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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

Female TED participants must have a negative serum pregnancy test

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 15

Awards & highlights

Study Summary

This trial studies the safety, tolerability and effectiveness of a new drug to treat chronic thyroid eye disease.

Who is the study for?

This trial is for individuals with chronic thyroid eye disease (TED) who have had symptoms or signs for over 15 months. They must not be pregnant, agree to use effective contraception, and have a Clinical Activity Score of 0-7. People can't join if they've used certain medications recently, had prior TED treatments like surgery or radiation, or have other eye conditions that could affect the study.Check my eligibility

What is being tested?

The trial is testing VRDN-001, a monoclonal antibody targeting the IGF-1 receptor. Participants will either receive this drug at a dose of 10 mg/kg or a placebo without knowing which one they're getting. The goal is to assess safety, tolerability, and effectiveness in treating TED.See study design

What are the potential side effects?

Potential side effects may include reactions related to the immune system due to the action of VRDN-001 on growth factors involved in inflammation but specific side effects are not listed here as it's under investigation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am not pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 15

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proptosis Responder Rate in the study eye

Secondary outcome measures

Change from Baseline in proptosis in the study eye at Week 15

Change from baseline in CAS in the study eye

Clinical Activity Responder Rate in the study eye

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: VRDN-001 10 mg/kgExperimental Treatment1 Intervention

Drug: 5 Infusions of VRDN-001 10 mg/kg

Group II: Placebo DrugExperimental Treatment1 Intervention

Placebo Drug: 5 Infusions of placebo

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Viridian Therapeutics, Inc.Lead Sponsor

3 Previous Clinical Trials

509 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment currently underway for this clinical research study?

"Data hosted on clinicaltrials.gov verifies that this medical study, which was first advertised on October 1st 2023 is actively recruiting participants. The information has been recently updated as of October 12th 2023."

Answered by AI

What is the overall participant count for this investigation?

"Absolutely. According to the information presented on clinicaltrials.gov, this trial is actively enrolling patients and began recruiting on October 1st 2o23 and was most recently updated twelve days later. The study requires 159 participants from one site in total."

Answered by AI

What are the security implications of administering VRDN-001 10 mg/kg to humans?

"The safety rating of VRDN-001 10 mg/kg was assessed as a 3, given the substantial evidence compiled in Phase 3 trials suggesting both efficacy and security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Randomized, Double-masked, Placebo-controlled Safety, Tolerability, and Efficacy Study of VRDN-001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Chronic Thyroid Eye Disease (TED)

2023. "A Randomized, Double-masked, Placebo-controlled Safety, Tolerability, and Efficacy Study of VRDN-001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Chronic Thyroid Eye Disease (TED)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06021054.