ANX 009
ANX009 is an antigen binding fragment (Fab) of a humanized antibody against C1q that inhibits C1q substrate interactions and fully blocks activation of all downstream classical complement components.
Enroll in this clinical study
How is ANX009 being studied in Lupus nephritis?
The safety, tolerability, and pharmacodynamics of repeat doses of ANX009 with standard-of-care therapy in adult patients with Lupus Nephritis were studied in this single-arm, Phase 1b, Open-Label Study. Participants will receive repeat doses of ANX009 administered by subcutaneous (SC) infusion 3 times weekly during the approximate 3-week intervention period.
The primary outcome is the number of participants with treatment-emergent adverse events. The secondary outcomes include the change from baseline in free Complement Component 1q (C1q) concentrations in serum over time and the change from baseline in Complement Factor C4 concentration and its activation product (Complement Component 4d [C4d]) in plasma over time.
Eligibility Criteria
Participants who have a history of International Society of Nephrology/Renal Pathology Society (ISN/RPS) Class III or IV with or without Class V glomerulonephritis on renal biopsy within 24 months before screening or as performed during screening.
Proteinuria level between ≥0.5 to 3.0 grams (g)/g/day assessed via urine protein to creatinine ratio (UPCR) during screening.
Evidence of classical complement activation at screening
History of receiving one or more standard therapies for LN