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Monoclonal Antibodies

VRDN-003 for Graves' Eye Disease (REVEAL-1 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
Female TED participants must have a negative serum pregnancy test at screening
Be older than 18 years old
Must not have
Must not have received systemic corticosteroids for any condition, including TED, within 2 weeks prior to first dose
Female TED participants who must not be pregnant or breastfeeding
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 well, is safe, and can be tolerated by people with active Thyroid Eye Disease."

Who is the study for?
This trial is for individuals with active Thyroid Eye Disease (TED), a condition associated with thyroid problems that affects the eyes. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on factors like other medical conditions or treatments that could interfere with the study.
What is being tested?
The trial is testing VRDN-003, an investigational drug, against a placebo to see if it's effective in treating TED. Participants will either receive VRDN-003 or a placebo without knowing which one they're getting to fairly measure the drug's effects.
What are the potential side effects?
While specific side effects of VRDN-003 are not listed here, common side effects in trials can include reactions at the injection site, headaches, nausea, and fatigue. The safety profile will be closely monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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 haven't taken any corticosteroids for any condition in the last 2 weeks.
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I am not pregnant or breastfeeding.
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I have never been treated with anti-IGF-1R therapy.
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I have not had radiation or surgery for eye bulging on the affected eye.
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I have never had inflammatory bowel disease.

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
Proptosis Responder Rate in the study eye
Secondary study objectives
Change from baseline in Clinical Activity Score (CAS) in the study eye
Change from baseline in proptosis in the study eye
Clinical Activity Responder Rate in the study eye
+4 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
823 Total Patients Enrolled
~56 spots leftby Mar 2026
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