Psoriasis
Conditions
Keywords
Psoriasis, Topical
Brief summary
The study is a randomized, double blinded, vehicle and active comparator controlled, multiple dose study in subjects with chronic plaque psoriasis. The study will have approximately 15 completers. Each subjects will receive three different topical doses of PF 06763809, PF 06763809 vehicle, and two active comparators. These will be applied to six different treatment fields for 18 days. The total duration of participation in the study will be approximately 7 weeks (minimum) to approximately 11 weeks (maximum), including the interval from Screening to the Follow up phone call visit.
Interventions
DRUGPF-06763809
Three different concentrations will be administered to three different treatment fields: 2.3%, 0.8% and 0.23%
OTHERVehicle
Vehicle matching PF-06763809.
DRUGCalcipotriene/calcipotriol
Calcipotriene/calcipotriol 50 ug/mL solution
DRUGBetamethasone
Betamethasone 1 mg/g solution
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
This study is a single arm multi-intervention study. The interventions are masked to participant, investigator, providers and assessors.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* History of skin sensitivity to topical prescription or non prescription products such as creams, lotions and cosmetics * Psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, and pustular psoriasis * Treatment with any biologics within 3 months prior to Day 1 of the study and during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve of the Psoriatic Skin Infiltrate Thickness | 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. |
| Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Calcipotriene/Calcipotriol Solution. | 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. |
| Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Betamethasone Solution. | 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. |
Countries
Germany
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | PF-06763809+Vehicle+Calcipotriene+Betamethasone |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 6 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Change From Baseline in Psoriatic Skin Infiltrate Thickness
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.
Time frame: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: PF-06763809 2.3% Solution | Change From Baseline in Psoriatic Skin Infiltrate Thickness | Day 7 | 0.89 micrometer (μm) | Standard Error 0.073 |
| A: PF-06763809 2.3% Solution | Change From Baseline in Psoriatic Skin Infiltrate Thickness | Day 19 | 0.71 micrometer (μm) | Standard Error 0.526 |
| A: PF-06763809 2.3% Solution | Change From Baseline in Psoriatic Skin Infiltrate Thickness | Day 13 | 0.74 micrometer (μm) | Standard Error 0.458 |
| B: PF-06763809 0.8% Solution | Change From Baseline in Psoriatic Skin Infiltrate Thickness | Day 7 | 0.92 micrometer (μm) | Standard Error 0.073 |
| B: PF-06763809 0.8% Solution | Change From Baseline in Psoriatic Skin Infiltrate Thickness | Day 19 | 0.70 micrometer (μm) | Standard Error 0.526 |
| B: PF-06763809 0.8% Solution | Change From Baseline in Psoriatic Skin Infiltrate Thickness | Day 13 | 0.76 micrometer (μm) | Standard Error 0.458 |
| C: PF-06763809 0.23% Solution | Change From Baseline in Psoriatic Skin Infiltrate Thickness | Day 13 | 0.87 micrometer (μm) | Standard Error 0.458 |
| C: PF-06763809 0.23% Solution | Change From Baseline in Psoriatic Skin Infiltrate Thickness | Day 7 | 0.97 micrometer (μm) | Standard Error 0.073 |
| C: PF-06763809 0.23% Solution | Change From Baseline in Psoriatic Skin Infiltrate Thickness | Day 19 | 0.80 micrometer (μm) | Standard Error 0.526 |
| D: PF-06763809 Vehicle | Change From Baseline in Psoriatic Skin Infiltrate Thickness | Day 7 | 0.93 micrometer (μm) | Standard Error 0.073 |
| D: PF-06763809 Vehicle | Change From Baseline in Psoriatic Skin Infiltrate Thickness | Day 19 | 0.70 micrometer (μm) | Standard Error 0.526 |
| D: PF-06763809 Vehicle | Change From Baseline in Psoriatic Skin Infiltrate Thickness | Day 13 | 0.80 micrometer (μm) | Standard Error 0.458 |
Comparison: The efficacy assessment of PF-06763809 was performed for the change from baseline in log of the psoriatic skin infiltrate thickness/EPB on Day 19 using a longitudinal analysis of covariance model, with treatment, visit, treatment by visit interaction as main effects and the log of the psoriatic skin infiltrate thickness/EPB at baseline as covariate.p-value: 0.988395% CI: [0.2364, 4.3226]Mixed Models Analysis
Comparison: The efficacy assessment of PF-06763809 was performed for the change from baseline in log of the psoriatic skin infiltrate thickness/EPB on Day 19 using a longitudinal analysis of covariance model, with treatment, visit, treatment by visit interaction as main effects and the log of the psoriatic skin infiltrate thickness/EPB at baseline as covariate.p-value: 0.997795% CI: [0.2334, 4.2671]Mixed Models Analysis
Comparison: The efficacy assessment of PF-06763809 was performed for the change from baseline in log of the psoriatic skin infiltrate thickness/EPB on Day 19 using a longitudinal analysis of covariance model, with treatment, visit, treatment by visit interaction as main effects and the log of the psoriatic skin infiltrate thickness/EPB at baseline as covariate.p-value: 0.8695% CI: [0.2662, 4.867]Mixed Models Analysis
Primary
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| A: PF-06763809 2.3% Solution | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria | Value>=300 msec (PR Interval) | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria | %Change (Chg)>=25/50% (PR Interval) | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria | 30<=Chg<60 msec (QTc Interval) | 2 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria | Chg>=60 msec (QTc Interval) | 1 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria | Value>=140 msec (QRS Interval) | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria | %Chg>=50% (QRS Interval) | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria | Value>=500 msec (QT Interval) | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria | 450<=Value<480 msec (QTc Interval) | 2 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria | 480<=Value<500 msec (QTc Interval) | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria | Value>=500 msec (QTc Interval) | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria | 450<=Value<480 msec (QTcF Interval) | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria | 480<=Value<500 msec (QTcF Interval) | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria | Value>=500 msec (QTcF Interval) | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria | 30<=Chg<60 msec (QTcF Interval) | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria | Chg>=60 msec (QTcF Interval) | 0 Participants |
Primary
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Hematocrit (%) <0.8xLLN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Erythrocytes (10^6/mm^3) <0.8xLLN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Ery. Mean Corpuscular Volume (μm^3) <0.9xLLN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Ery. Mean Corpuscular Volume (μm^3) >1.1xULN | 1 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Ery. Mean Corpuscular HGB (pg/cell) <0.9xLLN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Ery. Mean Corpuscular HGB (pg/cell) >1.1xULN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Neutrophils (10^3/mm^3) <0.8xLLN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Basophils (10^3/mm^3) >1.2xULN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Eosinophils (10^3/mm^3) >1.2xULN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Monocytes (10^3/mm^3) >1.2xULN | 1 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Bilirubin (mg/dL) >1.5xULN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Aspartate Aminotransferase (U/L) >3.0xULN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Protein (g/dL) <0.8xLLN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Protein (g/dL) >1.2xULN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Albumin (g/dL) <0.8x LLN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Calcium (mg/dL) <0.9x LLN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Calcium (mg/dL) >1.1xULN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Bicarbonate (mEq/L) <0.9x LLN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Bicarbonate (mEq/L) >1.1xULN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Glucose (mg/dL) <0.6xLLN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Glucose (mg/dL) >1.5xULN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | pH (Scalar) <4.5 | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Ketones (Scalar) >=1 | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | URINE Bilirubin (Scalar) >=1 | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Nitrite (Scalar) >=1 | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Hemoglobin (HGB) (g/dL) <0.8xLLN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Ery. Mean Corpuscular HGB Conc. (g/dL) <0.9xLLN | 1 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Ery. Mean Corpuscular HGB Conc. (g/dL) >1.1xULN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Platelets (10^3/mm^3) <0.5xLLN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Platelets (10^3/mm^3) >1.75xULN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Leukocytes (10^3/mm^3) <0.6xLLN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Leukocytes (10^3/mm^3) >1.5xULN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Lymphocytes (10^3/mm^3) <0.8xLLN | 2 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Lymphocytes (10^3/mm^3) >1.2xULN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Neutrophils (10^3/mm^3) >1.2xULN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Alanine Aminotransferase (U/L) >3.0xULN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Alkaline Phosphatase (U/L) >3.0xULN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Albumin (g/dL) >1.2xULN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urea Nitrogen (mg/dL) >1.3xULN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urea (mmol/L) >1.3xULN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Creatinine (mg/dL) >1.3xULN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urate (mg/dL) >1.2xULN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Sodium (mEq/L) <0.95xLLN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Sodium (mEq/L) >1.05xULN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Potassium (mEq/L) <0.9x LLN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Potassium (mEq/L) >1.1xULN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Chloride (mEq/L) <0.9xLLN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Chloride (mEq/L) >1.1xULN | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | pH (Scalar) >8 | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | URINE Glucose (Scalar) >=1 | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | URINE Protein (Scalar) >=1 | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | URINE Hemoglobin (Scalar) >=1 | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urobilinogen (Scalar) >=1 | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Leukocyte Esterase (Scalar) >=1 | 0 Participants |
Primary
Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| A: PF-06763809 2.3% Solution | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria | Pulse Rate Value <40 beats per minute (bpm) | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria | Pulse Rate Value >120 bpm | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria | SBP Value <90 mmHg | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria | SBP Chg >= 30 mmHg increase | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria | DBP Value <50 mmHg | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria | DBP Chg >= 20 mmHg increase | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria | DBP Chg >= 20 mmHg decrease | 0 Participants |
| A: PF-06763809 2.3% Solution | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria | SBP Chg >= 30 mmHg decrease | 0 Participants |
Primary
Number of Participants With Treatment-emergent Adverse Events (AEs)
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A: PF-06763809 2.3% Solution | Number of Participants With Treatment-emergent Adverse Events (AEs) | 6 Participants |
Secondary
Area Under the Curve of the Psoriatic Skin Infiltrate Thickness
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.
Time frame: Day 1 to Day 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| A: PF-06763809 2.3% Solution | Area Under the Curve of the Psoriatic Skin Infiltrate Thickness | 6191.52 nanograms*hour per milliliter (ng*h/mL) | Standard Error 0.124 |
| B: PF-06763809 0.8% Solution | Area Under the Curve of the Psoriatic Skin Infiltrate Thickness | 5996.26 nanograms*hour per milliliter (ng*h/mL) | Standard Error 0.115 |
| C: PF-06763809 0.23% Solution | Area Under the Curve of the Psoriatic Skin Infiltrate Thickness | 6921.58 nanograms*hour per milliliter (ng*h/mL) | Standard Error 0.107 |
| D: PF-06763809 Vehicle | Area Under the Curve of the Psoriatic Skin Infiltrate Thickness | 6204.82 nanograms*hour per milliliter (ng*h/mL) | Standard Error 0.094 |
Comparison: To evaluate the AUC of psoriatic skin infiltrate thickness/EPB for PF-06763809 compared to vehicle.p-value: 0.976395% CI: [0.8588, 1.1594]Mixed Models Analysis
Comparison: To evaluate the AUC of psoriatic skin infiltrate thickness/EPB for PF-06763809 compared to vehicle.p-value: 0.508195% CI: [0.8686, 1.0752]Mixed Models Analysis
Comparison: To evaluate the AUC of psoriatic skin infiltrate thickness/EPB for PF-06763809 compared to vehicle.p-value: 0.024995% CI: [1.0157, 1.2252]Mixed Models Analysis
Secondary
Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Betamethasone Solution.
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.
Time frame: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: PF-06763809 2.3% Solution | 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 |
| A: PF-06763809 2.3% Solution | 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 |
| A: PF-06763809 2.3% Solution | 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 |
| B: PF-06763809 0.8% Solution | Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Betamethasone Solution. | Day 19 | 0.70 μm | Standard Error 0.526 |
| B: PF-06763809 0.8% Solution | Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Betamethasone Solution. | Day 7 | 0.92 μm | Standard Error 0.073 |
| B: PF-06763809 0.8% Solution | Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Betamethasone Solution. | Day 13 | 0.76 μm | Standard Error 0.458 |
| C: PF-06763809 0.23% Solution | Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Betamethasone Solution. | Day 7 | 0.97 μm | Standard Error 0.073 |
| C: PF-06763809 0.23% Solution | Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Betamethasone Solution. | Day 19 | 0.80 μm | Standard Error 0.526 |
| C: PF-06763809 0.23% Solution | Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Betamethasone Solution. | Day 13 | 0.87 μm | Standard Error 0.458 |
| D: PF-06763809 Vehicle | Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Betamethasone Solution. | Day 19 | 0.01 μm | Standard Error 0.526 |
| D: PF-06763809 Vehicle | Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Betamethasone Solution. | Day 7 | 0.43 μm | Standard Error 0.073 |
| D: PF-06763809 Vehicle | Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Betamethasone Solution. | Day 13 | 0.03 μm | Standard Error 0.458 |
Comparison: The effect of PF-06763809 compared to betamethasone solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.p-value: <0.000195% CI: [0.25287, 4.623941]Mixed Models Analysis
Comparison: The effect of PF-06763809 compared to betamethasone solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.p-value: <0.000195% CI: [0.249631, 4.564555]Mixed Models Analysis
Comparison: The effect of PF-06763809 compared to betamethasone solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.p-value: <0.000195% CI: [0.284708, 5.206258]Mixed Models Analysis
Secondary
Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Calcipotriene/Calcipotriol Solution.
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.
Time frame: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: PF-06763809 2.3% Solution | 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 |
| A: PF-06763809 2.3% Solution | 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 |
| A: PF-06763809 2.3% Solution | 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 |
| B: PF-06763809 0.8% Solution | Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Calcipotriene/Calcipotriol Solution. | Day 19 | 0.70 μm | Standard Error 0.526 |
| B: PF-06763809 0.8% Solution | Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Calcipotriene/Calcipotriol Solution. | Day 13 | 0.76 μm | Standard Error 0.458 |
| B: PF-06763809 0.8% Solution | Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Calcipotriene/Calcipotriol Solution. | Day 7 | 0.92 μm | Standard Error 0.073 |
| C: PF-06763809 0.23% Solution | Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Calcipotriene/Calcipotriol Solution. | Day 7 | 0.97 μm | Standard Error 0.073 |
| C: PF-06763809 0.23% Solution | Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Calcipotriene/Calcipotriol Solution. | Day 19 | 0.80 μm | Standard Error 0.526 |
| C: PF-06763809 0.23% Solution | Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Calcipotriene/Calcipotriol Solution. | Day 13 | 0.87 μm | Standard Error 0.458 |
| D: PF-06763809 Vehicle | Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Calcipotriene/Calcipotriol Solution. | Day 19 | 0.90 μm | Standard Error 0.526 |
| D: PF-06763809 Vehicle | Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Calcipotriene/Calcipotriol Solution. | Day 13 | 0.86 μm | Standard Error 0.458 |
| D: PF-06763809 Vehicle | Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Calcipotriene/Calcipotriol Solution. | Day 7 | 0.77 μm | Standard Error 0.073 |
Comparison: The effect of PF-06763809 compared to calcipotriene/calcipotriol solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.p-value: 0.75495% CI: [0.1858, 3.3977]Mixed Models Analysis
Comparison: The effect of PF-06763809 compared to calcipotriene/calcipotriol solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.p-value: 0.740795% CI: [0.1834, 3.354]Mixed Models Analysis
Comparison: The effect of PF-06763809 compared to calcipotriene/calcipotriol solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.p-value: 0.879395% CI: [0.2092, 3.8256]Mixed Models Analysis