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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06744647 | Phase 2 Study of ALXN2030 in Patients With Antibody-Mediated Rejection After Kidney Transplantation | PHASE2 | RECRUITING | 45 | — | — | Mar 7, 2025 | Nov 7, 2028 | Apr 27, 2026 | 55 | United States, Brazil +6 |
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo will be administered during the Double-Blind Treatment Period of 52 weeks. |
| ALXN2030 Dose A | EXPERIMENTAL | During the Double-Blind Treatment Period, participants will receive ALXN2030 dose A over 52 weeks. At Week 52, participants may continue into the Open Label Extension (OLE). |
| ALXN2030 Dose B | EXPERIMENTAL | During the Double-Blind Treatment Period, participants will receive ALXN2030 dose B over 52 weeks. At Week 52, participants may continue into the OLE Period. |
| Name | Type | Description |
|---|---|---|
| ALXN2030 | DRUG | ALXN2030 will be administered subcutaneously (SC). |
| Placebo | DRUG | Placebo will be administered SC. |
Inclusion Criteria: * Kidney transplant received ≥ 6 months * Active or chronic active AMR according to Banff 2022 classification, based on Screening kidney biopsy * Either positive C4d on Screening kidney biopsy based on the Central Pathology Laboratory report and/or positive HLA Class I and/or II...