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NCT05176639 · ClinicalTrials.gov registry record · Phase 3
A Safety, Tolerability and Efficacy Study of Veligrotug (VRDN 001) in Healthy Volunteers and Participants With Thyroid Eye Disease (TED) ( THRIVE )
A Phase 3 study of Thyroid Eye Disease, sponsored by Viridian Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 113
- Enrollment target
- 20
- Study locations
NCT05176639 is a Phase 3 study of Thyroid Eye Disease that has completed, run by Viridian Therapeutics. The registered enrollment target is 113 participants, above the 99-participant average among 15 other Thyroid Eye Disease trials with a reported enrollment target (14% higher). The trial reports 20 study locations across 7 states.
The verdict
NCT05176639, a Phase 3 study of Thyroid Eye Disease, has completed, sponsored by Viridian Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 113 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG VRDN-001 Phase 3 Cohort (THRIVE)
- DRUG VRDN-001 Placebo
Study Locations (20)
California
- University of Colorado - Department of Ophthalmology - Aurora
- The Private Office of Raymond Douglas - Beverly Hills
- USC Roski Eye Institute - Los Angeles
- MACRO Trials, Inc. - Los Angeles
- Amy Patel Jain, MD - Newport Beach
- Byers Eye Institute/Stanford University - Palo Alto
- Senta Clinic - San Diego
- University of California, San Francisco - San Francisco
Florida
- Sina Medical Center - Homestead
- Med-Care Research Inc. - Miami
- Edward Jenner Research Group Center LLC - Plantation
- Sarasota Retina Institue - Sarasota
Kansas
- University Health Diabetes, Endocrinology & Nephrology Center - Kansas City
- KU Medical Center, University of Kansas - Kansas City
Massachusetts
- Massachusetts Eye and Ear - Boston
- Ophthalmic Consultants of Boston - Weymouth
Michigan
- Fraser Eye Care Center - Fraser
- Kahana Oculoplastic & Orbital Surgery - Livonia
Colorado
- University of Colorado - Aurora
Illinois
- Vision Medical Research Inc. - Orland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2021-12-03 |
| Est. Completion | 2025-03-27 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05176639
The ClinicalTrials.gov registry entry for NCT05176639 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 113 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 99-participant average among 15 other Thyroid Eye Disease trials with a reported enrollment target (14% higher). The listed sponsor is Viridian Therapeutics, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Thyroid Eye Disease appearing as the primary indexed condition, and to 2 interventions - of which VRDN-001 Phase 3 Cohort (THRIVE) is the first listed.
NCT05176639 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Florida, Kansas.
Frequently Asked Questions
What is clinical trial NCT05176639 about?
NCT05176639 is a clinical study titled "A Safety, Tolerability and Efficacy Study of Veligrotug (VRDN 001) in Healthy Volunteers and Participants With Thyroid Eye Disease (TED) ( THRIVE )". 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 ...
What is the current status of trial NCT05176639?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 113 participants. The study started on 2021-12-03. Estimated completion is 2025-03-27.
What conditions does trial NCT05176639 study?
This clinical trial studies the following conditions: Thyroid Eye Disease.
What interventions are being tested in trial NCT05176639?
The interventions under investigation include: VRDN-001 Phase 3 Cohort (THRIVE) (DRUG), VRDN-001 Placebo (DRUG).
Who is sponsoring clinical trial NCT05176639?
This trial is sponsored by Viridian Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05176639 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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