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A Safety, Tolerability and Pharmacokinetics Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)

A Randomized, Open-label Study Evaluating the Safety, Tolerability and Pharmacokinetics of VRDN-003 Administered Subcutaneously in Participants With Thyroid Eye Disease (TED)

NCT07155668•Viridian Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

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

Detailed Description

This is a randomized (meaning participants will be assigned to study arms by chance), open-label (meaning study doctor, participant and the sponsor will know which study arm participant is assigned to), parallel-group study that will enroll participants with TED of any duration. The key objectives of this study are to determine if VRDN-003 is safe and tolerable and to see how the body reacts to VRDN-003 when administered as a series of subcutaneous (SC) injections every 4 weeks or every 8 weeks in participants with TED either via autoinjector or via vial and syringe.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Have a clinical diagnosis of TED with or without proptosis, with any CAS (0-7) and in the opinion of the Investigator may benefit from VRDN-003
•Not require immediate ophthalmological or orbital surgery in the study eye for any reason
•Must agree to use highly effective contraception as specified in the protocol
•Female TED participants must have a negative serum pregnancy test at screening

Exclusion Criteria

•Must not have received prior treatment with another anti-IGF-1R therapy
•Must not have received systemic corticosteroids for any condition, including TED, or selenium within 2 weeks prior to first dose.
•Must not have received other immunosuppressive drugs for any condition, including TED, or any other therapy for TED, within 12 weeks prior to first dose
•Must not have received an investigational agent/device for any condition, including TED, within 8 weeks or longer (depending on the type of agent/device) 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 or history of ear conditions considered significant by study doctor
•Must not have a history of inflammatory bowel disease
•Female TED participants must not be pregnant or breastfeeding

Locations (13)

United Medical Research Institute

Inglewood, California, United States

C&A Clinical Trials Corp

Cape Coral, Florida, United States

Ilumina Medical Research

Kissimmee, Florida, United States

Med-Care Research

Miami, Florida, United States

Continental Clinical Research, llc

Miami, Florida, United States

Hype Clinical Research, LLC

Miami, Florida, United States

Advanced Quality Medical Research, LLC

Orland Park, Illinois, United States

Ophthalmic Consultants of Boston

East Weymouth, Massachusetts, United States

Fraser Eye Center

Fraser, Michigan, United States

Kahana Oculoplastic and Orbital Surgery

Livonia, Michigan, United States

Key Dates

Start Date

July 1, 2025

Primary Completion Date

July 1, 2026

Completion Date

November 1, 2026

Last Updated

January 14, 2026

Enrollment

ACTUAL participants

Conditions

Thyroid Eye Disease

Interventions

VRDN-003

DRUG

Autoinjector

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 14, 2026Data synced to Clareo: March 29, 2026

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 Conditions

A Safety, Tolerability and Pharmacokinetics Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)

Inclusion Criteria

Exclusion Criteria

Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

Exploring the Value of 18F-AlF-FAPI PET/CT in Assessing the Activity of Thyroid Eye Disease

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