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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07155668 | A Safety, Tolerability and Pharmacokinetics Study of VRDN-003 in Participants With Thyroid Eye Disease (TED) | PHASE3 | ACTIVE NOT_RECRUITING | 87 | — | — | Jul 1, 2025 | Nov 1, 2026 | Jan 14, 2026 | 13 | United States |
| NCT06625398 | An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Chronic Thyroid Eye Disease (TED) | PHASE3 | ACTIVE NOT_RECRUITING | 204 | — | — | Aug 27, 2024 | Dec 15, 2026 | May 19, 2026 | 37 | United States |
| NCT06625411 | An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Active Thyroid Eye Disease (TED) | PHASE3 | ACTIVE NOT_RECRUITING | 132 | — | — | Aug 27, 2024 | Nov 15, 2026 | Apr 14, 2026 | 34 | United States |
Description: Proportion of participants with a ≥2 mm reduction from baseline in proptosis in the most proptotic eye as measured by exophtalmometer \[without a corresponding increase of ≥2 mm in the other eye\]
Proportion of participants with a ≥2 mm reduction from baseline in proptosis in the most proptotic eye as measured by exophtalmometer \[without a corresponding increase of ≥2 mm in the other eye\]
| Arm | Type | Description |
|---|---|---|
| VRDN-003 every 4 weeks using autoinjector | EXPERIMENTAL | 6 subcutaneous administrations of VRDN-003 \[1 loading dose of 600mg and 5 doses of 300mg\] |
| VRDN-003 every 8 weeks using autoinjector | EXPERIMENTAL | 3 subcutaneous administrations of VRDN-003 \[1 loading dose of 600mg and 2 doses of 300mg\] |
| VRDN-003 every 8 weeks using vial and syringe | EXPERIMENTAL | 3 subcutaneous administrations of VRDN-003 \[1 loading dose of 600mg and 2 doses of 300mg\] |
| VRDN-003 every 4 weeks | EXPERIMENTAL | 6 subcutaneous administrations of VRDN-003 |
| VRDN-003 every 8 weeks | EXPERIMENTAL | 3 subcutaneous administrations of VRDN-003 and 3 subcutaneous administrations of placebo |
| Placebo every 4 weeks | PLACEBO_COMPARATOR | 6 subcutaneous administrations of placebo |
| Name | Type | Description |
|---|---|---|
| VRDN-003 | DRUG | VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R). |
| Autoinjector | DEVICE | The autoinjector is a single-dose, disposable, ready-to-use delivery device |
| Placebo | DRUG | All participants will receive the same number of injections to maintain masking. Masking will be maintained by the use of placebo injections that appear identical to VRDN-003 injections. |
Inclusion Criteria: * Have a clinical diagnosis of TED with or without proptosis, with any CAS (0-7) and in the opinion of the Investigator may benefit from VRDN-003 * Not require immediate ophthalmological or orbital surgery in the study eye for any reason * Must agree to use highly effective cont...