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PF06263276

Phase 1

Psoriasis Vulgaris | Small molecule | Dermatology |Pfizer, Inc.|Last Updated: Jun 9, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

PF06263276 · 1 trial · 1 indication

Phase 1 1
NCT02193815A 12 Day Study To Evaluate A Topical Drug To Treat Plaque PsoriasisPsoriasis Vulgaris
COMPLETED15 Analytics
PHASE1COMPLETED
A 12 Day Study To Evaluate A Topical Drug To Treat Plaque Psoriasis
Psoriasis VulgarisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Psoriatic Skin Thickness/Echo-Poor Band (EPB) for PF-06263276 4% Solution in Comparison to Corresponding Vehicle at Day 12
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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
One ArmEXPERIMENTALStudy treatments 1-6 Study drug, vehicle, Tofacitinib, vehicle, Daivonex solution and ointment

Interventions

NameTypeDescription
PF06263276DRUG4% PF 06263276 solution Daily dosage: approximately 8 mg PF 06263276 QD
VehicleOTHERActive ingredient-free vehicle to 4% solution
2%Tofacitinib OintmentDRUGDaily Dosage: approximately 4 mg tofacitinib
DaivonexDRUGDaivonex solution (50 ug/ml Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg
Daivonex OintmentDRUGDaivonex ointment (50 ug/g Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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 l...

Countries:Germany
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Frequently asked questions about PF06263276

What is PF06263276 used for?

PF06263276 is an investigational small molecule being studied for the treatment of psoriasis vulgaris, a form of plaque psoriasis. It is being developed as a topical drug and is currently in Phase 1 clinical development. The drug is not yet approved and remains under investigation.

Who makes PF06263276?

PF06263276 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational topical treatment for psoriasis vulgaris.

What phase is PF06263276 in?

PF06263276 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 clinical trial has been completed to evaluate the drug in patients with psoriasis vulgaris, but further studies are needed before it can be considered for approval.

What clinical trials is PF06263276 in?

PF06263276 has been studied in one completed Phase 1 clinical trial with the identifier NCT02193815. This was a 12-day study conducted in Germany that enrolled 15 participants with psoriasis vulgaris. The trial was randomized, double-blind, and uncontrolled, and it evaluated the topical drug in adult patients.

Is PF06263276 FDA approved?

PF06263276 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of psoriasis vulgaris. The drug has completed a Phase 1 trial, but it has not yet received regulatory approval and remains under investigation for safety and efficacy.