Study Of The Mechanism Of Action Of CP-690,550 In The Skin Of Subjects With Moderate To Severe Chronic Plaque Psoriasis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-11-30

Brief Summary

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There are cells in the skin and blood of humans with chronic moderate to severe plaque psoriasis with specific activities that may determine the effectiveness of treatment. These activities may be described by obtaining samples of skin and blood and analyzing them using a variety of tests.

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Detailed Description

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The final subject in Cohort 1 completed the study on 19-Nov-2013 (LSLV date). Because the study analyses were novel and exploratory, they required extensive analyses by study team and external experts. As a result of this analysis it was determined on 21-July-2014 that the data from Cohort 1 were sufficiently definitive and that enrollment of Cohort 2 would not be justified. Since this decision resulted in the LSLV for Cohort 1 becoming the LSLV for the study, the full data analysis and reporting is not projected to be complete within 12 Months of LSLV. The final analysis and final reporting is planned to be completed on 18-Feb-2015. Results for this data are anticipated to be released in April 2015.

Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Cohort 1

Group Type EXPERIMENTAL

(CP-6890,550) Tofacitinib

Intervention Type DRUG

2 x 5 mg oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks

Placebo

Intervention Type DRUG

2 matching oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks

Cohort 2

Group Type EXPERIMENTAL

(CP-690,550) Tofacitinib

Intervention Type DRUG

2 x 5 mg oral capsules taken twice daily (every 12 hours) for 12 weeks

Placebo

Intervention Type DRUG

2 matching oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks

Interventions

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(CP-6890,550) Tofacitinib

2 x 5 mg oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks

Intervention Type DRUG

Placebo

2 matching oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks

Intervention Type DRUG

(CP-690,550) Tofacitinib

2 x 5 mg oral capsules taken twice daily (every 12 hours) for 12 weeks

Intervention Type DRUG

Placebo

2 matching oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults over 18 years of age with a diagnosis of chronic moderate to severe plaque psoriasis for at least 12 months; in generally good health; on stable dose of non-prohibited medications; able to stop current psoriasis therapy (systemic or topical) for several weeks prior to and during study participation.

Exclusion Criteria

* Serious underlying disease including viral disorders such as hepatitis or HIV or skin condition that would interfere with skin biopsies or evaluation of psoriasis; conditions that could interfere with drug absorption after oral administration; history of malignancy or auto-immune disease.
* Use of oral or injected corticosteroids (steroids).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No