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ARGX-213

Phase 1

Healthy Volunteers | Monoclonal antibody | Other |argenx SE|Last Updated: Apr 23, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment88
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06968338A Study to Assess the Safety of ARGX-213 in Healthy VolunteersPHASE1 COMPLETED 88Apr 11, 2025Mar 20, 2026Apr 23, 20261 Canada
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Study Endpoints
Primary Endpoints
Incidence of adverse events, serious adverse events, and adverse events leading to the discontinuation
Up to 17 weeks
Secondary Endpoints
ARGX-213 serum concentrations
Up to 17 weeks
Percent change from baseline in total IgG concentrations in serum
Up to 17 weeks
Incidence of antidrug antibodies against ARGX-213 in serum
Up to 17 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ARGX-213EXPERIMENTALParticipants receiving the experimental drug
PlaceboPLACEBO_COMPARATORParticipants receiving placebo
Interventions
NameTypeDescription
ARGX-213BIOLOGICALIntravenous or subcutaneous administrations of ARGX-213
PlaceboOTHERIntravenous or subcutaneous administrations of placebo
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Is at least the local legal age of consent for clinical studies and is aged 18 to 65 years, inclusive, when signing the ICF * Is a female of nonchild bearing potential (either postmenopausal or surgically sterilized) or a male * Has a body weight between 50 and 100 kg and a BM...

Countries:Canada
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Recent Changes (Last 90 Days)
HIGHMay 26, 2026NCT06968338TRIAL_REMOVED: changed
LOWMay 24, 2026NCT06968338studyFirstPostDate: changed