A Randomized, Controlled, Safety and Tolerability Study of VRDN-001 in Participants With Thyroid Eye Disease (TED)
NCT06384547 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 231
Last updated 2026-08-13
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 TED. The primary objective of this clinical trial is to evaluate the safety and tolerability of VRDN-001 in participants with TED.
Conditions
Interventions
- DRUG
-
Veligrotug
5 infusions of veligrotug
Sponsors & Collaborators
-
Viridian Therapeutics, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-23
- Primary Completion
- 2025-05-01
- Completion
- 2026-01-19
- FDA Drug
- Yes
Countries
- United States
- Australia
- France
- Germany
- Poland
- Spain
- United Kingdom
Study Locations
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