Recent Updates
Recently added Catalysts

ARGX-121

Phase 2

Immunoglobulin A Nephropathy (IgAN) | Monoclonal antibody | Nephrology |argenx SE|Trials Updated: Oct 16, 2026

ARGX-121 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Aug 2026

ARGX-121 target and mechanism

Molecular targetIgA
Target classProtein
ModalityMonoclonal antibody

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment120

FDA Designations

No designations recorded

ARGX-121 clinical trials

ARGX-121 · 1 trial · 1 indication

Phase 2 1
NCT07773727A Study to Evaluate the Effect of ARGX-121 on the Change in Proteinuria in Adult Participants With IgANImmunoglobulin A Nephropathy (IgAN)
NOT YET_RECRUITING120 Analytics
PHASE2NOT YET_RECRUITING
A Study to Evaluate the Effect of ARGX-121 on the Change in Proteinuria in Adult Participants With IgAN
Immunoglobulin A Nephropathy (IgAN)Unlock trial analytics

Study Endpoints

Primary Endpoints

Change in proteinuria from baseline to week 24 as measured by the log-transformed urine protein-to-creatinine ratio (UPCR) derived from 24-h urine collection.
Up to 24 weeks

UPCR is urine protein-to-creatinine ratio

Secondary Endpoints

Total annualized rate of change (slope) in the estimated glomerular filtration rate (eGFR) at week 52
52 weeks
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Up to 68 weeks
Cmax (ARGX-121 maximum observed concentration) in serum
Up to 68 weeks
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ARGX-121EXPERIMENTALParticipants will receive ARGX-121 in subcutaneous injections during the double blinded treatment period and active only treatment periods (Total of 52 weeks)
Placebo followed by ARGX-121PLACEBO_COMPARATORParticipants receive placebo for the double-blinded period of 24 weeks, followed by subcutaneous injections of ARGX-121 during the active only treatment period of 28 weeks.

Interventions

NameTypeDescription
ARGX-121BIOLOGICALSubcutaneous Injection of ARGX-121
PlaceboBIOLOGICALSubcutaneous Injection of Placebo
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Males and females (not pregnant) * At least 18 years old * Clinically diagnosed with IgAN with biopsy confirmation Exclusion Criteria: * Diagnosis of another autoimmune disease or known medical condition that would interfere with accurate assessment of clinical systems of Ig...

Countries:United StatesJapan
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

LOWOct 16, 2026NCT07773727lastUpdatePostDate: changed
LOWOct 16, 2026NCT07773727lastUpdatePostDate: changed
LOWSep 23, 2026NCT07773727lastUpdatePostDate: changed
LOWSep 23, 2026NCT07773727lastUpdatePostDate: changed
LOWSep 17, 2026NCT07773727lastUpdatePostDate: changed
LOWSep 17, 2026NCT07773727lastUpdatePostDate: changed
LOWAug 20, 2026NCT07773727NEW_TRIAL: changed
LOWAug 20, 2026NCT07773727NEW_TRIAL: changed
LOWAug 20, 2026NCT07773727NEW_TRIAL: changed
LOWAug 20, 2026NCT07773727NEW_TRIAL: changed

Frequently asked questions about ARGX-121

What is ARGX-121 used for in Immunoglobulin A Nephropathy (IgAN)?

ARGX-121 is an investigational monoclonal antibody being developed for Immunoglobulin A Nephropathy (IgAN), a kidney disease. It is in Phase 2 clinical development and is designed to reduce proteinuria in adults with the condition. It is not approved for any use.

What does ARGX-121 target?

ARGX-121 targets immunoglobulin A (IgA), a protein. By binding IgA, the monoclonal antibody is designed to address the IgA-driven process underlying Immunoglobulin A Nephropathy. The Phase 2 study evaluates its effect on change in proteinuria in adults with IgAN.

Who is developing ARGX-121?

ARGX-121 is being developed by argenx SE, which trades under the ticker ARGX. The company is running the Phase 2 program in Immunoglobulin A Nephropathy across sites in the United States and Japan.

What phase is ARGX-121 in?

ARGX-121 is in Phase 2 clinical development for Immunoglobulin A Nephropathy. It is investigational and has not completed its clinical program. The single registered Phase 2 trial is not yet recruiting and is planned to enroll 120 adult participants.

What clinical trials is ARGX-121 in?

ARGX-121 is being studied in one Phase 2 trial, NCT07773727, titled a study to evaluate the effect of ARGX-121 on the change in proteinuria in adult participants with IgAN. The trial is randomized, double-blind, and placebo-controlled, plans to enroll 120 participants, and is not yet recruiting in the United States and Japan.