NCT06384547

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 231 (actual)
• Sponsor: Viridian Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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 patients with thyroid eye disease (TED). The primary objective of this clinical trial is to evaluate the safety and tolerability of VRDN-001 in patients with TED.

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).

Conditions

• Thyroid Eye Disease

Interventions

Type	Name	Description
DRUG	VRDN-001 10 mg/kg	5 infusions of VRDN-001 10 mg/kg
DRUG	VRDN-001 3 mg/kg	5 infusions of VRDN-001 3 mg/kg

Timeline

• Start date: 2024-05-23
• Primary completion: 2025-05-01
• Completion: 2026-01-19
• First posted: 2024-04-25
• Last updated: 2026-02-18

Locations

50 sites across 7 countries: United States, Australia, France, Germany, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study