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Efficacy and safety of VRDN-003 for chronic Thyroid Eye Disease

REVEAL-2 - a Phase 3, Randomized, Double-masked, Placebo-controlled, Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants with Chronic Thyroid Eye Disease (TED)

Phase 3 Interventional Viridian Therapeutics, Inc. · NCT06625398

This study is testing a new drug called VRDN-003 to see if it can help people with chronic Thyroid Eye Disease feel better compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment195 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorViridian Therapeutics, Inc. Industry-sponsored
Locations36 sites (Scottsdale, Arizona and 35 other locations)
Trial IDNCT06625398 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy, safety, and tolerability of an investigational drug called VRDN-003 in individuals with chronic Thyroid Eye Disease (TED). It is a randomized, double-masked, placebo-controlled study where participants will receive subcutaneous injections of VRDN-003 every 4 or 8 weeks. The study aims to determine if the treatment is effective compared to a placebo in alleviating symptoms of TED. Participants who do not show a meaningful response at Week 24 may be eligible for additional doses of the drug.

Who should consider this trial

Good fit: Ideal candidates are individuals with moderate to severe chronic TED who have experienced symptoms for over 15 months.

Not a fit: Patients who have previously received anti-IGF-1R therapy or other specific treatments for TED may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from chronic Thyroid Eye Disease.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific treatment is being evaluated for the first time in this context.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Must have moderate to severe chronic TED, with any CAS (0-7) on the 7-item scale, and with documented evidence of ocular symptoms or signs that began greater than 15 months prior to screening
* 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 Criteria:

* Must not have received prior treatment with another anti-IGF-1R therapy
* Must not have received systemic corticosteroids or steroid eye drops 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 for any condition, including TED, within 8 weeks or longer duration (depending on the type of investigational agent) 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. Must also not have a 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

NOTE: There are additional eligibility criteria for participants who do not have a meaningful response at Week 24 (irrespective of initial treatment arm) who may receive additional injections of VRDN-003. These are described in the protocol.

Where this trial is running

Scottsdale, Arizona and 35 other locations

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Thyroid Eye DiseaseTEDGravesThyroid-Associated OphthalmopathyDysthyroid OphthalmopathyGraves Eye DiseaseGraves OrbitopathyMyopathic Ophthalmopathy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.