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EFG PH20

Phase 2

Active Idiopathic Inflammatory Myopathy | Monoclonal antibody | Immunology |argenx SE|Last Updated: Jul 23, 2025

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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment265
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05523167A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.PHASE2 ACTIVE NOT_RECRUITING 265 — — Oct 12, 2022Feb 1, 2027Jul 23, 2025202 United States, Argentina +34
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Study Endpoints
Primary Endpoints
Total improvement score (TIS); measured on a [0,100] scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline).
phase 2: 24 weeks; phase 3: 52 weeks
Secondary Endpoints
Time to reach TIS ≥ 20 (first "minimal clinical improvement")
phase 2: up to 24 weeks; phase 3: up to 52 weeks
Percentage of participants with TIS ≥ 20
phase 2: 24 weeks; phase 3: 52 weeks
Time to reach TIS ≥ 40 (first "moderate clinical improvement")
phase 2: up to 24 weeks; phase 3: up to 52 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
EFG PH20 SCEXPERIMENTALparticipants receiving efgartigimod PH20 SC on top of background treatment
PBO PH20 SCPLACEBO_COMPARATORparticipants receiving placebo PH20 SC on top of background treatment
Interventions
NameTypeDescription
EFG PH20 SCBIOLOGICALSubcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer
PBOOTHERSubcutaneous injection of placebo coformulated with rHuPH20, a permeation enhancer
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites202

Inclusion Criteria: * Ability to consent in the jurisdiction in which the study is taking place and capable of giving signed informed consent. * A definite or probable clinical diagnosis of idiopathic inflammatory myopathy (IIM) * One of the following medical histories: Diagnosis of dermatomyositis...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBulgariaCanadaChinaCyprusCzechiaDenmarkFranceGeorgiaGermanyGreeceHungaryIrelandIsraelItalyJapanLithuaniaMexicoNetherlandsPeruPolandPortugalSerbiaSlovakiaSouth KoreaSpainSwedenSwitzerlandTaiwanThailandTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05523167primaryCompletionDate: changed
LOWMay 24, 2026NCT05523167studyFirstPostDate: changed