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Multiple Dose Escalation Study In Medically Stable Subjects With Psoriasis

Phase 1, Investigator-Blind, Subject-Blind, Sponsor-Open, Placebo-Controlled, Two-Week, Multiple Dose Escalation Study In Medically Stable Subjects With Psoriasis To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of CP-690,550

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01736696
Enrollment
59
Registered
2012-11-29
Start date
2002-11-30
Completion date
2004-04-30
Last updated
2013-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunomodulation, Psoriasis

Keywords

Psoriasis, PASI, plaques, skin biopsy, immunomodulation

Brief summary

This study was conducted in subjects with psoriasis to evaluate drug activity in this patient population by analysis of changes in psoriatic lesion biopsy characteristics. This subject population was selected to evaluate potentially relevant biological activity of CP-690,550 as well as assessing safety and pharmacokinetics.

Interventions

DRUGtofacitinib

5 mg BID For 13 days and once on Day 14

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Male and/or female subjects between the ages of 18 and 65 years, inclusive, with active psoriasis lesion(s). * Subjects should be healthy with the exception of psoriasis, where healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination. Blood pressure must be \< 140/89. Body Mass Index (BMI) between 18-36 kg/m2, inclusive; and a total body weight \>50 kg (110 lbs) * The following laboratory variables must be no more than 10% below the lower limit of the normal reference range: RBC, hemoglobin, hematocrit, WBC, absolute neutrophil count. The absolute lymphocyte count must be greater than or equal to the lower limit of the reference range. Values for AST, ALT, bilirubin and alkaline phosphatase must be no more than 10% above the upper limit of the normal reference range. Values for total cholesterol and LDL must be no more than 20% above the upper limit of the normal reference range except for subjects being treated for hyperlipidemia. Normal glomerular filtration rate (\> 80 mL/min).

Exclusion criteria

* Subjects with evidence or history of clinically significant hematological, renal, urological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic disorder. * Subjects with controlled essential hypertension and/or hyperlipidemia may be eligible for the study provided that any medications that are administered. * Screening 12-lead ECG demonstrating at least one of the following: heart rate \> 100 bpm, QRS \>120 msec, QTc \> 430 msec (males), QTc \> 450 msec (females) or PR \> 220 msec. * Abnormal chest radiographs including, but not limited to, evidence of past or present tuberculosis infection. History of tuberculosis without treatment and/or positive tuberculin reaction without known vaccination with BCG. * Subjects with a history of tumors with the exception of adequately treated basal cell carcinoma of the skin.

Design outcomes

Primary

MeasureTime frameDescription
Half Maximal Effective Area Under the Concentration-Time Curve 50 (EAUC 50)Day 14EAUC 50 was calculated from a regression analyses using area under the concentration-time curve (AUC) as the independent variable. A sigmoid maximum effect (Emax) model was used to explain the relationship between AUC and modified Psoriasis Severity Index (mPASI) score, where Emax was the maximum effect (100 percent reduction in the total mPASI score from baseline), and EAUC 50 was the AUC where 50 percent of the maximum effect was measured.
Change From Baseline in Reticulocyte Count at Day 7Baseline (Within 7 days prior to Day 1), Day 7Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.
Change From Baseline in Reticulocyte Count at Day 10Baseline (Within 7 days prior to Day 1), Day 10Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.
Change From Baseline in Reticulocyte Count at Day 15Baseline (Within 7 days prior to Day 1), Day 15Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.
Change From Baseline in Reticulocyte Count at Day 21Baseline (Within 7 days prior to Day 1), Day 21Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.
Change From Baseline in Reticulocyte Count at Day 28Baseline (Within 7 days prior to Day 1), Day 28Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.
Change From Baseline in Reticulocyte Count at Day 42Baseline (Within 7 days prior to Day 1), Day 42Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.
Time to Reach Maximum Change From Baseline and Time to Return to Baseline Value for Fluorescence-Activated Cell Sorting (FACS), Reticulocyte Counts and Immune Cell FunctionDay 0 (pre-dose), 1, 2, 4, 7, 10, 14, 15, 18, 21, 28, 42
Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 123 hours (hrs) prior to morning dose on Day 1 (Baseline for HPD 1), 1 hour (hr) post morning dose on Day 1Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. For each scheduled hour post morning dose (HPD), except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.
Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 122 hrs prior to morning dose on Day 1 (Baseline for HPD 2), 2 hrs post morning dose on Day 1Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. For each scheduled hour post morning dose (HPD), except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.
Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 120 hrs prior to morning dose on Day 1 (Baseline for HPD 4), 4 hrs post morning dose on Day 1Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.
Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 116 hrs prior to morning dose on Day 1 (Baseline for HPD 8), 8 hrs post morning dose on Day 1Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.
Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 112 hrs prior to morning dose on Day 1 (Baseline for HPD 12), 12 hrs post morning dose on Day 1Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.
Change From Baseline in QT Interval at 16 Hour Post Morning Dose (HPD 16) on Day 18 hrs prior to morning dose on Day 1 (Baseline for HPD 16), 16 hrs post morning dose on Day 1Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.Change from baseline in QT interval at HPD 16 was planned to be analyzed for participants who received CP-690,550 60 mg and matching placebo.
Change From Baseline in QT Interval at 0 Hour Post Morning Dose (HPD 0) on Day 14Hour 0 (pre-dose) on Day 1 (Baseline for HPD 0), 0 hr on Day 14Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. The mean of the triplicates at HPD=0 on Day 1 will be defined as the baseline for HPD=0.
Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1423 hrs prior to morning dose on Day 1 (Baseline for HPD 1), 1 hr post morning dose on Day 14Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.
Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 1422 hrs prior to morning dose on Day 1 (Baseline for HPD 2), 2 hrs post morning dose on Day 14Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.
Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 1420 hrs prior to morning dose on Day 1 (Baseline for HPD 4), 4 hrs post morning dose on Day 14Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.
Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 1416 hrs prior to morning dose on Day 1 (Baseline for HPD 8), 8 hrs post morning dose on Day 14Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.
Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 1412 hrs prior to morning dose on Day 1 (Baseline for HPD 12), 12 hrs post morning dose on Day 14Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.
Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval1, 2, 4, 8, 12 hrs post dose, additional 16 hrs post dose for 60 mg once daily group on Day 1; 1, 2 hrs post dose on Day 4, 7, 10;1,2,4,8,12 hrs post dose on Day 14; Day 21Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR) and by Bazette's formula (QTcB = QT divided by square root of RR). Participants with maximum increase from baseline of 30 to less than (\<) 60 msec(borderline) and greater than or equal to (\>=) 60 msec (prolonged) were summarized.
Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 Millisecond1, 2, 4, 8, 12 hrs post dose, additional 16 hrs post dose for 60 mg once daily group on Day 1; 1, 2 hrs post dose on Day 4, 7, 10;1,2,4,8,12 hrs post dose on Day 14; Day 21Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR) and by Bazette's formula (QTcB = QT divided by square root of RR). Participants with maximum QTc \>=500 msec were reported.
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 10 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1AUCtau = area under the curve from time zero to end of dosing interval.
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 140 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 14AUCtau = area under the curve from time zero to end of dosing interval.
Maximum Observed Plasma Concentration (Cmax) at Day 10 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1
Maximum Observed Plasma Concentration (Cmax) at Day 140 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 14
Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 10 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 140 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 14
Accumulation Ratio (R0)0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1 and Day 14Accumulation ratio was calculated as, R0 = area under the curve from time zero to end of dosing interval (AUCtau) on Day 14 divided by area under the curve from time zero to end of dosing interval (AUCtau) on Day 1.
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Baseline, 1 hr post-dose on Day 1Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Baseline, hr 0 on Day 2Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Baseline, hr 0 on Day 4Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Baseline, hr 0 on Day 7Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Baseline, hr 0 on Day 10Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Baseline; hr 0, 8 hr post-dose on Day 14Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Baseline, Hour 0 on Day 18Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Baseline, hr 0 on Day 21Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Baseline, hr 0 on Day 28Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Baseline, hr 0 on Day 42Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.
Change From Baseline in Immune Cell Function at Day 14Baseline (Within 7 days prior to Day 1), Day 14The degree of immunosuppression induced by the study drug administration was evaluated using a bioluminescent assay in which the concentration of Adenosine-5-Triphosphate (ATP) released by CD4 cells was measured. ATP concentrations released from stimulated and unstimulated cells were evaluated. ATP Concentration less than or equal to (\<=) 225: low immune cell response, 226 to 524: Moderate immune cell response, \>= 525: strong immune cell response. Baseline was defined as the mean of the samples collected during the pre-dose biopsy.
Change From Baseline in Reticulocyte Count at Day 2Baseline (Within 7 days prior to Day 1), Day 2Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.
Change From Baseline in Reticulocyte Count at Day 4Baseline (Within 7 days prior to Day 1), Day 4Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.

Secondary

MeasureTime frameDescription
Number of Participants With Physician's Global Assessment (PGA) of PsoriasisBaseline (Within 7 days prior to Day 1) up to Day 14Physician global assessment (PGA) of Psoriasis is a 7-point scale used to assess severity of psoriatic plaques, scaling and/or erythema. Severity scale ranged from 1 to 7: 1=severe, 2=moderate to severe, 3=moderate, 4=mild to moderate, 5=mild, 6=almost clear, 7=clear (no sign of psoriasis).
Gene Expression in Psoriatic Plaque BiopsiesDay 14Gene expression by quantitative polymerized chain reaction (PCR) using standard curve (SC) method generated by linear regression using log threshold cycle versus log(cell number). Keratin (K)-16, inducible nitric oxide synthase (iNOS), Interleukin 8 (IL-8), CD25, Granzyme B, IL-2, IL-7, IL-15, Interferon-gamma (INF-gamma), C-X-C motif chemokine(CXCL10), perforin 1, B-cell Lymphoma 2 (BCL-2), BCL2 associated X Protein (BAX), Tumor Necrosis Factor Fas Ligand (TNF-FasL), and proliferating cell nuclear antigen (PCNA) presented as control gene normalized expression (relative expression) within SC.
Immunohistochemistry From Psoriatic Plaque BiopsiesBaseline (within 7 days prior to Day 1), Day 14Immunohistochemical staining of skin biopsies was performed with monoclonal antibodies directed against cluster of differentiation 3 (CD3) and cluster of differentiation 8 (CD8) T-lymphocytes, cluster of differentiation 16/56 (CD16/56) natural killer cells, and cluster of differentiation 83 (CD83) mature dendritic cells. Baseline was defined as mean of samples obtained at the screening visit within 7 days prior to Day 1, at the baseline biopsy, and Day 0. Immunohistochemistry results were planned to be analyzed for participants who received CP-690,550 5, 20, 30 mg and matching placebo.
Number of Participants With Keratin 16 (K16) ExpressionBaseline (within 7 days prior to Day 1) up to Day 14Immunohistochemical staining of skin biopsies was performed with monoclonal antibodies directed against K16. Number of participants with K16 expression were assessed qualitatively using suprabasal keratinocytes.
Number of Participants With Intracellular Adhesion Molecule (ICAM-1) by Epidermal Keratinocytes ExpressionBaseline (within 7 days prior to Day 1) up to Day 14Immunohistochemical staining of skin biopsies was performed with monoclonal antibodies directed against ICAM-1. Number of participants with ICAM-1 expression was to be assessed qualitatively using epidermal keratinocytes.
Gene Expression in Peripheral BloodDay 14Punch biopsy and serum blood were assayed for messenger Ribonucleic acid (mRNA) gene expression by quantitative PCR using standard curve(SC) method generated by linear regression using log threshold cycle versus log(cell number). granzyme B, IFN-gamma, TNF-alpha (FasL and superfamily member 5 \[SF5\]), BCL2, BAX, iNOS, and CD 25 presented as control gene normalized expression(relative expression) within SC. The Relative mRNA Gene Expression Level is relative to baseline and normalized to the housekeeping gene 18 Svedberg unit ribosomal RNA (18S rRNA).
Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Baseline (Within 7 days prior to Day 1) up to Day 14Modified Psoriasis Area and Severity Index (mPASI) assessed lesion severity but not the body surface area affected. Severity was estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final mPASI = sum of the each component scores. Total score range 0-12 , higher score indicated more severity.

Countries

United States

Participant flow

Participants by arm

ArmCount
CP-690,550 5 mg (Cohort 1)
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
5
CP-690,550 10 mg (Cohort 2)
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
5
CP-690,550 20 mg (Cohort 3)
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
10
CP-690,550 30 mg (Cohort 4)
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
9
CP-690,550 60 mg (Cohort 5)
CP-690,550 60 mg tablets orally once daily up to Day 14.
9
CP-690,550 50 mg (Cohort 6)
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
8
Placebo
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
13
Total59

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006
Overall StudyWithdrawal by Subject0010000

Baseline characteristics

CharacteristicCP-690,550 5 mg (Cohort 1)CP-690,550 10 mg (Cohort 2)CP-690,550 20 mg (Cohort 3)CP-690,550 30 mg (Cohort 4)CP-690,550 60 mg (Cohort 5)CP-690,550 50 mg (Cohort 6)PlaceboTotal
Age Continuous40.2 years
STANDARD_DEVIATION 12.8
43.8 years
STANDARD_DEVIATION 7.4
39.6 years
STANDARD_DEVIATION 11.1
44.6 years
STANDARD_DEVIATION 11.1
46.9 years
STANDARD_DEVIATION 10.2
47.1 years
STANDARD_DEVIATION 9.7
44.4 years
STANDARD_DEVIATION 10.4
43.9 years
STANDARD_DEVIATION 10.3
Sex: Female, Male
Female
3 Participants2 Participants3 Participants1 Participants4 Participants4 Participants5 Participants22 Participants
Sex: Female, Male
Male
2 Participants3 Participants7 Participants8 Participants5 Participants4 Participants8 Participants37 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —— / —— / —— / —
other
Total, other adverse events
0 / 51 / 53 / 101 / 92 / 92 / 82 / 13
serious
Total, serious adverse events
0 / 51 / 50 / 100 / 90 / 90 / 80 / 13

Outcome results

Primary

Accumulation Ratio (R0)

Accumulation ratio was calculated as, R0 = area under the curve from time zero to end of dosing interval (AUCtau) on Day 14 divided by area under the curve from time zero to end of dosing interval (AUCtau) on Day 1.

Time frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1 and Day 14

Population: Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

ArmMeasureValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Accumulation Ratio (R0)0.974 RatioStandard Deviation 0.181
CP-690,550 10 mg (Cohort 2)Accumulation Ratio (R0)1.22 RatioStandard Deviation 0.203
CP-690,550 20 mg (Cohort 3)Accumulation Ratio (R0)1.22 RatioStandard Deviation 0.389
CP-690,550 30 mg (Cohort 4)Accumulation Ratio (R0)1.62 RatioStandard Deviation 0.343
CP-690,550 60 mg (Cohort 5)Accumulation Ratio (R0)1.16 RatioStandard Deviation 0.27
CP-690,550 50 mg (Cohort 6)Accumulation Ratio (R0)1.14 RatioStandard Deviation 0.176
Primary

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 1

AUCtau = area under the curve from time zero to end of dosing interval.

Time frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1

Population: Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

ArmMeasureValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 1161 nanogram*hour/milliliter (ng*hr/mL)Standard Deviation 86.1
CP-690,550 10 mg (Cohort 2)Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 1349 nanogram*hour/milliliter (ng*hr/mL)Standard Deviation 34.7
CP-690,550 20 mg (Cohort 3)Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 1732 nanogram*hour/milliliter (ng*hr/mL)Standard Deviation 232
CP-690,550 30 mg (Cohort 4)Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 1860 nanogram*hour/milliliter (ng*hr/mL)Standard Deviation 235
CP-690,550 60 mg (Cohort 5)Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 12120 nanogram*hour/milliliter (ng*hr/mL)Standard Deviation 837
CP-690,550 50 mg (Cohort 6)Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 11720 nanogram*hour/milliliter (ng*hr/mL)Standard Deviation 453
Primary

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 14

AUCtau = area under the curve from time zero to end of dosing interval.

Time frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 14

Population: Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

ArmMeasureValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 14154 ng*hr/mLStandard Deviation 80.3
CP-690,550 10 mg (Cohort 2)Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 14422 ng*hr/mLStandard Deviation 49.5
CP-690,550 20 mg (Cohort 3)Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 14850 ng*hr/mLStandard Deviation 216
CP-690,550 30 mg (Cohort 4)Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 141350 ng*hr/mLStandard Deviation 308
CP-690,550 60 mg (Cohort 5)Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 142600 ng*hr/mLStandard Deviation 1580
CP-690,550 50 mg (Cohort 6)Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 141780 ng*hr/mLStandard Deviation 501
Primary

Change From Baseline in Immune Cell Function at Day 14

The degree of immunosuppression induced by the study drug administration was evaluated using a bioluminescent assay in which the concentration of Adenosine-5-Triphosphate (ATP) released by CD4 cells was measured. ATP concentrations released from stimulated and unstimulated cells were evaluated. ATP Concentration less than or equal to (\<=) 225: low immune cell response, 226 to 524: Moderate immune cell response, \>= 525: strong immune cell response. Baseline was defined as the mean of the samples collected during the pre-dose biopsy.

Time frame: Baseline (Within 7 days prior to Day 1), Day 14

Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n' = participants evaluable for this measure at specified time points for each arm group respectively.

ArmMeasureGroupValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Change From Baseline in Immune Cell Function at Day 14Baseline: Unstimulated(Uns) ATP(n=2,5,10,9,9,7,13)11.50 ng/mLStandard Deviation 9.9
CP-690,550 5 mg (Cohort 1)Change From Baseline in Immune Cell Function at Day 14Change at Day 14:Uns ATP(n=2,5,9,9,9,7,13)9.50 ng/mLStandard Deviation 2.8
CP-690,550 5 mg (Cohort 1)Change From Baseline in Immune Cell Function at Day 14Baseline: Stimulated ATP(n=2,5,10,9,9,7,13)222.75 ng/mLStandard Deviation 157.3
CP-690,550 5 mg (Cohort 1)Change From Baseline in Immune Cell Function at Day 14Change at Day 14: Stimulated ATP(n=2,5,9,9,9,7,13)92.75 ng/mLStandard Deviation 120.6
CP-690,550 10 mg (Cohort 2)Change From Baseline in Immune Cell Function at Day 14Change at Day 14: Stimulated ATP(n=2,5,9,9,9,7,13)95.80 ng/mLStandard Deviation 135
CP-690,550 10 mg (Cohort 2)Change From Baseline in Immune Cell Function at Day 14Baseline: Stimulated ATP(n=2,5,10,9,9,7,13)205.40 ng/mLStandard Deviation 143.1
CP-690,550 10 mg (Cohort 2)Change From Baseline in Immune Cell Function at Day 14Baseline: Unstimulated(Uns) ATP(n=2,5,10,9,9,7,13)10.60 ng/mLStandard Deviation 3.2
CP-690,550 10 mg (Cohort 2)Change From Baseline in Immune Cell Function at Day 14Change at Day 14:Uns ATP(n=2,5,9,9,9,7,13)5.60 ng/mLStandard Deviation 11.4
CP-690,550 20 mg (Cohort 3)Change From Baseline in Immune Cell Function at Day 14Baseline: Unstimulated(Uns) ATP(n=2,5,10,9,9,7,13)16.30 ng/mLStandard Deviation 6.6
CP-690,550 20 mg (Cohort 3)Change From Baseline in Immune Cell Function at Day 14Change at Day 14: Stimulated ATP(n=2,5,9,9,9,7,13)155.11 ng/mLStandard Deviation 168
CP-690,550 20 mg (Cohort 3)Change From Baseline in Immune Cell Function at Day 14Baseline: Stimulated ATP(n=2,5,10,9,9,7,13)429.00 ng/mLStandard Deviation 115.3
CP-690,550 20 mg (Cohort 3)Change From Baseline in Immune Cell Function at Day 14Change at Day 14:Uns ATP(n=2,5,9,9,9,7,13)0.44 ng/mLStandard Deviation 8.9
CP-690,550 30 mg (Cohort 4)Change From Baseline in Immune Cell Function at Day 14Baseline: Stimulated ATP(n=2,5,10,9,9,7,13)406.11 ng/mLStandard Deviation 171.6
CP-690,550 30 mg (Cohort 4)Change From Baseline in Immune Cell Function at Day 14Baseline: Unstimulated(Uns) ATP(n=2,5,10,9,9,7,13)16.44 ng/mLStandard Deviation 10.2
CP-690,550 30 mg (Cohort 4)Change From Baseline in Immune Cell Function at Day 14Change at Day 14: Stimulated ATP(n=2,5,9,9,9,7,13)90.11 ng/mLStandard Deviation 125.9
CP-690,550 30 mg (Cohort 4)Change From Baseline in Immune Cell Function at Day 14Change at Day 14:Uns ATP(n=2,5,9,9,9,7,13)0.33 ng/mLStandard Deviation 10.6
CP-690,550 60 mg (Cohort 5)Change From Baseline in Immune Cell Function at Day 14Baseline: Stimulated ATP(n=2,5,10,9,9,7,13)210.56 ng/mLStandard Deviation 104.1
CP-690,550 60 mg (Cohort 5)Change From Baseline in Immune Cell Function at Day 14Change at Day 14:Uns ATP(n=2,5,9,9,9,7,13)1.67 ng/mLStandard Deviation 15.4
CP-690,550 60 mg (Cohort 5)Change From Baseline in Immune Cell Function at Day 14Baseline: Unstimulated(Uns) ATP(n=2,5,10,9,9,7,13)14.11 ng/mLStandard Deviation 8.3
CP-690,550 60 mg (Cohort 5)Change From Baseline in Immune Cell Function at Day 14Change at Day 14: Stimulated ATP(n=2,5,9,9,9,7,13)118.78 ng/mLStandard Deviation 88.2
CP-690,550 50 mg (Cohort 6)Change From Baseline in Immune Cell Function at Day 14Change at Day 14:Uns ATP(n=2,5,9,9,9,7,13)0.29 ng/mLStandard Deviation 13.1
CP-690,550 50 mg (Cohort 6)Change From Baseline in Immune Cell Function at Day 14Baseline: Unstimulated(Uns) ATP(n=2,5,10,9,9,7,13)7.14 ng/mLStandard Deviation 5.9
CP-690,550 50 mg (Cohort 6)Change From Baseline in Immune Cell Function at Day 14Change at Day 14: Stimulated ATP(n=2,5,9,9,9,7,13)61.21 ng/mLStandard Deviation 124.7
CP-690,550 50 mg (Cohort 6)Change From Baseline in Immune Cell Function at Day 14Baseline: Stimulated ATP(n=2,5,10,9,9,7,13)252.50 ng/mLStandard Deviation 146.3
PlaceboChange From Baseline in Immune Cell Function at Day 14Baseline: Unstimulated(Uns) ATP(n=2,5,10,9,9,7,13)16.00 ng/mLStandard Deviation 12.4
PlaceboChange From Baseline in Immune Cell Function at Day 14Baseline: Stimulated ATP(n=2,5,10,9,9,7,13)301.88 ng/mLStandard Deviation 152.9
PlaceboChange From Baseline in Immune Cell Function at Day 14Change at Day 14: Stimulated ATP(n=2,5,9,9,9,7,13)26.81 ng/mLStandard Deviation 66.6
PlaceboChange From Baseline in Immune Cell Function at Day 14Change at Day 14:Uns ATP(n=2,5,9,9,9,7,13)1.46 ng/mLStandard Deviation 11.2
Primary

Change From Baseline in QT Interval at 0 Hour Post Morning Dose (HPD 0) on Day 14

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. The mean of the triplicates at HPD=0 on Day 1 will be defined as the baseline for HPD=0.

Time frame: Hour 0 (pre-dose) on Day 1 (Baseline for HPD 0), 0 hr on Day 14

Population: Analysis population included all participants who met the eligibility criteria.

ArmMeasureGroupValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Change From Baseline in QT Interval at 0 Hour Post Morning Dose (HPD 0) on Day 14Change at HPD 0 on Day 14-14.53 msecStandard Deviation 11.39
CP-690,550 5 mg (Cohort 1)Change From Baseline in QT Interval at 0 Hour Post Morning Dose (HPD 0) on Day 14Baseline for HPD 0374.80 msecStandard Deviation 28.95
CP-690,550 10 mg (Cohort 2)Change From Baseline in QT Interval at 0 Hour Post Morning Dose (HPD 0) on Day 14Baseline for HPD 0360.40 msecStandard Deviation 28.03
CP-690,550 10 mg (Cohort 2)Change From Baseline in QT Interval at 0 Hour Post Morning Dose (HPD 0) on Day 14Change at HPD 0 on Day 1411.00 msecStandard Deviation 12
CP-690,550 20 mg (Cohort 3)Change From Baseline in QT Interval at 0 Hour Post Morning Dose (HPD 0) on Day 14Change at HPD 0 on Day 14-0.33 msecStandard Deviation 14.08
CP-690,550 20 mg (Cohort 3)Change From Baseline in QT Interval at 0 Hour Post Morning Dose (HPD 0) on Day 14Baseline for HPD 0367.70 msecStandard Deviation 30.28
CP-690,550 30 mg (Cohort 4)Change From Baseline in QT Interval at 0 Hour Post Morning Dose (HPD 0) on Day 14Baseline for HPD 0372.81 msecStandard Deviation 27.83
CP-690,550 30 mg (Cohort 4)Change From Baseline in QT Interval at 0 Hour Post Morning Dose (HPD 0) on Day 14Change at HPD 0 on Day 147.22 msecStandard Deviation 16.38
CP-690,550 60 mg (Cohort 5)Change From Baseline in QT Interval at 0 Hour Post Morning Dose (HPD 0) on Day 14Change at HPD 0 on Day 14-9.70 msecStandard Deviation 13.15
CP-690,550 60 mg (Cohort 5)Change From Baseline in QT Interval at 0 Hour Post Morning Dose (HPD 0) on Day 14Baseline for HPD 0383.41 msecStandard Deviation 19.25
CP-690,550 50 mg (Cohort 6)Change From Baseline in QT Interval at 0 Hour Post Morning Dose (HPD 0) on Day 14Baseline for HPD 0367.50 msecStandard Deviation 22.12
CP-690,550 50 mg (Cohort 6)Change From Baseline in QT Interval at 0 Hour Post Morning Dose (HPD 0) on Day 14Change at HPD 0 on Day 14-0.79 msecStandard Deviation 17.48
PlaceboChange From Baseline in QT Interval at 0 Hour Post Morning Dose (HPD 0) on Day 14Change at HPD 0 on Day 14-7.08 msecStandard Deviation 16.21
PlaceboChange From Baseline in QT Interval at 0 Hour Post Morning Dose (HPD 0) on Day 14Baseline for HPD 0364.03 msecStandard Deviation 20.96
Primary

Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 1

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.

Time frame: 12 hrs prior to morning dose on Day 1 (Baseline for HPD 12), 12 hrs post morning dose on Day 1

Population: Analysis population included all participants who met the eligibility criteria. Here, the 'n' is signifying those participants who were evaluable for this measure at the specified time point for each arm group.

ArmMeasureGroupValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 1Baseline for HPD 12 (n=5,5,10,9,9,8,13)371.73 msecStandard Deviation 31.5
CP-690,550 5 mg (Cohort 1)Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 1Change at HPD 12 on Day 1 (n=5,5,9,9,9,8,13)-6.27 msecStandard Deviation 19.05
CP-690,550 10 mg (Cohort 2)Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 1Baseline for HPD 12 (n=5,5,10,9,9,8,13)351.27 msecStandard Deviation 22.9
CP-690,550 10 mg (Cohort 2)Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 1Change at HPD 12 on Day 1 (n=5,5,9,9,9,8,13)-2.60 msecStandard Deviation 5.27
CP-690,550 20 mg (Cohort 3)Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 1Baseline for HPD 12 (n=5,5,10,9,9,8,13)372.63 msecStandard Deviation 22.54
CP-690,550 20 mg (Cohort 3)Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 1Change at HPD 12 on Day 1 (n=5,5,9,9,9,8,13)-4.15 msecStandard Deviation 17.9
CP-690,550 30 mg (Cohort 4)Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 1Baseline for HPD 12 (n=5,5,10,9,9,8,13)370.11 msecStandard Deviation 25.7
CP-690,550 30 mg (Cohort 4)Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 1Change at HPD 12 on Day 1 (n=5,5,9,9,9,8,13)0.15 msecStandard Deviation 9.79
CP-690,550 60 mg (Cohort 5)Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 1Baseline for HPD 12 (n=5,5,10,9,9,8,13)379.78 msecStandard Deviation 24.93
CP-690,550 60 mg (Cohort 5)Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 1Change at HPD 12 on Day 1 (n=5,5,9,9,9,8,13)-3.22 msecStandard Deviation 19.73
CP-690,550 50 mg (Cohort 6)Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 1Baseline for HPD 12 (n=5,5,10,9,9,8,13)363.08 msecStandard Deviation 31.21
CP-690,550 50 mg (Cohort 6)Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 1Change at HPD 12 on Day 1 (n=5,5,9,9,9,8,13)-2.88 msecStandard Deviation 14.01
PlaceboChange From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 1Baseline for HPD 12 (n=5,5,10,9,9,8,13)361.54 msecStandard Deviation 16.29
PlaceboChange From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 1Change at HPD 12 on Day 1 (n=5,5,9,9,9,8,13)-1.36 msecStandard Deviation 13.6
Primary

Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 14

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.

Time frame: 12 hrs prior to morning dose on Day 1 (Baseline for HPD 12), 12 hrs post morning dose on Day 14

Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

ArmMeasureValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 14-13.47 msecStandard Deviation 12.76
CP-690,550 10 mg (Cohort 2)Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 148.00 msecStandard Deviation 8.48
CP-690,550 20 mg (Cohort 3)Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 14-10.52 msecStandard Deviation 10.63
CP-690,550 30 mg (Cohort 4)Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 140.81 msecStandard Deviation 13.99
CP-690,550 60 mg (Cohort 5)Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 14-7.44 msecStandard Deviation 22.73
CP-690,550 50 mg (Cohort 6)Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 14-0.63 msecStandard Deviation 23.46
PlaceboChange From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 14-4.82 msecStandard Deviation 15.31
Primary

Change From Baseline in QT Interval at 16 Hour Post Morning Dose (HPD 16) on Day 1

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.Change from baseline in QT interval at HPD 16 was planned to be analyzed for participants who received CP-690,550 60 mg and matching placebo.

Time frame: 8 hrs prior to morning dose on Day 1 (Baseline for HPD 16), 16 hrs post morning dose on Day 1

Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

ArmMeasureGroupValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Change From Baseline in QT Interval at 16 Hour Post Morning Dose (HPD 16) on Day 1Baseline for HPD 16377.15 msecStandard Deviation 19.5
CP-690,550 5 mg (Cohort 1)Change From Baseline in QT Interval at 16 Hour Post Morning Dose (HPD 16) on Day 1Change at HPD 16 on Day 111.19 msecStandard Deviation 19.98
CP-690,550 10 mg (Cohort 2)Change From Baseline in QT Interval at 16 Hour Post Morning Dose (HPD 16) on Day 1Baseline for HPD 16345.44 msecStandard Deviation 18.77
CP-690,550 10 mg (Cohort 2)Change From Baseline in QT Interval at 16 Hour Post Morning Dose (HPD 16) on Day 1Change at HPD 16 on Day 113.11 msecStandard Deviation 7.26
Primary

Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1

Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. For each scheduled hour post morning dose (HPD), except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.

Time frame: 23 hours (hrs) prior to morning dose on Day 1 (Baseline for HPD 1), 1 hour (hr) post morning dose on Day 1

Population: Analysis population included all participants who met the eligibility criteria.

ArmMeasureGroupValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1Baseline for HPD 1372.20 millisecond (msec)Standard Deviation 34.3
CP-690,550 5 mg (Cohort 1)Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1Change at HPD 1 on Day 1-6.33 millisecond (msec)Standard Deviation 25.91
CP-690,550 10 mg (Cohort 2)Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1Baseline for HPD 1348.47 millisecond (msec)Standard Deviation 23.52
CP-690,550 10 mg (Cohort 2)Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1Change at HPD 1 on Day 115.73 millisecond (msec)Standard Deviation 9.04
CP-690,550 20 mg (Cohort 3)Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1Baseline for HPD 1369.40 millisecond (msec)Standard Deviation 19.47
CP-690,550 20 mg (Cohort 3)Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1Change at HPD 1 on Day 1-6.33 millisecond (msec)Standard Deviation 21.67
CP-690,550 30 mg (Cohort 4)Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1Baseline for HPD 1375.74 millisecond (msec)Standard Deviation 24.65
CP-690,550 30 mg (Cohort 4)Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1Change at HPD 1 on Day 12.70 millisecond (msec)Standard Deviation 14.54
CP-690,550 60 mg (Cohort 5)Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1Baseline for HPD 1383.96 millisecond (msec)Standard Deviation 18.1
CP-690,550 60 mg (Cohort 5)Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1Change at HPD 1 on Day 11.63 millisecond (msec)Standard Deviation 14.09
CP-690,550 50 mg (Cohort 6)Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1Baseline for HPD 1371.29 millisecond (msec)Standard Deviation 28.33
CP-690,550 50 mg (Cohort 6)Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1Change at HPD 1 on Day 1-2.79 millisecond (msec)Standard Deviation 13.28
PlaceboChange From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1Baseline for HPD 1370.95 millisecond (msec)Standard Deviation 18
PlaceboChange From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1Change at HPD 1 on Day 1-4.21 millisecond (msec)Standard Deviation 12.61
Primary

Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 14

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.

Time frame: 23 hrs prior to morning dose on Day 1 (Baseline for HPD 1), 1 hr post morning dose on Day 14

Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

ArmMeasureValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 14-8.87 msecStandard Deviation 12.12
CP-690,550 10 mg (Cohort 2)Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1422.27 msecStandard Deviation 13.72
CP-690,550 20 mg (Cohort 3)Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 140.11 msecStandard Deviation 12.55
CP-690,550 30 mg (Cohort 4)Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 142.81 msecStandard Deviation 15.98
CP-690,550 60 mg (Cohort 5)Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 14-0.96 msecStandard Deviation 14.63
CP-690,550 50 mg (Cohort 6)Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 140.71 msecStandard Deviation 20.43
PlaceboChange From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 14-12.87 msecStandard Deviation 17.82
Primary

Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 1

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. For each scheduled hour post morning dose (HPD), except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.

Time frame: 22 hrs prior to morning dose on Day 1 (Baseline for HPD 2), 2 hrs post morning dose on Day 1

Population: Analysis population included all participants who met the eligibility criteria.

ArmMeasureGroupValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 1Baseline for HPD 2369.67 msecStandard Deviation 33.78
CP-690,550 5 mg (Cohort 1)Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 1Change at HPD 2 on Day 1-0.40 msecStandard Deviation 26.39
CP-690,550 10 mg (Cohort 2)Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 1Baseline for HPD 2350.27 msecStandard Deviation 20.76
CP-690,550 10 mg (Cohort 2)Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 1Change at HPD 2 on Day 19.80 msecStandard Deviation 13.71
CP-690,550 20 mg (Cohort 3)Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 1Baseline for HPD 2372.87 msecStandard Deviation 21.1
CP-690,550 20 mg (Cohort 3)Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 1Change at HPD 2 on Day 1-6.90 msecStandard Deviation 22.22
CP-690,550 30 mg (Cohort 4)Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 1Baseline for HPD 2377.48 msecStandard Deviation 24.26
CP-690,550 30 mg (Cohort 4)Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 1Change at HPD 2 on Day 1-0.15 msecStandard Deviation 12.82
CP-690,550 60 mg (Cohort 5)Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 1Baseline for HPD 2387.00 msecStandard Deviation 18.81
CP-690,550 60 mg (Cohort 5)Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 1Change at HPD 2 on Day 1-0.07 msecStandard Deviation 9.4
CP-690,550 50 mg (Cohort 6)Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 1Baseline for HPD 2374.00 msecStandard Deviation 26.75
CP-690,550 50 mg (Cohort 6)Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 1Change at HPD 2 on Day 1-1.58 msecStandard Deviation 13.66
PlaceboChange From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 1Baseline for HPD 2369.87 msecStandard Deviation 17.53
PlaceboChange From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 1Change at HPD 2 on Day 1-2.05 msecStandard Deviation 16.76
Primary

Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 14

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.

Time frame: 22 hrs prior to morning dose on Day 1 (Baseline for HPD 2), 2 hrs post morning dose on Day 14

Population: Analysis population included all participants who met the eligibility criteria.'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

ArmMeasureValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 14-3.80 msecStandard Deviation 12.18
CP-690,550 10 mg (Cohort 2)Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 1418.67 msecStandard Deviation 11.15
CP-690,550 20 mg (Cohort 3)Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 14-3.93 msecStandard Deviation 13.21
CP-690,550 30 mg (Cohort 4)Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 146.89 msecStandard Deviation 13.98
CP-690,550 60 mg (Cohort 5)Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 14-3.81 msecStandard Deviation 17.18
CP-690,550 50 mg (Cohort 6)Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 142.46 msecStandard Deviation 22.04
PlaceboChange From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 14-12.28 msecStandard Deviation 19.35
Primary

Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 1

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.

Time frame: 20 hrs prior to morning dose on Day 1 (Baseline for HPD 4), 4 hrs post morning dose on Day 1

Population: Analysis population included all participants who met the eligibility criteria. Here, the 'n' is signifying those participants who were evaluable for this measure at the specified time point for each arm group.

ArmMeasureGroupValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 1Baseline for HPD 4 (n=5,5,10,9,9,8,13)373.73 msecStandard Deviation 31.71
CP-690,550 5 mg (Cohort 1)Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 1Change at HPD 4 on Day 1 (n=5,5,9,9,9,8,13)-4.53 msecStandard Deviation 23.17
CP-690,550 10 mg (Cohort 2)Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 1Baseline for HPD 4 (n=5,5,10,9,9,8,13)348.07 msecStandard Deviation 23.34
CP-690,550 10 mg (Cohort 2)Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 1Change at HPD 4 on Day 1 (n=5,5,9,9,9,8,13)11.53 msecStandard Deviation 12.32
CP-690,550 20 mg (Cohort 3)Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 1Baseline for HPD 4 (n=5,5,10,9,9,8,13)373.20 msecStandard Deviation 21.78
CP-690,550 20 mg (Cohort 3)Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 1Change at HPD 4 on Day 1 (n=5,5,9,9,9,8,13)2.19 msecStandard Deviation 20.98
CP-690,550 30 mg (Cohort 4)Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 1Baseline for HPD 4 (n=5,5,10,9,9,8,13)373.15 msecStandard Deviation 20.46
CP-690,550 30 mg (Cohort 4)Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 1Change at HPD 4 on Day 1 (n=5,5,9,9,9,8,13)2.96 msecStandard Deviation 17.94
CP-690,550 60 mg (Cohort 5)Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 1Baseline for HPD 4 (n=5,5,10,9,9,8,13)381.44 msecStandard Deviation 20.02
CP-690,550 60 mg (Cohort 5)Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 1Change at HPD 4 on Day 1 (n=5,5,9,9,9,8,13)7.74 msecStandard Deviation 14.69
CP-690,550 50 mg (Cohort 6)Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 1Baseline for HPD 4 (n=5,5,10,9,9,8,13)381.17 msecStandard Deviation 26.96
CP-690,550 50 mg (Cohort 6)Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 1Change at HPD 4 on Day 1 (n=5,5,9,9,9,8,13)-8.17 msecStandard Deviation 14.32
PlaceboChange From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 1Baseline for HPD 4 (n=5,5,10,9,9,8,13)368.00 msecStandard Deviation 18.04
PlaceboChange From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 1Change at HPD 4 on Day 1 (n=5,5,9,9,9,8,13)-2.82 msecStandard Deviation 10.82
Primary

Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 14

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.

Time frame: 20 hrs prior to morning dose on Day 1 (Baseline for HPD 4), 4 hrs post morning dose on Day 14

Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

ArmMeasureValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 14-13.80 msecStandard Deviation 15.37
CP-690,550 10 mg (Cohort 2)Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 146.53 msecStandard Deviation 7.81
CP-690,550 20 mg (Cohort 3)Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 14-8.41 msecStandard Deviation 7.25
CP-690,550 30 mg (Cohort 4)Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 1418.96 msecStandard Deviation 18.55
CP-690,550 60 mg (Cohort 5)Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 149.59 msecStandard Deviation 10.7
CP-690,550 50 mg (Cohort 6)Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 14-4.79 msecStandard Deviation 21.58
PlaceboChange From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 14-8.46 msecStandard Deviation 21.09
Primary

Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 1

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.

Time frame: 16 hrs prior to morning dose on Day 1 (Baseline for HPD 8), 8 hrs post morning dose on Day 1

Population: Analysis population included all participants who met the eligibility criteria. Here, the 'n' is signifying those participants who were evaluable for this measure at the specified time point for each arm group.

ArmMeasureGroupValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 1Baseline for HPD 8 (n=5,5,10,9,9,8,13)364.13 msecStandard Deviation 36
CP-690,550 5 mg (Cohort 1)Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 1Change at HPD 8 on Day 1 (n=5,5,9,9,9,8,13)-1.27 msecStandard Deviation 15.93
CP-690,550 10 mg (Cohort 2)Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 1Baseline for HPD 8 (n=5,5,10,9,9,8,13)356.73 msecStandard Deviation 25.62
CP-690,550 10 mg (Cohort 2)Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 1Change at HPD 8 on Day 1 (n=5,5,9,9,9,8,13)-6.60 msecStandard Deviation 10.71
CP-690,550 20 mg (Cohort 3)Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 1Baseline for HPD 8 (n=5,5,10,9,9,8,13)366.90 msecStandard Deviation 22.02
CP-690,550 20 mg (Cohort 3)Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 1Change at HPD 8 on Day 1 (n=5,5,9,9,9,8,13)-3.96 msecStandard Deviation 18.54
CP-690,550 30 mg (Cohort 4)Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 1Baseline for HPD 8 (n=5,5,10,9,9,8,13)374.56 msecStandard Deviation 22.73
CP-690,550 30 mg (Cohort 4)Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 1Change at HPD 8 on Day 1 (n=5,5,9,9,9,8,13)-3.44 msecStandard Deviation 12.75
CP-690,550 60 mg (Cohort 5)Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 1Baseline for HPD 8 (n=5,5,10,9,9,8,13)378.15 msecStandard Deviation 23.91
CP-690,550 60 mg (Cohort 5)Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 1Change at HPD 8 on Day 1 (n=5,5,9,9,9,8,13)7.67 msecStandard Deviation 16.08
CP-690,550 50 mg (Cohort 6)Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 1Baseline for HPD 8 (n=5,5,10,9,9,8,13)372.25 msecStandard Deviation 28.29
CP-690,550 50 mg (Cohort 6)Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 1Change at HPD 8 on Day 1 (n=5,5,9,9,9,8,13)-9.83 msecStandard Deviation 15.12
PlaceboChange From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 1Baseline for HPD 8 (n=5,5,10,9,9,8,13)367.56 msecStandard Deviation 17.95
PlaceboChange From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 1Change at HPD 8 on Day 1 (n=5,5,9,9,9,8,13)-9.03 msecStandard Deviation 11.52
Primary

Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 14

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.

Time frame: 16 hrs prior to morning dose on Day 1 (Baseline for HPD 8), 8 hrs post morning dose on Day 14

Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

ArmMeasureValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 14-9.33 msecStandard Deviation 11.31
CP-690,550 10 mg (Cohort 2)Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 14-0.53 msecStandard Deviation 9.83
CP-690,550 20 mg (Cohort 3)Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 14-6.15 msecStandard Deviation 15.86
CP-690,550 30 mg (Cohort 4)Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 14-1.96 msecStandard Deviation 13.75
CP-690,550 60 mg (Cohort 5)Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 144.85 msecStandard Deviation 18.51
CP-690,550 50 mg (Cohort 6)Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 14-2.67 msecStandard Deviation 23.28
PlaceboChange From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 14-12.36 msecStandard Deviation 11.38
Primary

Change From Baseline in Reticulocyte Count at Day 10

Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.

Time frame: Baseline (Within 7 days prior to Day 1), Day 10

Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

ArmMeasureValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Change From Baseline in Reticulocyte Count at Day 10-16.40 1000 cells/mm^3Standard Deviation 29.5
CP-690,550 10 mg (Cohort 2)Change From Baseline in Reticulocyte Count at Day 10-14.00 1000 cells/mm^3Standard Deviation 18.3
CP-690,550 20 mg (Cohort 3)Change From Baseline in Reticulocyte Count at Day 1016.00 1000 cells/mm^3Standard Deviation 25.9
CP-690,550 30 mg (Cohort 4)Change From Baseline in Reticulocyte Count at Day 10-18.22 1000 cells/mm^3Standard Deviation 15.9
CP-690,550 60 mg (Cohort 5)Change From Baseline in Reticulocyte Count at Day 106.56 1000 cells/mm^3Standard Deviation 17.5
CP-690,550 50 mg (Cohort 6)Change From Baseline in Reticulocyte Count at Day 10-29.50 1000 cells/mm^3Standard Deviation 21.5
PlaceboChange From Baseline in Reticulocyte Count at Day 10-3.42 1000 cells/mm^3Standard Deviation 38.8
Primary

Change From Baseline in Reticulocyte Count at Day 15

Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.

Time frame: Baseline (Within 7 days prior to Day 1), Day 15

Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

ArmMeasureValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Change From Baseline in Reticulocyte Count at Day 15-24.00 1000 cells/mm^3Standard Deviation 25.3
CP-690,550 10 mg (Cohort 2)Change From Baseline in Reticulocyte Count at Day 15-11.40 1000 cells/mm^3Standard Deviation 17.4
CP-690,550 20 mg (Cohort 3)Change From Baseline in Reticulocyte Count at Day 15-8.56 1000 cells/mm^3Standard Deviation 11.9
CP-690,550 30 mg (Cohort 4)Change From Baseline in Reticulocyte Count at Day 15-42.22 1000 cells/mm^3Standard Deviation 16.9
CP-690,550 60 mg (Cohort 5)Change From Baseline in Reticulocyte Count at Day 1524.11 1000 cells/mm^3Standard Deviation 16.8
CP-690,550 50 mg (Cohort 6)Change From Baseline in Reticulocyte Count at Day 15-31.57 1000 cells/mm^3Standard Deviation 25.9
PlaceboChange From Baseline in Reticulocyte Count at Day 15-17.92 1000 cells/mm^3Standard Deviation 28.4
Primary

Change From Baseline in Reticulocyte Count at Day 2

Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.

Time frame: Baseline (Within 7 days prior to Day 1), Day 2

Population: Analysis population included all participants who met the eligibility criteria. 'n' = participants evaluable for this measure at specified time points for each arm group respectively.

ArmMeasureGroupValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Change From Baseline in Reticulocyte Count at Day 2Change at Day 2 (n=5,5,9,9,8,8,12)-6.60 1000 cells/cubic millimeter (cells/mm^3)Standard Deviation 21.3
CP-690,550 5 mg (Cohort 1)Change From Baseline in Reticulocyte Count at Day 2Baseline (n=5,5,10,9,9,8,13)124.00 1000 cells/cubic millimeter (cells/mm^3)Standard Deviation 30.6
CP-690,550 10 mg (Cohort 2)Change From Baseline in Reticulocyte Count at Day 2Baseline (n=5,5,10,9,9,8,13)94.00 1000 cells/cubic millimeter (cells/mm^3)Standard Deviation 36.9
CP-690,550 10 mg (Cohort 2)Change From Baseline in Reticulocyte Count at Day 2Change at Day 2 (n=5,5,9,9,8,8,12)-2.00 1000 cells/cubic millimeter (cells/mm^3)Standard Deviation 13.7
CP-690,550 20 mg (Cohort 3)Change From Baseline in Reticulocyte Count at Day 2Baseline (n=5,5,10,9,9,8,13)81.50 1000 cells/cubic millimeter (cells/mm^3)Standard Deviation 20.1
CP-690,550 20 mg (Cohort 3)Change From Baseline in Reticulocyte Count at Day 2Change at Day 2 (n=5,5,9,9,8,8,12)20.00 1000 cells/cubic millimeter (cells/mm^3)Standard Deviation 16.1
CP-690,550 30 mg (Cohort 4)Change From Baseline in Reticulocyte Count at Day 2Change at Day 2 (n=5,5,9,9,8,8,12)-17.67 1000 cells/cubic millimeter (cells/mm^3)Standard Deviation 24.2
CP-690,550 30 mg (Cohort 4)Change From Baseline in Reticulocyte Count at Day 2Baseline (n=5,5,10,9,9,8,13)95.22 1000 cells/cubic millimeter (cells/mm^3)Standard Deviation 14.3
CP-690,550 60 mg (Cohort 5)Change From Baseline in Reticulocyte Count at Day 2Baseline (n=5,5,10,9,9,8,13)80.56 1000 cells/cubic millimeter (cells/mm^3)Standard Deviation 24.4
CP-690,550 60 mg (Cohort 5)Change From Baseline in Reticulocyte Count at Day 2Change at Day 2 (n=5,5,9,9,8,8,12)-10.88 1000 cells/cubic millimeter (cells/mm^3)Standard Deviation 19.7
CP-690,550 50 mg (Cohort 6)Change From Baseline in Reticulocyte Count at Day 2Baseline (n=5,5,10,9,9,8,13)79.75 1000 cells/cubic millimeter (cells/mm^3)Standard Deviation 25.8
CP-690,550 50 mg (Cohort 6)Change From Baseline in Reticulocyte Count at Day 2Change at Day 2 (n=5,5,9,9,8,8,12)-3.75 1000 cells/cubic millimeter (cells/mm^3)Standard Deviation 11.1
PlaceboChange From Baseline in Reticulocyte Count at Day 2Change at Day 2 (n=5,5,9,9,8,8,12)-7.25 1000 cells/cubic millimeter (cells/mm^3)Standard Deviation 28.8
PlaceboChange From Baseline in Reticulocyte Count at Day 2Baseline (n=5,5,10,9,9,8,13)100.69 1000 cells/cubic millimeter (cells/mm^3)Standard Deviation 46.2
Primary

Change From Baseline in Reticulocyte Count at Day 21

Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.

Time frame: Baseline (Within 7 days prior to Day 1), Day 21

Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

ArmMeasureValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Change From Baseline in Reticulocyte Count at Day 21-13.40 1000 cells/mm^3Standard Deviation 30.6
CP-690,550 10 mg (Cohort 2)Change From Baseline in Reticulocyte Count at Day 2117.60 1000 cells/mm^3Standard Deviation 11.5
CP-690,550 20 mg (Cohort 3)Change From Baseline in Reticulocyte Count at Day 2144.22 1000 cells/mm^3Standard Deviation 27.1
CP-690,550 30 mg (Cohort 4)Change From Baseline in Reticulocyte Count at Day 215.44 1000 cells/mm^3Standard Deviation 14.4
CP-690,550 60 mg (Cohort 5)Change From Baseline in Reticulocyte Count at Day 2140.25 1000 cells/mm^3Standard Deviation 15.6
CP-690,550 50 mg (Cohort 6)Change From Baseline in Reticulocyte Count at Day 21-9.17 1000 cells/mm^3Standard Deviation 23.9
PlaceboChange From Baseline in Reticulocyte Count at Day 2112.54 1000 cells/mm^3Standard Deviation 40.2
Primary

Change From Baseline in Reticulocyte Count at Day 28

Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.

Time frame: Baseline (Within 7 days prior to Day 1), Day 28

Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

ArmMeasureValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Change From Baseline in Reticulocyte Count at Day 28-16.20 1000 cells/mm^3Standard Deviation 8.2
CP-690,550 10 mg (Cohort 2)Change From Baseline in Reticulocyte Count at Day 2847.60 1000 cells/mm^3Standard Deviation 14.8
CP-690,550 20 mg (Cohort 3)Change From Baseline in Reticulocyte Count at Day 2849.56 1000 cells/mm^3Standard Deviation 24
CP-690,550 30 mg (Cohort 4)Change From Baseline in Reticulocyte Count at Day 2823.89 1000 cells/mm^3Standard Deviation 23.5
CP-690,550 60 mg (Cohort 5)Change From Baseline in Reticulocyte Count at Day 2821.75 1000 cells/mm^3Standard Deviation 13.6
CP-690,550 50 mg (Cohort 6)Change From Baseline in Reticulocyte Count at Day 2856.00 1000 cells/mm^3Standard Deviation 24.1
PlaceboChange From Baseline in Reticulocyte Count at Day 28-2.85 1000 cells/mm^3Standard Deviation 32.5
Primary

Change From Baseline in Reticulocyte Count at Day 4

Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.

Time frame: Baseline (Within 7 days prior to Day 1), Day 4

Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

ArmMeasureValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Change From Baseline in Reticulocyte Count at Day 4-14.00 1000 cells/mm^3Standard Deviation 17.2
CP-690,550 10 mg (Cohort 2)Change From Baseline in Reticulocyte Count at Day 4-7.60 1000 cells/mm^3Standard Deviation 16.5
CP-690,550 20 mg (Cohort 3)Change From Baseline in Reticulocyte Count at Day 417.33 1000 cells/mm^3Standard Deviation 26.6
CP-690,550 30 mg (Cohort 4)Change From Baseline in Reticulocyte Count at Day 4-48.44 1000 cells/mm^3Standard Deviation 13.3
CP-690,550 60 mg (Cohort 5)Change From Baseline in Reticulocyte Count at Day 4-14.67 1000 cells/mm^3Standard Deviation 16.4
CP-690,550 50 mg (Cohort 6)Change From Baseline in Reticulocyte Count at Day 4-20.00 1000 cells/mm^3Standard Deviation 14.9
PlaceboChange From Baseline in Reticulocyte Count at Day 4-20.85 1000 cells/mm^3Standard Deviation 41.2
Primary

Change From Baseline in Reticulocyte Count at Day 42

Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.

Time frame: Baseline (Within 7 days prior to Day 1), Day 42

Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

ArmMeasureValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Change From Baseline in Reticulocyte Count at Day 42-4.60 1000 cells/mm^3Standard Deviation 12.6
CP-690,550 10 mg (Cohort 2)Change From Baseline in Reticulocyte Count at Day 42-7.00 1000 cells/mm^3Standard Deviation 35.9
CP-690,550 20 mg (Cohort 3)Change From Baseline in Reticulocyte Count at Day 4234.56 1000 cells/mm^3Standard Deviation 30
CP-690,550 30 mg (Cohort 4)Change From Baseline in Reticulocyte Count at Day 42-3.67 1000 cells/mm^3Standard Deviation 12.5
CP-690,550 60 mg (Cohort 5)Change From Baseline in Reticulocyte Count at Day 42-2.33 1000 cells/mm^3Standard Deviation 21.9
CP-690,550 50 mg (Cohort 6)Change From Baseline in Reticulocyte Count at Day 4222.50 1000 cells/mm^3Standard Deviation 31.7
PlaceboChange From Baseline in Reticulocyte Count at Day 42-18.00 1000 cells/mm^3Standard Deviation 26.7
Primary

Change From Baseline in Reticulocyte Count at Day 7

Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.

Time frame: Baseline (Within 7 days prior to Day 1), Day 7

Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

ArmMeasureValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Change From Baseline in Reticulocyte Count at Day 7-3.40 1000 cells/mm^3Standard Deviation 18.7
CP-690,550 10 mg (Cohort 2)Change From Baseline in Reticulocyte Count at Day 76.40 1000 cells/mm^3Standard Deviation 15.9
CP-690,550 20 mg (Cohort 3)Change From Baseline in Reticulocyte Count at Day 717.11 1000 cells/mm^3Standard Deviation 26.5
CP-690,550 30 mg (Cohort 4)Change From Baseline in Reticulocyte Count at Day 7-14.44 1000 cells/mm^3Standard Deviation 13.6
CP-690,550 60 mg (Cohort 5)Change From Baseline in Reticulocyte Count at Day 73.22 1000 cells/mm^3Standard Deviation 20.6
CP-690,550 50 mg (Cohort 6)Change From Baseline in Reticulocyte Count at Day 7-30.38 1000 cells/mm^3Standard Deviation 13.8
PlaceboChange From Baseline in Reticulocyte Count at Day 7-1.38 1000 cells/mm^3Standard Deviation 31.1
Primary

Half Maximal Effective Area Under the Concentration-Time Curve 50 (EAUC 50)

EAUC 50 was calculated from a regression analyses using area under the concentration-time curve (AUC) as the independent variable. A sigmoid maximum effect (Emax) model was used to explain the relationship between AUC and modified Psoriasis Severity Index (mPASI) score, where Emax was the maximum effect (100 percent reduction in the total mPASI score from baseline), and EAUC 50 was the AUC where 50 percent of the maximum effect was measured.

Time frame: Day 14

Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

ArmMeasureValue (NUMBER)
CP-690,550 5 mg (Cohort 1)Half Maximal Effective Area Under the Concentration-Time Curve 50 (EAUC 50)2696 ng*hr/mL
Primary

Maximum Observed Plasma Concentration (Cmax) at Day 1

Time frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1

Population: Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

ArmMeasureValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Maximum Observed Plasma Concentration (Cmax) at Day 148.3 nanogram/milliliter (ng/mL)Standard Deviation 24.5
CP-690,550 10 mg (Cohort 2)Maximum Observed Plasma Concentration (Cmax) at Day 190.5 nanogram/milliliter (ng/mL)Standard Deviation 20.4
CP-690,550 20 mg (Cohort 3)Maximum Observed Plasma Concentration (Cmax) at Day 1212 nanogram/milliliter (ng/mL)Standard Deviation 62.3
CP-690,550 30 mg (Cohort 4)Maximum Observed Plasma Concentration (Cmax) at Day 1180 nanogram/milliliter (ng/mL)Standard Deviation 53.1
CP-690,550 60 mg (Cohort 5)Maximum Observed Plasma Concentration (Cmax) at Day 1457 nanogram/milliliter (ng/mL)Standard Deviation 88.2
CP-690,550 50 mg (Cohort 6)Maximum Observed Plasma Concentration (Cmax) at Day 1429 nanogram/milliliter (ng/mL)Standard Deviation 99.1
Primary

Maximum Observed Plasma Concentration (Cmax) at Day 14

Time frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 14

Population: Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

ArmMeasureValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Maximum Observed Plasma Concentration (Cmax) at Day 1450.9 ng/mLStandard Deviation 21.2
CP-690,550 10 mg (Cohort 2)Maximum Observed Plasma Concentration (Cmax) at Day 1487.7 ng/mLStandard Deviation 13.2
CP-690,550 20 mg (Cohort 3)Maximum Observed Plasma Concentration (Cmax) at Day 14194 ng/mLStandard Deviation 53.9
CP-690,550 30 mg (Cohort 4)Maximum Observed Plasma Concentration (Cmax) at Day 14225 ng/mLStandard Deviation 43.9
CP-690,550 60 mg (Cohort 5)Maximum Observed Plasma Concentration (Cmax) at Day 14568 ng/mLStandard Deviation 205
CP-690,550 50 mg (Cohort 6)Maximum Observed Plasma Concentration (Cmax) at Day 14403 ng/mLStandard Deviation 133
Primary

Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 Millisecond

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR) and by Bazette's formula (QTcB = QT divided by square root of RR). Participants with maximum QTc \>=500 msec were reported.

Time frame: 1, 2, 4, 8, 12 hrs post dose, additional 16 hrs post dose for 60 mg once daily group on Day 1; 1, 2 hrs post dose on Day 4, 7, 10;1,2,4,8,12 hrs post dose on Day 14; Day 21

Population: Analysis population included all participants who met the eligibility criteria.

ArmMeasureGroupValue (NUMBER)
CP-690,550 5 mg (Cohort 1)Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 MillisecondQTcB0 participants
CP-690,550 5 mg (Cohort 1)Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 MillisecondQTcF0 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 MillisecondQTcB0 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 MillisecondQTcF0 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 MillisecondQTcB0 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 MillisecondQTcF0 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 MillisecondQTcB0 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 MillisecondQTcF0 participants
CP-690,550 60 mg (Cohort 5)Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 MillisecondQTcB0 participants
CP-690,550 60 mg (Cohort 5)Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 MillisecondQTcF0 participants
CP-690,550 50 mg (Cohort 6)Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 MillisecondQTcB0 participants
CP-690,550 50 mg (Cohort 6)Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 MillisecondQTcF0 participants
PlaceboNumber of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 MillisecondQTcB0 participants
PlaceboNumber of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 MillisecondQTcF0 participants
Primary

Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR) and by Bazette's formula (QTcB = QT divided by square root of RR). Participants with maximum increase from baseline of 30 to less than (\<) 60 msec(borderline) and greater than or equal to (\>=) 60 msec (prolonged) were summarized.

Time frame: 1, 2, 4, 8, 12 hrs post dose, additional 16 hrs post dose for 60 mg once daily group on Day 1; 1, 2 hrs post dose on Day 4, 7, 10;1,2,4,8,12 hrs post dose on Day 14; Day 21

Population: Analysis population included all participants who met the eligibility criteria.

ArmMeasureGroupValue (NUMBER)
CP-690,550 5 mg (Cohort 1)Number of Participants With Increase From Baseline in Corrected QT (QTc) IntervalQTcF,Maximum increase from baseline:30 to <60msec0 participants
CP-690,550 5 mg (Cohort 1)Number of Participants With Increase From Baseline in Corrected QT (QTc) IntervalQTcB,Maximum increase from baseline:30 to <60msec0 participants
CP-690,550 5 mg (Cohort 1)Number of Participants With Increase From Baseline in Corrected QT (QTc) IntervalQTcB,Maximum increase from baseline:>=60msec0 participants
CP-690,550 5 mg (Cohort 1)Number of Participants With Increase From Baseline in Corrected QT (QTc) IntervalQTcF,Maximum increase from baseline:>=60msec0 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Increase From Baseline in Corrected QT (QTc) IntervalQTcB,Maximum increase from baseline:>=60msec0 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Increase From Baseline in Corrected QT (QTc) IntervalQTcF,Maximum increase from baseline:>=60msec0 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Increase From Baseline in Corrected QT (QTc) IntervalQTcB,Maximum increase from baseline:30 to <60msec1 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Increase From Baseline in Corrected QT (QTc) IntervalQTcF,Maximum increase from baseline:30 to <60msec1 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Increase From Baseline in Corrected QT (QTc) IntervalQTcB,Maximum increase from baseline:30 to <60msec2 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Increase From Baseline in Corrected QT (QTc) IntervalQTcF,Maximum increase from baseline:>=60msec0 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Increase From Baseline in Corrected QT (QTc) IntervalQTcF,Maximum increase from baseline:30 to <60msec0 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Increase From Baseline in Corrected QT (QTc) IntervalQTcB,Maximum increase from baseline:>=60msec0 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Increase From Baseline in Corrected QT (QTc) IntervalQTcF,Maximum increase from baseline:>=60msec0 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Increase From Baseline in Corrected QT (QTc) IntervalQTcB,Maximum increase from baseline:30 to <60msec1 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Increase From Baseline in Corrected QT (QTc) IntervalQTcB,Maximum increase from baseline:>=60msec0 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Increase From Baseline in Corrected QT (QTc) IntervalQTcF,Maximum increase from baseline:30 to <60msec1 participants
CP-690,550 60 mg (Cohort 5)Number of Participants With Increase From Baseline in Corrected QT (QTc) IntervalQTcB,Maximum increase from baseline:30 to <60msec3 participants
CP-690,550 60 mg (Cohort 5)Number of Participants With Increase From Baseline in Corrected QT (QTc) IntervalQTcF,Maximum increase from baseline:30 to <60msec3 participants
CP-690,550 60 mg (Cohort 5)Number of Participants With Increase From Baseline in Corrected QT (QTc) IntervalQTcF,Maximum increase from baseline:>=60msec0 participants
CP-690,550 60 mg (Cohort 5)Number of Participants With Increase From Baseline in Corrected QT (QTc) IntervalQTcB,Maximum increase from baseline:>=60msec1 participants
CP-690,550 50 mg (Cohort 6)Number of Participants With Increase From Baseline in Corrected QT (QTc) IntervalQTcB,Maximum increase from baseline:>=60msec0 participants
CP-690,550 50 mg (Cohort 6)Number of Participants With Increase From Baseline in Corrected QT (QTc) IntervalQTcB,Maximum increase from baseline:30 to <60msec2 participants
CP-690,550 50 mg (Cohort 6)Number of Participants With Increase From Baseline in Corrected QT (QTc) IntervalQTcF,Maximum increase from baseline:30 to <60msec0 participants
CP-690,550 50 mg (Cohort 6)Number of Participants With Increase From Baseline in Corrected QT (QTc) IntervalQTcF,Maximum increase from baseline:>=60msec0 participants
PlaceboNumber of Participants With Increase From Baseline in Corrected QT (QTc) IntervalQTcB,Maximum increase from baseline:30 to <60msec5 participants
PlaceboNumber of Participants With Increase From Baseline in Corrected QT (QTc) IntervalQTcF,Maximum increase from baseline:30 to <60msec1 participants
PlaceboNumber of Participants With Increase From Baseline in Corrected QT (QTc) IntervalQTcF,Maximum increase from baseline:>=60msec0 participants
PlaceboNumber of Participants With Increase From Baseline in Corrected QT (QTc) IntervalQTcB,Maximum increase from baseline:>=60msec0 participants
Primary

Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1

Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.

Time frame: Baseline, 1 hr post-dose on Day 1

Population: Analysis population included all participants who met the eligibility criteria.

ArmMeasureGroupValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD4-18.48 percent changeStandard Deviation 19.4
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD8-7.58 percent changeStandard Deviation 11
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD16/5611.22 percent changeStandard Deviation 27
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD3-14.39 percent changeStandard Deviation 14.6
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD19-27.11 percent changeStandard Deviation 16.7
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD826.05 percent changeStandard Deviation 25.1
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD19-4.02 percent changeStandard Deviation 30.9
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD312.02 percent changeStandard Deviation 18.2
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD16/5679.99 percent changeStandard Deviation 33.7
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD48.65 percent changeStandard Deviation 23.5
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD16/5681.44 percent changeStandard Deviation 62.7
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD4-4.29 percent changeStandard Deviation 15.2
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD31.17 percent changeStandard Deviation 17.7
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD19-10.30 percent changeStandard Deviation 18.1
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD88.90 percent changeStandard Deviation 22.1
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD19-8.23 percent changeStandard Deviation 10.4
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD818.34 percent changeStandard Deviation 21.4
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD16/5674.07 percent changeStandard Deviation 38.6
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD45.99 percent changeStandard Deviation 15.6
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD312.44 percent changeStandard Deviation 17.4
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD38.38 percent changeStandard Deviation 23.9
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD16/56104.44 percent changeStandard Deviation 85.8
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD813.90 percent changeStandard Deviation 21.9
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD19-6.22 percent changeStandard Deviation 29.9
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD4-1.13 percent changeStandard Deviation 19.9
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD48.54 percent changeStandard Deviation 10.7
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD312.83 percent changeStandard Deviation 14
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD825.44 percent changeStandard Deviation 14.6
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD19-0.66 percent changeStandard Deviation 9
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD16/56103.74 percent changeStandard Deviation 21.2
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD30.52 percent changeStandard Deviation 16.5
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD80.42 percent changeStandard Deviation 16.5
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD16/56-9.72 percent changeStandard Deviation 18.3
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD41.35 percent changeStandard Deviation 18.3
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1Change at Day 1: CD19-6.46 percent changeStandard Deviation 22.4
Primary

Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10

Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.

Time frame: Baseline, hr 0 on Day 10

Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.

ArmMeasureGroupValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD16/56-16.73 percent changeStandard Deviation 29.3
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD46.86 percent changeStandard Deviation 20.9
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD35.70 percent changeStandard Deviation 18.9
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD85.34 percent changeStandard Deviation 20.9
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD1924.06 percent changeStandard Deviation 26.9
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD416.87 percent changeStandard Deviation 34
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD16/56-25.53 percent changeStandard Deviation 41.4
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD1934.97 percent changeStandard Deviation 38.7
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD38.76 percent changeStandard Deviation 35.7
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD84.13 percent changeStandard Deviation 39.8
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD1976.05 percent changeStandard Deviation 71.1
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD16/56-16.22 percent changeStandard Deviation 22.8
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD80.68 percent changeStandard Deviation 35.4
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD414.50 percent changeStandard Deviation 50.8
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD312.47 percent changeStandard Deviation 49.1
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD16/56-33.38 percent changeStandard Deviation 27.2
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD828.77 percent changeStandard Deviation 40.5
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD336.76 percent changeStandard Deviation 43.8
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD438.22 percent changeStandard Deviation 43
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD1979.94 percent changeStandard Deviation 69.2
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD414.61 percent changeStandard Deviation 54.4
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD816.81 percent changeStandard Deviation 62.4
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD16/56-21.99 percent changeStandard Deviation 36.1
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD311.30 percent changeStandard Deviation 50
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD1963.64 percent changeStandard Deviation 180
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD16/56-37.90 percent changeStandard Deviation 24.8
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD416.85 percent changeStandard Deviation 32.4
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD312.61 percent changeStandard Deviation 30.6
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD87.87 percent changeStandard Deviation 20.1
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD1984.57 percent changeStandard Deviation 109.7
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD8-4.14 percent changeStandard Deviation 30.6
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD3-3.69 percent changeStandard Deviation 27.9
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD19-13.19 percent changeStandard Deviation 31.5
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD4-4.52 percent changeStandard Deviation 27.5
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10Change at Day 10: CD16/56-10.82 percent changeStandard Deviation 31.3
Primary

Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14

Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.

Time frame: Baseline; hr 0, 8 hr post-dose on Day 14

Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.

ArmMeasureGroupValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD810.36 percent changeStandard Deviation 17.3
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD16/56-8.06 percent changeStandard Deviation 19.7
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD47.31 percent changeStandard Deviation 18
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD1916.76 percent changeStandard Deviation 25.1
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD86.92 percent changeStandard Deviation 9.1
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD31.01 percent changeStandard Deviation 16
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD16/56-0.34 percent changeStandard Deviation 25
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD4-1.91 percent changeStandard Deviation 19
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD37.98 percent changeStandard Deviation 18.2
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD1920.74 percent changeStandard Deviation 19.8
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD825.57 percent changeStandard Deviation 37
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD870.26 percent changeStandard Deviation 34
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD16/5641.85 percent changeStandard Deviation 47.4
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD486.33 percent changeStandard Deviation 30.3
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD431.80 percent changeStandard Deviation 11
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD326.93 percent changeStandard Deviation 21.5
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD1992.47 percent changeStandard Deviation 47.9
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD1939.97 percent changeStandard Deviation 33.3
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD376.59 percent changeStandard Deviation 28.7
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD16/561.73 percent changeStandard Deviation 52.8
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD16/56-28.06 percent changeStandard Deviation 32.3
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD16/56-6.44 percent changeStandard Deviation 38
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD1969.43 percent changeStandard Deviation 75.9
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD37.07 percent changeStandard Deviation 33
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD49.86 percent changeStandard Deviation 41.2
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD19117.56 percent changeStandard Deviation 52.4
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD422.68 percent changeStandard Deviation 24.8
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD8-3.36 percent changeStandard Deviation 23.6
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD816.37 percent changeStandard Deviation 16.9
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD319.79 percent changeStandard Deviation 23.1
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD810.68 percent changeStandard Deviation 30.9
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD1995.87 percent changeStandard Deviation 86.6
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD16/56-43.06 percent changeStandard Deviation 21.4
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD414.80 percent changeStandard Deviation 32.3
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD340.85 percent changeStandard Deviation 36.7
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD1968.14 percent changeStandard Deviation 72.2
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD314.91 percent changeStandard Deviation 32.1
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD16/56-8.75 percent changeStandard Deviation 46.5
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD840.38 percent changeStandard Deviation 34.4
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD438.65 percent changeStandard Deviation 36.7
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD842.59 percent changeStandard Deviation 59.2
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD1960.99 percent changeStandard Deviation 151.4
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD817.58 percent changeStandard Deviation 42.4
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD1978.60 percent changeStandard Deviation 94
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD310.74 percent changeStandard Deviation 37.1
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD49.67 percent changeStandard Deviation 49.1
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD16/56-20.03 percent changeStandard Deviation 44.6
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD16/5645.94 percent changeStandard Deviation 114.4
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD344.08 percent changeStandard Deviation 61.6
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD457.94 percent changeStandard Deviation 91.5
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD19116.93 percent changeStandard Deviation 215.8
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD315.64 percent changeStandard Deviation 32.3
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD831.87 percent changeStandard Deviation 86.9
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD16/56-14.38 percent changeStandard Deviation 37.9
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD417.69 percent changeStandard Deviation 46.8
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD419.21 percent changeStandard Deviation 30.4
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD89.89 percent changeStandard Deviation 35.5
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD16/56-42.70 percent changeStandard Deviation 35
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD312.69 percent changeStandard Deviation 43.9
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD19152.66 percent changeStandard Deviation 263.6
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD16/56-4.09 percent changeStandard Deviation 34
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD16/56-6.49 percent changeStandard Deviation 25.4
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD19-16.04 percent changeStandard Deviation 33.1
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD8-14.21 percent changeStandard Deviation 20.2
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD4-5.88 percent changeStandard Deviation 23.1
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD4-15.51 percent changeStandard Deviation 25.1
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD3-7.20 percent changeStandard Deviation 20.7
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD8-6.94 percent changeStandard Deviation 18.9
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 8 hr post dose on Day 14: CD192.53 percent changeStandard Deviation 36.2
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14Change at 0 hr post dose on Day 14: CD3-15.05 percent changeStandard Deviation 21.7
Primary

Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18

Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.

Time frame: Baseline, Hour 0 on Day 18

Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.

ArmMeasureGroupValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD1916.98 percent changeStandard Deviation 50.8
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD313.89 percent changeStandard Deviation 27.9
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD817.52 percent changeStandard Deviation 32.7
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD16/5611.58 percent changeStandard Deviation 31.5
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD412.44 percent changeStandard Deviation 29.6
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD4-13.35 percent changeStandard Deviation 24.9
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD19-15.78 percent changeStandard Deviation 15.9
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD16/56-7.64 percent changeStandard Deviation 73.7
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD8-9.18 percent changeStandard Deviation 44.1
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD3-14.04 percent changeStandard Deviation 30.6
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD4-7.80 percent changeStandard Deviation 21.5
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD3-10.24 percent changeStandard Deviation 21.3
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD8-12.38 percent changeStandard Deviation 23.1
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD16/56-21.03 percent changeStandard Deviation 46
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD1913.95 percent changeStandard Deviation 32.5
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD8-18.76 percent changeStandard Deviation 24
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD4-8.89 percent changeStandard Deviation 17.4
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD3-10.65 percent changeStandard Deviation 18.5
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD1922.65 percent changeStandard Deviation 45.8
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD16/56-48.63 percent changeStandard Deviation 63.5
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD16/56-17.13 percent changeStandard Deviation 45.7
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD8-13.47 percent changeStandard Deviation 8
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD3-14.54 percent changeStandard Deviation 13.5
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD19-8.14 percent changeStandard Deviation 35.6
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD4-13.66 percent changeStandard Deviation 19.1
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD19-29.44 percent changeStandard Deviation 25.4
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD16/56-76.21 percent changeStandard Deviation 28.2
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD8-51.68 percent changeStandard Deviation 18.1
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD3-46.69 percent changeStandard Deviation 17.5
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD4-42.60 percent changeStandard Deviation 18.8
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD47.17 percent changeStandard Deviation 17.1
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD33.91 percent changeStandard Deviation 20
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD16/56-0.68 percent changeStandard Deviation 22.4
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD19-4.67 percent changeStandard Deviation 25.8
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18Change at Day 18: CD84.70 percent changeStandard Deviation 15.9
Primary

Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2

Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.

Time frame: Baseline, hr 0 on Day 2

Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.

ArmMeasureGroupValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD16/5618.27 percent changeStandard Deviation 30.4
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD38.88 percent changeStandard Deviation 24
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD197.58 percent changeStandard Deviation 40.3
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD812.67 percent changeStandard Deviation 19.3
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD48.58 percent changeStandard Deviation 26.7
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD199.56 percent changeStandard Deviation 30.5
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD16/5661.26 percent changeStandard Deviation 47.8
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD832.68 percent changeStandard Deviation 30.1
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD334.74 percent changeStandard Deviation 27.4
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD433.29 percent changeStandard Deviation 25.4
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD1917.40 percent changeStandard Deviation 24.5
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD819.68 percent changeStandard Deviation 29.3
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD426.73 percent changeStandard Deviation 31.9
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD323.93 percent changeStandard Deviation 31.1
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD16/5652.84 percent changeStandard Deviation 54.8
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD346.07 percent changeStandard Deviation 31.4
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD16/5663.21 percent changeStandard Deviation 45.1
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD444.17 percent changeStandard Deviation 33.9
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD1930.39 percent changeStandard Deviation 11.3
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD843.04 percent changeStandard Deviation 29.1
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD16/560.61 percent changeStandard Deviation 37.7
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD314.05 percent changeStandard Deviation 24.4
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD816.96 percent changeStandard Deviation 25.1
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD418.85 percent changeStandard Deviation 34.9
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD197.04 percent changeStandard Deviation 33.5
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD16/56103.79 percent changeStandard Deviation 45.8
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD352.43 percent changeStandard Deviation 34.3
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD850.97 percent changeStandard Deviation 30.4
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD455.80 percent changeStandard Deviation 35.5
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD1945.72 percent changeStandard Deviation 44.4
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD8-4.17 percent changeStandard Deviation 20.2
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD4-6.85 percent changeStandard Deviation 18
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD3-5.18 percent changeStandard Deviation 17.4
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD19-4.22 percent changeStandard Deviation 24.4
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2Change at Day 2: CD16/565.61 percent changeStandard Deviation 35.7
Primary

Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21

Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.

Time frame: Baseline, hr 0 on Day 21

Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.

ArmMeasureGroupValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD16/56-7.23 percent changeStandard Deviation 23.5
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD3-25.48 percent changeStandard Deviation 10.5
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD19-20.90 percent changeStandard Deviation 25.4
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD8-19.51 percent changeStandard Deviation 14
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD4-29.75 percent changeStandard Deviation 9.6
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD3-6.38 percent changeStandard Deviation 14.8
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD16/56-9.21 percent changeStandard Deviation 63.8
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD8-6.00 percent changeStandard Deviation 31.1
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD19-14.61 percent changeStandard Deviation 26.7
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD4-2.88 percent changeStandard Deviation 7.4
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD8-43.55 percent changeStandard Deviation 28.9
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD3-42.27 percent changeStandard Deviation 23.9
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD16/56-47.87 percent changeStandard Deviation 30.7
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD19-22.60 percent changeStandard Deviation 26.6
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD4-41.01 percent changeStandard Deviation 24.4
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD8-23.78 percent changeStandard Deviation 21.1
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD3-14.82 percent changeStandard Deviation 20.2
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD19-7.67 percent changeStandard Deviation 34.8
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD16/56-48.04 percent changeStandard Deviation 19
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD4-11.01 percent changeStandard Deviation 20.7
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD8-2.12 percent changeStandard Deviation 14.8
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD16/565.62 percent changeStandard Deviation 35.4
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD19-17.50 percent changeStandard Deviation 27.7
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD3-7.93 percent changeStandard Deviation 13.5
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD4-9.41 percent changeStandard Deviation 16.5
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD3-27.37 percent changeStandard Deviation 13.3
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD19-12.51 percent changeStandard Deviation 22.9
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD16/56-66.94 percent changeStandard Deviation 19.2
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD8-32.49 percent changeStandard Deviation 15.6
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD4-22.38 percent changeStandard Deviation 13.1
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD8-4.01 percent changeStandard Deviation 17.8
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD190.98 percent changeStandard Deviation 24.3
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD3-1.12 percent changeStandard Deviation 17.8
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD16/56-2.22 percent changeStandard Deviation 44.1
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21Change at Day 21: CD41.16 percent changeStandard Deviation 19.8
Primary

Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28

Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.

Time frame: Baseline, hr 0 on Day 28

Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.

ArmMeasureGroupValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD3-18.11 percent changeStandard Deviation 10
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD4-21.29 percent changeStandard Deviation 13.3
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD8-11.96 percent changeStandard Deviation 9
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD16/565.13 percent changeStandard Deviation 35.9
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD19-7.96 percent changeStandard Deviation 24.3
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD39.29 percent changeStandard Deviation 24.5
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD811.58 percent changeStandard Deviation 18.8
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD1921.29 percent changeStandard Deviation 23.5
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD16/5621.93 percent changeStandard Deviation 51.3
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD410.97 percent changeStandard Deviation 29.8
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD41.02 percent changeStandard Deviation 35.2
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD191.96 percent changeStandard Deviation 42.3
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD30.38 percent changeStandard Deviation 34.1
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD8-2.84 percent changeStandard Deviation 35
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD16/56-10.27 percent changeStandard Deviation 31.2
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD16/56-28.52 percent changeStandard Deviation 51.6
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD8-9.33 percent changeStandard Deviation 18.5
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD4-5.90 percent changeStandard Deviation 15.7
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD19-6.53 percent changeStandard Deviation 21.8
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD3-4.60 percent changeStandard Deviation 17.9
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD16/5611.21 percent changeStandard Deviation 55.9
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD19-16.50 percent changeStandard Deviation 28.3
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD8-6.13 percent changeStandard Deviation 21.8
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD3-7.60 percent changeStandard Deviation 23.3
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD4-11.51 percent changeStandard Deviation 19.8
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD4-19.90 percent changeStandard Deviation 6.3
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD19-11.58 percent changeStandard Deviation 22.1
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD8-23.56 percent changeStandard Deviation 13.7
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD3-22.08 percent changeStandard Deviation 9.7
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD16/56-26.96 percent changeStandard Deviation 39.4
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD16/5613.32 percent changeStandard Deviation 50.8
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD8-1.56 percent changeStandard Deviation 26.7
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD19-12.51 percent changeStandard Deviation 19.1
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD4-2.86 percent changeStandard Deviation 24.9
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28Change at Day 28: CD3-2.57 percent changeStandard Deviation 25
Primary

Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4

Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.

Time frame: Baseline, hr 0 on Day 4

Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.

ArmMeasureGroupValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD8-10.94 percent changeStandard Deviation 17.8
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD4-15.87 percent changeStandard Deviation 22.4
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD16/56-23.08 percent changeStandard Deviation 22.5
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD19-12.59 percent changeStandard Deviation 27.2
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD3-15.29 percent changeStandard Deviation 21.1
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD16/5690.73 percent changeStandard Deviation 41.6
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD351.71 percent changeStandard Deviation 31.4
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD443.87 percent changeStandard Deviation 22
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD856.72 percent changeStandard Deviation 43.5
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD1941.44 percent changeStandard Deviation 18.2
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD818.18 percent changeStandard Deviation 41.7
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD329.11 percent changeStandard Deviation 49
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD1953.84 percent changeStandard Deviation 71.8
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD16/5610.67 percent changeStandard Deviation 44.3
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD430.90 percent changeStandard Deviation 51.7
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD472.02 percent changeStandard Deviation 43.1
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD371.55 percent changeStandard Deviation 44.5
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD861.61 percent changeStandard Deviation 41.4
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD16/5624.27 percent changeStandard Deviation 55.5
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD1956.27 percent changeStandard Deviation 35.1
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD831.95 percent changeStandard Deviation 32.6
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD16/56-5.23 percent changeStandard Deviation 43.2
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD442.50 percent changeStandard Deviation 56.7
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD334.28 percent changeStandard Deviation 41.8
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD1944.76 percent changeStandard Deviation 55.7
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD16/56-1.66 percent changeStandard Deviation 44.8
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD1977.25 percent changeStandard Deviation 50.7
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD829.81 percent changeStandard Deviation 33.5
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD439.46 percent changeStandard Deviation 27.2
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD332.81 percent changeStandard Deviation 28
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD8-0.31 percent changeStandard Deviation 24.8
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD16/567.18 percent changeStandard Deviation 59.8
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD19-2.55 percent changeStandard Deviation 37.5
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD46.08 percent changeStandard Deviation 31.3
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4Change at Day 4: CD33.80 percent changeStandard Deviation 28.2
Primary

Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42

Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.

Time frame: Baseline, hr 0 on Day 42

Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.

ArmMeasureGroupValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD8-12.74 percent changeStandard Deviation 29.1
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD19-31.86 percent changeStandard Deviation 30.9
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD4-25.65 percent changeStandard Deviation 30.3
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD3-20.79 percent changeStandard Deviation 29
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD16/56-9.01 percent changeStandard Deviation 25.4
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD196.43 percent changeStandard Deviation 33.6
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD16/5621.15 percent changeStandard Deviation 70.8
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD4-19.27 percent changeStandard Deviation 29.2
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD8-10.04 percent changeStandard Deviation 37.2
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD3-15.72 percent changeStandard Deviation 29.9
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD19-9.39 percent changeStandard Deviation 29.2
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD16/56-2.32 percent changeStandard Deviation 27.9
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD8-12.93 percent changeStandard Deviation 33.9
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD3-11.58 percent changeStandard Deviation 30
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD4-11.42 percent changeStandard Deviation 30
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD3-1.60 percent changeStandard Deviation 19.5
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD4-4.08 percent changeStandard Deviation 17.5
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD8-5.60 percent changeStandard Deviation 19.8
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD16/562.87 percent changeStandard Deviation 76.1
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD19-10.22 percent changeStandard Deviation 27.3
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD16/5624.08 percent changeStandard Deviation 35.8
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD19-20.20 percent changeStandard Deviation 30
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD4-12.27 percent changeStandard Deviation 24.6
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD8-3.24 percent changeStandard Deviation 17.6
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD3-9.17 percent changeStandard Deviation 21.5
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD4-3.81 percent changeStandard Deviation 12
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD84.19 percent changeStandard Deviation 31.4
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD16/56-4.54 percent changeStandard Deviation 37.4
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD3-1.63 percent changeStandard Deviation 20.2
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD19-8.30 percent changeStandard Deviation 16.8
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD16/5619.90 percent changeStandard Deviation 41.5
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD40.96 percent changeStandard Deviation 35.7
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD30.19 percent changeStandard Deviation 32.6
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD83.57 percent changeStandard Deviation 33.5
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42Change at Day 42: CD19-3.93 percent changeStandard Deviation 52.5
Primary

Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7

Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.

Time frame: Baseline, hr 0 on Day 7

Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.

ArmMeasureGroupValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD46.52 percent changeStandard Deviation 22.6
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD35.72 percent changeStandard Deviation 20.6
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD16/56-10.57 percent changeStandard Deviation 14.3
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD86.76 percent changeStandard Deviation 18.5
CP-690,550 5 mg (Cohort 1)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD1913.01 percent changeStandard Deviation 36.3
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD831.50 percent changeStandard Deviation 42.3
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD1934.47 percent changeStandard Deviation 24.6
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD16/5629.97 percent changeStandard Deviation 56.6
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD328.15 percent changeStandard Deviation 26
CP-690,550 10 mg (Cohort 2)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD429.39 percent changeStandard Deviation 22.2
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD87.21 percent changeStandard Deviation 50.1
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD313.47 percent changeStandard Deviation 55.4
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD16/5617.02 percent changeStandard Deviation 83
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD1955.54 percent changeStandard Deviation 83.2
CP-690,550 20 mg (Cohort 3)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD414.99 percent changeStandard Deviation 56.6
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD325.51 percent changeStandard Deviation 38.9
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD424.48 percent changeStandard Deviation 39.3
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD1972.86 percent changeStandard Deviation 67.4
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD16/56-1.43 percent changeStandard Deviation 40
CP-690,550 30 mg (Cohort 4)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD821.74 percent changeStandard Deviation 37.5
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD31.61 percent changeStandard Deviation 26
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD16/56-2.37 percent changeStandard Deviation 56.4
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD81.74 percent changeStandard Deviation 25.2
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD1915.14 percent changeStandard Deviation 46
CP-690,550 60 mg (Cohort 5)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD40.91 percent changeStandard Deviation 26.6
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD830.95 percent changeStandard Deviation 27.8
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD1998.64 percent changeStandard Deviation 102.9
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD16/56-7.95 percent changeStandard Deviation 30.2
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD334.77 percent changeStandard Deviation 33.1
CP-690,550 50 mg (Cohort 6)Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD437.42 percent changeStandard Deviation 33.1
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD3-3.08 percent changeStandard Deviation 17.3
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD8-3.10 percent changeStandard Deviation 19.8
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD19-2.40 percent changeStandard Deviation 22.3
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD4-3.28 percent changeStandard Deviation 17.8
PlaceboPercent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7Change at Day 7: CD16/562.26 percent changeStandard Deviation 35.2
Primary

Time to Reach Maximum Change From Baseline and Time to Return to Baseline Value for Fluorescence-Activated Cell Sorting (FACS), Reticulocyte Counts and Immune Cell Function

Time frame: Day 0 (pre-dose), 1, 2, 4, 7, 10, 14, 15, 18, 21, 28, 42

Population: Data was not analyzed as per planned analyses due to pattern of changes observed.

Primary

Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 1

Time frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1

Population: Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

ArmMeasureValue (MEDIAN)
CP-690,550 5 mg (Cohort 1)Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 10.50 hr
CP-690,550 10 mg (Cohort 2)Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 10.50 hr
CP-690,550 20 mg (Cohort 3)Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 10.50 hr
CP-690,550 30 mg (Cohort 4)Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 10.50 hr
CP-690,550 60 mg (Cohort 5)Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 11.00 hr
CP-690,550 50 mg (Cohort 6)Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 11.00 hr
Primary

Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 14

Time frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 14

Population: Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

ArmMeasureValue (MEDIAN)
CP-690,550 5 mg (Cohort 1)Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 140.50 hr
CP-690,550 10 mg (Cohort 2)Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 141.00 hr
CP-690,550 20 mg (Cohort 3)Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 140.50 hr
CP-690,550 30 mg (Cohort 4)Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 141.00 hr
CP-690,550 60 mg (Cohort 5)Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 141.00 hr
CP-690,550 50 mg (Cohort 6)Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 141.00 hr
Secondary

Gene Expression in Peripheral Blood

Punch biopsy and serum blood were assayed for messenger Ribonucleic acid (mRNA) gene expression by quantitative PCR using standard curve(SC) method generated by linear regression using log threshold cycle versus log(cell number). granzyme B, IFN-gamma, TNF-alpha (FasL and superfamily member 5 \[SF5\]), BCL2, BAX, iNOS, and CD 25 presented as control gene normalized expression(relative expression) within SC. The Relative mRNA Gene Expression Level is relative to baseline and normalized to the housekeeping gene 18 Svedberg unit ribosomal RNA (18S rRNA).

Time frame: Day 14

Population: Analysis population:all participants who met eligibility criteria. 'N'(number of participants analyzed)=participants evaluable for this measure. 'n =participants evaluable for specified category for each arm group respectively. Gene expression results were planned to be analyzed for participants who received CP-690,550 5,30 mg and matching placebo.

ArmMeasureGroupValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Gene Expression in Peripheral BloodBAX (n=9,9,6)1.10 relative expression unit (REU)Standard Deviation 0.32
CP-690,550 5 mg (Cohort 1)Gene Expression in Peripheral BloodIFN-gamma (n=9,9,6)2.06 relative expression unit (REU)Standard Deviation 1.58
CP-690,550 5 mg (Cohort 1)Gene Expression in Peripheral BloodCD 25 (n=9,9,6)1.19 relative expression unit (REU)Standard Deviation 0.5
CP-690,550 5 mg (Cohort 1)Gene Expression in Peripheral BloodTNF-FasL (n=9,9,6)0.99 relative expression unit (REU)Standard Deviation 0.37
CP-690,550 5 mg (Cohort 1)Gene Expression in Peripheral BloodTNF-SF5 (n=9,9,6)1.79 relative expression unit (REU)Standard Deviation 1.14
CP-690,550 5 mg (Cohort 1)Gene Expression in Peripheral BloodiNOS (n=2,1,1)77.79 relative expression unit (REU)Standard Deviation 40.1
CP-690,550 5 mg (Cohort 1)Gene Expression in Peripheral BloodBCL2 (n=9,9,6)0.71 relative expression unit (REU)Standard Deviation 0.4
CP-690,550 5 mg (Cohort 1)Gene Expression in Peripheral BloodGranzyme B (n=9,9,6)0.69 relative expression unit (REU)Standard Deviation 0.33
CP-690,550 10 mg (Cohort 2)Gene Expression in Peripheral BloodBCL2 (n=9,9,6)0.90 relative expression unit (REU)Standard Deviation 0.3
CP-690,550 10 mg (Cohort 2)Gene Expression in Peripheral BloodBAX (n=9,9,6)0.98 relative expression unit (REU)Standard Deviation 0.25
CP-690,550 10 mg (Cohort 2)Gene Expression in Peripheral BloodiNOS (n=2,1,1)0.97 relative expression unit (REU)Standard Deviation 0.08
CP-690,550 10 mg (Cohort 2)Gene Expression in Peripheral BloodCD 25 (n=9,9,6)1.02 relative expression unit (REU)Standard Deviation 0.29
CP-690,550 10 mg (Cohort 2)Gene Expression in Peripheral BloodGranzyme B (n=9,9,6)0.99 relative expression unit (REU)Standard Deviation 0.58
CP-690,550 10 mg (Cohort 2)Gene Expression in Peripheral BloodIFN-gamma (n=9,9,6)1.16 relative expression unit (REU)Standard Deviation 0.59
CP-690,550 10 mg (Cohort 2)Gene Expression in Peripheral BloodTNF-SF5 (n=9,9,6)1.29 relative expression unit (REU)Standard Deviation 0.48
CP-690,550 10 mg (Cohort 2)Gene Expression in Peripheral BloodTNF-FasL (n=9,9,6)1.09 relative expression unit (REU)Standard Deviation 0.53
CP-690,550 20 mg (Cohort 3)Gene Expression in Peripheral BloodCD 25 (n=9,9,6)1.01 relative expression unit (REU)Standard Deviation 0.24
CP-690,550 20 mg (Cohort 3)Gene Expression in Peripheral BloodTNF-FasL (n=9,9,6)1.27 relative expression unit (REU)Standard Deviation 0.83
CP-690,550 20 mg (Cohort 3)Gene Expression in Peripheral BloodBAX (n=9,9,6)0.97 relative expression unit (REU)Standard Deviation 0.22
CP-690,550 20 mg (Cohort 3)Gene Expression in Peripheral BloodIFN-gamma (n=9,9,6)1.46 relative expression unit (REU)Standard Deviation 0.86
CP-690,550 20 mg (Cohort 3)Gene Expression in Peripheral BloodTNF-SF5 (n=9,9,6)1.24 relative expression unit (REU)Standard Deviation 0.38
CP-690,550 20 mg (Cohort 3)Gene Expression in Peripheral BloodBCL2 (n=9,9,6)1.01 relative expression unit (REU)Standard Deviation 0.22
CP-690,550 20 mg (Cohort 3)Gene Expression in Peripheral BloodiNOS (n=2,1,1)0.02 relative expression unit (REU)
CP-690,550 20 mg (Cohort 3)Gene Expression in Peripheral BloodGranzyme B (n=9,9,6)1.58 relative expression unit (REU)Standard Deviation 1.13
Secondary

Gene Expression in Psoriatic Plaque Biopsies

Gene expression by quantitative polymerized chain reaction (PCR) using standard curve (SC) method generated by linear regression using log threshold cycle versus log(cell number). Keratin (K)-16, inducible nitric oxide synthase (iNOS), Interleukin 8 (IL-8), CD25, Granzyme B, IL-2, IL-7, IL-15, Interferon-gamma (INF-gamma), C-X-C motif chemokine(CXCL10), perforin 1, B-cell Lymphoma 2 (BCL-2), BCL2 associated X Protein (BAX), Tumor Necrosis Factor Fas Ligand (TNF-FasL), and proliferating cell nuclear antigen (PCNA) presented as control gene normalized expression (relative expression) within SC.

Time frame: Day 14

Population: Analysis population:all participants who met eligibility criteria. 'N'(number of participants analyzed)=participants evaluable for this measure. 'n =participants evaluable for specified category for each arm group respectively. Gene expression results were planned to be analyzed for participants who received CP-690,550 5,30 mg and matching placebo.

ArmMeasureGroupValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Gene Expression in Psoriatic Plaque BiopsiesPerforin2.80 relative expression unit (REU)Standard Deviation 2.56
CP-690,550 5 mg (Cohort 1)Gene Expression in Psoriatic Plaque BiopsiesPCNA2.09 relative expression unit (REU)Standard Deviation 0.77
CP-690,550 5 mg (Cohort 1)Gene Expression in Psoriatic Plaque BiopsiesCD257.34 relative expression unit (REU)Standard Deviation 2.33
CP-690,550 5 mg (Cohort 1)Gene Expression in Psoriatic Plaque BiopsiesIL-20.98 relative expression unit (REU)Standard Deviation 0.16
CP-690,550 5 mg (Cohort 1)Gene Expression in Psoriatic Plaque BiopsiesCXCL1015.03 relative expression unit (REU)Standard Deviation 5.75
CP-690,550 5 mg (Cohort 1)Gene Expression in Psoriatic Plaque BiopsiesBCL-20.47 relative expression unit (REU)Standard Deviation 0.09
CP-690,550 5 mg (Cohort 1)Gene Expression in Psoriatic Plaque BiopsiesIL-8556.12 relative expression unit (REU)Standard Deviation 754.91
CP-690,550 5 mg (Cohort 1)Gene Expression in Psoriatic Plaque BiopsiesTNF-FasL0.95 relative expression unit (REU)Standard Deviation 0.24
CP-690,550 5 mg (Cohort 1)Gene Expression in Psoriatic Plaque BiopsiesK-1669.04 relative expression unit (REU)Standard Deviation 7.6
CP-690,550 5 mg (Cohort 1)Gene Expression in Psoriatic Plaque BiopsiesGranzyme B42.71 relative expression unit (REU)Standard Deviation 18.54
CP-690,550 5 mg (Cohort 1)Gene Expression in Psoriatic Plaque BiopsiesINF-gamma2.26 relative expression unit (REU)Standard Deviation 1.49
CP-690,550 5 mg (Cohort 1)Gene Expression in Psoriatic Plaque BiopsiesINOS77.79 relative expression unit (REU)Standard Deviation 40.1
CP-690,550 5 mg (Cohort 1)Gene Expression in Psoriatic Plaque BiopsiesBAX1.16 relative expression unit (REU)Standard Deviation 0.21
CP-690,550 5 mg (Cohort 1)Gene Expression in Psoriatic Plaque BiopsiesIL-150.51 relative expression unit (REU)Standard Deviation 0.01
CP-690,550 5 mg (Cohort 1)Gene Expression in Psoriatic Plaque BiopsiesIL-70.85 relative expression unit (REU)Standard Deviation 0.11
CP-690,550 10 mg (Cohort 2)Gene Expression in Psoriatic Plaque BiopsiesIL-150.70 relative expression unit (REU)Standard Deviation 0.06
CP-690,550 10 mg (Cohort 2)Gene Expression in Psoriatic Plaque BiopsiesIL-71.26 relative expression unit (REU)Standard Deviation 0.51
CP-690,550 10 mg (Cohort 2)Gene Expression in Psoriatic Plaque BiopsiesBAX0.83 relative expression unit (REU)Standard Deviation 0.28
CP-690,550 10 mg (Cohort 2)Gene Expression in Psoriatic Plaque BiopsiesK-165.18 relative expression unit (REU)Standard Deviation 2.63
CP-690,550 10 mg (Cohort 2)Gene Expression in Psoriatic Plaque BiopsiesCD251.05 relative expression unit (REU)Standard Deviation 0.27
CP-690,550 10 mg (Cohort 2)Gene Expression in Psoriatic Plaque BiopsiesPCNA1.15 relative expression unit (REU)Standard Deviation 0.06
CP-690,550 10 mg (Cohort 2)Gene Expression in Psoriatic Plaque BiopsiesPerforin0.65 relative expression unit (REU)Standard Deviation 0.17
CP-690,550 10 mg (Cohort 2)Gene Expression in Psoriatic Plaque BiopsiesTNF-FasL1.24 relative expression unit (REU)Standard Deviation 0.86
CP-690,550 10 mg (Cohort 2)Gene Expression in Psoriatic Plaque BiopsiesCXCL100.44 relative expression unit (REU)Standard Deviation 0.45
CP-690,550 10 mg (Cohort 2)Gene Expression in Psoriatic Plaque BiopsiesINOS0.97 relative expression unit (REU)Standard Deviation 0.08
CP-690,550 10 mg (Cohort 2)Gene Expression in Psoriatic Plaque BiopsiesGranzyme B1.20 relative expression unit (REU)Standard Deviation 0.07
CP-690,550 10 mg (Cohort 2)Gene Expression in Psoriatic Plaque BiopsiesIL-20.87 relative expression unit (REU)Standard Deviation 0.02
CP-690,550 10 mg (Cohort 2)Gene Expression in Psoriatic Plaque BiopsiesIL-814.66 relative expression unit (REU)
CP-690,550 10 mg (Cohort 2)Gene Expression in Psoriatic Plaque BiopsiesBCL-20.36 relative expression unit (REU)Standard Deviation 0.14
CP-690,550 10 mg (Cohort 2)Gene Expression in Psoriatic Plaque BiopsiesINF-gamma0.90 relative expression unit (REU)Standard Deviation 0.09
CP-690,550 20 mg (Cohort 3)Gene Expression in Psoriatic Plaque BiopsiesINF-gamma0.22 relative expression unit (REU)
CP-690,550 20 mg (Cohort 3)Gene Expression in Psoriatic Plaque BiopsiesIL-150.86 relative expression unit (REU)
CP-690,550 20 mg (Cohort 3)Gene Expression in Psoriatic Plaque BiopsiesBCL-22.29 relative expression unit (REU)
CP-690,550 20 mg (Cohort 3)Gene Expression in Psoriatic Plaque BiopsiesCD250.16 relative expression unit (REU)
CP-690,550 20 mg (Cohort 3)Gene Expression in Psoriatic Plaque BiopsiesCXCL100.04 relative expression unit (REU)
CP-690,550 20 mg (Cohort 3)Gene Expression in Psoriatic Plaque BiopsiesGranzyme B0.03 relative expression unit (REU)
CP-690,550 20 mg (Cohort 3)Gene Expression in Psoriatic Plaque BiopsiesIL-20.75 relative expression unit (REU)
CP-690,550 20 mg (Cohort 3)Gene Expression in Psoriatic Plaque BiopsiesIL-80.00 relative expression unit (REU)
CP-690,550 20 mg (Cohort 3)Gene Expression in Psoriatic Plaque BiopsiesINOS0.02 relative expression unit (REU)
CP-690,550 20 mg (Cohort 3)Gene Expression in Psoriatic Plaque BiopsiesBAX0.68 relative expression unit (REU)
CP-690,550 20 mg (Cohort 3)Gene Expression in Psoriatic Plaque BiopsiesIL-71.19 relative expression unit (REU)
CP-690,550 20 mg (Cohort 3)Gene Expression in Psoriatic Plaque BiopsiesK-160.04 relative expression unit (REU)
CP-690,550 20 mg (Cohort 3)Gene Expression in Psoriatic Plaque BiopsiesPCNA0.41 relative expression unit (REU)
CP-690,550 20 mg (Cohort 3)Gene Expression in Psoriatic Plaque BiopsiesPerforin0.23 relative expression unit (REU)
CP-690,550 20 mg (Cohort 3)Gene Expression in Psoriatic Plaque BiopsiesTNF-FasL0.64 relative expression unit (REU)
Secondary

Immunohistochemistry From Psoriatic Plaque Biopsies

Immunohistochemical staining of skin biopsies was performed with monoclonal antibodies directed against cluster of differentiation 3 (CD3) and cluster of differentiation 8 (CD8) T-lymphocytes, cluster of differentiation 16/56 (CD16/56) natural killer cells, and cluster of differentiation 83 (CD83) mature dendritic cells. Baseline was defined as mean of samples obtained at the screening visit within 7 days prior to Day 1, at the baseline biopsy, and Day 0. Immunohistochemistry results were planned to be analyzed for participants who received CP-690,550 5, 20, 30 mg and matching placebo.

Time frame: Baseline (within 7 days prior to Day 1), Day 14

Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n' = participants evaluable for this measure at specified time points for each arm group respectively.

ArmMeasureGroupValue (MEAN)Dispersion
CP-690,550 5 mg (Cohort 1)Immunohistochemistry From Psoriatic Plaque BiopsiesBaseline: Absolute CD16/56 (n=0,0,0,0)NA cells/microliter (cells/μL)
CP-690,550 5 mg (Cohort 1)Immunohistochemistry From Psoriatic Plaque BiopsiesDay 14: CD3 epidermal (n=1,1,4,2)148.00 cells/microliter (cells/μL)
CP-690,550 5 mg (Cohort 1)Immunohistochemistry From Psoriatic Plaque BiopsiesDay 14: CD83 dermal (n=1,1,4,2)26.00 cells/microliter (cells/μL)
CP-690,550 5 mg (Cohort 1)Immunohistochemistry From Psoriatic Plaque BiopsiesDay 14: CD8 epidermal (n=1,1,4,2)85.00 cells/microliter (cells/μL)
CP-690,550 5 mg (Cohort 1)Immunohistochemistry From Psoriatic Plaque BiopsiesDay 14: CD3 dermal (n=1,1,4,2)120.00 cells/microliter (cells/μL)
CP-690,550 5 mg (Cohort 1)Immunohistochemistry From Psoriatic Plaque BiopsiesBaseline: CD3 epidermal (n=1,1,4,2)115.00 cells/microliter (cells/μL)
CP-690,550 5 mg (Cohort 1)Immunohistochemistry From Psoriatic Plaque BiopsiesBaseline: CD3 dermal (n=1,1,4,2)189.00 cells/microliter (cells/μL)
CP-690,550 5 mg (Cohort 1)Immunohistochemistry From Psoriatic Plaque BiopsiesBaseline: CD83 dermal (n=1,1,4,2)11.00 cells/microliter (cells/μL)
CP-690,550 5 mg (Cohort 1)Immunohistochemistry From Psoriatic Plaque BiopsiesDay 14: Absolute CD16/56 (n=0,0,0,0)NA cells/microliter (cells/μL)
CP-690,550 5 mg (Cohort 1)Immunohistochemistry From Psoriatic Plaque BiopsiesDay 14: CD83 epidermal (n=1,1,4,2)42.00 cells/microliter (cells/μL)
CP-690,550 5 mg (Cohort 1)Immunohistochemistry From Psoriatic Plaque BiopsiesBaseline: CD8 dermal (n=1,1,4,2)23.00 cells/microliter (cells/μL)
CP-690,550 5 mg (Cohort 1)Immunohistochemistry From Psoriatic Plaque BiopsiesBaseline: CD83 epidermal (n=1,1,4,2)13.00 cells/microliter (cells/μL)
CP-690,550 5 mg (Cohort 1)Immunohistochemistry From Psoriatic Plaque BiopsiesBaseline: CD8 epidermal (n=1,1,4,2)66.00 cells/microliter (cells/μL)
CP-690,550 5 mg (Cohort 1)Immunohistochemistry From Psoriatic Plaque BiopsiesDay 14: CD8 dermal (n=1,1,4,2)27.00 cells/microliter (cells/μL)
CP-690,550 10 mg (Cohort 2)Immunohistochemistry From Psoriatic Plaque BiopsiesDay 14: CD8 dermal (n=1,1,4,2)42.00 cells/microliter (cells/μL)
CP-690,550 10 mg (Cohort 2)Immunohistochemistry From Psoriatic Plaque BiopsiesBaseline: Absolute CD16/56 (n=0,0,0,0)NA cells/microliter (cells/μL)
CP-690,550 10 mg (Cohort 2)Immunohistochemistry From Psoriatic Plaque BiopsiesDay 14: Absolute CD16/56 (n=0,0,0,0)NA cells/microliter (cells/μL)
CP-690,550 10 mg (Cohort 2)Immunohistochemistry From Psoriatic Plaque BiopsiesDay 14: CD8 epidermal (n=1,1,4,2)56.00 cells/microliter (cells/μL)
CP-690,550 10 mg (Cohort 2)Immunohistochemistry From Psoriatic Plaque BiopsiesDay 14: CD83 epidermal (n=1,1,4,2)11.00 cells/microliter (cells/μL)
CP-690,550 10 mg (Cohort 2)Immunohistochemistry From Psoriatic Plaque BiopsiesDay 14: CD3 epidermal (n=1,1,4,2)96.00 cells/microliter (cells/μL)
CP-690,550 10 mg (Cohort 2)Immunohistochemistry From Psoriatic Plaque BiopsiesBaseline: CD8 epidermal (n=1,1,4,2)55.00 cells/microliter (cells/μL)
CP-690,550 10 mg (Cohort 2)Immunohistochemistry From Psoriatic Plaque BiopsiesDay 14: CD83 dermal (n=1,1,4,2)17.00 cells/microliter (cells/μL)
CP-690,550 10 mg (Cohort 2)Immunohistochemistry From Psoriatic Plaque BiopsiesBaseline: CD83 epidermal (n=1,1,4,2)44.00 cells/microliter (cells/μL)
CP-690,550 10 mg (Cohort 2)Immunohistochemistry From Psoriatic Plaque BiopsiesDay 14: CD3 dermal (n=1,1,4,2)114.00 cells/microliter (cells/μL)
CP-690,550 10 mg (Cohort 2)Immunohistochemistry From Psoriatic Plaque BiopsiesBaseline: CD83 dermal (n=1,1,4,2)78.00 cells/microliter (cells/μL)
CP-690,550 10 mg (Cohort 2)Immunohistochemistry From Psoriatic Plaque BiopsiesBaseline: CD3 epidermal (n=1,1,4,2)108.00 cells/microliter (cells/μL)
CP-690,550 10 mg (Cohort 2)Immunohistochemistry From Psoriatic Plaque BiopsiesBaseline: CD8 dermal (n=1,1,4,2)53.00 cells/microliter (cells/μL)
CP-690,550 10 mg (Cohort 2)Immunohistochemistry From Psoriatic Plaque BiopsiesBaseline: CD3 dermal (n=1,1,4,2)135.00 cells/microliter (cells/μL)
CP-690,550 20 mg (Cohort 3)Immunohistochemistry From Psoriatic Plaque BiopsiesBaseline: CD3 dermal (n=1,1,4,2)130.00 cells/microliter (cells/μL)Standard Deviation 81.3
CP-690,550 20 mg (Cohort 3)Immunohistochemistry From Psoriatic Plaque BiopsiesBaseline: CD8 dermal (n=1,1,4,2)123.75 cells/microliter (cells/μL)Standard Deviation 103.6
CP-690,550 20 mg (Cohort 3)Immunohistochemistry From Psoriatic Plaque BiopsiesDay 14: CD8 dermal (n=1,1,4,2)90.50 cells/microliter (cells/μL)Standard Deviation 54.4
CP-690,550 20 mg (Cohort 3)Immunohistochemistry From Psoriatic Plaque BiopsiesDay 14: CD83 dermal (n=1,1,4,2)3.25 cells/microliter (cells/μL)Standard Deviation 2.2
CP-690,550 20 mg (Cohort 3)Immunohistochemistry From Psoriatic Plaque BiopsiesBaseline: CD3 epidermal (n=1,1,4,2)122.50 cells/microliter (cells/μL)Standard Deviation 50.8
CP-690,550 20 mg (Cohort 3)Immunohistochemistry From Psoriatic Plaque BiopsiesBaseline: CD8 epidermal (n=1,1,4,2)108.50 cells/microliter (cells/μL)Standard Deviation 40.9
CP-690,550 20 mg (Cohort 3)Immunohistochemistry From Psoriatic Plaque BiopsiesBaseline: CD83 epidermal (n=1,1,4,2)17.00 cells/microliter (cells/μL)Standard Deviation 12.1
CP-690,550 20 mg (Cohort 3)Immunohistochemistry From Psoriatic Plaque BiopsiesBaseline: CD83 dermal (n=1,1,4,2)18.00 cells/microliter (cells/μL)Standard Deviation 7.3
CP-690,550 20 mg (Cohort 3)Immunohistochemistry From Psoriatic Plaque BiopsiesBaseline: Absolute CD16/56 (n=0,0,0,0)NA cells/microliter (cells/μL)
CP-690,550 20 mg (Cohort 3)Immunohistochemistry From Psoriatic Plaque BiopsiesDay 14: CD3 epidermal (n=1,1,4,2)82.25 cells/microliter (cells/μL)Standard Deviation 121
CP-690,550 20 mg (Cohort 3)Immunohistochemistry From Psoriatic Plaque BiopsiesDay 14: CD3 dermal (n=1,1,4,2)95.25 cells/microliter (cells/μL)Standard Deviation 59.4
CP-690,550 20 mg (Cohort 3)Immunohistochemistry From Psoriatic Plaque BiopsiesDay 14: CD8 epidermal (n=1,1,4,2)51.50 cells/microliter (cells/μL)Standard Deviation 50.8
CP-690,550 20 mg (Cohort 3)Immunohistochemistry From Psoriatic Plaque BiopsiesDay 14: CD83 epidermal (n=1,1,4,2)1.25 cells/microliter (cells/μL)Standard Deviation 1.5
CP-690,550 20 mg (Cohort 3)Immunohistochemistry From Psoriatic Plaque BiopsiesDay 14: Absolute CD16/56 (n=0,0,0,0)NA cells/microliter (cells/μL)
CP-690,550 30 mg (Cohort 4)Immunohistochemistry From Psoriatic Plaque BiopsiesBaseline: CD83 dermal (n=1,1,4,2)3.00 cells/microliter (cells/μL)Standard Deviation 0
CP-690,550 30 mg (Cohort 4)Immunohistochemistry From Psoriatic Plaque BiopsiesDay 14: CD8 epidermal (n=1,1,4,2)41.50 cells/microliter (cells/μL)Standard Deviation 34.6
CP-690,550 30 mg (Cohort 4)Immunohistochemistry From Psoriatic Plaque BiopsiesBaseline: CD83 epidermal (n=1,1,4,2)1.50 cells/microliter (cells/μL)Standard Deviation 0.7
CP-690,550 30 mg (Cohort 4)Immunohistochemistry From Psoriatic Plaque BiopsiesBaseline: CD8 dermal (n=1,1,4,2)74.00 cells/microliter (cells/μL)Standard Deviation 70.7
CP-690,550 30 mg (Cohort 4)Immunohistochemistry From Psoriatic Plaque BiopsiesDay 14: CD8 dermal (n=1,1,4,2)25.00 cells/microliter (cells/μL)Standard Deviation 9.9
CP-690,550 30 mg (Cohort 4)Immunohistochemistry From Psoriatic Plaque BiopsiesBaseline: CD8 epidermal (n=1,1,4,2)71.50 cells/microliter (cells/μL)Standard Deviation 19.1
CP-690,550 30 mg (Cohort 4)Immunohistochemistry From Psoriatic Plaque BiopsiesBaseline: CD3 dermal (n=1,1,4,2)196.00 cells/microliter (cells/μL)Standard Deviation 99
CP-690,550 30 mg (Cohort 4)Immunohistochemistry From Psoriatic Plaque BiopsiesBaseline: CD3 epidermal (n=1,1,4,2)124.50 cells/microliter (cells/μL)Standard Deviation 55.9
CP-690,550 30 mg (Cohort 4)Immunohistochemistry From Psoriatic Plaque BiopsiesDay 14: CD83 epidermal (n=1,1,4,2)7.00 cells/microliter (cells/μL)Standard Deviation 9.9
CP-690,550 30 mg (Cohort 4)Immunohistochemistry From Psoriatic Plaque BiopsiesDay 14: Absolute CD16/56 (n=0,0,0,0)NA cells/microliter (cells/μL)
CP-690,550 30 mg (Cohort 4)Immunohistochemistry From Psoriatic Plaque BiopsiesDay 14: CD83 dermal (n=1,1,4,2)9.50 cells/microliter (cells/μL)Standard Deviation 9.2
CP-690,550 30 mg (Cohort 4)Immunohistochemistry From Psoriatic Plaque BiopsiesDay 14: CD3 dermal (n=1,1,4,2)92.00 cells/microliter (cells/μL)Standard Deviation 53.7
CP-690,550 30 mg (Cohort 4)Immunohistochemistry From Psoriatic Plaque BiopsiesDay 14: CD3 epidermal (n=1,1,4,2)97.00 cells/microliter (cells/μL)Standard Deviation 41
CP-690,550 30 mg (Cohort 4)Immunohistochemistry From Psoriatic Plaque BiopsiesBaseline: Absolute CD16/56 (n=0,0,0,0)NA cells/microliter (cells/μL)
Secondary

Number of Participants With Intracellular Adhesion Molecule (ICAM-1) by Epidermal Keratinocytes Expression

Immunohistochemical staining of skin biopsies was performed with monoclonal antibodies directed against ICAM-1. Number of participants with ICAM-1 expression was to be assessed qualitatively using epidermal keratinocytes.

Time frame: Baseline (within 7 days prior to Day 1) up to Day 14

Population: Analysis of ICAM-1 in biopsy specimens was not performed as it often continues to be expressed on vessels in the skin even when psoriasis was resolved, thus would not provide a measure of response to therapy.

Secondary

Number of Participants With Keratin 16 (K16) Expression

Immunohistochemical staining of skin biopsies was performed with monoclonal antibodies directed against K16. Number of participants with K16 expression were assessed qualitatively using suprabasal keratinocytes.

Time frame: Baseline (within 7 days prior to Day 1) up to Day 14

Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

ArmMeasureGroupValue (NUMBER)
CP-690,550 5 mg (Cohort 1)Number of Participants With Keratin 16 (K16) ExpressionBaseline1 participants
CP-690,550 5 mg (Cohort 1)Number of Participants With Keratin 16 (K16) ExpressionDay 141 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Keratin 16 (K16) ExpressionDay 141 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Keratin 16 (K16) ExpressionBaseline1 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Keratin 16 (K16) ExpressionDay 144 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Keratin 16 (K16) ExpressionBaseline4 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Keratin 16 (K16) ExpressionBaseline2 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Keratin 16 (K16) ExpressionDay 142 participants
Secondary

Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14

Modified Psoriasis Area and Severity Index (mPASI) assessed lesion severity but not the body surface area affected. Severity was estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final mPASI = sum of the each component scores. Total score range 0-12 , higher score indicated more severity.

Time frame: Baseline (Within 7 days prior to Day 1) up to Day 14

Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.

ArmMeasureGroupValue (NUMBER)
CP-690,550 5 mg (Cohort 1)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 40 participants
CP-690,550 5 mg (Cohort 1)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 12 participants
CP-690,550 5 mg (Cohort 1)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 00 participants
CP-690,550 5 mg (Cohort 1)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 40 participants
CP-690,550 5 mg (Cohort 1)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 30 participants
CP-690,550 5 mg (Cohort 1)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 13 participants
CP-690,550 5 mg (Cohort 1)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 30 participants
CP-690,550 5 mg (Cohort 1)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 22 participants
CP-690,550 5 mg (Cohort 1)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 13 participants
CP-690,550 5 mg (Cohort 1)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 21 participants
CP-690,550 5 mg (Cohort 1)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 01 participants
CP-690,550 5 mg (Cohort 1)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 00 participants
CP-690,550 5 mg (Cohort 1)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 40 participants
CP-690,550 5 mg (Cohort 1)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 31 participants
CP-690,550 5 mg (Cohort 1)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 22 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 40 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 13 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 12 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 01 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 40 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 00 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 30 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 40 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 21 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 30 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 21 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 30 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 14 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 01 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 22 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 18 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 30 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 40 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 00 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 21 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 03 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 15 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 21 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 30 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 40 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 01 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 16 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 22 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 30 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 40 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 22 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 22 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 40 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 17 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 13 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 17 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 30 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 30 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 40 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 04 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 02 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 40 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 30 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 20 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 00 participants
CP-690,550 60 mg (Cohort 5)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 40 participants
CP-690,550 60 mg (Cohort 5)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 30 participants
CP-690,550 60 mg (Cohort 5)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 40 participants
CP-690,550 60 mg (Cohort 5)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 22 participants
CP-690,550 60 mg (Cohort 5)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 16 participants
CP-690,550 60 mg (Cohort 5)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 24 participants
CP-690,550 60 mg (Cohort 5)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 13 participants
CP-690,550 60 mg (Cohort 5)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 30 participants
CP-690,550 60 mg (Cohort 5)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 40 participants
CP-690,550 60 mg (Cohort 5)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 14 participants
CP-690,550 60 mg (Cohort 5)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 01 participants
CP-690,550 60 mg (Cohort 5)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 30 participants
CP-690,550 60 mg (Cohort 5)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 23 participants
CP-690,550 60 mg (Cohort 5)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 02 participants
CP-690,550 60 mg (Cohort 5)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 02 participants
CP-690,550 50 mg (Cohort 6)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 30 participants
CP-690,550 50 mg (Cohort 6)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 10 participants
CP-690,550 50 mg (Cohort 6)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 30 participants
CP-690,550 50 mg (Cohort 6)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 22 participants
CP-690,550 50 mg (Cohort 6)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 40 participants
CP-690,550 50 mg (Cohort 6)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 30 participants
CP-690,550 50 mg (Cohort 6)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 20 participants
CP-690,550 50 mg (Cohort 6)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 05 participants
CP-690,550 50 mg (Cohort 6)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 14 participants
CP-690,550 50 mg (Cohort 6)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 12 participants
CP-690,550 50 mg (Cohort 6)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 21 participants
CP-690,550 50 mg (Cohort 6)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 04 participants
CP-690,550 50 mg (Cohort 6)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 40 participants
CP-690,550 50 mg (Cohort 6)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 40 participants
CP-690,550 50 mg (Cohort 6)Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 06 participants
PlaceboNumber of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 24 participants
PlaceboNumber of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 00 participants
PlaceboNumber of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 01 participants
PlaceboNumber of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 31 participants
PlaceboNumber of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 40 participants
PlaceboNumber of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 40 participants
PlaceboNumber of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 30 participants
PlaceboNumber of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 29 participants
PlaceboNumber of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 31 participants
PlaceboNumber of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 29 participants
PlaceboNumber of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 18 participants
PlaceboNumber of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Erythema: 14 participants
PlaceboNumber of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 00 participants
PlaceboNumber of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Scaling: 40 participants
PlaceboNumber of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14Induration: 12 participants
Secondary

Number of Participants With Physician's Global Assessment (PGA) of Psoriasis

Physician global assessment (PGA) of Psoriasis is a 7-point scale used to assess severity of psoriatic plaques, scaling and/or erythema. Severity scale ranged from 1 to 7: 1=severe, 2=moderate to severe, 3=moderate, 4=mild to moderate, 5=mild, 6=almost clear, 7=clear (no sign of psoriasis).

Time frame: Baseline (Within 7 days prior to Day 1) up to Day 14

Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.

ArmMeasureGroupValue (NUMBER)
CP-690,550 5 mg (Cohort 1)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:40 participants
CP-690,550 5 mg (Cohort 1)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:33 participants
CP-690,550 5 mg (Cohort 1)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:51 participants
CP-690,550 5 mg (Cohort 1)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:60 participants
CP-690,550 5 mg (Cohort 1)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:10 participants
CP-690,550 5 mg (Cohort 1)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:70 participants
CP-690,550 5 mg (Cohort 1)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:21 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:43 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:50 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:20 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:61 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:31 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:70 participants
CP-690,550 10 mg (Cohort 2)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:10 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:33 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:62 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:52 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:70 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:10 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:20 participants
CP-690,550 20 mg (Cohort 3)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:42 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:62 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:70 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:32 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:20 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:41 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:54 participants
CP-690,550 30 mg (Cohort 4)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:10 participants
CP-690,550 60 mg (Cohort 5)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:30 participants
CP-690,550 60 mg (Cohort 5)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:71 participants
CP-690,550 60 mg (Cohort 5)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:53 participants
CP-690,550 60 mg (Cohort 5)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:60 participants
CP-690,550 60 mg (Cohort 5)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:21 participants
CP-690,550 60 mg (Cohort 5)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:10 participants
CP-690,550 60 mg (Cohort 5)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:44 participants
CP-690,550 50 mg (Cohort 6)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:10 participants
CP-690,550 50 mg (Cohort 6)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:64 participants
CP-690,550 50 mg (Cohort 6)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:20 participants
CP-690,550 50 mg (Cohort 6)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:30 participants
CP-690,550 50 mg (Cohort 6)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:42 participants
CP-690,550 50 mg (Cohort 6)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:50 participants
CP-690,550 50 mg (Cohort 6)Number of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:72 participants
PlaceboNumber of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:55 participants
PlaceboNumber of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:42 participants
PlaceboNumber of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:35 participants
PlaceboNumber of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:21 participants
PlaceboNumber of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:10 participants
PlaceboNumber of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:70 participants
PlaceboNumber of Participants With Physician's Global Assessment (PGA) of PsoriasisPGA:61 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026