Purpose of this Study
We are doing this study to find out if an investigational drug called VRDN-001 (the study drug) is safe and works well to treat thyroid eye disease.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with Graves' disease
- Have moderate to severe (your daily life is impacted by it) active TED
For more information about who can be in this study, please contact the study team at DEC-RA@duke.edu.
- Are diagnosed with Graves' disease
- Have moderate to severe (your daily life is impacted by it) active TED
For more information about who can be in this study, please contact the study team at DEC-RA@duke.edu.
What is Involved?
If you choose to join the study, you will:
- Receive an injection in a vein in your arm of either the study drug or placebo (dummy drug)
- Have an MRI of your orbits to look at the muscles outside the eyeball
- Have pictures taken of your eyes
- Visit our clinic 9 times
At various visits, you will have blood draws, and have eye and vision tests. The study will last for about 6 months.
- Receive an injection in a vein in your arm of either the study drug or placebo (dummy drug)
- Have an MRI of your orbits to look at the muscles outside the eyeball
- Have pictures taken of your eyes
- Visit our clinic 9 times
At various visits, you will have blood draws, and have eye and vision tests. The study will last for about 6 months.
Study Details
Full Title
A multiple ascending dose (MAD) safety, tolerability and efficacy study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in healthy volunteers (HVs) and subjects with thyroid eye disease (TED)
Principal Investigator
Mays
Dairi
Protocol Number
PRO00109980
NCT ID
NCT05176639
Phase
I/II
Enrollment Status
OPEN TO ACCRUAL