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VRDN-001 for Thyroid Eye Disease
Study Summary
This trial is testing a new drug, VRDN-001, to see if it's safe and effective in treating thyroid eye disease. The drug works by inhibiting a cell surface receptor called IGF-1R. If the drug is effective, it could help reduce the inflammation and associated tissue swelling that occurs in patients with thyroid eye disease.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am not able to become pregnant.I have never been treated with anti-IGF-1R monoclonal antibody.Your eye condition must be rated as at least a 3 on a 7-point scale for the study.I haven't taken rituximab, tocilizumab, or similar drugs in the last 8 weeks.I haven't taken oral steroids in the last 2 weeks.I don't have any serious illnesses besides my current condition.I do not have diabetes, kidney issues, inflammatory bowel disease, or significant ear problems.I do not have significant hearing problems or ear conditions.I haven't taken rituximab, tocilizumab, or similar drugs in the last 90 days.I have active or chronic eye disease with symptoms starting before or over a year ago.My eye condition started within the last 15 months and is moderate to severe.My optic nerve has not been affected in the last 6 months.I have not had eye radiation or surgery for thyroid eye disease in the affected eye.My eye condition responds to treatment.My eye condition is active with significant symptoms or it's chronic with no severe symptoms needed.I haven't taken oral steroids in the last 4 weeks.I have never had inflammatory bowel disease.
- Group 1: Phase 1/2 MAD (HV and TED)
- Group 2: Phase 3 Cohort (THRIVE)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are any new enrollees being welcomed into this experiment?
"Affirmative. According to clinicaltrials.gov, this research is presently seeking volunteers for the study which was initially posted on December 3rd 2021 and modified most recently on August 11th 2022. 76 individuals have been enrolled at 18 different medical sites thus far."
How widely is this investigation being administered within the city?
"The trial is currently running at 18 different sites, including Sarasota, Minneapolis and Palo Alto. For your convenience and to reduce travel demands, it important to choose the hospital closest to you if enrolling."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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