Loading clinical trials...
Loading clinical trials...
REVEAL-1 - A Phase 3, Randomized, Double-masked, Placebo-controlled, Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Active Thyroid Eye Disease (TED)
This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, VRDN-003, in participants with active Thyroid Eye Disease (TED).
This is a randomized (meaning participants will be assigned to study arms by chance), double-masked (meaning study doctor and participant will not know which study arm participant is assigned to), placebo-controlled study that will include participants with active TED. The key objectives of this study are to determine if VRDN-003 is efficacious, safe and tolerable when administered as a series of subcutaneous/SC injections given every 4 weeks or every 8 weeks compared to placebo in participants with active TED. Participants who do not have a meaningful response at Week 24 (irrespective of the initial treatment arm) may be eligible to receive additional subcutaneous injections of VRDN-003.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
August 27, 2024
Primary Completion Date
March 1, 2026
Completion Date
November 15, 2026
Last Updated
September 30, 2025
117
ESTIMATED participants
VRDN-003
DRUG
Placebo
DRUG
Lead Sponsor
Viridian Therapeutics, Inc.
NCT06112340
NCT06359795
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05012033