ACTIVE_NOT_RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

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

Quick Facts

Study Start:2025-07-01

Study Completion:2026-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT07155668

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.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Locations (Sites)

United Medical Research Institute

Inglewood, California, 90301

United States

C&A Clinical Trials Corp

Cape Coral, Florida, 33990

United States

Ilumina Medical Research

Kissimmee, Florida, 34744

United States

Med-Care Research

Miami, Florida, 33125

United States

Continental Clinical Research, llc

Miami, Florida, 33144

United States

Hype Clinical Research, LLC

Miami, Florida, 33145

United States

Advanced Quality Medical Research, LLC

Orland Park, Illinois, 60462

United States

Ophthalmic Consultants of Boston

East Weymouth, Massachusetts, 02189

United States

Fraser Eye Center

Fraser, Michigan, 48026

United States

Kahana Oculoplastic and Orbital Surgery

Livonia, Michigan, 48152

United States

Vector Clinical Trials

Sparks, Nevada, 89128

United States

Baylor College of Medicine, Alkek Eye Center

Houston, Texas, 77030

United States

Neuro Eye Clinical Trials INC

Houston, Texas, 77074

United States

Collaborators and Investigators

Sponsor: Viridian Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-01

Study Completion Date2026-11

Study Record Updates

Study Start Date2025-07-01

Study Completion Date2026-11

Terms related to this study

Additional Relevant MeSH Terms

Thyroid Eye Disease