An Open-label Study (OLE) for Non-responders of VRDN-001-101 and VRDN-001-301
Public ClinicalTrials.gov record NCT06179875. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-label Study for Participants Who Are Non-responders at the End of Treatment Assessment on the VRDN-001-101 and VRDN-001-301 Pivotal Studies
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06179875
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 139 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 30, 2024
- Primary completion
- Apr 24, 2025
- Completion
- Jun 22, 2025
- Last update posted
- Aug 13, 2026
2024 – 2025
United States locations
- U.S. sites
- 18
- U.S. states
- 11
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Advancing Research International, LLC | Los Angeles | California | 90023 | — |
| USC Eye Institute | Los Angeles | California | 90033 | — |
| Advancing Research International, LLC | Newport Beach | California | 90023 | — |
| Stanford Byers Eye Institute | Palo Alto | California | 94303 | — |
| Cockerham Eye Consultants, PC | San Diego | California | 92108 | — |
| University of Miami Miller School of Medicine, Bascom Palmer Eye Institute | Miami | Florida | 33136 | — |
| Sarasota Retina Institute | Sarasota | Florida | 34239 | — |
| Vision Medical Research | Oak Lawn | Illinois | 60453 | — |
| Ophthalmic Consultants of Boston | East Weymouth | Massachusetts | 02189 | — |
| Kahana Oculoplastic & Orbital Surgery | Livonia | Michigan | 48152 | — |
| Ophthalmic Plastic, Reconstructive, Orbital and Cosmetic Surgery | Las Vegas | Nevada | 89144 | — |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07103 | — |
| The Center for Eye and Facial Plastic Surgery | Somerset | New Jersey | 08873 | — |
| Hospital of the University of Pennsylvania Perleman Center | Philadelphia | Pennsylvania | 19104 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Neuro-Eye Clinical Trials | Houston | Texas | 77074 | — |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | — |
| University of Washington Medical Center | Seattle | Washington | 98104-2430 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 27 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06179875, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 13, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06179875 live on ClinicalTrials.gov.