A Randomized, Controlled, Safety and Tolerability Study of VRDN-001 in Participants With Thyroid Eye Disease (TED) (STRIVE)

April 24, 2026 updated by: Viridian Therapeutics, Inc.

A Randomized, Controlled, Safety and Tolerability Study of VRDN-001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Thyroid Eye Disease (TED)

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 objective of this clinical trial is to evaluate the safety and tolerability of VRDN-001 in patients with TED.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized, controlled, safety and tolerability study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in participants with thyroid eye disease (TED).

Study Type

Interventional

Enrollment (Actual)

231

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Sydney, Australia, 2000
        • Sydney Eye Hospital
      • Sydney, Australia, 2065
        • North Shore Eye Surgery
  • France
      • Angers, France, 49100
        • CHU d'Angers
      • Des Quinze Vingts Paris, France, 75012
        • Centre Hospitalier National D'ophtalmologie
      • Nice, France, 06000
        • CH Nice
      • Paris, France, 75013
        • AP-HP - Hôpital de la Pitié Salpétrière
  • Germany
      • Göttingen, Germany, 37075
        • Universitatsmedizin Gottingen
      • Mainz, Germany, 55131
        • Johannes Gutenberg-University Medical Center
  • Poland
      • Bialystok, Poland, 15-879
        • NZOZ E-Vita
      • Bydgoszcz, Poland, 85-870
        • Specjalistyczny Osrodek Okulistyczny Oculomedica
      • Lódz, Poland, 90-302
        • Santa Familia PTG Lodz
      • Warsaw, Poland, 02-507
        • PANSTWOWY INSTYTUT MEDYCZNY MSWiA
      • Wroclaw, Poland, 53-114
        • 4 Wojskowy Szpital Kliniczny Z Poliklinika SP ZOZ
  • Spain
      • Barcelona, Spain, 08022
        • Clinica Bonanova de Cirugia Ocular
      • Córdoba, Spain, 14012
        • Hospital Arruzafa
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28027
        • Clinica Universidad de Navarra
      • Pamplona, Spain, 31008
        • Clinica Universidad de Navarra
      • Santiago de Compostela, A Coruña, Spain, 15706
        • Complexo Hospitalario Universitario de Santiago-Hospital Médico-Cirúrxico de Conxo
      • Seville, Spain, 41071
        • Hospital Universitario Virgen De La Macarena, Servicio de Oftalmología
      • Zaragoza, Spain, 50009
        • Miguel Servet University Hospital, Clinical Trials Unit
  • United Kingdom
      • London, United Kingdom, HA1 3UJ
        • Northwick Park Hospital
      • London, United Kingdom, SE1 7EH
        • Guy's and St. Thomas NHS Trust
      • London, United Kingdom, NW1 5QH
        • Western Eye Hospital, Imperial College NHS Trust
  • United States
    • California
      • Inglewood, California, United States, 90301
        • United Medical Research Institute
      • Los Angeles, California, United States, 90023
        • Advancing Research International, LLC
      • Palo Alto, California, United States, 94303
        • Stanford Byers Eye Institute
      • San Diego, California, United States, 92108
        • Cockerham Eye Consultants, PC
      • Santa Maria, California, United States, 93454
        • FOMAT Medical Research
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado - Dept of Ophthalmology
    • Florida
      • Homestead, Florida, United States, 33034
        • Sina Medical Center LLC
      • Miami, Florida, United States, 33125
        • Med-Care Research Inc.
      • Plantation, Florida, United States, 33317
        • Edward Jenner Research Group Center LLC
      • Sarasota, Florida, United States, 34231
        • Sarasota Retina Institute
    • Illinois
      • Orland Park, Illinois, United States, 60462
        • Vision Medical Research Inc.
    • Kansas
      • Kansas City, Kansas, United States, 64108
        • University Health Diabetes, Endocrinology & Nephrology Center
      • Kansas City, Kansas, United States, 66103
        • KU Medical Center, University of Kansas
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Eye and Ear
      • Weymouth, Massachusetts, United States, 02189
        • Ophthalmic Consultants of Boston
    • Michigan
      • Fraser, Michigan, United States, 48026
        • Fraser Eye Care Center
      • Livonia, Michigan, United States, 48152
        • Kahana Oculoplastic & Orbital Surgery
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota, Department of Ophthalmology and Visual Neurosciences
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • Advancing Research International, LLC
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Rutgers- New Jersey Medical School- Newark
    • New York
      • New York, New York, United States, 10003
        • New York Eye Ear Infirmary of Mount Sinai
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine (BCM) - Ophthalmology
      • Houston, Texas, United States, 77074
        • Neuro-Eye Clinical Trials
      • Houston, Texas, United States, 77074
        • Neuro-Ophthalmology of Texas, PLLC
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont Medical Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Eye Institute

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Must not have received prior treatment with another anti-IGF-1R therapy
  • Must not have used systemic corticosteroids, or selenium within 2 weeks prior to Day 1
  • Must not have received rituximab, tocilizumab or other immunosuppressive agents within 8 weeks prior to Day 1
  • Must not have received any other therapy for TED within 8 weeks prior to Day 1
  • Must not have received an investigational agent for any condition within 8 weeks prior to the first dose of study medication
  • Must not have a pre-existing ophthalmic condition in the study eye that in the opinion of the Investigator would confound interpretation of the study results
  • Must not have had previous orbital irradiation or decompression surgery involving excision of fat for TED in the study eye's orbit
  • Must not have inflammatory bowel disease
  • 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 received an investigational agent for any condition within 8 weeks prior to Day 1
  • Female TED participants must not be pregnant or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VRDN-001 10 mg/kg
5 infusions of VRDN-001 10 mg/kg
Drug: VRDN-001 10 mg/kg
5 infusions of VRDN-001 10 mg/kg
Experimental: 5 infusions of VRDN-001 3 mg/kg
Drug: VRDN-001 3 mg/kg
5 infusions of VRDN-001 3 mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment Emergent Adverse Event (TEAE) incidence rate
Time Frame: Week 15
Week 15

Secondary Outcome Measures

Outcome Measure
Time Frame
Treatment Emergent Adverse Event (TEAE) incidence rate
Time Frame: Week 52
Week 52
Change from baseline in proptosis in the study eye as measured by exophthalmometer
Time Frame: Week 15
Week 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (Actual)

May 23, 2024

Primary Completion (Actual)

May 1, 2025

Study Completion (Actual)

January 19, 2026

Study Registration Dates

First Submitted

April 22, 2024

First Submitted That Met QC Criteria

April 22, 2024

First Posted (Actual)

April 25, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VRDN-001-303

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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