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An Open-label Study (OLE) for Non-responders of VRDN-001-101 and VRDN-001-301 | Clinical Trials | Clareo Health

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An Open-label Study (OLE) for Non-responders of VRDN-001-101 and VRDN-001-301

An Open-label Study for Participants Who Are Non-responders at the End of Treatment Assessment on the VRDN-001-101 and VRDN-001-301 Pivotal Studies

NCT06179875•Viridian Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

The investigational drug, VRDN-001, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in patients with thyroid eye disease (TED). The primary objectives of this clinical trial are to provide open-label access to VRDN-001 for participants who were previously non-responders at 3 weeks post the fifth IV infusion (i.e., 15 weeks) in the VRDN-001-101 (THRIVE) and VRDN-001-301 (THRIVE-2) pivotal studies and assess the safety and efficacy of VRDN-001 in participants who were previously treated with VRDN-001 or placebo.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Be able to understand the study procedures and the risks involved and be willing to provide written informed consent before the first study-related activity
•2. Have completed at least 5 IV infusions and assessments required to determine proptosis responder status 3 weeks post the fifth IV infusion (i.e., Week 15) as defined in either the VRDN-001-101 or VRDN-001-301 pivotal studies
•3. Been a participant in either the VRDN-001-101 or VRDN-001-301 studies and found to be a non-responder as defined within the VRDN-001-101 or VRDN-001-301 study
•4. Not require immediate surgical ophthalmological or orbital surgery in the study eye for any reason
•5. Must agree to use highly effective contraception as specified in the protocol
•6. Female TED participants must have a negative urine pregnancy test at screening
•7. Be willing and able to comply with all the requirements of the protocol for the entire duration of the study

Exclusion Criteria

•Participants must not:
•1. Have received prior treatment with another anti-IGF-1R agent
•2. Have received systemic corticosteroids for any condition, including TED, or selenium within 2 weeks prior to first dose
•3. Have received other immunosuppressive drugs or another investigational agent for any condition, including TED (other than VRDN-001 or placebo associated with the VRDN-001-101 or VRDN-001-301 pivotal studies), or any other therapy for TED, within 8 weeks prior to first dose
•4. Have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose
•5. Have had previous orbital irradiation or decompression surgery involving excision of fat for TED to the study eye's orbit
•6. Have abnormal hearing test before first dose. Have a history of ear conditions considered significant by study doctor

Locations (45)

Advancing Research International, LLC

Los Angeles, California, United States

USC Eye Institute

Los Angeles, California, United States

Advancing Research International, LLC

Newport Beach, California, United States

Stanford Byers Eye Institute

Palo Alto, California, United States

Cockerham Eye Consultants, PC

San Diego, California, United States

University of Miami Miller School of Medicine, Bascom Palmer Eye Institute

Miami, Florida, United States

Sarasota Retina Institute

Sarasota, Florida, United States

Vision Medical Research

Oak Lawn, Illinois, United States

Ophthalmic Consultants of Boston

East Weymouth, Massachusetts, United States

Kahana Oculoplastic & Orbital Surgery

Livonia, Michigan, United States

Key Dates

Start Date

January 31, 2024

Primary Completion Date

April 25, 2025

Completion Date

June 23, 2025

Last Updated

February 12, 2026

Enrollment

143

ACTUAL participants

Conditions

Thyroid Eye Disease

Interventions

Intervention/Treatment

DRUG

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

NCT06112340

Thyroid Eye DiseaseGraves Orbitopathy+10 more

View study

RECRUITINGNA

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

NCT06359795

Thyroid Eye Disease

View study

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: February 12, 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

An Open-label Study (OLE) for Non-responders of VRDN-001-101 and VRDN-001-301

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

Evaluation of High Dose Prednisolone Pharmacokinetics in the Acute and Chronic Setting

A Trial Investigating Lu AG22515 in Adult Participants With Moderate-to-Severe Thyroid Eye Disease

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

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