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ACTIVE NOT RECRUITING
NCT06625398
PHASE3

An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Chronic Thyroid Eye Disease (TED)

Sponsor: Viridian Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, VRDN-003, in participants with chronic Thyroid Eye Disease (TED).

Official title: REVEAL-2 - A Phase 3, Randomized, Double-masked, Placebo-controlled, Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Chronic Thyroid Eye Disease (TED)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

195

Start Date

2024-08-27

Completion Date

2026-12-15

Last Updated

2025-09-30

Healthy Volunteers

No

Interventions

DRUG

VRDN-003

VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R).

DRUG

Placebo

All participants will receive the same number of injections to maintain masking. Masking will be maintained by the use of placebo injections that appear identical to VRDN-003 injections.

Locations (37)

Scottsdale Clinical Trials

Scottsdale, Arizona, United States

Alliance Research Institute - Canoga Park

Canoga Park, California, United States

Marvel Clinical Research

Huntington Beach, California, United States

United Medical Research Institute

Inglewood, California, United States

Advancing Research International, LLC

Los Angeles, California, United States

Roski Eye Institute, Keck School of Medicine, USC

Los Angeles, California, United States

Alliance Research Institute - Lynwood

Lynwood, California, United States

A.P.J. Office

Newport Beach, California, United States

Byers Eye Institute at Stanford University

Palo Alto, California, United States

Pasadena Clinical Trials

Pasadena, California, United States

Senta Clinic

San Diego, California, United States

Ilumina Medical Research

Kissimmee, Florida, United States

Med-Care Research

Miami, Florida, United States

Hype Clinical Research LLC

Miami, Florida, United States

Anmed Health Services LLC

Miami, Florida, United States

Southern Clinical Research LLc

Miami, Florida, United States

Sarasota Retina Institute

Sarasota, Florida, United States

Agile Clinical Research Trials, LLC

Atlanta, Georgia, United States

Vision Medical Research

Orland Park, Illinois, United States

Massachusetts Eye and Ear

Boston, Massachusetts, United States

Opthalmic Consultants of Boston

East Weymouth, Massachusetts, United States

Fraser Eye Care Center

Fraser, Michigan, United States

Kahana Oculoplastic & Orbital Surgery

Livonia, Michigan, United States

University Health

Kansas City, Missouri, United States

S.L. Office

Las Vegas, Nevada, United States

Vector Clinical Trials

Sparks, Nevada, United States

Rutgers New Jersey Medical School

Newark, New Jersey, United States

Asheville Clinical Research

Asheville, North Carolina, United States

Duke Eye Center

Durham, North Carolina, United States

Scheie Eye Institute Penn Presbyterian

Philadelphia, Pennsylvania, United States

Wills Eye Hospital

Philadelphia, Pennsylvania, United States

Horizon Clinical Research Group

Cypress, Texas, United States

Baylor College of Medicine/Alkek Eye Center

Houston, Texas, United States

Gulf Coast Clinical Trials

Houston, Texas, United States

Neuro-Eye Clinical Trials

Houston, Texas, United States

University of Washington, Eye institute

Seattle, Washington, United States

West Virginia University Eye Institute

Morgantown, West Virginia, United States