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ARGX-121

Phase 2

Immunoglobulin A Nephropathy (IgAN) | Monoclonal antibody | Nephrology |argenx SE|Last Updated: Aug 19, 2026

Target and mechanism

Molecular targetIgA
Target classProtein
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

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
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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
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

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...

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Recent Changes (Last 90 Days)

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?

ARGX-121 is an investigational monoclonal antibody being developed for the treatment of Immunoglobulin A Nephropathy (IgAN), a kidney disease. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

What does ARGX-121 target?

ARGX-121 targets IgA, a protein involved in the immune system. By binding to IgA, the drug is designed to interfere with the disease process in Immunoglobulin A Nephropathy (IgAN), potentially reducing proteinuria in affected patients.

Who is developing ARGX-121?

ARGX-121 is being developed by argenx SE, a biopharmaceutical company traded on the NASDAQ under the ticker symbol ARGX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Immunoglobulin A Nephropathy.

What phase is ARGX-121 in?

ARGX-121 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied in clinical trials for the treatment of Immunoglobulin A Nephropathy.

What clinical trials is ARGX-121 in?

ARGX-121 is being evaluated in a Phase 2 clinical trial with the identifier NCT07773727. This randomized, double-blind, placebo-controlled study is designed to assess the effect of ARGX-121 on the change in proteinuria in adult participants with Immunoglobulin A Nephropathy, with an estimated enrollment of 120 participants.