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RPC4046

Phase 2

Eosinophilic Esophagitis | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: May 9, 2017

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_CONTROLLED
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02098473Dose Ranging Study of RPC4046 in Eosinophilic EsophagitisPHASE2 COMPLETED 100Aug 31, 2014Jan 30, 2017May 9, 201730 United States, Canada +1
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Study Endpoints
Primary Endpoints
Mean Eosinophil Count
Week 16
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
RPC4046 Low DoseEXPERIMENTALintravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, low dose
RPC4046 High DoseEXPERIMENTALintravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, high dose
PlaceboPLACEBO_COMPARATORintravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks
Interventions
NameTypeDescription
RPC4046DRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites30

Inclusion Criteria: * Histologic evidence of EoE * Clinical symptoms of EoE including dysphagia Exclusion Criteria: * Primary causes of esophageal eosinophilia other than EoE

Countries:United StatesCanadaSwitzerland
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