, including TED, within 8 weeks or longer (depending on the type of agent/device) 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 or 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
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT07155668
Start Date
July 1 2025
End Date
November 1 2026
Last Update
December 9 2025
Active Locations (14)
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1
Marvel Clinical Research
Huntington Beach, California, United States, 92647
2
United Medical Research Institute
Inglewood, California, United States, 90301
3
C&A Clinical Trials Corp
Cape Coral, Florida, United States, 33990
4
Ilumina Medical Research
Kissimmee, Florida, United States, 34744