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Monoclonal Antibodies

VRDN-003 for Graves' Eye Disease (REVEAL-2 Trial)

Phase 3
Recruiting
Research Sponsored by Viridian Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Female TED participants must have a negative serum pregnancy test at screening
Must not have
Must not have a history of inflammatory bowel disease
Must not have received prior treatment with another anti-IGF-1R therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 24
Awards & highlights
Pivotal Trial

Summary

"This trial is testing a new drug called VRDN-003 to see if it works, is safe, and can be tolerated by people with chronic Thyroid Eye Disease."

Who is the study for?
This trial is for individuals with chronic Thyroid Eye Disease (TED), a condition often associated with thyroid problems, where the eyes may become swollen, red, and painful. Specific eligibility criteria are not provided but typically include age range, disease severity, and overall health status.
What is being tested?
The study is testing VRDN-003 to see if it's effective in treating TED symptoms compared to a placebo. Participants will be randomly assigned to receive either VRDN-003 or an inactive substance (placebo) without knowing which one they're getting.
What are the potential side effects?
While specific side effects of VRDN-003 aren't listed here, common ones for new treatments can include reactions at the injection site, headaches, nausea, fatigue or allergic responses. The trial aims to assess these potential adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had moderate to severe thyroid eye disease for over 15 months.
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I am a woman and my pregnancy test was negative.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have never had inflammatory bowel disease.
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I have never been treated with anti-IGF-1R therapy.
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I haven't taken any corticosteroids for any reason in the last 2 weeks.
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I have not had radiation or surgery for eye bulging in the affected eye.
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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Title: Proptosis Responder Rate in the study eye
Secondary study objectives
Change from baseline in proptosis in the study eye
Clinical Activity Responder Rate in the study eye
Diplopia Resolution Rate for participants with baseline Diplopia Score greater than 0
+2 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: VRDN-003 every 8 weeksExperimental Treatment2 Interventions
3 subcutaneous administrations of VRDN-003 and 3 subcutaneous administrations of placebo
Group II: VRDN-003 every 4 weeksExperimental Treatment1 Intervention
6 subcutaneous administrations of VRDN-003
Group III: Placebo every 4 weeksPlacebo Group1 Intervention
6 subcutaneous administrations of placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Viridian Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
781 Total Patients Enrolled
~84 spots leftby Apr 2026
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