A Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)

NCT06812325 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2026-05-22

No results posted yet for this study

Summary

This is a clinical trial assessing the safety and tolerability of an investigational drug, VRDN-003, in participants with Thyroid Eye Disease (TED).

Conditions

  • Thyroid Eye Disease (TED)

Interventions

DRUG

VRDN-003

VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R).

DRUG

Placebo

Placebo injections that appear identical to VRDN-003 injections but have no active drug.

Sponsors & Collaborators

  • Viridian Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-03
Primary Completion
2026-04-22
Completion
2026-10-31
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Drugs

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 NCT06812325 on ClinicalTrials.gov