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

Sponsor
Pfizer
Study ID
NCT02193815
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 30, 2014
Status verified
May 2016
Primary completion
Feb 28, 2015
Completion
Feb 28, 2015

Study Design

Enrollment
15 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

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 ]

Related Studies