drugset / Trial / NCT05176639

A Safety, Tolerability and Efficacy Study of Veligrotug (VRDN 001) in Healthy Volunteers and Participants With Thyroid Eye Disease (TED) ( THRIVE )

NCT05176639

Phase 3 Completed 113 enrolled Viridian Therapeutics, Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

The investigational drug, veligrotug (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 establish the safety, tolerability, and efficacy of veligrotug, and the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of veligrotug in active TED patients who received 10 mg/kg.

Timeline

Start
2021-12-03
Primary completion
2024-07-15
Completion
2025-03-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Veligrotug Monoclonal antibody 10 mg/kg Intravenous