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PF-06763809

Phase 1

Psoriasis | Small molecule | Immunology |Pfizer, Inc.|Last Updated: Jun 25, 2020

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03469336Safety, Tolerability And Efficacy Study Of Topical PF-06763809 In Subjects With Mild To Moderate Chronic Plaque PsoriasisPHASE1 COMPLETED 18Apr 24, 2018Mar 20, 2019Jun 25, 20202 Germany
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Study Endpoints
Primary Endpoints
Change From Baseline in Psoriatic Skin Infiltrate Thickness
Baseline, Days 7, 13 and 19

Baseline was defined to be the measurement on Day 1. MMRM analysis of changes in psoriatic skin in psoriatic skin infiltrate thickness/echo poor band (EPB) in response to PF-06763809 2.3%, 0.8% and 0.23% applied topically for 18 consecutive days as compared to the vehicle control. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.

Number of Participants With Treatment-emergent Adverse Events (AEs)
Day 1 to Day 49

Baseline was defined to be the measurement on Day 1. An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of investigational product.

Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Day 1 to Day 49

Baseline was defined to be the measurement on Day 1. The safety laboratory tests including Hematology, Clinical Chemistry and Urinalysis were performed. Hematology evaluation included: hemoglobin (HGB) (gram per decilitre=g/dL), hematocrit, erythrocytes (Ery.), Ery. Mean Corpuscular Volume, Ery. Mean Corpuscular Hemoglobin, Ery. Mean Corpuscular HGB Concentration (picograms per cell=pg/cell), platelets, leukocytes, lymphocytes, and neutrophils. Clinical chemistry evaluation included: bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, urea nitrogen, urea, creatinine, urate, sodium, potassium, chloride, calcium, bicarbonate, creatine kinase, and glucose. Urinalysis evaluation included: pH, urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, and leukocyte esterase. LLN=lower limit of normal, ULN=upper limit of normal.

Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria
Day 1 to Day 49

Baseline was defined to be the measurement on Day 1. ECG categorical summarization criteria: 1) PR interval (Value\>=300 milliseconds \[msec\], %Change \[Chg\]\>=25/50%); 2) QRS interval (Value\>=140 msec, \>=50% change from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): \>=300 msec, \>=25% change when baseline is \> 200 msec or \>=50% change when baseline is less than or equal to (\<=) 200 msec; 3) QT interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole): absolute value of \>=500 msec; 4) QTc interval (QT corrected for heart rate): absolute value of 450 to \<480 msec, 480 to \<500 msec, \>=500 msec; a change from baseline of 30 to \<60 msec or \>=60 msec. The corrected QT interval by Fredericia=QTcF Interval.

Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria
Day 1 to Day 49

Baseline was defined to be the measurement on Day 1. Vital Signs including diastolic blood pressure (DBP), pulse rate, and systolic blood pressure (SBP) were measured.

Secondary Endpoints
Area Under the Curve of the Psoriatic Skin Infiltrate Thickness
Day 1 to Day 19
Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Calcipotriene/Calcipotriol Solution.
Baseline, Days 7, 13 and 19
Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Betamethasone Solution.
Baseline, Days 7, 13 and 19
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
All subjectsOTHERAll subjects will receive all six interventions/treatments applied to six different treatment fields.
Interventions
NameTypeDescription
PF-06763809DRUGThree different concentrations will be administered to three different treatment fields: 2.3%, 0.8% and 0.23%
VehicleOTHERVehicle matching PF-06763809.
Calcipotriene/calcipotriolDRUGCalcipotriene/calcipotriol 50 ug/mL solution
BetamethasoneDRUGBetamethasone 1 mg/g solution
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Psoriasis vulgaris in a chronic stable phase and with a plaque area of mild to moderate severity sufficient for six treatment fields located in up to three plaque areas * Target lesion(s) should be on the trunk or extremities (excluding palms/soles). Exclusion Criteria: * Hi...

Countries:Germany
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