Trial Outcomes & Findings for A 12 Day Study To Evaluate A Topical Drug To Treat Plaque Psoriasis (NCT NCT02193815)

NCT ID: NCT02193815

Last Updated: 2016-06-09

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 15 participants
• Primary outcome timeframe: Day 1 (Baseline), Day 12
• Results posted on: 2016-06-09

Participant Flow

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.

Participant milestones

Measure	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.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	All Participants n=15 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.
Age, Continuous	50.4 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 (Baseline), Day 12

Population: 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.

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.

Outcome measures

Measure	PF-06263276 4% Solution n=15 Participants All participants who received PF-06263276 4% solution topically once daily for 11 days.	PF-06263276 Vehicle n=15 Participants All participants who received PF-06263276 vehicle (active ingredient- free) topically once daily for 11 days.	Tofacitinib 2% Ointment All participants who received tofacitinib 2% ointment topically once daily for 11 days.	Tofacitinib Vehicle All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.	Daivonex Solution All participants who received calcipotriol solution (50 micrograms per milliliter \[mcg/mL\]) topically once daily for 11 days.	Daivonex Ointment All participants who received calcipotriol ointment (50 micrograms per gram \[mcg/g\]) topically once daily for 11 days.
Change From Baseline in Psoriatic Skin Thickness/Echo-Poor Band (EPB) for PF-06263276 4% Solution in Comparison to Corresponding Vehicle at Day 12 Baseline	358.9 micrometers Standard Deviation 132.84 • Interval 285.0 to 432.0	353.1 micrometers Standard Deviation 121.03 • Interval 286.0 to 420.0	—	—	—	—
Change From Baseline in Psoriatic Skin Thickness/Echo-Poor Band (EPB) for PF-06263276 4% Solution in Comparison to Corresponding Vehicle at Day 12 Change at Day 12	17.7 micrometers Standard Deviation 91.10 • Interval -33.0 to 68.0	32.9 micrometers Standard Deviation 96.72 • Interval -21.0 to 86.0	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 (Baseline), Day 12

Population: The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.

Outcome measures

Measure	PF-06263276 4% Solution n=15 Participants All participants who received PF-06263276 4% solution topically once daily for 11 days.	PF-06263276 Vehicle n=15 Participants All participants who received PF-06263276 vehicle (active ingredient- free) topically once daily for 11 days.	Tofacitinib 2% Ointment All participants who received tofacitinib 2% ointment topically once daily for 11 days.	Tofacitinib Vehicle All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.	Daivonex Solution All participants who received calcipotriol solution (50 micrograms per milliliter \[mcg/mL\]) topically once daily for 11 days.	Daivonex Ointment All participants who received calcipotriol ointment (50 micrograms per gram \[mcg/g\]) topically once daily for 11 days.
Change From Baseline in Psoriatic Skin Thickness/EPB for PF-06263276 4% Solution in Comparison to Daivonex Solution at Day 12	17.7 micrometers Standard Deviation 91.10	-135.5 micrometers Standard Deviation 114.27	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 (Baseline), Day 12

Population: The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.

Outcome measures

Measure	PF-06263276 4% Solution n=15 Participants All participants who received PF-06263276 4% solution topically once daily for 11 days.	PF-06263276 Vehicle n=15 Participants All participants who received PF-06263276 vehicle (active ingredient- free) topically once daily for 11 days.	Tofacitinib 2% Ointment All participants who received tofacitinib 2% ointment topically once daily for 11 days.	Tofacitinib Vehicle All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.	Daivonex Solution All participants who received calcipotriol solution (50 micrograms per milliliter \[mcg/mL\]) topically once daily for 11 days.	Daivonex Ointment All participants who received calcipotriol ointment (50 micrograms per gram \[mcg/g\]) topically once daily for 11 days.
Change From Baseline in Psoriatic Skin Thickness/EPB for Tofacitinib 2% Ointment in Comparison to Corresponding Vehicle at Day 12 Baseline	364.1 micrometers Standard Deviation 135.82	357.3 micrometers Standard Deviation 135.60	—	—	—	—
Change From Baseline in Psoriatic Skin Thickness/EPB for Tofacitinib 2% Ointment in Comparison to Corresponding Vehicle at Day 12 Change at Day 12	-117.8 micrometers Standard Deviation 115.15	0.1 micrometers Standard Deviation 95.04	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 (Baseline), Day 8

Population: The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.

Outcome measures

Measure	PF-06263276 4% Solution n=15 Participants All participants who received PF-06263276 4% solution topically once daily for 11 days.	PF-06263276 Vehicle n=15 Participants All participants who received PF-06263276 vehicle (active ingredient- free) topically once daily for 11 days.	Tofacitinib 2% Ointment n=15 Participants All participants who received tofacitinib 2% ointment topically once daily for 11 days.	Tofacitinib Vehicle n=15 Participants All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.	Daivonex Solution n=15 Participants All participants who received calcipotriol solution (50 micrograms per milliliter \[mcg/mL\]) topically once daily for 11 days.	Daivonex Ointment n=15 Participants All participants who received calcipotriol ointment (50 micrograms per gram \[mcg/g\]) topically once daily for 11 days.
Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8 Baseline	358.9 micrometers Standard Deviation 132.84	353.1 micrometers Standard Deviation 121.03	364.1 micrometers Standard Deviation 135.82	357.3 micrometers Standard Deviation 135.60	376.1 micrometers Standard Deviation 148.44	364.1 micrometers Standard Deviation 124.35
Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8 Change at Day 8	18.0 micrometers Standard Deviation 86.37	38.5 micrometers Standard Deviation 65.45	-90.5 micrometers Standard Deviation 84.11	15.1 micrometers Standard Deviation 104.55	-98.8 micrometers Standard Deviation 127.18	-104.7 micrometers Standard Deviation 65.83

SECONDARY outcome

Timeframe: Day 1 (baseline) up to Day 12

Population: The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.

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.

Outcome measures

Measure	PF-06263276 4% Solution n=15 Participants All participants who received PF-06263276 4% solution topically once daily for 11 days.	PF-06263276 Vehicle n=15 Participants All participants who received PF-06263276 vehicle (active ingredient- free) topically once daily for 11 days.	Tofacitinib 2% Ointment n=15 Participants All participants who received tofacitinib 2% ointment topically once daily for 11 days.	Tofacitinib Vehicle n=15 Participants All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.	Daivonex Solution n=15 Participants All participants who received calcipotriol solution (50 micrograms per milliliter \[mcg/mL\]) topically once daily for 11 days.	Daivonex Ointment n=15 Participants All participants who received calcipotriol ointment (50 micrograms per gram \[mcg/g\]) topically once daily for 11 days.
Area Under the Curve (AUC) of Psoriatic Skin Thickness/EPB	4082.60 micrometers*day Standard Deviation 1726.167	4161.40 micrometers*day Standard Deviation 1436.733	3271.93 micrometers*day Standard Deviation 1210.138	4013.07 micrometers*day Standard Deviation 1465.339	3322.40 micrometers*day Standard Deviation 1663.668	3165.47 micrometers*day Standard Deviation 1113.937

SECONDARY outcome

Timeframe: Day 1, Day 8, Day 12

Population: The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.

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).

Outcome measures

Measure	PF-06263276 4% Solution n=15 Participants All participants who received PF-06263276 4% solution topically once daily for 11 days.	PF-06263276 Vehicle n=15 Participants All participants who received PF-06263276 vehicle (active ingredient- free) topically once daily for 11 days.	Tofacitinib 2% Ointment n=15 Participants All participants who received tofacitinib 2% ointment topically once daily for 11 days.	Tofacitinib Vehicle n=15 Participants All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.	Daivonex Solution n=15 Participants All participants who received calcipotriol solution (50 micrograms per milliliter \[mcg/mL\]) topically once daily for 11 days.	Daivonex Ointment n=15 Participants All participants who received calcipotriol ointment (50 micrograms per gram \[mcg/g\]) topically once daily for 11 days.
Global Clinical Assessment at Day 1, 8 and 12 Day 1: Score -1	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Global Clinical Assessment at Day 1, 8 and 12 Day 1: Score 0	15 participants	15 participants	15 participants	15 participants	15 participants	15 participants
Global Clinical Assessment at Day 1, 8 and 12 Day 1: Score 1	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Global Clinical Assessment at Day 1, 8 and 12 Day 1: Score 2	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Global Clinical Assessment at Day 1, 8 and 12 Day 1: Score 3	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Global Clinical Assessment at Day 1, 8 and 12 Day 8: Score -1	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants
Global Clinical Assessment at Day 1, 8 and 12 Day 8: Score 0	13 participants	15 participants	4 participants	14 participants	1 participants	1 participants
Global Clinical Assessment at Day 1, 8 and 12 Day 8: Score 1	2 participants	0 participants	8 participants	0 participants	9 participants	6 participants
Global Clinical Assessment at Day 1, 8 and 12 Day 8: Score 2	0 participants	0 participants	3 participants	1 participants	4 participants	8 participants
Global Clinical Assessment at Day 1, 8 and 12 Day 8: Score 3	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Global Clinical Assessment at Day 1, 8 and 12 Day 12: Score -1	0 participants	0 participants	0 participants	0 participants	1 participants	1 participants
Global Clinical Assessment at Day 1, 8 and 12 Day 12: Score 0	13 participants	15 participants	4 participants	11 participants	1 participants	2 participants
Global Clinical Assessment at Day 1, 8 and 12 Day 12: Score 1	2 participants	0 participants	8 participants	3 participants	6 participants	4 participants
Global Clinical Assessment at Day 1, 8 and 12 Day 12: Score 2	0 participants	0 participants	3 participants	1 participants	7 participants	8 participants
Global Clinical Assessment at Day 1, 8 and 12 Day 12: Score 3	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 28 days after last study drug administration (Day 21)

Population: The safety population included all enrolled participants who received at least 1 dose of investigational product.

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.

Outcome measures

Measure	PF-06263276 4% Solution n=15 Participants All participants who received PF-06263276 4% solution topically once daily for 11 days.	PF-06263276 Vehicle n=15 Participants All participants who received PF-06263276 vehicle (active ingredient- free) topically once daily for 11 days.	Tofacitinib 2% Ointment n=15 Participants All participants who received tofacitinib 2% ointment topically once daily for 11 days.	Tofacitinib Vehicle n=15 Participants All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.	Daivonex Solution n=15 Participants All participants who received calcipotriol solution (50 micrograms per milliliter \[mcg/mL\]) topically once daily for 11 days.	Daivonex Ointment n=15 Participants All participants who received calcipotriol ointment (50 micrograms per gram \[mcg/g\]) topically once daily for 11 days.
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs Specified Skin AEs	0 participants	0 participants	0 participants	0 participants	0 participants	2 participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs Specified Skin SAEs	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to Day 12

Population: The safety population included all enrolled participants who received at least 1 dose of investigational product.

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).

Outcome measures

Measure	PF-06263276 4% Solution n=15 Participants All participants who received PF-06263276 4% solution topically once daily for 11 days.	PF-06263276 Vehicle All participants who received PF-06263276 vehicle (active ingredient- free) topically once daily for 11 days.	Tofacitinib 2% Ointment All participants who received tofacitinib 2% ointment topically once daily for 11 days.	Tofacitinib Vehicle All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.	Daivonex Solution All participants who received calcipotriol solution (50 micrograms per milliliter \[mcg/mL\]) topically once daily for 11 days.	Daivonex Ointment All participants who received calcipotriol ointment (50 micrograms per gram \[mcg/g\]) topically once daily for 11 days.
Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern	6 participants	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to Day 12

Population: The safety population included all enrolled participants who received at least 1 dose of investigational product.

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.

Outcome measures

Measure	PF-06263276 4% Solution n=15 Participants All participants who received PF-06263276 4% solution topically once daily for 11 days.	PF-06263276 Vehicle All participants who received PF-06263276 vehicle (active ingredient- free) topically once daily for 11 days.	Tofacitinib 2% Ointment All participants who received tofacitinib 2% ointment topically once daily for 11 days.	Tofacitinib Vehicle All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.	Daivonex Solution All participants who received calcipotriol solution (50 micrograms per milliliter \[mcg/mL\]) topically once daily for 11 days.	Daivonex Ointment All participants who received calcipotriol ointment (50 micrograms per gram \[mcg/g\]) topically once daily for 11 days.
Number of Participants With Potentially Clinically Significant Vital Signs Findings SBP <90 mmHg	0 participants	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Vital Signs Findings DBP <50 mmHg	0 participants	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Vital Signs Findings Pulse Rate <40 or >120 bpm	0 participants	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Vital Signs Findings Maximum Increase from Baseline in SBP >=30 mmHg	0 participants	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Vital Signs Findings Maximum Increase from Baseline in DBP >=20 mmHg	0 participants	—	—	—	—	—

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	All Participants n=15 participants at risk 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.
Gastrointestinal disorders Nausea	6.7% 1/15 • Baseline up to 28 days after last study drug administration (Day 21)
General disorders Facial pain	6.7% 1/15 • Baseline up to 28 days after last study drug administration (Day 21)
Nervous system disorders Dizziness	6.7% 1/15 • Baseline up to 28 days after last study drug administration (Day 21)
Skin and subcutaneous tissue disorders Blister	13.3% 2/15 • Baseline up to 28 days after last study drug administration (Day 21)
Skin and subcutaneous tissue disorders Dermatitis	6.7% 1/15 • Baseline up to 28 days after last study drug administration (Day 21)
Skin and subcutaneous tissue disorders Erythema	6.7% 1/15 • Baseline up to 28 days after last study drug administration (Day 21)

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER