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GW842470X

Phase 2

Atopic Dermatitis | Small molecule | Immunology |GSK plc|Last Updated: Jun 4, 2012

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment190
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00354510Topical GW842470X In Adults Patients With Moderate Atopic DermatitisPHASE2 COMPLETED 190Mar 1, 2006 -Jun 4, 201213 Germany, Netherlands
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Study Endpoints
Primary Endpoints
Clinical efficacy of 3% GW842470X cream applied to involved skin of adult patients with moderate atopic dermatitis using the Eczema Area Severity Index (EASI).
Secondary Endpoints
Safety and tolerability of 3% GW842470X cream
Clinical efficacy using SCORing Atopic Dermatitis score & Investigators Global Assessment Scale
Symptoms: pruritus & sleep loss
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
GW842470X creamDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion criteria: * Moderate atopic dermatitis patients (IGA=3). * The disease involvement must be \>5% of body surface area. * Female patients of child-bearing potential must use an appropriate method of contraception. Exclusion criteria: * Patients with any active skin disease other than atop...

Countries:GermanyNetherlands
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