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Monoclonal Antibodies

VRDN-001 for Thyroid Eye Disease (STRIVE 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
Must not have
Must not have received prior treatment with another anti-IGF-1R therapy or any investigational agent for TED
Must not have inflammatory bowel disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is testing a new drug called VRDN-001 that blocks a receptor in the body to help reduce inflammation and tissue swelling in patients with thyroid eye disease. The main goal of the trial is

Who is the study for?
This trial is for individuals with Thyroid Eye Disease (TED), a condition often associated with Graves' disease. Participants should have active symptoms and be adults who can provide informed consent. Specific details about what makes someone eligible or not are not provided here.
What is being tested?
The study tests two different doses of VRDN-001, a new drug designed to block a receptor that might cause eye problems in TED. It's given to see if it's safe and how well patients tolerate it compared to existing treatments.
What are the potential side effects?
Possible side effects aren't listed, but as VRDN-001 is an antibody that affects the immune system, common risks may include allergic reactions, fatigue, headache, and potential impact on the body’s normal immune responses.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had treatments targeting IGF-1R or experimental drugs for TED.
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I do not have inflammatory bowel disease.
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I haven't taken any corticosteroids in the last 2 weeks.
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I haven't taken rituximab, tocilizumab, or similar drugs in the last 8 weeks.
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I have not had eye socket radiation or surgery for TED.
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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Group I: VRDN-001 10 mg/kgExperimental Treatment1 Intervention
5 infusions of VRDN-001 10 mg/kg
Group II: 5 infusions of VRDN-001 3 mg/kgExperimental Treatment1 Intervention
5 infusions of VRDN-001 3 mg/kg

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Who is running the clinical trial?

Viridian Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
456 Total Patients Enrolled
~135 spots leftby May 2025
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