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Also known as Empasiprubart IV
ARGX-117 · 3 trials · 3 indications
Estimated glomerular filtration rate
AE : Adverse Events, SAE: Serious Adverse Events
| Arm | Type | Description |
|---|---|---|
| ARGX-117 | EXPERIMENTAL | Patients receiving ARGX-117 intravenous infusions |
| Placebo | PLACEBO_COMPARATOR | Patients receiving placebo intravenous infusions |
| Name | Type | Description |
|---|---|---|
| ARGX-117 | BIOLOGICAL | Intravenous administration of ARGX-117 |
| Placebo | OTHER | Intravenous administration of placebo |
Inclusion Criteria: * Is at least the local legal age of consent for clinical studies and at least aged 18 years and less than 70 years * Agree to use contraceptive measures consistent with local regulations * Are diagnosed with ESRD and have been stable on chronic dialysis for at least 3 months * ...
ARGX-117 is an investigational monoclonal antibody being studied for delayed graft function in deceased donor kidney transplant recipients and for multifocal motor neuropathy. Both programs are in Phase 2 clinical development. It is not approved for any indication.
ARGX-117 targets C2, a complement protein. By binding C2, the antibody is designed to modulate the classical and lectin pathways of the complement system, which are implicated in the conditions being studied.
ARGX-117 is being developed by argenx SE, which trades on Nasdaq under the ticker ARGX. The company is running the Phase 2 clinical programs for the drug in delayed graft function and multifocal motor neuropathy.
ARGX-117 is in Phase 2 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. Two Phase 2 trials are active and not recruiting, and one Phase 2 trial has been completed.
ARGX-117 has been studied in three Phase 2 trials. NCT05907096 evaluates it in deceased donor kidney transplant recipients at risk for delayed graft function. NCT05405361 and NCT05225675 evaluate it in adults with multifocal motor neuropathy, with NCT05225675 completed.
Across the three Phase 2 trials, 208 participants have been enrolled: 103 in the delayed graft function study NCT05907096, 51 in the multifocal motor neuropathy study NCT05405361, and 54 in the completed multifocal motor neuropathy study NCT05225675.