A 12 Day Study To Evaluate A Topical Drug To Treat Plaque Psoriasis

A Phase 1, Single- Center, Randomized, Double-blind, Vehicle And Active Comparator-controlled Trial To Evaluate The Antipsoriatic Activity And Safety Of A Topically Applied Pf-06263276 Formulation In A Psoriasis Plaque Test

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Drug: PF06263276; Other: Vehicle; Drug: 2%Tofacitinib Ointment; Other: Vehicle; Drug: Daivonex; Drug: Daivonex Ointment

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20095
    • bioskin GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male and/or female subjects age 18 years and older, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests.
• Subjects with 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.
• The target lesion(s) should be on the trunk or extremities (excluding palms/soles). Psoriatic lesions on the knees or elbows are not to be used as a target lesion.

Exclusion Criteria:

• Subjects with psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, psoriasis arthropathica and pustular psoriasis.
• Treatment with any systemic medications which in the opinion of the investigator might counter or influence the trial aim (including anti psoriasis medications, eg, corticosteroids, cytostatics or retinoids) or medications which are known to provoke or aggravate psoriasis (eg, beta blocker, anti malarial drugs, lithium) or phototherapy/psoralen+UVA (PUVA) within 4 weeks preceding the treatment phase of the trial and during the trial.
• Treatment with any locally acting medications (including anti-psoriasis medications like vitamin D analogues, dithranol) within 4 weeks of the treatment phase.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: One Arm; Study treatments 1-6 Study drug, vehicle, Tofacitinib, vehicle, Daivonex solution and ointment

Drug: PF06263276; 4% PF 06263276 solution Daily dosage: approximately 8 mg PF 06263276 QD; Other: Vehicle; Active ingredient-free vehicle to 4% solution; Drug: 2%Tofacitinib Ointment; Daily Dosage: approximately 4 mg tofacitinib; Other: Vehicle; Active ingredient-free vehicle to 2% Ointment; Drug: Daivonex; Daivonex solution (50 ug/ml Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg; Drug: Daivonex Ointment; Daivonex ointment (50 ug/g Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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		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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: July 16, 2014
• First Submitted That Met QC Criteria: July 16, 2014
• First Posted (Estimate): July 18, 2014

Study Record Updates

• Last Update Posted (Estimate): June 9, 2016
• Last Update Submitted That Met QC Criteria: May 2, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: safety; phase 1; topical; psoriasis; plaque; randomized; double-blind; vulgaris
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dermatologic Agents; Micronutrients; Membrane Transport Modulators; Protein Kinase Inhibitors; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vasoconstrictor Agents; Calcium Channel Agonists; Calcipotriene; Tofacitinib; Calcitriol
• Other Study ID Numbers: B5391003; 2014-000068-16 (EudraCT Number)