NCT06179875

An Open-label Study (OLE) for Non-responders of VRDN-001-101 and VRDN-001-301

An Open-label Study for Participants Who Are Non-responders at the End of Treatment Assessment on the VRDN-001-101 and VRDN-001-301 Pivotal Studies

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Viridian Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 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 objectives of this clinical trial are to provide open-label access to VRDN-001 for participants who were previously non-responders at 3 weeks post the fifth IV infusion (i.e., 15 weeks) in the VRDN-001-101 (THRIVE) and VRDN-001-301 (THRIVE-2) pivotal studies and assess the safety and efficacy of VRDN-001 in participants who were previously treated with VRDN-001 or placebo.

Conditions

• Thyroid Eye Disease

Interventions

Type	Name	Description
DRUG	Intervention/Treatment	VRDN-001 10 mg/kg (5 infusions of VRDN-001 10 mg/kg)

Timeline

• Start date: 2024-01-31
• Primary completion: 2025-04-25
• Completion: 2025-06-23
• First posted: 2023-12-22
• Last updated: 2026-02-12

Locations

45 sites across 8 countries: United States, France, Germany, Netherlands, Poland, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study