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efgartigimod PH20 in stage B

Phase 2

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Monoclonal antibody | Neurology |argenx SE|Last Updated: Aug 20, 2024

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 Enrollment322
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04281472A Study to Assess the Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)PHASE2 COMPLETED 322 — — Apr 15, 2020May 11, 2023Aug 20, 2024216 United States, Austria +23
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Study Endpoints
Primary Endpoints
Stage A: Percentage of Participants With Confirmed Evidence of Clinical Improvement(ECI)
Up to 12 weeks during the open-label stage A
Stage B: Time to First Adjusted INCAT Deterioration Compared to Stage B Baseline
Up to 48 weeks during the randomized placebo-controlled stage B
Secondary Endpoints
Stage A: Time to Initial Confirmed Evidence of Clinical Improvement (ECI)
Up to 12 weeks during the open-label stage A
Stage A: Change From Stage A Baseline to Last Assessment in Stage A, in Adjusted INCAT Score
Up to 12 weeks during the open-label stage A
Stage A: Change From Stage A Baseline to Last Assessment in Stage A, in Medical Research Council (MRC) Sum Score
Up to 12 weeks during the open-label stage A
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
efgartigimod PH20 SCEXPERIMENTALpatients receiving efgartigimod PH20 SC in both stage A as stage B
PlaceboPLACEBO_COMPARATORpatients receiving efgartigimod PH20 SC during stage A and receiving placebo in stage B
Interventions
NameTypeDescription
efgartigimod PH20 SC in stage BBIOLOGICALStage A: efgartigimod PH20 SC, Stage B: efgartigimod PH20 SC
placebo in stage BOTHERStage A: N/A, stage B: placebo
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites216

Inclusion Criteria: 1. Ability to understand the requirements of the trial, provide written informed consent (include consent for the use and disclosure of research-related health information), willingness and ability to comply with the trial protocol procedures (including required trial visits) 2....

Countries:United StatesAustriaBelgiumBulgariaChinaCzechiaDenmarkFranceGeorgiaGermanyHungaryIsraelItalyJapanLatviaNetherlandsPolandRomaniaRussiaSerbiaSpainTaiwanTurkey (Türkiye)UkraineUnited Kingdom
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