In short
ARGX-121 is an investigational substance being studied for the treatment of immunoglobulin A nephropathy (IgAN), a kidney disease. The clinical data currently comes from one Phase 2 trial, which is authorised but not yet recruiting, with a planned enrollment of 111 adult participants. The trial will measure how ARGX-121 affects proteinuria, or protein in the urine, over 24 weeks.
Key points
- ARGX-121 is an investigational therapy, with no marketing authorisation in these records.
- The only registered trial is a Phase 2 study in immunoglobulin A nephropathy (IgAN).
- The trial is authorised but not yet recruiting, with a planned enrollment of 111 adult participants.
- The primary outcome is the change in proteinuria from baseline to week 24, measured by the urine protein-to-creatinine ratio (UPCR).
- ARGX-121 is given as a subcutaneous injection; the trial also includes a placebo arm.
What is ARGX-121?
ARGX-121 is an investigational substance, meaning it has not yet been approved as a medicine by regulatory authorities. It is being developed and studied for the treatment of immunoglobulin A nephropathy (IgAN), a chronic kidney disease. In the European Union Clinical Trials Information System (CTIS), ARGX-121 appears as a test substance with no marketing authorisation.
How does ARGX-121 work?
The mechanism of action of ARGX-121 is not described in the available registry data. The trial record does not include information about the molecular target or the biological pathway affected by this substance.
Which conditions is ARGX-121 studied for?
- Immunoglobulin A nephropathy (IgAN) — a kidney disease in which the antibody immunoglobulin A builds up in the kidneys, causing inflammation and damage that can lead to protein in the urine and reduced kidney function.
How is ARGX-121 given?
In the registered clinical trial, ARGX-121 is given as a subcutaneous injection, which means it is injected under the skin. The trial record lists a dose of 0 mg, indicating that the specific dose information has not been reported in the register.
What do the clinical trials show?
There is one registered clinical trial for ARGX-121. It is a Phase 2, interventional study in adult participants with immunoglobulin A nephropathy (IgAN). The trial is currently authorised, meaning it has received approval to proceed, but it is not yet recruiting participants. The planned enrollment is 111 participants.
The primary outcome is the change in proteinuria from baseline to week 24. Proteinuria means protein in the urine, which is a sign of kidney damage. The trial will measure this using the urine protein-to-creatinine ratio (UPCR) derived from a 24-hour urine collection, with the values log-transformed for analysis. The study also includes a placebo arm, in which participants receive an injection that looks like ARGX-121 but contains no active substance, to allow comparison of the effects.
What side effects are known?
No side effect data for ARGX-121 is available in the current registry records or supplementary sources. As an investigational substance in an early-stage trial, the safety profile has not yet been established.