Trial Outcomes & Findings for Safety, Tolerability And Efficacy Study Of Topical PF-06763809 In Subjects With Mild To Moderate Chronic Plaque Psoriasis (NCT NCT03469336)

Last Updated: 2020-06-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

18 participants

Primary outcome timeframe

Baseline, Days 7, 13 and 19

Results posted on

2020-06-25

Participant Flow

Of 26 participants screened for entry into the study, 4 participants failed at Screening and 4 participants were eligible at Screening but were not randomized in the study, and the remaining 18 participants were assigned to the study treatment.

Participant milestones

Participant milestones
Measure	PF-06763809+Vehicle+Calcipotriene+Betamethasone All participants with at least 6 test fields received blinded topical doses (2.3%, 0.8% and 0.23%) of PF-06763809, PF-06763809 vehicle, Calcipotriene (50 g/mL) and betamethasone 1 mg/g solution at the six test fields respectively. The dosing volume for all study treatments was 180 µL (164 µL/cm\^2), applied topically once daily to 1.1 cm\^2 skin surface area of each test field during an 18-day treatment period.
Overall Study STARTED	18
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	PF-06763809+Vehicle+Calcipotriene+Betamethasone All participants with at least 6 test fields received blinded topical doses (2.3%, 0.8% and 0.23%) of PF-06763809, PF-06763809 vehicle, Calcipotriene (50 g/mL) and betamethasone 1 mg/g solution at the six test fields respectively. The dosing volume for all study treatments was 180 µL (164 µL/cm\^2), applied topically once daily to 1.1 cm\^2 skin surface area of each test field during an 18-day treatment period.
Overall Study Adverse Event	1

Baseline Characteristics

Safety, Tolerability And Efficacy Study Of Topical PF-06763809 In Subjects With Mild To Moderate Chronic Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PF-06763809+Vehicle+Calcipotriene+Betamethasone n=18 Participants All participants with at least 6 test fields received blinded topical doses (2.3%, 0.8% and 0.23%) of PF-06763809, PF-06763809 vehicle, Calcipotriene (50 g/mL) and betamethasone 1 mg/g solution at the six test fields respectively. The dosing volume for all study treatments was 180 µL (164 µL/cm\^2), applied topically once daily to 1.1 cm\^2 skin surface area of each test field during an 18-day treatment period.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Days 7, 13 and 19

Population: Analysis population included all participants who had at least one application of the investigational products and had at least one post-baseline assessment of the primary efficacy variable, were included in the Full Analysis Set (FAS).

Outcome measures

Outcome measures
Measure	A: PF-06763809 2.3% Solution n=18 Participants Participants were exposed to 2.3% PF-06763809 solution once daily during an 18-day treatment period. Daily dosage: approximately 4.1 mg PF-06763809. Total dosage: approximately 75 mg PF-06763809	B: PF-06763809 0.8% Solution n=18 Participants Participants were exposed to 0.8% PF-06763809 solution once daily during an 18-day treatment period. Daily dosage: approximately 1.4 mg PF-06763809. Total dosage: approximately 26 mg PF-06763809	C: PF-06763809 0.23% Solution n=18 Participants Participants were exposed to 0.23% PF-06763809 solution once daily during an 18-day treatment period. Daily dosage: approximately 0.41 mg PF-06763809. Total dosage: approximately 7.5 mg PF-06763809.	D: PF-06763809 Vehicle n=18 Participants Participants were exposed to active ingredient-free vehicle to PF-06763809 treatments once daily during an 18-day treatment period.
Change From Baseline in Psoriatic Skin Infiltrate Thickness Day 7	0.89 micrometer (μm) Standard Error 0.073	0.92 micrometer (μm) Standard Error 0.073	0.97 micrometer (μm) Standard Error 0.073	0.93 micrometer (μm) Standard Error 0.073
Change From Baseline in Psoriatic Skin Infiltrate Thickness Day 13	0.74 micrometer (μm) Standard Error 0.458	0.76 micrometer (μm) Standard Error 0.458	0.87 micrometer (μm) Standard Error 0.458	0.80 micrometer (μm) Standard Error 0.458
Change From Baseline in Psoriatic Skin Infiltrate Thickness Day 19	0.71 micrometer (μm) Standard Error 0.526	0.70 micrometer (μm) Standard Error 0.526	0.80 micrometer (μm) Standard Error 0.526	0.70 micrometer (μm) Standard Error 0.526

PRIMARY outcome

Timeframe: Day 1 to Day 49

Population: Analysis population included all participants who received at least one application of the investigational products and had at least one post-baseline efficacy assessment value.

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.

Outcome measures

Outcome measures
Measure	A: PF-06763809 2.3% Solution n=18 Participants Participants were exposed to 2.3% PF-06763809 solution once daily during an 18-day treatment period. Daily dosage: approximately 4.1 mg PF-06763809. Total dosage: approximately 75 mg PF-06763809	B: PF-06763809 0.8% Solution Participants were exposed to 0.8% PF-06763809 solution once daily during an 18-day treatment period. Daily dosage: approximately 1.4 mg PF-06763809. Total dosage: approximately 26 mg PF-06763809	C: PF-06763809 0.23% Solution Participants were exposed to 0.23% PF-06763809 solution once daily during an 18-day treatment period. Daily dosage: approximately 0.41 mg PF-06763809. Total dosage: approximately 7.5 mg PF-06763809.	D: PF-06763809 Vehicle Participants were exposed to active ingredient-free vehicle to PF-06763809 treatments once daily during an 18-day treatment period.
Number of Participants With Treatment-emergent Adverse Events (AEs)	6 Participants	—	—	—

PRIMARY outcome

Timeframe: Day 1 to Day 49

Population: Analysis population included all participants who received at least one application of the investigational products and had at least one post-baseline efficacy assessment value.

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.

Outcome measures

Outcome measures
Measure	A: PF-06763809 2.3% Solution n=18 Participants Participants were exposed to 2.3% PF-06763809 solution once daily during an 18-day treatment period. Daily dosage: approximately 4.1 mg PF-06763809. Total dosage: approximately 75 mg PF-06763809	B: PF-06763809 0.8% Solution Participants were exposed to 0.8% PF-06763809 solution once daily during an 18-day treatment period. Daily dosage: approximately 1.4 mg PF-06763809. Total dosage: approximately 26 mg PF-06763809	C: PF-06763809 0.23% Solution Participants were exposed to 0.23% PF-06763809 solution once daily during an 18-day treatment period. Daily dosage: approximately 0.41 mg PF-06763809. Total dosage: approximately 7.5 mg PF-06763809.	D: PF-06763809 Vehicle Participants were exposed to active ingredient-free vehicle to PF-06763809 treatments once daily during an 18-day treatment period.
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Creatinine (mg/dL) >1.3xULN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Nitrite (Scalar) >=1	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Hemoglobin (HGB) (g/dL) <0.8xLLN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Hematocrit (%) <0.8xLLN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Erythrocytes (10^6/mm^3) <0.8xLLN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Ery. Mean Corpuscular Volume (μm^3) <0.9xLLN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Ery. Mean Corpuscular Volume (μm^3) >1.1xULN	1 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Ery. Mean Corpuscular HGB (pg/cell) <0.9xLLN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Ery. Mean Corpuscular HGB (pg/cell) >1.1xULN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Ery. Mean Corpuscular HGB Conc. (g/dL) <0.9xLLN	1 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Ery. Mean Corpuscular HGB Conc. (g/dL) >1.1xULN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Platelets (10^3/mm^3) <0.5xLLN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Platelets (10^3/mm^3) >1.75xULN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Leukocytes (10^3/mm^3) <0.6xLLN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Leukocytes (10^3/mm^3) >1.5xULN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Lymphocytes (10^3/mm^3) <0.8xLLN	2 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Lymphocytes (10^3/mm^3) >1.2xULN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Neutrophils (10^3/mm^3) <0.8xLLN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Neutrophils (10^3/mm^3) >1.2xULN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Basophils (10^3/mm^3) >1.2xULN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Eosinophils (10^3/mm^3) >1.2xULN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Monocytes (10^3/mm^3) >1.2xULN	1 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Bilirubin (mg/dL) >1.5xULN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Aspartate Aminotransferase (U/L) >3.0xULN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Alanine Aminotransferase (U/L) >3.0xULN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Alkaline Phosphatase (U/L) >3.0xULN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Protein (g/dL) <0.8xLLN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Protein (g/dL) >1.2xULN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Albumin (g/dL) <0.8x LLN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Albumin (g/dL) >1.2xULN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Urea Nitrogen (mg/dL) >1.3xULN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Urea (mmol/L) >1.3xULN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Urate (mg/dL) >1.2xULN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Sodium (mEq/L) <0.95xLLN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Sodium (mEq/L) >1.05xULN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Potassium (mEq/L) <0.9x LLN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Potassium (mEq/L) >1.1xULN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Chloride (mEq/L) <0.9xLLN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Chloride (mEq/L) >1.1xULN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Calcium (mg/dL) <0.9x LLN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Calcium (mg/dL) >1.1xULN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Bicarbonate (mEq/L) <0.9x LLN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Bicarbonate (mEq/L) >1.1xULN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Glucose (mg/dL) <0.6xLLN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Glucose (mg/dL) >1.5xULN	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) pH (Scalar) <4.5	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) pH (Scalar) >8	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) URINE Glucose (Scalar) >=1	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Ketones (Scalar) >=1	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) URINE Protein (Scalar) >=1	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) URINE Hemoglobin (Scalar) >=1	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Urobilinogen (Scalar) >=1	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) URINE Bilirubin (Scalar) >=1	0 Participants	—	—	—
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Leukocyte Esterase (Scalar) >=1	0 Participants	—	—	—

PRIMARY outcome

Timeframe: Day 1 to Day 49

Population: Analysis population included all participants who received at least one application of the investigational products and had at least one post-baseline efficacy assessment value. All scheduled ECGs were performed after the participant had rested quietly for 10 minutes in a supine position.

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.

Outcome measures

Outcome measures
Measure	A: PF-06763809 2.3% Solution n=18 Participants Participants were exposed to 2.3% PF-06763809 solution once daily during an 18-day treatment period. Daily dosage: approximately 4.1 mg PF-06763809. Total dosage: approximately 75 mg PF-06763809	B: PF-06763809 0.8% Solution Participants were exposed to 0.8% PF-06763809 solution once daily during an 18-day treatment period. Daily dosage: approximately 1.4 mg PF-06763809. Total dosage: approximately 26 mg PF-06763809	C: PF-06763809 0.23% Solution Participants were exposed to 0.23% PF-06763809 solution once daily during an 18-day treatment period. Daily dosage: approximately 0.41 mg PF-06763809. Total dosage: approximately 7.5 mg PF-06763809.	D: PF-06763809 Vehicle Participants were exposed to active ingredient-free vehicle to PF-06763809 treatments once daily during an 18-day treatment period.
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria Value>=300 msec (PR Interval)	0 Participants	—	—	—
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria %Change (Chg)>=25/50% (PR Interval)	0 Participants	—	—	—
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria Value>=140 msec (QRS Interval)	0 Participants	—	—	—
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria %Chg>=50% (QRS Interval)	0 Participants	—	—	—
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria Value>=500 msec (QT Interval)	0 Participants	—	—	—
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria 450<=Value<480 msec (QTc Interval)	2 Participants	—	—	—
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria 480<=Value<500 msec (QTc Interval)	0 Participants	—	—	—
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria Value>=500 msec (QTc Interval)	0 Participants	—	—	—
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria 30<=Chg<60 msec (QTc Interval)	2 Participants	—	—	—
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria Chg>=60 msec (QTc Interval)	1 Participants	—	—	—
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria 450<=Value<480 msec (QTcF Interval)	0 Participants	—	—	—
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria 480<=Value<500 msec (QTcF Interval)	0 Participants	—	—	—
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria Value>=500 msec (QTcF Interval)	0 Participants	—	—	—
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria 30<=Chg<60 msec (QTcF Interval)	0 Participants	—	—	—
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria Chg>=60 msec (QTcF Interval)	0 Participants	—	—	—

PRIMARY outcome

Timeframe: Day 1 to Day 49

Population: Analysis population included all participants who received at least one application of the investigational products and had at least one post-baseline efficacy assessment value.

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.

Outcome measures

Outcome measures
Measure	A: PF-06763809 2.3% Solution n=18 Participants Participants were exposed to 2.3% PF-06763809 solution once daily during an 18-day treatment period. Daily dosage: approximately 4.1 mg PF-06763809. Total dosage: approximately 75 mg PF-06763809	B: PF-06763809 0.8% Solution Participants were exposed to 0.8% PF-06763809 solution once daily during an 18-day treatment period. Daily dosage: approximately 1.4 mg PF-06763809. Total dosage: approximately 26 mg PF-06763809	C: PF-06763809 0.23% Solution Participants were exposed to 0.23% PF-06763809 solution once daily during an 18-day treatment period. Daily dosage: approximately 0.41 mg PF-06763809. Total dosage: approximately 7.5 mg PF-06763809.	D: PF-06763809 Vehicle Participants were exposed to active ingredient-free vehicle to PF-06763809 treatments once daily during an 18-day treatment period.
Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria DBP Value <50 mmHg	0 Participants	—	—	—
Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria DBP Chg >= 20 mmHg increase	0 Participants	—	—	—
Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria DBP Chg >= 20 mmHg decrease	0 Participants	—	—	—
Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria Pulse Rate Value <40 beats per minute (bpm)	0 Participants	—	—	—
Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria Pulse Rate Value >120 bpm	0 Participants	—	—	—
Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria SBP Value <90 mmHg	0 Participants	—	—	—
Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria SBP Chg >= 30 mmHg increase	0 Participants	—	—	—
Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria SBP Chg >= 30 mmHg decrease	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Day 1 to Day 19

Baseline was defined to be the measurement on Day 1. To evaluate the Area Under the Curve (AUC) of psoriatic skin infiltrate thickness/EPB for PF 06763809 compared to vehicle by mixed model analysis. The AUC of the psoriatic skin infiltrate thickness/EPB from Day 1 to Day 19 was determined using the linear trapezoidal rule. The log AUC was performed by the natural logarithm of the AUC of the psoriatic skin infiltrate thickness/EPB. 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.

Outcome measures

Outcome measures
Measure	A: PF-06763809 2.3% Solution n=18 Participants Participants were exposed to 2.3% PF-06763809 solution once daily during an 18-day treatment period. Daily dosage: approximately 4.1 mg PF-06763809. Total dosage: approximately 75 mg PF-06763809	B: PF-06763809 0.8% Solution n=18 Participants Participants were exposed to 0.8% PF-06763809 solution once daily during an 18-day treatment period. Daily dosage: approximately 1.4 mg PF-06763809. Total dosage: approximately 26 mg PF-06763809	C: PF-06763809 0.23% Solution n=18 Participants Participants were exposed to 0.23% PF-06763809 solution once daily during an 18-day treatment period. Daily dosage: approximately 0.41 mg PF-06763809. Total dosage: approximately 7.5 mg PF-06763809.	D: PF-06763809 Vehicle n=18 Participants Participants were exposed to active ingredient-free vehicle to PF-06763809 treatments once daily during an 18-day treatment period.
Area Under the Curve of the Psoriatic Skin Infiltrate Thickness	6191.52 nanogramshour per milliliter (ngh/mL) Standard Error 0.124	5996.26 nanogramshour per milliliter (ngh/mL) Standard Error 0.115	6921.58 nanogramshour per milliliter (ngh/mL) Standard Error 0.107	6204.82 nanogramshour per milliliter (ngh/mL) Standard Error 0.094

SECONDARY outcome

Timeframe: Baseline, Days 7, 13 and 19

The effect of PF-06763809 compared to calcipotriene/calcipotriol solution in the change of psoriatic skin infiltrate thickness/EPB both within and following 18 days of treatment. Baseline was defined to be the measurement on Day 1. 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.

Outcome measures

Outcome measures
Measure	A: PF-06763809 2.3% Solution n=18 Participants Participants were exposed to 2.3% PF-06763809 solution once daily during an 18-day treatment period. Daily dosage: approximately 4.1 mg PF-06763809. Total dosage: approximately 75 mg PF-06763809	B: PF-06763809 0.8% Solution n=18 Participants Participants were exposed to 0.8% PF-06763809 solution once daily during an 18-day treatment period. Daily dosage: approximately 1.4 mg PF-06763809. Total dosage: approximately 26 mg PF-06763809	C: PF-06763809 0.23% Solution n=18 Participants Participants were exposed to 0.23% PF-06763809 solution once daily during an 18-day treatment period. Daily dosage: approximately 0.41 mg PF-06763809. Total dosage: approximately 7.5 mg PF-06763809.	D: PF-06763809 Vehicle n=18 Participants Participants were exposed to active ingredient-free vehicle to PF-06763809 treatments once daily during an 18-day treatment period.
Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Calcipotriene/Calcipotriol Solution. Day 13	0.74 μm Standard Error 0.458	0.76 μm Standard Error 0.458	0.87 μm Standard Error 0.458	0.86 μm Standard Error 0.458
Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Calcipotriene/Calcipotriol Solution. Day 7	0.89 μm Standard Error 0.073	0.92 μm Standard Error 0.073	0.97 μm Standard Error 0.073	0.77 μm Standard Error 0.073
Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Calcipotriene/Calcipotriol Solution. Day 19	0.71 μm Standard Error 0.526	0.70 μm Standard Error 0.526	0.80 μm Standard Error 0.526	0.90 μm Standard Error 0.526

SECONDARY outcome

Timeframe: Baseline, Days 7, 13 and 19

The effect of PF-06763809 compared to betamethasone solution in the change of psoriatic skin infiltrate thickness/EPB both within and following 18 days of treatment. Baseline was defined to be the measurement on Day 1. 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.

Outcome measures

Outcome measures
Measure	A: PF-06763809 2.3% Solution n=18 Participants Participants were exposed to 2.3% PF-06763809 solution once daily during an 18-day treatment period. Daily dosage: approximately 4.1 mg PF-06763809. Total dosage: approximately 75 mg PF-06763809	B: PF-06763809 0.8% Solution n=18 Participants Participants were exposed to 0.8% PF-06763809 solution once daily during an 18-day treatment period. Daily dosage: approximately 1.4 mg PF-06763809. Total dosage: approximately 26 mg PF-06763809	C: PF-06763809 0.23% Solution n=18 Participants Participants were exposed to 0.23% PF-06763809 solution once daily during an 18-day treatment period. Daily dosage: approximately 0.41 mg PF-06763809. Total dosage: approximately 7.5 mg PF-06763809.	D: PF-06763809 Vehicle n=18 Participants Participants were exposed to active ingredient-free vehicle to PF-06763809 treatments once daily during an 18-day treatment period.
Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Betamethasone Solution. Day 19	0.71 μm Standard Error 0.526	0.70 μm Standard Error 0.526	0.80 μm Standard Error 0.526	0.01 μm Standard Error 0.526
Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Betamethasone Solution. Day 7	0.89 μm Standard Error 0.073	0.92 μm Standard Error 0.073	0.97 μm Standard Error 0.073	0.43 μm Standard Error 0.073
Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Betamethasone Solution. Day 13	0.74 μm Standard Error 0.458	0.76 μm Standard Error 0.458	0.87 μm Standard Error 0.458	0.03 μm Standard Error 0.458

Adverse Events

PF-06763809+Vehicle+Calcipotriene+Betamethasone

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	PF-06763809+Vehicle+Calcipotriene+Betamethasone n=18 participants at risk All participants with at least 6 test fields received blinded topical doses (2.3%, 0.8% and 0.23%) of PF-06763809, PF-06763809 vehicle, Calcipotriene (50 g/mL) and betamethasone 1 mg/g solution at the six test fields respectively. The dosing volume for all study treatments was 180 µL (164 µL/cm\^2), applied topically once daily to 1.1 cm\^2 skin surface area of each test field during an 18-day treatment period.
Eye disorders Blepharitis	5.6% 1/18 • Number of events 1 • Day 1 to Day 49 All Participants with a treatment area sufficient for 6 treatment fields received topical doses (2.3%, 0.8% and 0.23%) of PF-06763809, vehicle, Calcipotriene (50 g/mL) and betamethasone 1 mg/g solution at 6 test areas, respectively. Therefore, although treatment-emergent skin-related AEs could tell which treatment caused the AE, other treatment-emergent AEs not related to a specific treatment area could not be assigned to a treatment and were reported for the entire participant population.
Skin and subcutaneous tissue disorders Psoriasis	5.6% 1/18 • Number of events 1 • Day 1 to Day 49 All Participants with a treatment area sufficient for 6 treatment fields received topical doses (2.3%, 0.8% and 0.23%) of PF-06763809, vehicle, Calcipotriene (50 g/mL) and betamethasone 1 mg/g solution at 6 test areas, respectively. Therefore, although treatment-emergent skin-related AEs could tell which treatment caused the AE, other treatment-emergent AEs not related to a specific treatment area could not be assigned to a treatment and were reported for the entire participant population.
Skin and subcutaneous tissue disorders Dermatitis contact	22.2% 4/18 • Number of events 4 • Day 1 to Day 49 All Participants with a treatment area sufficient for 6 treatment fields received topical doses (2.3%, 0.8% and 0.23%) of PF-06763809, vehicle, Calcipotriene (50 g/mL) and betamethasone 1 mg/g solution at 6 test areas, respectively. Therefore, although treatment-emergent skin-related AEs could tell which treatment caused the AE, other treatment-emergent AEs not related to a specific treatment area could not be assigned to a treatment and were reported for the entire participant population.
Skin and subcutaneous tissue disorders Pruritus	5.6% 1/18 • Number of events 1 • Day 1 to Day 49 All Participants with a treatment area sufficient for 6 treatment fields received topical doses (2.3%, 0.8% and 0.23%) of PF-06763809, vehicle, Calcipotriene (50 g/mL) and betamethasone 1 mg/g solution at 6 test areas, respectively. Therefore, although treatment-emergent skin-related AEs could tell which treatment caused the AE, other treatment-emergent AEs not related to a specific treatment area could not be assigned to a treatment and were reported for the entire participant population.
Infections and infestations Nasopharyngitis	5.6% 1/18 • Number of events 1 • Day 1 to Day 49 All Participants with a treatment area sufficient for 6 treatment fields received topical doses (2.3%, 0.8% and 0.23%) of PF-06763809, vehicle, Calcipotriene (50 g/mL) and betamethasone 1 mg/g solution at 6 test areas, respectively. Therefore, although treatment-emergent skin-related AEs could tell which treatment caused the AE, other treatment-emergent AEs not related to a specific treatment area could not be assigned to a treatment and were reported for the entire participant population.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER