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

Psoriasis Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02193815
• Other study ID #: B5391003
• Secondary ID: 2014-000068-16
• Status: Completed
• Phase: Phase 1
• First received: July 16, 2014
• Last updated: March 4, 2015
• Start date: September 2014
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

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
• Daivonex Ointment
Daivonex ointment (50 ug/g Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg

Locations

Country	Name	City	State
Germany	Bioskin GmbH	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in psoriatic skin thickness using 4% solution of PF-06263276 in comparison to vehicle.	Assessed using 20 MHz sonographic measurement	11 days of treatment	No
Secondary	Change from baseline in psoriatic skin thickness using 4% solution of PF-06263276 in comparison to Daivonex solution (50 ug/ml).	Assessed using 20 MHz sonographic measurement	11 days of treatment	No
Secondary	Change from baseline in psoriatic skin thickness using 2% ointment of Tofacitinib in comparison to vehicle.	Assessed using 20 MHz sonographic measurement	11 days of treatment	No
Secondary	Change from baseline in psoriatic skin thickness	Assessed using 20 MHz sonographic measurement	7 days of treatment	No
Secondary	Area Under the Curve from Time Zero to end of dosing interval (AUCtau)	Assessed using 20 MHz sonographic measurement	11 days of treatment	No
Secondary	Global Clinical Assessment	Visual examination using a 5 point score	Study Days 1, 8 and 12	No

External Links

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