Study Of The Mechanism Of Action Of CP-690,550 In The Skin Of Subjects With Moderate To Severe Chronic Plaque Psoriasis
NCT01710046
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- 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.
- 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).
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Descriptive Information | ||||
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Brief Title ICMJE | Study Of The Mechanism Of Action Of CP-690,550 In The Skin Of Subjects With Moderate To Severe Chronic Plaque Psoriasis | |||
Official Title ICMJE | An Exploratory Phase 2a, Randomized, Double-blind, Placebo-controlled, Multicenter Study To Assess Mechanism Of Action (Moa) Of Cp-690,550 In The Skin When Administered Orally At 10 Mg Twice Daily (Bid) For 12 Weeks In Subjects With Moderate To Severe Chronic Plaque Psoriasis | |||
Brief Summary | 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. | |||
Detailed Description | 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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Plaque Psoriasis | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 12 | |||
Original Estimated Enrollment ICMJE | 42 | |||
Actual Study Completion Date ICMJE | November 2013 | |||
Actual Primary Completion Date | November 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01710046 | |||
Other Study ID Numbers ICMJE | A3921147 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | March 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |