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

Phase 1

Completed

• Conditions: Psoriasis
• Interventions: Drug: PF-06763809; Other: Vehicle; Drug: Calcipotriene/calcipotriol; Drug: Betamethasone

• Registration Number: NCT03469336
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-13
• Study First Submitted QC: 2018-03-13
• Study First Posted: 2018-03-19
• Study Start: 2018-04-24
• Primary Completion: 2019-03-20
• Study Completion: 2019-03-20
• Results First Submitted: 2020-03-17
• Status Verified: 2020-06
• Results First Submitted QC: 2020-06-24
• Last Update Submitted: 2020-06-24
• Results First Posted: 2020-06-25
• Last Update Posted: 2020-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All subjects	PF-06763809	All subjects will receive all six interventions/treatments applied to six different treatment fields.
All subjects	Vehicle	All subjects will receive all six interventions/treatments applied to six different treatment fields.
All subjects	Calcipotriene/calcipotriol	All subjects will receive all six interventions/treatments applied to six different treatment fields.
All subjects	Betamethasone	All subjects will receive all six interventions/treatments applied to six different treatment fields.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

bioskin GmbH; 🇩🇪 Hamburg, Germany

Rothaar Studien GmbH; 🇩🇪 Berlin, Germany