VRDN-001-101 (Thyroid Eye Disease) - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Thyroid Eye Disease (TED)

Who Can Participate in the Study?

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.

Age Group

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.

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 normal healthy volunteers (NHVs) and subjects with thyroid eye disease (TED)
Principal Investigator
Protocol Number
IRB: PRO00109980
NCT: NCT05176639
Phase I/II
Enrollment Status
Open for Enrollment