REVEAL-1 Study (Thyroid Eye Disease) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an investigational drug named VRDN-003 (the study drug) is a safe and effective option for patients with thyroid eye disease (TED).

What is the Condition Being Studied?

Thyroid Eye Disease (TED)

Who Can Participate in the Study?

Adults ages 18-75 who:

Are diagnosed with TED
Have never had orbital irradiation or decompression surgery for TED

For more information, contact the study team at DEC_ResearchAdmin@dm.duke.edu.

Grupo etario

Adultos

What is Involved?

If you choose to join this study, you will get a random assignment (by chance) to 1 of 3 groups. Depending on your assignment, you will:

Get injections of the study drug; OR
Get a combination of the study drug and a placebo (inactive substance with no drug in it); OR
Get a placebo

Participation in this study will last approximately 56 weeks (about one year and one month including the 4-week screening period). There are 15 study visits, including the screening visit, during which participants will have various tests and examinations.

Study Details

Full Title

A phase 3, randomized, double-masked, placebo-controlled, efficacy, safety, and tolerability study of VRDN-003 in participants with active thyroid eye disease (TED) - VRDN-003-301 (REVEAL-1)

Principal Investigator