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Efficacy and safety of VRDN-003 for treating active Thyroid Eye Disease

REVEAL-1 - a Phase 3, Randomized, Double-masked, Placebo-controlled, Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants with Active Thyroid Eye Disease (TED)

Phase 3 Interventional Viridian Therapeutics, Inc. · NCT06625411

This study is testing a new drug called VRDN-003 to see if it can help people with active Thyroid Eye Disease feel better over 24 weeks.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment117 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorViridian Therapeutics, Inc. Industry-sponsored
Locations31 sites (Scottsdale, Arizona and 30 other locations)
Trial IDNCT06625411 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy, safety, and tolerability of an investigational drug called VRDN-003 in participants diagnosed with active Thyroid Eye Disease (TED). It employs a randomized, double-masked, placebo-controlled design, where participants will receive either VRDN-003 or a placebo through subcutaneous injections every 4 or 8 weeks. The study aims to determine the drug's effectiveness in alleviating symptoms of TED over a 24-week period, with the possibility of additional treatment for those who do not respond adequately. Participants will be monitored for safety and tolerability throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are individuals with moderate to severe active TED who have experienced ocular symptoms within the last 15 months.

Not a fit: Patients who have previously received anti-IGF-1R therapy or other treatments for TED within specified timeframes 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 active Thyroid Eye Disease.

How similar studies have performed: Other studies have explored treatments for Thyroid Eye Disease, but the specific approach of using VRDN-003 is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Must have moderate to severe active TED with documented evidence of ocular symptoms or signs that began within 15 months prior to screening
* Must have a Clinical Activity Score (CAS) of ≥ 3 on the 7-item scale for the study eye
* 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 who 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 30 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.