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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000068-16 | EudraCT Number |
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This is a vehicle and comparator controlled Proof of Mechanism (PoM) trial to evaluate the effect on psoriasis disease activity and safety of topically applied PF 06263276 in subjects with psoriasis vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One Arm | Experimental | Study treatments 1-6 Study drug, vehicle, Tofacitinib, vehicle, Daivonex solution and ointment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF06263276 | Drug | 4% PF 06263276 solution Daily dosage: approximately 8 mg PF 06263276 QD |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Psoriatic Skin Thickness/Echo-Poor Band (EPB) for PF-06263276 4% Solution in Comparison to Corresponding Vehicle at Day 12 | Psoriatic skin thickness was measured using a 20 megahertz (MHz) high frequency sonograph. Serial A-scans were composed and presented on a monitor as a section of the skin. | Day 1 (Baseline), Day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Psoriatic Skin Thickness/EPB for PF-06263276 4% Solution in Comparison to Daivonex Solution at Day 12 | Day 1 (Baseline), Day 12 | |
| Change From Baseline in Psoriatic Skin Thickness/EPB for Tofacitinib 2% Ointment in Comparison to Corresponding Vehicle at Day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs | An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. The number of participants with specified skin AEs was reported. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bioskin GmbH | Hamburg | 20095 | Germany |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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This trial enrolled participants with chronic plaque type psoriasis and with a treatment area sufficient for 6 treatment fields on 1 to 3 comparable plaques defined as having treatment fields with psoriatic skin thickness/Echo-Poor Band (EPB) of at least 200 micrometers.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The safety population included all enrolled participants who received at least 1 dose of investigational product.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-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, Continuous | Mean |
| 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 Thickness/Echo-Poor Band (EPB) for PF-06263276 4% Solution in Comparison to Corresponding Vehicle at Day 12 | Psoriatic skin thickness was measured using a 20 megahertz (MHz) high frequency sonograph. Serial A-scans were composed and presented on a monitor as a section of the skin. | The Intent-to-Treat (ITT) population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable. | Posted | Mean | Standard Deviation | micrometers | Day 1 (Baseline), Day 12 |
|
Baseline up to 28 days after last study drug administration (Day 21)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
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| ID | Term |
|---|---|
| C000620977 | PF-06263276 |
| C055085 | calcipotriene |
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| Vehicle |
| Other |
Active ingredient-free vehicle to 4% solution |
|
| 2%Tofacitinib Ointment | Drug | Daily Dosage: approximately 4 mg tofacitinib |
|
| Vehicle | Other | Active ingredient-free vehicle to 2% Ointment |
|
| Daivonex | Drug | Daivonex solution (50 ug/ml Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg |
|
| Daivonex Ointment | Drug | Daivonex ointment (50 ug/g Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg |
|
| Day 1 (Baseline), Day 12 |
| Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8 | Day 1 (Baseline), Day 8 |
| Area Under the Curve (AUC) of Psoriatic Skin Thickness/EPB | The AUC of psoriatic skin thickness/EPB from Day 1 to Day 12 was determined using the linear trapezoidal rule. The mean raw values are reported. | Day 1 (baseline) up to Day 12 |
| Global Clinical Assessment at Day 1, 8 and 12 | Global Clinical Assessment of the test fields was performed by visual examination using a 5-point score (-1=worsened; 0=unchanged [no effect]; 1=slight improvement; 2=clear improvement but not completely healed; 3=completely healed). Clinically apparent differences in erythema and infiltration will contribute to this global assessment. At baseline (Day 1), the score was documented as "0" (unchanged). | Day 1, Day 8, Day 12 |
| Baseline up to 28 days after last study drug administration (Day 21) |
| Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern | The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (e.g., urine human chorionic gonadotropin [hCG] for females of childbearing potential). | Baseline up to Day 12 |
| Number of Participants With Potentially Clinically Significant Vital Signs Findings | Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) >=30 millimeters of mercury (mmHg) change from baseline in same posture or SBP <90 mmHg, diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or DBP <50 mmHg. | Baseline up to Day 12 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
All participants who received PF-06263276 vehicle (active ingredient- free) topically once daily for 11 days. |
|
|
|
| Secondary | Change From Baseline in Psoriatic Skin Thickness/EPB for PF-06263276 4% Solution in Comparison to Daivonex Solution at Day 12 | The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable. | Posted | Mean | Standard Deviation | micrometers | Day 1 (Baseline), Day 12 |
|
|
|
|
| Secondary | Change From Baseline in Psoriatic Skin Thickness/EPB for Tofacitinib 2% Ointment in Comparison to Corresponding Vehicle at Day 12 | The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable. | Posted | Mean | Standard Deviation | micrometers | Day 1 (Baseline), Day 12 |
|
|
|
|
| Secondary | Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8 | The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable. | Posted | Mean | Standard Deviation | micrometers | Day 1 (Baseline), Day 8 |
|
|
|
|
| Secondary | Area Under the Curve (AUC) of Psoriatic Skin Thickness/EPB | The AUC of psoriatic skin thickness/EPB from Day 1 to Day 12 was determined using the linear trapezoidal rule. The mean raw values are reported. | The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable. | Posted | Mean | Standard Deviation | micrometers*day | Day 1 (baseline) up to Day 12 |
|
|
|
|
| Secondary | Global Clinical Assessment at Day 1, 8 and 12 | Global Clinical Assessment of the test fields was performed by visual examination using a 5-point score (-1=worsened; 0=unchanged [no effect]; 1=slight improvement; 2=clear improvement but not completely healed; 3=completely healed). Clinically apparent differences in erythema and infiltration will contribute to this global assessment. At baseline (Day 1), the score was documented as "0" (unchanged). | The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable. | Posted | Number | participants | Day 1, Day 8, Day 12 |
|
|
|
| Other Pre-specified | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs | An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. The number of participants with specified skin AEs was reported. | The safety population included all enrolled participants who received at least 1 dose of investigational product. | Posted | Number | participants | Baseline up to 28 days after last study drug administration (Day 21) |
|
|
|
| Other Pre-specified | Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern | The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (e.g., urine human chorionic gonadotropin [hCG] for females of childbearing potential). | The safety population included all enrolled participants who received at least 1 dose of investigational product. | Posted | Number | participants | Baseline up to Day 12 |
|
|
|
| Other Pre-specified | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) >=30 millimeters of mercury (mmHg) change from baseline in same posture or SBP <90 mmHg, diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or DBP <50 mmHg. | The safety population included all enrolled participants who received at least 1 dose of investigational product. | Posted | Number | participants | Baseline up to Day 12 |
|
|
|
| 0 |
| 15 |
| 3 |
| 15 |
| Facial pain | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.1 | 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.
| D013568 | Pathological Conditions, Signs and Symptoms |
| Change at Day 8 |
|
| <0.0001 |
| Adjusted Mean |
| 149.56 |
| Standard Error of the Mean |
| 0.075 |
| 2-Sided |
| 95 |
| 129.04 |
| 173.34 |
| No |
| Superiority or Other |
| Mixed Models Analysis | 0.3991 | Adjusted Mean | 106.51 | Standard Error of the Mean | 0.075 | 2-Sided | 95 | 91.92 | 123.41 | No | Superiority or Other |
| Mixed Models Analysis | <0.0001 | Adjusted Mean | 71.94 | Standard Error of the Mean | 0.075 | 2-Sided | 95 | 62.08 | 83.36 | No | Superiority or Other |
| 0.1318 |
| Adjusted Mean |
| 125.62 |
| Standard Error of the Mean |
| 0.147 |
| 2-Sided |
| 95 |
| 92.96 |
| 169.75 |
| No |
| Superiority or Other |
| Mixed Models Analysis | 0.8009 | Adjusted Mean | 103.35 | Standard Error of the Mean | 0.129 | 2-Sided | 95 | 79.30 | 134.68 | No | Superiority or Other |
| Mixed Models Analysis | 0.1012 | Adjusted Mean | 81.09 | Standard Error of the Mean | 0.124 | 2-Sided | 95 | 62.94 | 104.47 | No | Superiority or Other |
| Day 1: Score 0 |
|
| Day 1: Score 1 |
|
| Day 1: Score 2 |
|
| Day 1: Score 3 |
|
| Day 8: Score -1 |
|
| Day 8: Score 0 |
|
| Day 8: Score 1 |
|
| Day 8: Score 2 |
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| Day 8: Score 3 |
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| Day 12: Score -1 |
|
| Day 12: Score 0 |
|
| Day 12: Score 1 |
|
| Day 12: Score 2 |
|
| Day 12: Score 3 |
|
| Specified Skin SAEs |
|
| Title | Measurements |
|---|---|
|
| Maximum Increase from Baseline in SBP >=30 mmHg |
|
| Maximum Increase from Baseline in DBP >=20 mmHg |
|