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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


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
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