NCT06812325

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 321 (actual)
• Sponsor: Viridian Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Thyroid Eye Disease (TED)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-03
• Primary completion: 2026-04-01
• Completion: 2026-10-01
• First posted: 2025-02-06
• Last updated: 2026-04-08

Locations

64 sites across 7 countries: United States, France, Germany, Poland, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study