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Also known as Recombinant humanized immunoglobulin G1 (IgG1) Fab
ANX009 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| ANX009 | EXPERIMENTAL | Participants will receive repeat doses of ANX009 administered by subcutaneous (SC) infusion 3 times weekly during the approximate 3-week intervention period. |
| Name | Type | Description |
|---|---|---|
| ANX009 | BIOLOGICAL | ANX009 will be administered per schedule specified in the arm description. |
Key Inclusion Criteria: * Participants who have a diagnosis of SLE according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 2019 Criteria * Has a history of International Society of Nephrology/Renal Pathology Society (ISN/RPS) Class III or IV with or without Clas...
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ANX009 is an investigational monoclonal antibody developed by Annexon, Inc. for lupus nephritis, a kidney complication of lupus. It is in Phase 1 clinical development and has been studied in a completed Phase 1 trial. It is not an approved therapy.
ANX009 is being developed for the treatment of lupus nephritis, a form of kidney inflammation that occurs in people with lupus. Its only clinical study to date enrolled adults with lupus nephritis. The drug remains investigational and has not been approved for any use.
ANX009 targets C1q, a complement protein. By binding C1q, the monoclonal antibody is designed to act on the complement pathway. C1q is part of the classical complement cascade, a component of the immune system implicated in lupus nephritis.
ANX009 is being developed by Annexon, Inc., a biopharmaceutical company that trades on the Nasdaq under the ticker ANNX. Annexon is the sponsor of the clinical program evaluating ANX009 in lupus nephritis.
ANX009 is in Phase 1 clinical development. Its single reported trial, NCT05780515, was a Phase 1 study in adults with lupus nephritis that has been completed. ANX009 is investigational and has not been approved by the FDA.
ANX009 has been evaluated in one clinical trial, NCT05780515, titled A Study of ANX009 in Adult Participants With Lupus Nephritis. The Phase 1 trial enrolled 7 adults, was uncontrolled, and has been completed. It was conducted in the Philippines and Taiwan.