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

July 22, 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 participants with TED. The primary objective of this clinical trial is to evaluate the safety and tolerability of VRDN-001 in participants with TED.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
231

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Universitätsmedizin Göttingen
      • 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
        • Państwowy 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 clinical activity score (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 at screening
  • 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.
  • 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Veligrotug 10 mg/kg
Participants will receive 5 intravenous (IV) infusions of veligrotug 10 milligrams (mg)/kilogram (kg) at 3-week intervals for 12 weeks.
Drug: Veligrotug
5 infusions of veligrotug
Other Names:
  • VRDN-001
Experimental: Veligrotug 3 mg/kg
Participants will receive 5 IV infusions of veligrotug 3 mg/kg at 3-week intervals for 12 weeks.
Drug: Veligrotug
5 infusions of veligrotug
Other Names:
  • VRDN-001

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Through Week 15
Time Frame: Baseline through Week 15
An adverse event (AE) was defined as any untoward medical occurrence that developed or worsened in severity during the conduct of a clinical study and did not necessarily have a causal relationship to study drug. TEAE was defined as an AE occurring on or after the day of the first dose of study medication through the end of the study. A summary of all Serious Adverse Events (SAEs) and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Baseline through Week 15

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Proptosis in the Study Eye as Measured by Exophthalmometer
Time Frame: Baseline, Week 15
Proptosis was defined as distance between the lateral orbital rim and the most anterior position of the cornea in millimeters (mm), measured using an exophthalmometer. Observed change from baseline in proptosis in study eye is reported. Missing data were not imputed.
Baseline, Week 15
Number of Participants With TEAEs Through Week 52
Time Frame: Baseline through Week 52
An AE was defined as any untoward medical occurrence that developed or worsened in severity during the conduct of a clinical study and did not necessarily have a causal relationship to study drug. TEAE was defined as an AE occurring on or after the day of the first dose of study medication through the end of the study. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Baseline through Week 52

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 23, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 19, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VRDN-001-303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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