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

• ClinicalTrials.gov Identifier: NCT02193815
• Recruitment Status: Completed
• First Posted: July 18, 2014
• Results First Posted: June 9, 2016
• Last Update Posted: June 9, 2016
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Psoriasis Vulgaris	Drug: PF06263276; Other: Vehicle; Drug: 2%Tofacitinib Ointment; Drug: Daivonex; Drug: Daivonex Ointment	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: September 2014
• Actual Primary Completion Date: February 2015
• Actual Study Completion Date: February 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Psoriatic Skin Thickness/Echo-Poor Band (EPB) for PF-06263276 4% Solution in Comparison to Corresponding Vehicle at Day 12 [ Time Frame: Day 1 (Baseline), 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.

Secondary Outcome Measures :

1. Change From Baseline in Psoriatic Skin Thickness/EPB for PF-06263276 4% Solution in Comparison to Daivonex Solution at Day 12 [ Time Frame: Day 1 (Baseline), Day 12 ]
2. Change From Baseline in Psoriatic Skin Thickness/EPB for Tofacitinib 2% Ointment in Comparison to Corresponding Vehicle at Day 12 [ Time Frame: Day 1 (Baseline), Day 12 ]
3. Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8 [ Time Frame: Day 1 (Baseline), Day 8 ]
4. Area Under the Curve (AUC) of Psoriatic Skin Thickness/EPB [ Time Frame: Day 1 (baseline) up to Day 12 ]
   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.
5. Global Clinical Assessment at Day 1, 8 and 12 [ Time Frame: Day 1, Day 8, Day 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).

Other Outcome Measures:

1. Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs [ Time Frame: Baseline up to 28 days after last study drug administration (Day 21) ]
   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.
2. Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern [ Time Frame: Baseline up to Day 12 ]
   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).
3. Number of Participants With Potentially Clinically Significant Vital Signs Findings [ Time Frame: Baseline up to Day 12 ]
   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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

Germany

Bioskin GmbH

Hamburg, Germany, 20095

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02193815
• Other Study ID Numbers: B5391003; 2014-000068-16 ( EudraCT Number )
• First Posted: July 18, 2014
• Results First Posted: June 9, 2016
• Last Update Posted: June 9, 2016
• Last Verified: May 2016

Keywords provided by Pfizer:

psoriasis; plaque; vulgaris; phase 1; randomized; double-blind; topical; safety

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Calcitriol; Calcipotriene; Tofacitinib; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Calcium Channel Agonists; Membrane Transport Modulators; Vasoconstrictor Agents; Vitamins; Micronutrients; Bone Density Conservation Agents