A PHASE 1, RANDOMIZED, DOUBLE-BLIND, VEHICLE AND ACTIVE COMPARATOR-CONTROLLED, PSORIASIS PLAQUE TEST STUDY TO ASSESS SAFETY, TOLERABILITY, AND PSORIATIC SKIN INFILTRATE THICKNESS FOLLOWING REPEATED, TOPICAL DOSES OF PF-06763809 SOLUTION IN SUBJECTS WITH MILD TO MODERATE CHRONIC PLAQUE PSORIASIS
Overview
- Phase
- Phase 1
- Intervention
- PF-06763809
- Conditions
- Psoriasis
- Sponsor
- Pfizer
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Change From Baseline in Psoriatic Skin Infiltrate Thickness
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
All subjects
All subjects will receive all six interventions/treatments applied to six different treatment fields.
Intervention: PF-06763809
All subjects
All subjects will receive all six interventions/treatments applied to six different treatment fields.
Intervention: Vehicle
All subjects
All subjects will receive all six interventions/treatments applied to six different treatment fields.
Intervention: Calcipotriene/calcipotriol
All subjects
All subjects will receive all six interventions/treatments applied to six different treatment fields.
Intervention: Betamethasone
Outcomes
Primary Outcomes
Change From Baseline in Psoriatic Skin Infiltrate Thickness
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Calcipotriene/Calcipotriol Solution.(Baseline, Days 7, 13 and 19)
- Area Under the Curve of the Psoriatic Skin Infiltrate Thickness(Day 1 to Day 19)
- Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Betamethasone Solution.(Baseline, Days 7, 13 and 19)