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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06384547 | A Randomized, Controlled, Safety and Tolerability Study of VRDN-001 in Participants With Thyroid Eye Disease (TED) | PHASE3 | COMPLETED | 231 | — | — | May 23, 2024 | Jan 19, 2026 | Apr 30, 2026 | 50 | United States, Australia +5 |
| Arm | Type | Description |
|---|---|---|
| VRDN-001 10 mg/kg | EXPERIMENTAL | 5 infusions of VRDN-001 10 mg/kg |
| 5 infusions of VRDN-001 3 mg/kg | EXPERIMENTAL | 5 infusions of VRDN-001 3 mg/kg |
| Name | Type | Description |
|---|---|---|
| VRDN-001 10 mg/kg | DRUG | 5 infusions of VRDN-001 10 mg/kg |
| VRDN-001 3 mg/kg | DRUG | 5 infusions of VRDN-001 3 mg/kg |
Inclusion Criteria: * Have a clinical diagnosis of TED with or without proptosis and with any CAS (0 - 7) and in the opinion of the investigator may benefit from treatment * Must agree to use highly effective contraception method as specified in the protocol * Female TED participants must have a ne...