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

NCT06812325 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: VRDN-003-303
• Study Type: interventional
• Target: 321
• Locations: 7 countries
• Sites: 64

Brief Summary

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

Conditions

Thyroid Eye Disease (TED)

Keywords

Graves; Thyroid Eye Disease; Thyroid-Associated Ophthalmopathy; Dysthyroid Ophthalmopathy; Graves Eye Disease; Graves Orbitopathy; Myopathic Ophthalmopathy; Congestive Ophthalmopathy; Edematous Ophthalmopathy; Infiltrative Ophthalmopathy

Outcome Measures

Primary Outcomes (1)

• Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24

  Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24

  Week 24

Secondary Outcomes (2)

• Change from baseline in proptosis in the study eye at Week 24 as measured by exophthalmometer

  Week 24

• TEAE incident rate through study completion

  Week 52

Study Arms (2)

VRDN-003 every 4 weeks

EXPERIMENTAL

6 subcutaneous administrations of VRDN-003

Drug: VRDN-003

VRDN-003 every 8 weeks

EXPERIMENTAL

3 subcutaneous administrations of VRDN-003 and 3 subcutaneous administrations of placebo

Drug: VRDN-003; Drug: Placebo

Interventions

VRDN-003 DRUG

VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R).

VRDN-003 every 4 weeks; VRDN-003 every 8 weeks

Placebo DRUG

Placebo injections that appear identical to VRDN-003 injections but have no active drug.

VRDN-003 every 8 weeks

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Viridian Therapeutics, Inc.: lead

Study Sites (64)

Catalina Eye Care

Tuscon, Arizona, 85712, United States

Location

United Medical Research Institute

Inglewood, California, 90301, United States

Location

Orbital Plastics

Newport Beach, California, 92660, United States

Location

California Eye Specialists Medical Group INC

Pasadena, California, 91107, United States

Location

FOMAT Medical Research

Pismo Beach, California, 93030, United States

Location

Pacific Neuroscience Institute

Santa Monica, California, 90404, United States

Location

Pacific Neuroscience Institute at Saint John's Physician Partners

Torrance, California, 90503, United States

Location

C A Clinical Trial Corp.

Cape Coral, Florida, 33990, United States

Location

Herco Medical and Research Center

Coral Gables, Florida, 33134, United States

Location

Alfa Medical Research

Davie, Florida, 33024, United States

Location

D H Doral Research Center

Doral, Florida, 33132, United States

Location

Eye Centers of Florida

Fort Myers, Florida, 33901, United States

Location

Sina Medical Center

Homestead, Florida, 33034, United States

Location

East Coast Institute for Research, LLC

Jacksonville, Florida, 32216, United States

Location

Southern Clinical Research LLC

Miami, Florida, 33125, United States

Location

Retreat Medical Research

Miami, Florida, 33135, United States

Location

Continental Clinical Research

Miami, Florida, 33144, United States

Location

Edward Jenner Research Group LLC

Plantation, Florida, 33317, United States

Location

Sarasota Retina Institute

Sarasota, Florida, 34239, United States

Location

Advanced Quality Medical Research

Orland Park, Illinois, 60462, United States

Location

Ophthalmic Consultants of Boston

East Weymouth, Massachusetts, 02189, United States

Location

Fraser Eye Care Center

Fraser, Michigan, 48026, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

University of Missouri Kansas City

Kansas City, Missouri, 64108, United States

Location

Rutgers New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

Jackson Clinic

Jackson, Tennessee, 38305, United States

Location

DFW Clinical Trials

Carrollton, Texas, 75010, United States

Location

Neuro Eye Clinical Trials

Houston, Texas, 77074, United States

Location

Pioneer Research Solutions Inc.

Houston, Texas, 77099, United States

Location

San Antonio Clinical Trials

San Antonio, Texas, 78240, United States

Location

Eyeplastx

San Antonio, Texas, 78258, United States

Location

Elevate Clinical Research

Seabrook, Texas, 77586, United States

Location

Servicde d'Endocrinologie, Diabetologieet Nutrition Centre Hospitalier Universitaire d'Angers

Angers, France

Location

Abeillon du Payrat

Bron, 69500, France

Location

Hôpital La Pitiélsalpêtrière

Paris, France

Location

Charite Universitatsmeizin Berlin KoR Campus Virchow Klinikum

Berlin, Germany

Location

Universitatsklinikum Essen

Essen, Germany

Location

Universitaetsmedizin Goettingen

Göttingen, 37075, Germany

Location

Johannes Gutenberg University Medical Center Department of Medicine 1

Mainz, Germany

Location

Uniwersytecki Szpital Kliniczny w Białymstoku, Klinika Okulistyki, Centrum Badań Klinicznych

Bialystok, 15-276, Poland

Location

Optimum Profesorskie Centrum Okulistyki Sp. z o. o.

Gdansk, 80-180, Poland

Location

Centrum Medyczne Pratia Gdynia

Gdynia, 81-338, Poland

Location

Santa Familia PTG Lodz

Lodz, 90-302, Poland

Location

ETG Lublin

Lublin, 20-412, Poland

Location

Centrum Medyczne Pulawska Sp. z o.o.

Piaseczno, 05-500, Poland

Location

Warszawski Szpital Okulistyczny

Warsaw, 01-258, Poland

Location

Polimedica PTG

Warsaw, 02-777, Poland

Location

Hospital Provincial de Conxo

A Coruña, 15706, Spain

Location

Institut Català de Retina

Barcelona, 08017, Spain

Location

Hospital La Arruzafa

Córdoba, 14012, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Clinica Universidad de Navarre

Navarrés, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Universitario Miguel Servet Consultas de Oftalmologia

Zaragoza, Spain

Location

Gazi University Medical Faculty Hospital

Ankara, Turkey (Türkiye)

Location

Hacettepe Univeristy Medical Fculty Hospital

Ankara, Turkey (Türkiye)

Location

Akdeniz Üniversitesi Tıp Fakültesi Göz Hastalıkları Anabilim Dalı

Antalya, 07059, Turkey (Türkiye)

Location

Marmara Üniversitesi Pendik Eğitim ve Araştırma Hastanesi Göz Hastalıkları Kliniği

Istanbul, Turkey (Türkiye)

Location

University Hospitals Bristol and Weston NHS Foundation Trust Clinical Research Unit

Bristol, United Kingdom

Location

Addenbrookes Hospital

Cambridge, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, NW1 5QH, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

Moorefields Eye Hospital NHS Foundation Trust

London, United Kingdom

Location

The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle, United Kingdom

Location

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant, Site personnel (except pharmacy personnel preparing the injection), and Sponsor are masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to one of the two study arms.

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 6, 2025
• Study Start: February 3, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

DE (4); ES (7); US (32); PL (8); TU (4); GB (6); FR (3)