Clinical Trials

Inclusion Criteria:

* Kidney transplant received ≥ 6 months
* Active or chronic active AMR according to Banff 2022 classification, based on Screening kidney biopsy
* HLA-DSA (preformed and/or de novo DSA)
* MVI score ≥ 2 (g ≥ 1 and ptc ≥ 1)
* eGFR ≥ 30 mL/min/1.73 m2
* Must be vaccinated for S pneumoniae prior to randomization
* Must be vaccinated for H influenzae type B (where available) prior to randomization

Exclusion Criteria:

* Biopsy-based diagnosis of any of the following at Screening:
* TCMR, according to the Banff grade ≥ 1
* Polyoma virus nephropathy
* Severe thrombotic microangiopathy
* Glomerulonephritis
* ABO-incompatible transplant
* uACR > 2200 mg/g indicating nephrotic range proteinuria
* Hemoglobin < 8 g/dL
* Platelets < 100 × 109/L
* Leucocytes < 3 × 109/L
* Neutrophils < 1.5 × 109/L
* Multiorgan transplant recipient (except for previous multiple kidney transplants) or cell transplant (islet, bone marrow, stem cell) recipient
* Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization
* Participants with history of HIV who are not on anti-retroviral therapy or if on therapy have a known detectable viral load within 1 year of Screening
* Evidence of hepatitis B or hepatitis C infections
* Congenital immunodeficiency
* History of unexplained, recurrent infection
* Pregnant, breastfeeding, or intending to conceive within 6 months after the last dose of study intervention
* ALT or AST > 2.0 × ULN
* Total bilirubin > 2 × ULN (participants with Gilbert's syndrome can be included with total bilirubin > 2 × ULN as long as direct bilirubin is ≤ 1.5 × ULN)
* Current or chronic history of liver disease that is considered clinically significant by the Investigator
* Planned or recent treatments, < 3 months prior to the Screening Visit, for Acute Rejection, AMR (including plasmapheresis, plasma exchange, IVIg, B-cell depleting therapy, IL inhibitors, proteasome inhibitors, high-dose corticosteroids [except for tapering]), TCMR (including T-cell depleting therapy), excluding the SoC treatment which will be allowed and should be stable during the entire treatment

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/13/2025. Questions regarding updates should be directed to the study team contact.