Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06179875 | An Open-label Study (OLE) for Non-responders of VRDN-001-101 (NCT05176639) and VRDN-001-301 (NCT06021054) | PHASE3 | COMPLETED | 143 | — | — | Jan 31, 2024 | Jun 23, 2025 | Apr 30, 2026 | 45 | United States, France +6 |
| NCT06021054 | An Efficacy, Safety, and Tolerability Study of Veligrotug (VRDN-001), in Participants With Chronic Thyroid Eye Disease (TED) (THRIVE-2) | PHASE3 | COMPLETED | 188 | — | — | Nov 14, 2023 | Jul 25, 2025 | Oct 23, 2025 | 57 | United States, Australia +7 |
Proptosis Responder Rate in the most proptotic eye (i.e., reduction of proptosis of ≥ 2 mm from baseline \[without a corresponding increase of ≥ 2 mm in the other eye\]) as measured by exophthalmometer
| Arm | Type | Description |
|---|---|---|
| Veligrotug 10 mg/kg | EXPERIMENTAL | 5 infusions of Veligrotug 10 mg/kg |
| Veligrotug (VRDN-001)10 mg/kg | EXPERIMENTAL | Drug: 5 IV Infusions of veligrotug (VRDN-001)10 mg/kg |
| Placebo Drug | EXPERIMENTAL | Placebo Drug: 5 IV Infusions of placebo |
| Name | Type | Description |
|---|---|---|
| Veligrotug | DRUG | Veligrotug 10 mg/kg (5 infusions of Veligrotug 10 mg/kg) |
| Veligrotug (VRDN-001) | DRUG | Veligrotug (VRDN-001) is a humanized monoclonal antibody directed against the IGF-1 receptor |
| Placebo | DRUG | 5 IV infusions of placebo |
Key Inclusion Criteria: 1. Be able to understand the study procedures and the risks involved and be willing to provide written informed consent before the first study-related activity 2. Have completed at least 5 IV infusions and assessments required to determine proptosis responder status 3 weeks ...