REVEAL-1 Study (Thyroid Eye Disease)

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).

Who Can Participate?

Eligibility

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.

Age Range

18-75

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

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.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

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

Mays
Dairi

Protocol Number

PRO00117046

NCT ID

NCT06812325

Phase

III

Enrollment Status

Open to Enrollment
ClinicalTrials.gov