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New Treatment for Graves' Eye Disease (OLE 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 15
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is for participants who did not respond well to treatment after 15 weeks in two previous studies called THRIVE and THRIVE-2.

Who is the study for?
This trial is for people with Graves' Eye Disease who didn't respond to previous treatments in the VRDN-001-101 or VRDN-001-301 studies. Participants must have completed at least 5 infusions, be non-pregnant if female, and agree to use effective contraception.
What is being tested?
The study tests a treatment on those who didn't improve after prior therapy for Graves' Ophthalmopathy. It's an open-label trial, meaning both researchers and participants know what treatment is being given.
What are the potential side effects?
Specific side effects are not listed here but may include reactions similar to those experienced during the initial trials (VRDN-001-101/301), as this is a continuation for non-responders.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 15 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 proptosis in the study eye at Week 15
Change from baseline in Clinical Activity Score in the study eye
Clinical Activity Responder Rate in the study eye
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: VRDN-001 10 mg/kgExperimental Treatment1 Intervention
5 infusions of VRDN-001 10 mg/kg

Find a Location

Who is running the clinical trial?

Viridian Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
764 Total Patients Enrolled
~30 spots leftby Jul 2025
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