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

Description

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).

Conditions

Thyroid Eye Disease

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Study Overview

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Study Details

Study overview

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).

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)

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

Condition
Thyroid Eye Disease
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Advancing Research International, LLC, Los Angeles, California, United States, 90023

Newport Beach

Amy Patel Jain, MD, Newport Beach, California, United States, 92660

San Diego

Senta Clinic, San Diego, California, United States, 92108

Orland Park

Vision Medical Research, Orland Park, Illinois, United States, 60462

East Weymouth

Opthalmic Consultants of Boston, East Weymouth, Massachusetts, United States, 02189

Fraser

Fraser Eye Care Center, Fraser, Michigan, United States, 48026

Livonia

Kahana Oculoplastic & Orbital Surgery, Livonia, Michigan, United States, 48152

Kansas City

University Health, Kansas City, Missouri, United States, 64108

Las Vegas

Steven Leibowitz Office, Las Vegas, Nevada, United States, 89144

Houston

Neuro-Eye Clinical Trials, Houston, Texas, United States, 77074

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Must have moderate to severe active TED with documented evidence of ocular symptoms or signs that began within 15 months prior to screening
  • * Must have a Clinical Activity Score (CAS) of ≥ 4 on the 7-item scale for the study eye
  • * Must agree to use highly effective contraception as specified in the protocol
  • * Female TED participants must have a negative serum pregnancy test at screening
  • * Must not have received prior treatment with another anti-IGF-1R therapy
  • * Must not have received systemic corticosteroids for any condition, including TED, within 2 weeks prior to first dose.
  • * Must not have received other immunosuppressive drugs or another investigational agent for any condition, including TED, or any other therapy for TED, within 8 weeks prior to first dose
  • * Must not have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose
  • * Must not have had previous orbital irradiation or decompression surgery for TED to the study eye's orbit
  • * Must not have a pre-existing ophthalmic condition in the study eye which in the study doctor's opinion, would interfere with interpretation of study results
  • * Must not have abnormal hearing test before first dose. Must also not have a history of ear conditions considered significant by study doctor
  • * Must not have a history of inflammatory bowel disease
  • * Female TED participants who must not be pregnant or breastfeeding

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Viridian Therapeutics, Inc.,

Study Record Dates

2026-11-15