Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ANX009 · 2 trials · 2 indications
Incidence and severity of treatment-emergent adverse events (AEs). AEs will be coded using MedDRA and severity of AEs will be graded using National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE).
| 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. |
| ANX009, Single Ascending Doses | EXPERIMENTAL | Single dose of ANX009 with a 7-day follow-up before escalation to the next dose level. |
| Placebo, Single Ascending Doses | PLACEBO_COMPARATOR | Single doses of matching placebo |
| ANX009, Multiple Ascending Doses | EXPERIMENTAL | ANX009 once daily on Days 1-14 |
| Placebo, Multiple doses | PLACEBO_COMPARATOR | Matching placebo once daily on Days 1-14 |
| Name | Type | Description |
|---|---|---|
| ANX009 | BIOLOGICAL | ANX009 will be administered per schedule specified in the arm description. |
| Placebo | DRUG | Single or multiple ascending dose |
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...
ANX009 is an investigational monoclonal antibody being studied for lupus nephritis. It is also being evaluated for safety and tolerability in healthy volunteers. The drug is in Phase 1 clinical development and is not yet approved by regulatory authorities.
ANX009 is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. The drug is being studied for its effects in lupus nephritis, an inflammatory kidney condition, though the exact mechanism of action is not publicly detailed.
ANX009 is being developed by Annexon, Inc., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol ANNX. Annexon is conducting clinical trials to evaluate the drug's safety and efficacy.
ANX009 is currently in Phase 1 clinical development. It has completed two Phase 1 trials: one in healthy volunteers and one in participants with lupus nephritis. The drug is investigational and has not received FDA approval.
ANX009 has been studied in two completed Phase 1 trials. The first, NCT04535752, evaluated single and multiple ascending doses in healthy volunteers in Australia. The second, NCT05780515, studied the drug in adults with lupus nephritis in the Philippines and Taiwan.
ANX009 is not known to have alternative names. It is a distinct investigational monoclonal antibody developed by Annexon, Inc. No other names for this drug have been reported in clinical trial registries or public information.