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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05524571 | Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease | PHASE3 | COMPLETED | 86 | — | — | Jan 5, 2023 | Mar 3, 2026 | Apr 1, 2026 | 45 | United States, Australia +9 |
| NCT05517421 | Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease | PHASE3 | COMPLETED | 114 | — | — | Nov 23, 2022 | Nov 18, 2025 | Dec 3, 2025 | 93 | United States, Canada +7 |
Proptosis is the amount of protrusion of the eye from the orbital rim. Measurements are recorded using the Hertel exophthalmometer. The study eye is defined as the most severely affected eye at the Baseline visit. Proptosis responder is defined as the participant with a greater than or equal to (≥) 2 millimeters (mm) reduction in the study eye without deterioration (≥2 mm increase) in the fellow eye.
| Arm | Type | Description |
|---|---|---|
| Batoclimab | EXPERIMENTAL | Participants will be administered batoclimab 680 mg SC weekly for 12 weeks followed by 340 mg SC weekly for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants will be administered matching placebo SC weekly for 24 weeks. |
| Name | Type | Description |
|---|---|---|
| Batoclimab | DRUG | Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody |
| Placebo | DRUG | Matching Placebo |
Inclusion criteria: 1. Are ≥18 years of age at screening. 2. Have a clinical diagnosis of TED associated with active, moderate to severe TED with the following at screening and Visit 0: * A CAS ≥ 4 in either eye, and * Clinical evidence of worsened proptosis with: * Proptosis ≥ 18 mm a...