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Monoclonal Antibodies
VRDN-001 for Thyroid Eye Disease
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 active TED with documented evidence of ocular symptoms or signs that began within 1 year prior to screening OR moderate to severe chronic TED with documented evidence of ocular symptoms or signs that began over 1 year prior to screening
Must be free of clinically significant disease or medical conditions as determined by the Investigator
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 50 for mad healthy volunteers, up to day 169 for mad ted subjects, and up to week 52 for the phase 3 study subjects
Awards & highlights
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.
Who is the study for?
This trial is for healthy individuals and those with Thyroid Eye Disease (TED), specifically moderate to severe cases. Participants should not have certain medical conditions like diabetes, recent kidney issues, or hearing loss. They must not have used specific medications recently and agree to use effective contraception.Check my eligibility
What is being tested?
The study tests VRDN-001, a monoclonal antibody targeting the IGF-1R receptor which could reduce inflammation in TED patients. It's being compared against a placebo in different phases of trials to assess safety, tolerability, and how it's processed by the body.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include reactions typical of monoclonal antibodies such as infusion-related reactions, immune system effects or allergic responses due to inhibition of the IGF-1R pathway.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have active or chronic eye disease with symptoms starting before or over a year ago.
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I don't have any serious illnesses besides my current condition.
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I am not able to become pregnant.
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My eye condition started within the last 15 months and is moderate to severe.
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My eye condition is active with significant symptoms or it's chronic with no severe symptoms needed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 50 for mad healthy volunteers, up to day 169 for mad ted subjects, and up to week 52 for the phase 3 study subjects
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 50 for mad healthy volunteers, up to day 169 for mad ted subjects, and up to week 52 for the phase 3 study subjects
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
Proptosis responder rate
Secondary outcome measures
Change from baseline in Clinical Activity Score (CAS)
Change from baseline in Graves Orbitopathy-Quality of Life (GO-QoL) combined score
Change from baseline in Subjective Diplopia Score
+5 moreOther outcome measures
Incidence of anti-drug antibody (ADA) development in VRDN-001-treated subjects over time
VRDN-001 concentrations in the blood over time
Trial Design
2Treatment groups
Experimental Treatment
Group I: Phase 3 Cohort (THRIVE)Experimental Treatment2 Interventions
Participants with TED will be randomized to either VRDN-001 10mg/kg or placebo.
Group II: Phase 1/2 MAD (HV and TED)Experimental Treatment1 Intervention
Healthy participants and participants with TED will be randomized to receive two intravenous infusions of VRDN-001 or placebo with an interval of 3 weeks.
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Who is running the clinical trial?
Viridian Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
302 Total Patients Enrolled
Barrett Katz, MD, MBAStudy DirectorViridian Therapeutics, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1/2 MAD (HV and TED)
- Group 2: Phase 3 Cohort (THRIVE)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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