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ARGX-117

Phase 2

Delayed Graft Function | Monoclonal antibody | Nephrology |argenx SE|Last Updated: May 8, 2026

Target and mechanism

Molecular targetC2
Target classComplement Protein
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment103

FDA Designations

No designations recorded

Clinical trial landscape

ARGX-117 · 4 trials · 4 indications

Phase 2 3Phase 1 1
NCT05907096ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft FunctionDelayed Graft Function
ACTIVE NOT_RECRUITING103 Analytics
NCT05405361A Clinical Trial to Investigate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor NeuropathyMultifocal Motor Neuropathy (MMN)
ACTIVE NOT_RECRUITING51 Analytics
NCT05225675A Clinical Trial to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor NeuropathyMultifocal Motor Neuropathy
COMPLETED54 Analytics
PHASE2ACTIVE NOT_RECRUITING
ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function
Delayed Graft FunctionUnlock trial analytics
PHASE2ACTIVE NOT_RECRUITING
A Clinical Trial to Investigate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy
Multifocal Motor Neuropathy (MMN)Unlock trial analytics
PHASE2COMPLETED
A Clinical Trial to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy
Multifocal Motor NeuropathyUnlock trial analytics

Study Endpoints

Primary Endpoints

eGFR at 24 weeks posttransplant
Up to 24 weeks

Estimated glomerular filtration rate

Safety outcomes based on adverse event (AE) monitoring.
Until marketing authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Number of Participants With AEs and SAEs
Up to 80 weeks

AE : Adverse Events, SAE: Serious Adverse Events

Number of (S)AE
Up to 37 weeks (arm 1) and up to 42 weeks (arm 2)

Secondary Endpoints

Proportion of participants with Delayed Graft Function (DGF)
Up to 52 weeks
Proportion of participants with fDGF
Up to 52 weeks
Duration of dialysis treatment for DGF within the first 30 days posttransplant
up to 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ARGX-117EXPERIMENTALPatients receiving ARGX-117 intravenous infusions
PlaceboPLACEBO_COMPARATORPatients receiving placebo intravenous infusions
ARGX-117 IVEXPERIMENTALSubjects receiving ARGX-117 IV
Placebo IVPLACEBO_COMPARATORSubjects receiving placebo IV
ARGX-117 PH20 SCEXPERIMENTALSubjects receiving ARGX-117 PH20 SC
Placebo PH20 SCPLACEBO_COMPARATORSubjects receiving placebo PH20 SC
ARGX-117 + rHuPH20EXPERIMENTALSubjects receiving ARGX-117 + rHuPH20
Placebo + rHuPH20PLACEBO_COMPARATORSubjects receiving placebo + rHuPH20

Interventions

NameTypeDescription
ARGX-117BIOLOGICALIntravenous administration of ARGX-117
PlaceboOTHERIntravenous administration of placebo
ARGX-117 + rHuPH20BIOLOGICALSubjects treated with ARGX-117 + rHuPH20
placebo + rHuPH20OTHERSubjects treated with placebo + rHuPH20
ARGX-117 PH20 SCBIOLOGICALSubjects treated with ARGX-117 PH20 SC
Placebo PH20 SCOTHERSubjects treated with placebo PH20 SC
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites45

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 * ...

Countries:United StatesAustraliaAustriaBelgiumBrazilCanadaFranceItalyPortugalSpainSwedenGermanyNetherlandsPolandUnited Kingdom
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Recent Changes (Last 90 Days)

MEDIUMJun 8, 2026NCT05225675TRIAL_REMOVED: changed
MEDIUMJun 8, 2026NCT05225675TRIAL_REMOVED: changed
MEDIUMJun 8, 2026NCT05225675TRIAL_REMOVED: changed
MEDIUMJun 8, 2026NCT05225675TRIAL_REMOVED: changed
MEDIUMJun 8, 2026NCT05225675TRIAL_REMOVED: changed

Frequently asked questions about ARGX-117

What is ARGX-117 used for?

ARGX-117 is an investigational monoclonal antibody being studied for multifocal motor neuropathy (MMN) and delayed graft function in deceased donor kidney transplant recipients. It has also been evaluated in healthy volunteers. The drug is in Phase 2 clinical development for these conditions.

What does ARGX-117 target?

ARGX-117 targets complement protein C2, which is part of the complement system. By targeting C2, the drug is designed to modulate complement pathway activity. This mechanism is being investigated in conditions like multifocal motor neuropathy and delayed graft function.

Who is developing ARGX-117?

ARGX-117 is being developed by argenx SE, a biopharmaceutical company traded on the NASDAQ under the ticker ARGX. The company is conducting clinical trials to evaluate the safety, efficacy, and pharmacokinetics of ARGX-117 in multiple patient populations.

What phase is ARGX-117 in?

ARGX-117 is in Phase 2 clinical development. It has completed a Phase 1 study in healthy volunteers and is being evaluated in Phase 2 trials for multifocal motor neuropathy and delayed graft function. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is ARGX-117 in?

ARGX-117 is being studied in several clinical trials. NCT04532125 is a completed Phase 1 study in healthy volunteers. NCT05225675 is a completed Phase 2 trial in multifocal motor neuropathy. NCT05405361 is an active Phase 2 long-term extension study in MMN, and NCT05907096 is an active Phase 2 trial in delayed graft function.

Is ARGX-117 the same as any other drug?

ARGX-117 is the sole name provided for this investigational drug. It is a monoclonal antibody targeting complement protein C2, developed by argenx SE. No alternative names or brand names have been associated with this asset in the available clinical trial information.