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

May 21, 2026 updated by: Viridian Therapeutics, Inc.

A Randomized, Double-masked, Controlled, Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized (meaning participants will be assigned to study arms by chance), double-masked (meaning study doctor and participant will not know which study arm participant is assigned to), controlled study that will include participants with TED of any duration. The key objectives of this study are to determine if VRDN-003 is safe and tolerable when administered as a series of subcutaneous (SC) injections every 4 weeks or every 8 weeks in participants with TED.

Study Type

Interventional

Enrollment (Actual)

320

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

  • France
      • Angers, France
        • Servicde d'Endocrinologie, Diabetologieet Nutrition Centre Hospitalier Universitaire d'Angers
      • Bron, France, 69500
        • Abeillon du Payrat
      • Paris, France
        • Hôpital La Pitiélsalpêtrière
  • Germany
      • Berlin, Germany
        • Charite Universitatsmeizin Berlin KoR Campus Virchow Klinikum
      • Essen, Germany
        • Universitatsklinikum Essen
      • Göttingen, Germany, 37075
        • Universitaetsmedizin Goettingen
      • Mainz, Germany
        • Johannes Gutenberg University Medical Center Department of Medicine 1
  • Poland
      • Bialystok, Poland, 15-276
        • Uniwersytecki Szpital Kliniczny w Białymstoku, Klinika Okulistyki, Centrum Badań Klinicznych
      • Gdansk, Poland, 80-180
        • Optimum Profesorskie Centrum Okulistyki Sp. z o. o.
      • Gdynia, Poland, 81-338
        • Centrum Medyczne Pratia Gdynia
      • Lodz, Poland, 90-302
        • Santa Familia PTG Lodz
      • Lublin, Poland, 20-412
        • ETG Lublin
      • Piaseczno, Poland, 05-500
        • Centrum Medyczne Pulawska Sp. z o.o.
      • Warsaw, Poland, 01-258
        • Warszawski Szpital Okulistyczny
      • Warsaw, Poland, 02-777
        • Polimedica PTG
  • Spain
      • A Coruña, Spain, 15706
        • Hospital Provincial de Conxo
      • Barcelona, Spain, 08017
        • Institut Catalâ de Retina
      • Córdoba, Spain, 14012
        • Hospital La Arruzafa
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon Y Cajal
      • Navarrés, Spain
        • Clinica Universidad de Navarre
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Zaragoza, Spain
        • Hospital Universitario Miguel Servet Consultas de Oftalmologia
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye)
        • Gazi University Medical Faculty Hospital
      • Ankara, Turkey (Türkiye)
        • Hacettepe Univeristy Medical Fculty Hospital
      • Antalya, Turkey (Türkiye), 07059
        • Akdeniz Üniversitesi Tıp Fakültesi Göz Hastalıkları Anabilim Dalı
      • Istanbul, Turkey (Türkiye)
        • Marmara Üniversitesi Pendik Eğitim ve Araştırma Hastanesi Göz Hastalıkları Kliniği
  • United Kingdom
      • Bristol, United Kingdom
        • University Hospitals Bristol and Weston NHS Foundation Trust Clinical Research Unit
      • Cambridge, United Kingdom
        • Addenbrookes Hospital
      • London, United Kingdom, SE1 7EH
        • Guy's and St Thomas' NHS Foundation Trust
      • London, United Kingdom, NW1 5QH
        • Imperial College Healthcare NHS Trust
      • London, United Kingdom
        • Moorefields Eye Hospital NHS Foundation Trust
      • Newcastle, United Kingdom
        • The Newcastle Upon Tyne Hospitals NHS Foundation Trust
  • United States
    • Arizona
      • Tuscon, Arizona, United States, 85712
        • Catalina Eye Care
    • California
      • Inglewood, California, United States, 90301
        • United Medical Research Institute
      • Newport Beach, California, United States, 92660
        • Orbital Plastics
      • Pasadena, California, United States, 91107
        • California Eye Specialists Medical Group Inc
      • Pismo Beach, California, United States, 93030
        • Fomat Medical Research
      • Santa Monica, California, United States, 90404
        • Pacific Neuroscience Institute
      • Torrance, California, United States, 90503
        • Pacific Neuroscience Institute at Saint John's Physician Partners
    • Florida
      • Cape Coral, Florida, United States, 33990
        • C A Clinical Trial Corp.
      • Coral Gables, Florida, United States, 33134
        • Herco Medical and Research Center
      • Davie, Florida, United States, 33024
        • Alfa Medical Research
      • Doral, Florida, United States, 33132
        • D H Doral Research Center
      • Fort Myers, Florida, United States, 33901
        • Eye Centers of Florida
      • Homestead, Florida, United States, 33034
        • Sina Medical Center
      • Jacksonville, Florida, United States, 32216
        • East Coast Institute for Research, LLC
      • Miami, Florida, United States, 33144
        • Continental Clinical Research
      • Miami, Florida, United States, 33125
        • Southern Clinical Research LLc
      • Miami, Florida, United States, 33135
        • Retreat Medical Research
      • Plantation, Florida, United States, 33317
        • Edward Jenner Research Group LLC
      • Sarasota, Florida, United States, 34239
        • Sarasota Retina Institute
    • Illinois
      • Orland Park, Illinois, United States, 60462
        • Advanced Quality Medical Research
    • Massachusetts
      • East Weymouth, Massachusetts, United States, 02189
        • Ophthalmic Consultants of Boston
    • Michigan
      • Fraser, Michigan, United States, 48026
        • Fraser Eye Care Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • University of Missouri Kansas City
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Rutgers New Jersey Medical School
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Jackson Clinic
    • Texas
      • Carrollton, Texas, United States, 75010
        • DFW Clinical Trials
      • Houston, Texas, United States, 77099
        • Pioneer Research Solutions Inc.
      • Houston, Texas, United States, 77074
        • Neuro Eye Clinical Trials
      • San Antonio, Texas, United States, 78240
        • San Antonio Clinical Trials
      • San Antonio, Texas, United States, 78258
        • Eyeplastx
      • Seabrook, Texas, United States, 77586
        • Elevate Clinical Research

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

Key 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 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

Key Exclusion Criteria:

  • Must not have received prior treatment with another anti-IGF-1R therapy
  • Must not have received systemic corticosteroids or steroid eye drops 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 for any condition, including TED, within 8 weeks or longer duration (depending on the type of investigational agent) 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. Must also not have a 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

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VRDN-003 every 4 weeks
6 subcutaneous administrations of VRDN-003
Drug: VRDN-003
VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R).
Experimental: VRDN-003 every 8 weeks
3 subcutaneous administrations of VRDN-003 and 3 subcutaneous administrations of placebo
Drug: VRDN-003
VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R).
Drug: Placebo
Placebo injections that appear identical to VRDN-003 injections but have no active drug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24
Time Frame: Week 24
Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in proptosis in the study eye at Week 24 as measured by exophthalmometer
Time Frame: Week 24
Change from baseline in proptosis in the study eye
Week 24
TEAE incident rate through study completion
Time Frame: Week 52
Treatment Emergent Adverse Event (TEAE) incidence rate measurement through study completion
Week 52

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)

February 3, 2025

Primary Completion (Actual)

April 22, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

January 31, 2025

First Posted (Actual)

February 6, 2025

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VRDN-003-303

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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