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

NCT07155668 | Active Not Recruiting Phase 3 DMC FDA Drug FDA Device

• 1 other identifier: VRDN-003-304
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 13

Brief Summary

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

Conditions

Thyroid Eye Disease

Outcome Measures

Primary Outcomes (1)

• Treatment Emergent Adverse Event (TEAE) incidence rate

  Treatment Emergent Adverse Event (TEAE) incidence rate

  Through Week 24

Secondary Outcomes (2)

• Pharmacokinetic outcome measures

  Through Week 24

• Pharmacokinetic outcome measures

  Through Week 24

Study Arms (3)

VRDN-003 every 4 weeks using autoinjector

EXPERIMENTAL

6 subcutaneous administrations of VRDN-003 \[1 loading dose of 600mg and 5 doses of 300mg\]

Drug: VRDN-003; Device: Autoinjector

VRDN-003 every 8 weeks using autoinjector

EXPERIMENTAL

3 subcutaneous administrations of VRDN-003 \[1 loading dose of 600mg and 2 doses of 300mg\]

Drug: VRDN-003; Device: Autoinjector

VRDN-003 every 8 weeks using vial and syringe

EXPERIMENTAL

3 subcutaneous administrations of VRDN-003 \[1 loading dose of 600mg and 2 doses of 300mg\]

Drug: VRDN-003

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 using autoinjector; VRDN-003 every 8 weeks using autoinjector; VRDN-003 every 8 weeks using vial and syringe

Autoinjector DEVICE

The autoinjector is a single-dose, disposable, ready-to-use delivery device

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

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, 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 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/device for any condition, including TED, within 8 weeks or longer (depending on the type of agent/device) 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 or 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 (13)

United Medical Research Institute

Inglewood, California, 90301, United States

Location

C&A Clinical Trials Corp

Cape Coral, Florida, 33990, United States

Location

Ilumina Medical Research

Kissimmee, Florida, 34744, United States

Location

Med-Care Research

Miami, Florida, 33125, United States

Location

Continental Clinical Research, llc

Miami, Florida, 33144, United States

Location

Hype Clinical Research, LLC

Miami, Florida, 33145, United States

Location

Advanced Quality Medical Research, LLC

Orland Park, Illinois, 60462, United States

Location

Ophthalmic Consultants of Boston

East Weymouth, Massachusetts, 02189, United States

Location

Fraser Eye Center

Fraser, Michigan, 48026, United States

Location

Kahana Oculoplastic and Orbital Surgery

Livonia, Michigan, 48152, United States

Location

Vector Clinical Trials

Sparks, Nevada, 89128, United States

Location

Baylor College of Medicine, Alkek Eye Center

Houston, Texas, 77030, United States

Location

Neuro Eye Clinical Trials INC

Houston, Texas, 77074, United States

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: NONE
• Masking Details: This is an open label study with no masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: September 4, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2025-12

Locations

US (13)