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PF06263276

Phase 1

Psoriasis Vulgaris | Small molecule | Immunology |Pfizer, Inc.|Last Updated: Jun 9, 2016

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 Enrollment15
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02193815A 12 Day Study To Evaluate A Topical Drug To Treat Plaque PsoriasisPHASE1 COMPLETED 15Sep 1, 2014Feb 1, 2015Jun 9, 20161 Germany
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Study Endpoints
Primary Endpoints
Change From Baseline in Psoriatic Skin Thickness/Echo-Poor Band (EPB) for PF-06263276 4% Solution in Comparison to Corresponding Vehicle at Day 12
Day 1 (Baseline), Day 12

Psoriatic skin thickness was measured using a 20 megahertz (MHz) high frequency sonograph. Serial A-scans were composed and presented on a monitor as a section of the skin.

Secondary Endpoints
Change From Baseline in Psoriatic Skin Thickness/EPB for PF-06263276 4% Solution in Comparison to Daivonex Solution at Day 12
Day 1 (Baseline), Day 12
Change From Baseline in Psoriatic Skin Thickness/EPB for Tofacitinib 2% Ointment in Comparison to Corresponding Vehicle at Day 12
Day 1 (Baseline), Day 12
Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8
Day 1 (Baseline), Day 8
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
One ArmEXPERIMENTALStudy treatments 1-6 Study drug, vehicle, Tofacitinib, vehicle, Daivonex solution and ointment
Interventions
NameTypeDescription
PF06263276DRUG4% PF 06263276 solution Daily dosage: approximately 8 mg PF 06263276 QD
VehicleOTHERActive ingredient-free vehicle to 4% solution
2%Tofacitinib OintmentDRUGDaily Dosage: approximately 4 mg tofacitinib
DaivonexDRUGDaivonex solution (50 ug/ml Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg
Daivonex OintmentDRUGDaivonex ointment (50 ug/g Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects age 18 years and older, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical l...

Countries:Germany
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