Clinical trial NCT01710046: Study Of The Mechanism Of Action Of CP-690,550 In The Skin Of Subjects With Moderate To Severe Chronic Plaque Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plaque Psoriasis
Keywords: plaque psoriasis
tofacitinib
biopsy
Janus Kinase
randomized placebo controlled clinical trial
psoriasis vulgaris
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-10-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of Participants Achieving a 75% Reduction in the Psoriasis Area and Severity Index (PASI75) at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Psoriasis Area and Severity Index (PASI) Score by Visit
timeFrame: Baseline and Weeks 1, 2, 4, and 12
measure: Change From Baseline in PASI by Visit
timeFrame: Weeks 1, 2, 4 and 12
measure: Percent Change From Baseline in PASI by Visit
timeFrame: Weeks 1, 2, 4, and 12
measure: Percentage of Participants Achieving a PASI75 Response at Weeks 1, 2, and 4
timeFrame: Weeks 1, 2, and 4
measure: Change From Baseline in PGA Score by Visit
timeFrame: Weeks 1, 2, 4, and 12
measure: Percentage of Participants in Each PGA Category at Various Timepoints by Baseline Category
timeFrame: Baseline and Weeks 1, 2, 4, and 12
measure: Percentage of Participants by PGA Response Category and Timepoint
timeFrame: Baseline and Weeks 1, 2, 4, and 12
measure: Body Surface Area (BSA)
timeFrame: Baseline and Weeks 1, 2, 4, and 12
measure: Change From Baseline in BSA
timeFrame: Weeks 1, 2, 4, and 12
measure: Percent Change From Baseline in BSA
timeFrame: Weeks 1, 2, 4, and 12
measure: Itch Severity Item (ISI) Score by Visit
timeFrame: Baseline and Weeks 1, 2, 4, and 12
measure: Change From Baseline in ISI by Visit
timeFrame: Weeks 1, 2, 4 and 12
measure: Target Plaque Severity Score (TPSS) by Visit
timeFrame: Baseline and Weeks 1, 2, 4, and 12
measure: Percent Change From Baseline in TPSS by Visit
timeFrame: Weeks 1, 2, 4, and 12
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: Dallas
country: United States
facility: Menter Dermatology Research Institute
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20.
citation: Krueger J, Clark JD, Suarez-Farinas M, Fuentes-Duculan J, Cueto I, Wang CQ, Tan H, Wolk R, Rottinghaus ST, Whitley MZ, Valdez H, von Schack D, O'Neil SP, Reddy PS, Tatulych S; A3921147 Study Investigators. Tofacitinib attenuates pathologic immune pathways in patients with psoriasis: A randomized phase 2 study. J Allergy Clin Immunol. 2016 Apr;137(4):1079-1090. doi: 10.1016/j.jaci.2015.12.1318.