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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05907668 | A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease | PHASE2 | COMPLETED | 35 | — | — | May 15, 2023 | Jul 25, 2025 | Feb 2, 2026 | 1 | Germany |
| Arm | Type | Description |
|---|---|---|
| Batoclimab | EXPERIMENTAL | Participants will receive batoclimab 680 milligrams (mg) subcutaneously (SC) weekly (QW) injection for 12 weeks followed by 340 mg SC QW for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| IMVT-1401 (batoclimab) | DRUG | Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody. |
Inclusion Criteria: * Have serologically confirmed GD as documented by presence of elevated stimulatory thyrotropin receptor antibody (TSH-R-Ab) level (i.e., \> specimen-to-reference ratio of 140%) at the Screening Visit. * Have active hyperthyroidism due to GD with the following laboratory values ...