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ALXN2030 · 1 trial · 4 indications
| 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...
ALXN2030 is an investigational small molecule being developed by AstraZeneca PLC for antibody-mediated rejection, a complication that can occur after kidney transplantation. It is currently in Phase 2 clinical development and has not been approved by any regulatory agency. The program is being studied in a single active trial.
ALXN2030 is being studied for the treatment of antibody-mediated rejection in patients who have received a kidney transplant. The Phase 2 trial enrolls adults with biopsy-proven histologic scores consistent with AMR. It is investigational and its safety and efficacy in this indication have not been established.
ALXN2030 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is running the clinical program for the asset in antibody-mediated rejection following kidney transplantation. The drug remains investigational and is not commercially available.
ALXN2030 is in Phase 2 clinical development. One Phase 2 trial is currently active and not recruiting, and no trials for ALXN2030 have been completed. The drug is investigational, meaning it has not received approval from the FDA or any other regulatory authority.
ALXN2030 is being evaluated in the Phase 2 study NCT06744647, titled a Phase 2 Study of ALXN2030 in Patients With Antibody-Mediated Rejection After Kidney Transplantation. The trial is randomized, double-blind, and placebo-controlled, with an enrollment of 47 patients across the United States, Brazil, Canada, China, South Korea, Spain, Taiwan, and the United Kingdom.
The Phase 2 trial NCT06744647 enrolls patients aged 18 years and older of any sex. Participants must have antibody-mediated rejection after kidney transplantation, and healthy volunteers are not eligible. The study is currently active but not recruiting new participants.