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

NCT06179875 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2026-08-14

Study results available
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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 participants 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

Interventions

DRUG

Veligrotug

Veligrotug 10 mg/kg (5 infusions of Veligrotug 10 mg/kg)

Sponsors & Collaborators

  • Viridian Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2025-04-25
Completion
2025-06-23
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Netherlands
  • Poland
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06179875 on ClinicalTrials.gov