Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002684-18 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | Other | All subjects will receive all six interventions/treatments applied to six different treatment fields. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06763809 | Drug | Three different concentrations will be administered to three different treatment fields: 2.3%, 0.8% and 0.23% |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Days 7, 13 and 19 |
| 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. | Day 1 to Day 49 |
| 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. | Day 1 to Day 49 |
| Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rothaar Studien GmbH | Berlin | 10783 | Germany | |||
| bioskin GmbH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32767679 | Derived | Berstein G, Zhang Y, Berger Z, Kieras E, Li G, Samuel A, Yeoh T, Dowty H, Beaumont K, Wigger-Alberti W, von Mackensen Y, Kroencke U, Hamscho R, Garcet S, Krueger JG, Banfield C, Oemar B. A phase I, randomized, double-blind study to assess the safety, tolerability and efficacy of the topical RORC2 inverse agonist PF-06763809 in participants with mild-to-moderate plaque psoriasis. Clin Exp Dermatol. 2021 Jan;46(1):122-129. doi: 10.1111/ced.14412. Epub 2020 Sep 14. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Geometric Mean | Standard Error | micrometer (μm) | Baseline, Days 7, 13 and 19 |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blepharitis | Eye disorders | MedDRA v21.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 3, 2018 | Mar 17, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 8, 2018 | Mar 17, 2020 | Prot_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000719649 | pf-06763809 |
| C055085 | calcipotriene |
| D001623 | Betamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a single arm multi-intervention study. The interventions are masked to participant, investigator, providers and assessors.
Not provided
| Vehicle | Other | Vehicle matching PF-06763809. |
|
| Calcipotriene/calcipotriol | Drug | Calcipotriene/calcipotriol 50 ug/mL solution |
|
| Betamethasone | Drug | Betamethasone 1 mg/g solution |
|
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. |
| Day 1 to Day 49 |
| 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. | Day 1 to Day 49 |
| Day 1 to Day 19 |
| 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. | Baseline, Days 7, 13 and 19 |
| 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. | Baseline, Days 7, 13 and 19 |
| Hamburg |
| 20095 |
| Germany |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | 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
| OG001 | 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 |
| OG002 | 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. |
| OG003 | D: PF-06763809 Vehicle | Participants were exposed to active ingredient-free vehicle to PF-06763809 treatments once daily during an 18-day treatment period. |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Day 1 to Day 49 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Day 1 to Day 49 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Day 1 to Day 49 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Day 1 to Day 49 |
|
|
|
| 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. | 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). | Posted | Geometric Mean | Standard Error | nanograms*hour per milliliter (ng*h/mL) | Day 1 to Day 19 |
|
|
|
|
| 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. | 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). | Posted | Geometric Mean | Standard Error | μm | Baseline, Days 7, 13 and 19 |
|
|
|
|
| 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. | 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). | Posted | Geometric Mean | Standard Error | μm | Baseline, Days 7, 13 and 19 |
|
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 6 |
| 18 |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment | One (1) TEAE of acute exacerbation of Psoriasis (severe in severity) was reported independent of treatment field and was considered not treatment-related by the investigator. |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment | Four treatment-emergent skin-related AEs of Dermatitis contact were all reported on the Calcipotriene (50 g/mL) solution treated fields. |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment | One (1) treatment-emergent skin related TEAE of Pruritus was reported on PF-06763809 vehicle treated field. |
|
| Nasopharyngitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
|
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.
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Ery. Mean Corpuscular Volume (μm^3) <0.9xLLN |
|
| Ery. Mean Corpuscular Volume (μm^3) >1.1xULN |
|
| Ery. Mean Corpuscular HGB (pg/cell) <0.9xLLN |
|
| Ery. Mean Corpuscular HGB (pg/cell) >1.1xULN |
|
| Ery. Mean Corpuscular HGB Conc. (g/dL) <0.9xLLN |
|
| Ery. Mean Corpuscular HGB Conc. (g/dL) >1.1xULN |
|
| Platelets (10^3/mm^3) <0.5xLLN |
|
| Platelets (10^3/mm^3) >1.75xULN |
|
| Leukocytes (10^3/mm^3) <0.6xLLN |
|
| Leukocytes (10^3/mm^3) >1.5xULN |
|
| Lymphocytes (10^3/mm^3) <0.8xLLN |
|
| Lymphocytes (10^3/mm^3) >1.2xULN |
|
| Neutrophils (10^3/mm^3) <0.8xLLN |
|
| Neutrophils (10^3/mm^3) >1.2xULN |
|
| Basophils (10^3/mm^3) >1.2xULN |
|
| Eosinophils (10^3/mm^3) >1.2xULN |
|
| Monocytes (10^3/mm^3) >1.2xULN |
|
| Bilirubin (mg/dL) >1.5xULN |
|
| Aspartate Aminotransferase (U/L) >3.0xULN |
|
| Alanine Aminotransferase (U/L) >3.0xULN |
|
| Alkaline Phosphatase (U/L) >3.0xULN |
|
| Protein (g/dL) <0.8xLLN |
|
| Protein (g/dL) >1.2xULN |
|
| Albumin (g/dL) <0.8x LLN |
|
| Albumin (g/dL) >1.2xULN |
|
| Urea Nitrogen (mg/dL) >1.3xULN |
|
| Urea (mmol/L) >1.3xULN |
|
| Creatinine (mg/dL) >1.3xULN |
|
| Urate (mg/dL) >1.2xULN |
|
| Sodium (mEq/L) <0.95xLLN |
|
| Sodium (mEq/L) >1.05xULN |
|
| Potassium (mEq/L) <0.9x LLN |
|
| Potassium (mEq/L) >1.1xULN |
|
| Chloride (mEq/L) <0.9xLLN |
|
| Chloride (mEq/L) >1.1xULN |
|
| Calcium (mg/dL) <0.9x LLN |
|
| Calcium (mg/dL) >1.1xULN |
|
| Bicarbonate (mEq/L) <0.9x LLN |
|
| Bicarbonate (mEq/L) >1.1xULN |
|
| Glucose (mg/dL) <0.6xLLN |
|
| Glucose (mg/dL) >1.5xULN |
|
| pH (Scalar) <4.5 |
|
| pH (Scalar) >8 |
|
| URINE Glucose (Scalar) >=1 |
|
| Ketones (Scalar) >=1 |
|
| URINE Protein (Scalar) >=1 |
|
| URINE Hemoglobin (Scalar) >=1 |
|
| Urobilinogen (Scalar) >=1 |
|
| URINE Bilirubin (Scalar) >=1 |
|
| Nitrite (Scalar) >=1 |
|
| Leukocyte Esterase (Scalar) >=1 |
|
| Title | Measurements |
|---|---|
|
| %Chg>=50% (QRS Interval) |
|
| Value>=500 msec (QT Interval) |
|
| 450<=Value<480 msec (QTc Interval) |
|
| 480<=Value<500 msec (QTc Interval) |
|
| Value>=500 msec (QTc Interval) |
|
| 30<=Chg<60 msec (QTc Interval) |
|
| Chg>=60 msec (QTc Interval) |
|
| 450<=Value<480 msec (QTcF Interval) |
|
| 480<=Value<500 msec (QTcF Interval) |
|
| Value>=500 msec (QTcF Interval) |
|
| 30<=Chg<60 msec (QTcF Interval) |
|
| Chg>=60 msec (QTcF Interval) |
|
| Title | Measurements |
|---|---|
|
| Pulse Rate Value <40 beats per minute (bpm) |
|
| Pulse Rate Value >120 bpm |
|
| SBP Value <90 mmHg |
|
| SBP Chg >= 30 mmHg increase |
|
| SBP Chg >= 30 mmHg decrease |
|
To evaluate the AUC of psoriatic skin infiltrate thickness/EPB for PF-06763809 compared to vehicle. |
| Mixed Models Analysis |
| 0.5081 |
| Mean Ratio (Test/Reference) |
| 0.9664 |
| Standard Error of the Mean |
| 0.051 |
| 2-Sided |
| 95 |
| 0.8686 |
| 1.0752 |
| Other |
Ratio |
| To evaluate the AUC of psoriatic skin infiltrate thickness/EPB for PF-06763809 compared to vehicle. | Mixed Models Analysis | 0.0249 | Mean Ratio (Test/Reference) | 1.1155 | Standard Error of the Mean | 0.044 | 2-Sided | 95 | 1.0157 | 1.2252 | Other | Ratio |
|
| Day 13 |
|
|
| Day 19 |
|
|
The effect of PF-06763809 compared to calcipotriene/calcipotriol solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19. |
| Mixed Models Analysis |
| 0.7407 |
| Mean Ratio (Test/Reference) |
| 0.7844 |
| Standard Error of the Mean |
| 0.732 |
| 2-Sided |
| 95 |
| 0.1834 |
| 3.3540 |
| Other |
Ratio |
| The effect of PF-06763809 compared to calcipotriene/calcipotriol solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19. | Mixed Models Analysis | 0.8793 | Mean Ratio (Test/Reference) | 0.8946 | Standard Error of the Mean | 0.732 | 2-Sided | 95 | 0.2092 | 3.8256 | Other | Ratio |
|
| Day 13 |
|
|
| Day 19 |
|
|
The effect of PF-06763809 compared to betamethasone solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19. |
| Mixed Models Analysis |
| <0.0001 |
| Mean Ratio (Test/Reference) |
| 1.067453 |
| Standard Error of the Mean |
| 0.732 |
| 2-Sided |
| 95 |
| 0.249631 |
| 4.564555 |
| Other |
Ratio |
| The effect of PF-06763809 compared to betamethasone solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19. | Mixed Models Analysis | <0.0001 | Mean Ratio (Test/Reference) | 1.217483 | Standard Error of the Mean | 0.732 | 2-Sided | 95 | 0.284708 | 5.206258 | Other | Ratio |