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VRDN-001 10 mg/kg for Graves' Ophthalmopathy

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

Study 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.Check my eligibility

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.See study design

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 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 Clinical Activity Score in the study eye

Clinical Activity Responder Rate in the study eye

+2 more

Trial Design

1Treatment groups

Experimental Treatment

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

5 infusions of VRDN-001 10 mg/kg

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Viridian Therapeutics, Inc.Lead Sponsor

3 Previous Clinical Trials

525 Total Patients Enrolled

Frequently Asked Questions

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

How many participants in total are involved in this research investigation?

"Affirmative. Information displayed on clinicaltrials.gov reveals that this medical investigation is actively seeking volunteers. The trial was originally posted on February 1st, 2023 and last updated on March 5th, 2024. A total of 143 participants are being sought from four locations."

Answered by AI

Are there any available slots for patients to participate in this clinical trial?

"Indeed, data on clinicaltrials.gov affirms that this medical investigation is actively seeking eligible participants. Originally shared on February 1st, 2023, the trial received its latest update on March 5th, 2024. The research team aims to recruit a total of 143 patients spread across four distinct sites."

Answered by AI

In how many diverse venues is this experimental examination currently being conducted?

"Four active sites participating in this trial are the Neuro-eye Clinical Trials situated in Houston, MACRO Trials, Inc. located in Los Angeles, and The Center for Eye and Facial Plastic Surgery based in Somerset. Additionally, there are four other undisclosed locations involved."

Answered by AI

Has the drug VRDN-001 at a dosage of 10 mg/kg received approval from the FDA?

"The safety rating for VRDN-001 at a dosage of 10 mg/kg is considered to be 3 by our experts due to the Phase III nature of the trial, indicating existing efficacy data and robust safety evidence."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Open-label Study for Participants Who Are Non-responders at the End of Treatment Assessment on the VRDN-001-101 and VRDN-001-301 Pivotal Studies

2023. "An Open-label Study for Participants Who Are Non-responders at the End of Treatment Assessment on the VRDN-001-101 and VRDN-001-301 Pivotal Studies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06179875.

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