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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06503731 | A Study to Evaluate the Safety and Tolerability of Efgartigimod PH20 SC Given by Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection (AMR) | PHASE2 | RECRUITING | 30 | — | — | Aug 30, 2024 | Sep 1, 2027 | Mar 18, 2026 | 23 | United States, Austria +6 |
| Arm | Type | Description |
|---|---|---|
| Treatment arm 1 | EXPERIMENTAL | Participants receiving Efgartigimod PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids) |
| Treatment arm 2 | EXPERIMENTAL | Participants receiving Efgartigimod PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids) up to week 24 followed by placebo PH20 SC on top of optimized standard background immunosuppression therapy from weeks 24 to 48 |
| Treatment arm 3 | PLACEBO_COMPARATOR | Participants receiving Placebo PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids) |
| Name | Type | Description |
|---|---|---|
| Efgartigimod PH20 SC - prefilled syringe | COMBINATION_PRODUCT | Subcutaneous efgartigimod PH20 SC given by prefilled syringe |
| Placebo PH20 SC - prefilled syringe | OTHER | Subcutaneous placebo PH20 SC given by prefilled syringe |
Inclusion Criteria: * The participant is within the ages of 18 and 80 years old * The participant had a kidney transplant (living or deceased donor) at least 6 months before the study * The participant has received a diagnosis of active or chronic active antibody-mediated rejection (AMR) with detec...