Immunomodulation, Psoriasis
Conditions
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
5 mg BID For 13 days and once on Day 14
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Half Maximal Effective Area Under the Concentration-Time Curve 50 (EAUC 50) | Day 14 | 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. |
| Change From Baseline in Reticulocyte Count at Day 7 | Baseline (Within 7 days prior to Day 1), Day 7 | Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis. |
| Change From Baseline in Reticulocyte Count at Day 10 | Baseline (Within 7 days prior to Day 1), Day 10 | Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis. |
| Change From Baseline in Reticulocyte Count at Day 15 | Baseline (Within 7 days prior to Day 1), Day 15 | Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis. |
| Change From Baseline in Reticulocyte Count at Day 21 | Baseline (Within 7 days prior to Day 1), Day 21 | Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis. |
| Change From Baseline in Reticulocyte Count at Day 28 | Baseline (Within 7 days prior to Day 1), Day 28 | Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis. |
| Change From Baseline in Reticulocyte Count at Day 42 | Baseline (Within 7 days prior to Day 1), Day 42 | Reticulocyte 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 Function | Day 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 1 | 23 hours (hrs) prior to morning dose on Day 1 (Baseline for HPD 1), 1 hour (hr) post morning dose 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. |
| Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 1 | 22 hrs prior to morning dose on Day 1 (Baseline for HPD 2), 2 hrs post morning dose 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. |
| Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 1 | 20 hrs prior to morning dose on Day 1 (Baseline for HPD 4), 4 hrs post morning dose 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 8 Hour Post Morning Dose (HPD 8) on Day 1 | 16 hrs prior to morning dose on Day 1 (Baseline for HPD 8), 8 hrs post morning dose 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 12 Hour Post Morning Dose (HPD 12) on Day 1 | 12 hrs prior to morning dose on Day 1 (Baseline for HPD 12), 12 hrs post morning dose 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 16 Hour Post Morning Dose (HPD 16) on Day 1 | 8 hrs prior to morning dose on Day 1 (Baseline for HPD 16), 16 hrs post morning dose 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. |
| Change From Baseline in QT Interval at 0 Hour Post Morning Dose (HPD 0) on Day 14 | Hour 0 (pre-dose) on Day 1 (Baseline for HPD 0), 0 hr 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. |
| Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 14 | 23 hrs prior to morning dose on Day 1 (Baseline for HPD 1), 1 hr post morning dose 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. |
| Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 14 | 22 hrs prior to morning dose on Day 1 (Baseline for HPD 2), 2 hrs post morning dose 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. |
| Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 14 | 20 hrs prior to morning dose on Day 1 (Baseline for HPD 4), 4 hrs post morning dose 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. |
| Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 14 | 16 hrs prior to morning dose on Day 1 (Baseline for HPD 8), 8 hrs post morning dose 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. |
| Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 14 | 12 hrs prior to morning dose on Day 1 (Baseline for HPD 12), 12 hrs post morning dose 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. |
| Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval | 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 | 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. |
| Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 Millisecond | 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 | 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. |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 1 | 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1 | AUCtau = 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 14 | 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 14 | AUCtau = area under the curve from time zero to end of dosing interval. |
| Maximum Observed Plasma Concentration (Cmax) at Day 1 | 0 (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 14 | 0 (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 1 | 0 (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 14 | 0 (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 14 | 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. |
| Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Baseline, 1 hr post-dose on 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. |
| Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Baseline, hr 0 on 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. |
| Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Baseline, hr 0 on 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. |
| Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Baseline, hr 0 on 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. |
| Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Baseline, hr 0 on 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. |
| Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Baseline; hr 0, 8 hr post-dose on 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. |
| Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Baseline, Hour 0 on 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. |
| Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Baseline, hr 0 on 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. |
| Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Baseline, hr 0 on 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. |
| Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Baseline, hr 0 on 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. |
| Change From Baseline in Immune Cell Function at Day 14 | Baseline (Within 7 days prior to Day 1), 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. |
| Change From Baseline in Reticulocyte Count at Day 2 | Baseline (Within 7 days prior to Day 1), Day 2 | Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis. |
| Change From Baseline in Reticulocyte Count at Day 4 | Baseline (Within 7 days prior to Day 1), Day 4 | Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | Baseline (Within 7 days prior to Day 1) up to Day 14 | 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). |
| Gene Expression in Psoriatic Plaque Biopsies | Day 14 | 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. |
| Immunohistochemistry From Psoriatic Plaque Biopsies | Baseline (within 7 days prior to Day 1), Day 14 | 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. |
| Number of Participants With Keratin 16 (K16) Expression | Baseline (within 7 days prior to Day 1) up to Day 14 | 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. |
| Number of Participants With Intracellular Adhesion Molecule (ICAM-1) by Epidermal Keratinocytes Expression | Baseline (within 7 days prior to Day 1) up to Day 14 | 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. |
| Gene Expression in Peripheral Blood | Day 14 | 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). |
| Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Baseline (Within 7 days prior to Day 1) up to 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | CP-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) | Placebo | Total |
|---|---|---|---|---|---|---|---|---|
| Age Continuous | 40.2 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 Participants | 2 Participants | 3 Participants | 1 Participants | 4 Participants | 4 Participants | 5 Participants | 22 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 7 Participants | 8 Participants | 5 Participants | 4 Participants | 8 Participants | 37 Participants |
Adverse events
| Event type | EG000 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 / 5 | 1 / 5 | 3 / 10 | 1 / 9 | 2 / 9 | 2 / 8 | 2 / 13 |
| serious Total, serious adverse events | 0 / 5 | 1 / 5 | 0 / 10 | 0 / 9 | 0 / 9 | 0 / 8 | 0 / 13 |
Outcome results
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Accumulation Ratio (R0) | 0.974 Ratio | Standard Deviation 0.181 |
| CP-690,550 10 mg (Cohort 2) | Accumulation Ratio (R0) | 1.22 Ratio | Standard Deviation 0.203 |
| CP-690,550 20 mg (Cohort 3) | Accumulation Ratio (R0) | 1.22 Ratio | Standard Deviation 0.389 |
| CP-690,550 30 mg (Cohort 4) | Accumulation Ratio (R0) | 1.62 Ratio | Standard Deviation 0.343 |
| CP-690,550 60 mg (Cohort 5) | Accumulation Ratio (R0) | 1.16 Ratio | Standard Deviation 0.27 |
| CP-690,550 50 mg (Cohort 6) | Accumulation Ratio (R0) | 1.14 Ratio | Standard Deviation 0.176 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 1 | 161 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 1 | 349 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 1 | 732 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 1 | 860 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 1 | 2120 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 1 | 1720 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 453 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 14 | 154 ng*hr/mL | Standard 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 14 | 422 ng*hr/mL | Standard 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 14 | 850 ng*hr/mL | Standard Deviation 216 |
| CP-690,550 30 mg (Cohort 4) | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 14 | 1350 ng*hr/mL | Standard Deviation 308 |
| CP-690,550 60 mg (Cohort 5) | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 14 | 2600 ng*hr/mL | Standard Deviation 1580 |
| CP-690,550 50 mg (Cohort 6) | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 14 | 1780 ng*hr/mL | Standard Deviation 501 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Change From Baseline in Immune Cell Function at Day 14 | Baseline: Unstimulated(Uns) ATP(n=2,5,10,9,9,7,13) | 11.50 ng/mL | Standard Deviation 9.9 |
| CP-690,550 5 mg (Cohort 1) | Change From Baseline in Immune Cell Function at Day 14 | Change at Day 14:Uns ATP(n=2,5,9,9,9,7,13) | 9.50 ng/mL | Standard Deviation 2.8 |
| CP-690,550 5 mg (Cohort 1) | Change From Baseline in Immune Cell Function at Day 14 | Baseline: Stimulated ATP(n=2,5,10,9,9,7,13) | 222.75 ng/mL | Standard Deviation 157.3 |
| CP-690,550 5 mg (Cohort 1) | Change From Baseline in Immune Cell Function at Day 14 | Change at Day 14: Stimulated ATP(n=2,5,9,9,9,7,13) | 92.75 ng/mL | Standard Deviation 120.6 |
| CP-690,550 10 mg (Cohort 2) | Change From Baseline in Immune Cell Function at Day 14 | Change at Day 14: Stimulated ATP(n=2,5,9,9,9,7,13) | 95.80 ng/mL | Standard Deviation 135 |
| CP-690,550 10 mg (Cohort 2) | Change From Baseline in Immune Cell Function at Day 14 | Baseline: Stimulated ATP(n=2,5,10,9,9,7,13) | 205.40 ng/mL | Standard Deviation 143.1 |
| CP-690,550 10 mg (Cohort 2) | Change From Baseline in Immune Cell Function at Day 14 | Baseline: Unstimulated(Uns) ATP(n=2,5,10,9,9,7,13) | 10.60 ng/mL | Standard Deviation 3.2 |
| CP-690,550 10 mg (Cohort 2) | Change From Baseline in Immune Cell Function at Day 14 | Change at Day 14:Uns ATP(n=2,5,9,9,9,7,13) | 5.60 ng/mL | Standard Deviation 11.4 |
| CP-690,550 20 mg (Cohort 3) | Change From Baseline in Immune Cell Function at Day 14 | Baseline: Unstimulated(Uns) ATP(n=2,5,10,9,9,7,13) | 16.30 ng/mL | Standard Deviation 6.6 |
| CP-690,550 20 mg (Cohort 3) | Change From Baseline in Immune Cell Function at Day 14 | Change at Day 14: Stimulated ATP(n=2,5,9,9,9,7,13) | 155.11 ng/mL | Standard Deviation 168 |
| CP-690,550 20 mg (Cohort 3) | Change From Baseline in Immune Cell Function at Day 14 | Baseline: Stimulated ATP(n=2,5,10,9,9,7,13) | 429.00 ng/mL | Standard Deviation 115.3 |
| CP-690,550 20 mg (Cohort 3) | Change From Baseline in Immune Cell Function at Day 14 | Change at Day 14:Uns ATP(n=2,5,9,9,9,7,13) | 0.44 ng/mL | Standard Deviation 8.9 |
| CP-690,550 30 mg (Cohort 4) | Change From Baseline in Immune Cell Function at Day 14 | Baseline: Stimulated ATP(n=2,5,10,9,9,7,13) | 406.11 ng/mL | Standard Deviation 171.6 |
| CP-690,550 30 mg (Cohort 4) | Change From Baseline in Immune Cell Function at Day 14 | Baseline: Unstimulated(Uns) ATP(n=2,5,10,9,9,7,13) | 16.44 ng/mL | Standard Deviation 10.2 |
| CP-690,550 30 mg (Cohort 4) | Change From Baseline in Immune Cell Function at Day 14 | Change at Day 14: Stimulated ATP(n=2,5,9,9,9,7,13) | 90.11 ng/mL | Standard Deviation 125.9 |
| CP-690,550 30 mg (Cohort 4) | Change From Baseline in Immune Cell Function at Day 14 | Change at Day 14:Uns ATP(n=2,5,9,9,9,7,13) | 0.33 ng/mL | Standard Deviation 10.6 |
| CP-690,550 60 mg (Cohort 5) | Change From Baseline in Immune Cell Function at Day 14 | Baseline: Stimulated ATP(n=2,5,10,9,9,7,13) | 210.56 ng/mL | Standard Deviation 104.1 |
| CP-690,550 60 mg (Cohort 5) | Change From Baseline in Immune Cell Function at Day 14 | Change at Day 14:Uns ATP(n=2,5,9,9,9,7,13) | 1.67 ng/mL | Standard Deviation 15.4 |
| CP-690,550 60 mg (Cohort 5) | Change From Baseline in Immune Cell Function at Day 14 | Baseline: Unstimulated(Uns) ATP(n=2,5,10,9,9,7,13) | 14.11 ng/mL | Standard Deviation 8.3 |
| CP-690,550 60 mg (Cohort 5) | Change From Baseline in Immune Cell Function at Day 14 | Change at Day 14: Stimulated ATP(n=2,5,9,9,9,7,13) | 118.78 ng/mL | Standard Deviation 88.2 |
| CP-690,550 50 mg (Cohort 6) | Change From Baseline in Immune Cell Function at Day 14 | Change at Day 14:Uns ATP(n=2,5,9,9,9,7,13) | 0.29 ng/mL | Standard Deviation 13.1 |
| CP-690,550 50 mg (Cohort 6) | Change From Baseline in Immune Cell Function at Day 14 | Baseline: Unstimulated(Uns) ATP(n=2,5,10,9,9,7,13) | 7.14 ng/mL | Standard Deviation 5.9 |
| CP-690,550 50 mg (Cohort 6) | Change From Baseline in Immune Cell Function at Day 14 | Change at Day 14: Stimulated ATP(n=2,5,9,9,9,7,13) | 61.21 ng/mL | Standard Deviation 124.7 |
| CP-690,550 50 mg (Cohort 6) | Change From Baseline in Immune Cell Function at Day 14 | Baseline: Stimulated ATP(n=2,5,10,9,9,7,13) | 252.50 ng/mL | Standard Deviation 146.3 |
| Placebo | Change From Baseline in Immune Cell Function at Day 14 | Baseline: Unstimulated(Uns) ATP(n=2,5,10,9,9,7,13) | 16.00 ng/mL | Standard Deviation 12.4 |
| Placebo | Change From Baseline in Immune Cell Function at Day 14 | Baseline: Stimulated ATP(n=2,5,10,9,9,7,13) | 301.88 ng/mL | Standard Deviation 152.9 |
| Placebo | Change From Baseline in Immune Cell Function at Day 14 | Change at Day 14: Stimulated ATP(n=2,5,9,9,9,7,13) | 26.81 ng/mL | Standard Deviation 66.6 |
| Placebo | Change From Baseline in Immune Cell Function at Day 14 | Change at Day 14:Uns ATP(n=2,5,9,9,9,7,13) | 1.46 ng/mL | Standard Deviation 11.2 |
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.
| Arm | Measure | Group | Value (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 14 | Change at HPD 0 on Day 14 | -14.53 msec | Standard 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 14 | Baseline for HPD 0 | 374.80 msec | Standard 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 14 | Baseline for HPD 0 | 360.40 msec | Standard 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 14 | Change at HPD 0 on Day 14 | 11.00 msec | Standard 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 14 | Change at HPD 0 on Day 14 | -0.33 msec | Standard 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 14 | Baseline for HPD 0 | 367.70 msec | Standard 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 14 | Baseline for HPD 0 | 372.81 msec | Standard 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 14 | Change at HPD 0 on Day 14 | 7.22 msec | Standard 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 14 | Change at HPD 0 on Day 14 | -9.70 msec | Standard 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 14 | Baseline for HPD 0 | 383.41 msec | Standard 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 14 | Baseline for HPD 0 | 367.50 msec | Standard 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 14 | Change at HPD 0 on Day 14 | -0.79 msec | Standard Deviation 17.48 |
| Placebo | Change From Baseline in QT Interval at 0 Hour Post Morning Dose (HPD 0) on Day 14 | Change at HPD 0 on Day 14 | -7.08 msec | Standard Deviation 16.21 |
| Placebo | Change From Baseline in QT Interval at 0 Hour Post Morning Dose (HPD 0) on Day 14 | Baseline for HPD 0 | 364.03 msec | Standard Deviation 20.96 |
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.
| Arm | Measure | Group | Value (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 1 | Baseline for HPD 12 (n=5,5,10,9,9,8,13) | 371.73 msec | Standard 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 1 | Change at HPD 12 on Day 1 (n=5,5,9,9,9,8,13) | -6.27 msec | Standard 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 1 | Baseline for HPD 12 (n=5,5,10,9,9,8,13) | 351.27 msec | Standard 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 1 | Change at HPD 12 on Day 1 (n=5,5,9,9,9,8,13) | -2.60 msec | Standard 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 1 | Baseline for HPD 12 (n=5,5,10,9,9,8,13) | 372.63 msec | Standard 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 1 | Change at HPD 12 on Day 1 (n=5,5,9,9,9,8,13) | -4.15 msec | Standard 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 1 | Baseline for HPD 12 (n=5,5,10,9,9,8,13) | 370.11 msec | Standard 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 1 | Change at HPD 12 on Day 1 (n=5,5,9,9,9,8,13) | 0.15 msec | Standard 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 1 | Baseline for HPD 12 (n=5,5,10,9,9,8,13) | 379.78 msec | Standard 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 1 | Change at HPD 12 on Day 1 (n=5,5,9,9,9,8,13) | -3.22 msec | Standard 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 1 | Baseline for HPD 12 (n=5,5,10,9,9,8,13) | 363.08 msec | Standard 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 1 | Change at HPD 12 on Day 1 (n=5,5,9,9,9,8,13) | -2.88 msec | Standard Deviation 14.01 |
| Placebo | Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 1 | Baseline for HPD 12 (n=5,5,10,9,9,8,13) | 361.54 msec | Standard Deviation 16.29 |
| Placebo | Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 1 | Change at HPD 12 on Day 1 (n=5,5,9,9,9,8,13) | -1.36 msec | Standard Deviation 13.6 |
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.
| Arm | Measure | Value (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 msec | Standard 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 14 | 8.00 msec | Standard 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 msec | Standard 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 14 | 0.81 msec | Standard 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 msec | Standard 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 msec | Standard Deviation 23.46 |
| Placebo | Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 14 | -4.82 msec | Standard Deviation 15.31 |
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.
| Arm | Measure | Group | Value (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 1 | Baseline for HPD 16 | 377.15 msec | Standard 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 1 | Change at HPD 16 on Day 1 | 11.19 msec | Standard 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 1 | Baseline for HPD 16 | 345.44 msec | Standard 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 1 | Change at HPD 16 on Day 1 | 13.11 msec | Standard Deviation 7.26 |
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.
| Arm | Measure | Group | Value (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 1 | Baseline for HPD 1 | 372.20 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 1 | Change 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 1 | Baseline for HPD 1 | 348.47 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 1 | Change at HPD 1 on Day 1 | 15.73 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 1 | Baseline for HPD 1 | 369.40 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 1 | Change 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 1 | Baseline for HPD 1 | 375.74 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 1 | Change at HPD 1 on Day 1 | 2.70 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 1 | Baseline for HPD 1 | 383.96 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 1 | Change at HPD 1 on Day 1 | 1.63 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 1 | Baseline for HPD 1 | 371.29 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 1 | Change at HPD 1 on Day 1 | -2.79 millisecond (msec) | Standard Deviation 13.28 |
| Placebo | Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1 | Baseline for HPD 1 | 370.95 millisecond (msec) | Standard Deviation 18 |
| Placebo | Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1 | Change at HPD 1 on Day 1 | -4.21 millisecond (msec) | Standard Deviation 12.61 |
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.
| Arm | Measure | Value (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 msec | Standard 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 14 | 22.27 msec | Standard 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 14 | 0.11 msec | Standard 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 14 | 2.81 msec | Standard 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 msec | Standard 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 14 | 0.71 msec | Standard Deviation 20.43 |
| Placebo | Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 14 | -12.87 msec | Standard Deviation 17.82 |
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.
| Arm | Measure | Group | Value (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 1 | Baseline for HPD 2 | 369.67 msec | Standard 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 1 | Change at HPD 2 on Day 1 | -0.40 msec | Standard 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 1 | Baseline for HPD 2 | 350.27 msec | Standard 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 1 | Change at HPD 2 on Day 1 | 9.80 msec | Standard 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 1 | Baseline for HPD 2 | 372.87 msec | Standard 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 1 | Change at HPD 2 on Day 1 | -6.90 msec | Standard 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 1 | Baseline for HPD 2 | 377.48 msec | Standard 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 1 | Change at HPD 2 on Day 1 | -0.15 msec | Standard 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 1 | Baseline for HPD 2 | 387.00 msec | Standard 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 1 | Change at HPD 2 on Day 1 | -0.07 msec | Standard 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 1 | Baseline for HPD 2 | 374.00 msec | Standard 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 1 | Change at HPD 2 on Day 1 | -1.58 msec | Standard Deviation 13.66 |
| Placebo | Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 1 | Baseline for HPD 2 | 369.87 msec | Standard Deviation 17.53 |
| Placebo | Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 1 | Change at HPD 2 on Day 1 | -2.05 msec | Standard Deviation 16.76 |
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.
| Arm | Measure | Value (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 msec | Standard 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 14 | 18.67 msec | Standard 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 msec | Standard 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 14 | 6.89 msec | Standard 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 msec | Standard 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 14 | 2.46 msec | Standard Deviation 22.04 |
| Placebo | Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 14 | -12.28 msec | Standard Deviation 19.35 |
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.
| Arm | Measure | Group | Value (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 1 | Baseline for HPD 4 (n=5,5,10,9,9,8,13) | 373.73 msec | Standard 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 1 | Change at HPD 4 on Day 1 (n=5,5,9,9,9,8,13) | -4.53 msec | Standard 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 1 | Baseline for HPD 4 (n=5,5,10,9,9,8,13) | 348.07 msec | Standard 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 1 | Change at HPD 4 on Day 1 (n=5,5,9,9,9,8,13) | 11.53 msec | Standard 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 1 | Baseline for HPD 4 (n=5,5,10,9,9,8,13) | 373.20 msec | Standard 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 1 | Change at HPD 4 on Day 1 (n=5,5,9,9,9,8,13) | 2.19 msec | Standard 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 1 | Baseline for HPD 4 (n=5,5,10,9,9,8,13) | 373.15 msec | Standard 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 1 | Change at HPD 4 on Day 1 (n=5,5,9,9,9,8,13) | 2.96 msec | Standard 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 1 | Baseline for HPD 4 (n=5,5,10,9,9,8,13) | 381.44 msec | Standard 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 1 | Change at HPD 4 on Day 1 (n=5,5,9,9,9,8,13) | 7.74 msec | Standard 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 1 | Baseline for HPD 4 (n=5,5,10,9,9,8,13) | 381.17 msec | Standard 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 1 | Change at HPD 4 on Day 1 (n=5,5,9,9,9,8,13) | -8.17 msec | Standard Deviation 14.32 |
| Placebo | Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 1 | Baseline for HPD 4 (n=5,5,10,9,9,8,13) | 368.00 msec | Standard Deviation 18.04 |
| Placebo | Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 1 | Change at HPD 4 on Day 1 (n=5,5,9,9,9,8,13) | -2.82 msec | Standard Deviation 10.82 |
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.
| Arm | Measure | Value (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 msec | Standard 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 14 | 6.53 msec | Standard 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 msec | Standard 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 14 | 18.96 msec | Standard 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 14 | 9.59 msec | Standard 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 msec | Standard Deviation 21.58 |
| Placebo | Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 14 | -8.46 msec | Standard Deviation 21.09 |
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.
| Arm | Measure | Group | Value (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 1 | Baseline for HPD 8 (n=5,5,10,9,9,8,13) | 364.13 msec | Standard 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 1 | Change at HPD 8 on Day 1 (n=5,5,9,9,9,8,13) | -1.27 msec | Standard 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 1 | Baseline for HPD 8 (n=5,5,10,9,9,8,13) | 356.73 msec | Standard 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 1 | Change at HPD 8 on Day 1 (n=5,5,9,9,9,8,13) | -6.60 msec | Standard 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 1 | Baseline for HPD 8 (n=5,5,10,9,9,8,13) | 366.90 msec | Standard 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 1 | Change at HPD 8 on Day 1 (n=5,5,9,9,9,8,13) | -3.96 msec | Standard 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 1 | Baseline for HPD 8 (n=5,5,10,9,9,8,13) | 374.56 msec | Standard 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 1 | Change at HPD 8 on Day 1 (n=5,5,9,9,9,8,13) | -3.44 msec | Standard 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 1 | Baseline for HPD 8 (n=5,5,10,9,9,8,13) | 378.15 msec | Standard 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 1 | Change at HPD 8 on Day 1 (n=5,5,9,9,9,8,13) | 7.67 msec | Standard 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 1 | Baseline for HPD 8 (n=5,5,10,9,9,8,13) | 372.25 msec | Standard 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 1 | Change at HPD 8 on Day 1 (n=5,5,9,9,9,8,13) | -9.83 msec | Standard Deviation 15.12 |
| Placebo | Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 1 | Baseline for HPD 8 (n=5,5,10,9,9,8,13) | 367.56 msec | Standard Deviation 17.95 |
| Placebo | Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 1 | Change at HPD 8 on Day 1 (n=5,5,9,9,9,8,13) | -9.03 msec | Standard Deviation 11.52 |
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.
| Arm | Measure | Value (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 msec | Standard 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 msec | Standard 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 msec | Standard 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 msec | Standard 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 14 | 4.85 msec | Standard 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 msec | Standard Deviation 23.28 |
| Placebo | Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 14 | -12.36 msec | Standard Deviation 11.38 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Change From Baseline in Reticulocyte Count at Day 10 | -16.40 1000 cells/mm^3 | Standard Deviation 29.5 |
| CP-690,550 10 mg (Cohort 2) | Change From Baseline in Reticulocyte Count at Day 10 | -14.00 1000 cells/mm^3 | Standard Deviation 18.3 |
| CP-690,550 20 mg (Cohort 3) | Change From Baseline in Reticulocyte Count at Day 10 | 16.00 1000 cells/mm^3 | Standard Deviation 25.9 |
| CP-690,550 30 mg (Cohort 4) | Change From Baseline in Reticulocyte Count at Day 10 | -18.22 1000 cells/mm^3 | Standard Deviation 15.9 |
| CP-690,550 60 mg (Cohort 5) | Change From Baseline in Reticulocyte Count at Day 10 | 6.56 1000 cells/mm^3 | Standard Deviation 17.5 |
| CP-690,550 50 mg (Cohort 6) | Change From Baseline in Reticulocyte Count at Day 10 | -29.50 1000 cells/mm^3 | Standard Deviation 21.5 |
| Placebo | Change From Baseline in Reticulocyte Count at Day 10 | -3.42 1000 cells/mm^3 | Standard Deviation 38.8 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Change From Baseline in Reticulocyte Count at Day 15 | -24.00 1000 cells/mm^3 | Standard Deviation 25.3 |
| CP-690,550 10 mg (Cohort 2) | Change From Baseline in Reticulocyte Count at Day 15 | -11.40 1000 cells/mm^3 | Standard Deviation 17.4 |
| CP-690,550 20 mg (Cohort 3) | Change From Baseline in Reticulocyte Count at Day 15 | -8.56 1000 cells/mm^3 | Standard Deviation 11.9 |
| CP-690,550 30 mg (Cohort 4) | Change From Baseline in Reticulocyte Count at Day 15 | -42.22 1000 cells/mm^3 | Standard Deviation 16.9 |
| CP-690,550 60 mg (Cohort 5) | Change From Baseline in Reticulocyte Count at Day 15 | 24.11 1000 cells/mm^3 | Standard Deviation 16.8 |
| CP-690,550 50 mg (Cohort 6) | Change From Baseline in Reticulocyte Count at Day 15 | -31.57 1000 cells/mm^3 | Standard Deviation 25.9 |
| Placebo | Change From Baseline in Reticulocyte Count at Day 15 | -17.92 1000 cells/mm^3 | Standard Deviation 28.4 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Change From Baseline in Reticulocyte Count at Day 2 | Change 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 2 | Baseline (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 2 | Baseline (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 2 | Change 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 2 | Baseline (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 2 | Change 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 2 | Change 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 2 | Baseline (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 2 | Baseline (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 2 | Change 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 2 | Baseline (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 2 | Change at Day 2 (n=5,5,9,9,8,8,12) | -3.75 1000 cells/cubic millimeter (cells/mm^3) | Standard Deviation 11.1 |
| Placebo | Change From Baseline in Reticulocyte Count at Day 2 | Change at Day 2 (n=5,5,9,9,8,8,12) | -7.25 1000 cells/cubic millimeter (cells/mm^3) | Standard Deviation 28.8 |
| Placebo | Change From Baseline in Reticulocyte Count at Day 2 | Baseline (n=5,5,10,9,9,8,13) | 100.69 1000 cells/cubic millimeter (cells/mm^3) | Standard Deviation 46.2 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Change From Baseline in Reticulocyte Count at Day 21 | -13.40 1000 cells/mm^3 | Standard Deviation 30.6 |
| CP-690,550 10 mg (Cohort 2) | Change From Baseline in Reticulocyte Count at Day 21 | 17.60 1000 cells/mm^3 | Standard Deviation 11.5 |
| CP-690,550 20 mg (Cohort 3) | Change From Baseline in Reticulocyte Count at Day 21 | 44.22 1000 cells/mm^3 | Standard Deviation 27.1 |
| CP-690,550 30 mg (Cohort 4) | Change From Baseline in Reticulocyte Count at Day 21 | 5.44 1000 cells/mm^3 | Standard Deviation 14.4 |
| CP-690,550 60 mg (Cohort 5) | Change From Baseline in Reticulocyte Count at Day 21 | 40.25 1000 cells/mm^3 | Standard Deviation 15.6 |
| CP-690,550 50 mg (Cohort 6) | Change From Baseline in Reticulocyte Count at Day 21 | -9.17 1000 cells/mm^3 | Standard Deviation 23.9 |
| Placebo | Change From Baseline in Reticulocyte Count at Day 21 | 12.54 1000 cells/mm^3 | Standard Deviation 40.2 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Change From Baseline in Reticulocyte Count at Day 28 | -16.20 1000 cells/mm^3 | Standard Deviation 8.2 |
| CP-690,550 10 mg (Cohort 2) | Change From Baseline in Reticulocyte Count at Day 28 | 47.60 1000 cells/mm^3 | Standard Deviation 14.8 |
| CP-690,550 20 mg (Cohort 3) | Change From Baseline in Reticulocyte Count at Day 28 | 49.56 1000 cells/mm^3 | Standard Deviation 24 |
| CP-690,550 30 mg (Cohort 4) | Change From Baseline in Reticulocyte Count at Day 28 | 23.89 1000 cells/mm^3 | Standard Deviation 23.5 |
| CP-690,550 60 mg (Cohort 5) | Change From Baseline in Reticulocyte Count at Day 28 | 21.75 1000 cells/mm^3 | Standard Deviation 13.6 |
| CP-690,550 50 mg (Cohort 6) | Change From Baseline in Reticulocyte Count at Day 28 | 56.00 1000 cells/mm^3 | Standard Deviation 24.1 |
| Placebo | Change From Baseline in Reticulocyte Count at Day 28 | -2.85 1000 cells/mm^3 | Standard Deviation 32.5 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Change From Baseline in Reticulocyte Count at Day 4 | -14.00 1000 cells/mm^3 | Standard Deviation 17.2 |
| CP-690,550 10 mg (Cohort 2) | Change From Baseline in Reticulocyte Count at Day 4 | -7.60 1000 cells/mm^3 | Standard Deviation 16.5 |
| CP-690,550 20 mg (Cohort 3) | Change From Baseline in Reticulocyte Count at Day 4 | 17.33 1000 cells/mm^3 | Standard Deviation 26.6 |
| CP-690,550 30 mg (Cohort 4) | Change From Baseline in Reticulocyte Count at Day 4 | -48.44 1000 cells/mm^3 | Standard Deviation 13.3 |
| CP-690,550 60 mg (Cohort 5) | Change From Baseline in Reticulocyte Count at Day 4 | -14.67 1000 cells/mm^3 | Standard Deviation 16.4 |
| CP-690,550 50 mg (Cohort 6) | Change From Baseline in Reticulocyte Count at Day 4 | -20.00 1000 cells/mm^3 | Standard Deviation 14.9 |
| Placebo | Change From Baseline in Reticulocyte Count at Day 4 | -20.85 1000 cells/mm^3 | Standard Deviation 41.2 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Change From Baseline in Reticulocyte Count at Day 42 | -4.60 1000 cells/mm^3 | Standard Deviation 12.6 |
| CP-690,550 10 mg (Cohort 2) | Change From Baseline in Reticulocyte Count at Day 42 | -7.00 1000 cells/mm^3 | Standard Deviation 35.9 |
| CP-690,550 20 mg (Cohort 3) | Change From Baseline in Reticulocyte Count at Day 42 | 34.56 1000 cells/mm^3 | Standard Deviation 30 |
| CP-690,550 30 mg (Cohort 4) | Change From Baseline in Reticulocyte Count at Day 42 | -3.67 1000 cells/mm^3 | Standard Deviation 12.5 |
| CP-690,550 60 mg (Cohort 5) | Change From Baseline in Reticulocyte Count at Day 42 | -2.33 1000 cells/mm^3 | Standard Deviation 21.9 |
| CP-690,550 50 mg (Cohort 6) | Change From Baseline in Reticulocyte Count at Day 42 | 22.50 1000 cells/mm^3 | Standard Deviation 31.7 |
| Placebo | Change From Baseline in Reticulocyte Count at Day 42 | -18.00 1000 cells/mm^3 | Standard Deviation 26.7 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Change From Baseline in Reticulocyte Count at Day 7 | -3.40 1000 cells/mm^3 | Standard Deviation 18.7 |
| CP-690,550 10 mg (Cohort 2) | Change From Baseline in Reticulocyte Count at Day 7 | 6.40 1000 cells/mm^3 | Standard Deviation 15.9 |
| CP-690,550 20 mg (Cohort 3) | Change From Baseline in Reticulocyte Count at Day 7 | 17.11 1000 cells/mm^3 | Standard Deviation 26.5 |
| CP-690,550 30 mg (Cohort 4) | Change From Baseline in Reticulocyte Count at Day 7 | -14.44 1000 cells/mm^3 | Standard Deviation 13.6 |
| CP-690,550 60 mg (Cohort 5) | Change From Baseline in Reticulocyte Count at Day 7 | 3.22 1000 cells/mm^3 | Standard Deviation 20.6 |
| CP-690,550 50 mg (Cohort 6) | Change From Baseline in Reticulocyte Count at Day 7 | -30.38 1000 cells/mm^3 | Standard Deviation 13.8 |
| Placebo | Change From Baseline in Reticulocyte Count at Day 7 | -1.38 1000 cells/mm^3 | Standard Deviation 31.1 |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Half Maximal Effective Area Under the Concentration-Time Curve 50 (EAUC 50) | 2696 ng*hr/mL |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Maximum Observed Plasma Concentration (Cmax) at Day 1 | 48.3 nanogram/milliliter (ng/mL) | Standard Deviation 24.5 |
| CP-690,550 10 mg (Cohort 2) | Maximum Observed Plasma Concentration (Cmax) at Day 1 | 90.5 nanogram/milliliter (ng/mL) | Standard Deviation 20.4 |
| CP-690,550 20 mg (Cohort 3) | Maximum Observed Plasma Concentration (Cmax) at Day 1 | 212 nanogram/milliliter (ng/mL) | Standard Deviation 62.3 |
| CP-690,550 30 mg (Cohort 4) | Maximum Observed Plasma Concentration (Cmax) at Day 1 | 180 nanogram/milliliter (ng/mL) | Standard Deviation 53.1 |
| CP-690,550 60 mg (Cohort 5) | Maximum Observed Plasma Concentration (Cmax) at Day 1 | 457 nanogram/milliliter (ng/mL) | Standard Deviation 88.2 |
| CP-690,550 50 mg (Cohort 6) | Maximum Observed Plasma Concentration (Cmax) at Day 1 | 429 nanogram/milliliter (ng/mL) | Standard Deviation 99.1 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Maximum Observed Plasma Concentration (Cmax) at Day 14 | 50.9 ng/mL | Standard Deviation 21.2 |
| CP-690,550 10 mg (Cohort 2) | Maximum Observed Plasma Concentration (Cmax) at Day 14 | 87.7 ng/mL | Standard Deviation 13.2 |
| CP-690,550 20 mg (Cohort 3) | Maximum Observed Plasma Concentration (Cmax) at Day 14 | 194 ng/mL | Standard Deviation 53.9 |
| CP-690,550 30 mg (Cohort 4) | Maximum Observed Plasma Concentration (Cmax) at Day 14 | 225 ng/mL | Standard Deviation 43.9 |
| CP-690,550 60 mg (Cohort 5) | Maximum Observed Plasma Concentration (Cmax) at Day 14 | 568 ng/mL | Standard Deviation 205 |
| CP-690,550 50 mg (Cohort 6) | Maximum Observed Plasma Concentration (Cmax) at Day 14 | 403 ng/mL | Standard Deviation 133 |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 Millisecond | QTcB | 0 participants |
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 Millisecond | QTcF | 0 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 Millisecond | QTcB | 0 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 Millisecond | QTcF | 0 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 Millisecond | QTcB | 0 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 Millisecond | QTcF | 0 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 Millisecond | QTcB | 0 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 Millisecond | QTcF | 0 participants |
| CP-690,550 60 mg (Cohort 5) | Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 Millisecond | QTcB | 0 participants |
| CP-690,550 60 mg (Cohort 5) | Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 Millisecond | QTcF | 0 participants |
| CP-690,550 50 mg (Cohort 6) | Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 Millisecond | QTcB | 0 participants |
| CP-690,550 50 mg (Cohort 6) | Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 Millisecond | QTcF | 0 participants |
| Placebo | Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 Millisecond | QTcB | 0 participants |
| Placebo | Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 Millisecond | QTcF | 0 participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval | QTcF,Maximum increase from baseline:30 to <60msec | 0 participants |
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval | QTcB,Maximum increase from baseline:30 to <60msec | 0 participants |
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval | QTcB,Maximum increase from baseline:>=60msec | 0 participants |
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval | QTcF,Maximum increase from baseline:>=60msec | 0 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval | QTcB,Maximum increase from baseline:>=60msec | 0 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval | QTcF,Maximum increase from baseline:>=60msec | 0 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval | QTcB,Maximum increase from baseline:30 to <60msec | 1 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval | QTcF,Maximum increase from baseline:30 to <60msec | 1 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval | QTcB,Maximum increase from baseline:30 to <60msec | 2 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval | QTcF,Maximum increase from baseline:>=60msec | 0 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval | QTcF,Maximum increase from baseline:30 to <60msec | 0 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval | QTcB,Maximum increase from baseline:>=60msec | 0 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval | QTcF,Maximum increase from baseline:>=60msec | 0 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval | QTcB,Maximum increase from baseline:30 to <60msec | 1 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval | QTcB,Maximum increase from baseline:>=60msec | 0 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval | QTcF,Maximum increase from baseline:30 to <60msec | 1 participants |
| CP-690,550 60 mg (Cohort 5) | Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval | QTcB,Maximum increase from baseline:30 to <60msec | 3 participants |
| CP-690,550 60 mg (Cohort 5) | Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval | QTcF,Maximum increase from baseline:30 to <60msec | 3 participants |
| CP-690,550 60 mg (Cohort 5) | Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval | QTcF,Maximum increase from baseline:>=60msec | 0 participants |
| CP-690,550 60 mg (Cohort 5) | Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval | QTcB,Maximum increase from baseline:>=60msec | 1 participants |
| CP-690,550 50 mg (Cohort 6) | Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval | QTcB,Maximum increase from baseline:>=60msec | 0 participants |
| CP-690,550 50 mg (Cohort 6) | Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval | QTcB,Maximum increase from baseline:30 to <60msec | 2 participants |
| CP-690,550 50 mg (Cohort 6) | Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval | QTcF,Maximum increase from baseline:30 to <60msec | 0 participants |
| CP-690,550 50 mg (Cohort 6) | Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval | QTcF,Maximum increase from baseline:>=60msec | 0 participants |
| Placebo | Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval | QTcB,Maximum increase from baseline:30 to <60msec | 5 participants |
| Placebo | Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval | QTcF,Maximum increase from baseline:30 to <60msec | 1 participants |
| Placebo | Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval | QTcF,Maximum increase from baseline:>=60msec | 0 participants |
| Placebo | Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval | QTcB,Maximum increase from baseline:>=60msec | 0 participants |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD4 | -18.48 percent change | Standard Deviation 19.4 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD8 | -7.58 percent change | Standard Deviation 11 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD16/56 | 11.22 percent change | Standard Deviation 27 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD3 | -14.39 percent change | Standard Deviation 14.6 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD19 | -27.11 percent change | Standard Deviation 16.7 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD8 | 26.05 percent change | Standard Deviation 25.1 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD19 | -4.02 percent change | Standard Deviation 30.9 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD3 | 12.02 percent change | Standard Deviation 18.2 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD16/56 | 79.99 percent change | Standard Deviation 33.7 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD4 | 8.65 percent change | Standard Deviation 23.5 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD16/56 | 81.44 percent change | Standard Deviation 62.7 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD4 | -4.29 percent change | Standard Deviation 15.2 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD3 | 1.17 percent change | Standard Deviation 17.7 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD19 | -10.30 percent change | Standard Deviation 18.1 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD8 | 8.90 percent change | Standard Deviation 22.1 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD19 | -8.23 percent change | Standard Deviation 10.4 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD8 | 18.34 percent change | Standard Deviation 21.4 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD16/56 | 74.07 percent change | Standard Deviation 38.6 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD4 | 5.99 percent change | Standard Deviation 15.6 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD3 | 12.44 percent change | Standard Deviation 17.4 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD3 | 8.38 percent change | Standard Deviation 23.9 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD16/56 | 104.44 percent change | Standard Deviation 85.8 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD8 | 13.90 percent change | Standard Deviation 21.9 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD19 | -6.22 percent change | Standard Deviation 29.9 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD4 | -1.13 percent change | Standard Deviation 19.9 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD4 | 8.54 percent change | Standard Deviation 10.7 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD3 | 12.83 percent change | Standard Deviation 14 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD8 | 25.44 percent change | Standard Deviation 14.6 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD19 | -0.66 percent change | Standard Deviation 9 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD16/56 | 103.74 percent change | Standard Deviation 21.2 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD3 | 0.52 percent change | Standard Deviation 16.5 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD8 | 0.42 percent change | Standard Deviation 16.5 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD16/56 | -9.72 percent change | Standard Deviation 18.3 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD4 | 1.35 percent change | Standard Deviation 18.3 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1 | Change at Day 1: CD19 | -6.46 percent change | Standard Deviation 22.4 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD16/56 | -16.73 percent change | Standard Deviation 29.3 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD4 | 6.86 percent change | Standard Deviation 20.9 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD3 | 5.70 percent change | Standard Deviation 18.9 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD8 | 5.34 percent change | Standard Deviation 20.9 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD19 | 24.06 percent change | Standard Deviation 26.9 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD4 | 16.87 percent change | Standard Deviation 34 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD16/56 | -25.53 percent change | Standard Deviation 41.4 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD19 | 34.97 percent change | Standard Deviation 38.7 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD3 | 8.76 percent change | Standard Deviation 35.7 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD8 | 4.13 percent change | Standard Deviation 39.8 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD19 | 76.05 percent change | Standard Deviation 71.1 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD16/56 | -16.22 percent change | Standard Deviation 22.8 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD8 | 0.68 percent change | Standard Deviation 35.4 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD4 | 14.50 percent change | Standard Deviation 50.8 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD3 | 12.47 percent change | Standard Deviation 49.1 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD16/56 | -33.38 percent change | Standard Deviation 27.2 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD8 | 28.77 percent change | Standard Deviation 40.5 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD3 | 36.76 percent change | Standard Deviation 43.8 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD4 | 38.22 percent change | Standard Deviation 43 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD19 | 79.94 percent change | Standard Deviation 69.2 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD4 | 14.61 percent change | Standard Deviation 54.4 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD8 | 16.81 percent change | Standard Deviation 62.4 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD16/56 | -21.99 percent change | Standard Deviation 36.1 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD3 | 11.30 percent change | Standard Deviation 50 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD19 | 63.64 percent change | Standard Deviation 180 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD16/56 | -37.90 percent change | Standard Deviation 24.8 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD4 | 16.85 percent change | Standard Deviation 32.4 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD3 | 12.61 percent change | Standard Deviation 30.6 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD8 | 7.87 percent change | Standard Deviation 20.1 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD19 | 84.57 percent change | Standard Deviation 109.7 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD8 | -4.14 percent change | Standard Deviation 30.6 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD3 | -3.69 percent change | Standard Deviation 27.9 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD19 | -13.19 percent change | Standard Deviation 31.5 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD4 | -4.52 percent change | Standard Deviation 27.5 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10 | Change at Day 10: CD16/56 | -10.82 percent change | Standard Deviation 31.3 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD8 | 10.36 percent change | Standard Deviation 17.3 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD16/56 | -8.06 percent change | Standard Deviation 19.7 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD4 | 7.31 percent change | Standard Deviation 18 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD19 | 16.76 percent change | Standard Deviation 25.1 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD8 | 6.92 percent change | Standard Deviation 9.1 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD3 | 1.01 percent change | Standard Deviation 16 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD16/56 | -0.34 percent change | Standard Deviation 25 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD4 | -1.91 percent change | Standard Deviation 19 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD3 | 7.98 percent change | Standard Deviation 18.2 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD19 | 20.74 percent change | Standard Deviation 19.8 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD8 | 25.57 percent change | Standard Deviation 37 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD8 | 70.26 percent change | Standard Deviation 34 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD16/56 | 41.85 percent change | Standard Deviation 47.4 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD4 | 86.33 percent change | Standard Deviation 30.3 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD4 | 31.80 percent change | Standard Deviation 11 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD3 | 26.93 percent change | Standard Deviation 21.5 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD19 | 92.47 percent change | Standard Deviation 47.9 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD19 | 39.97 percent change | Standard Deviation 33.3 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD3 | 76.59 percent change | Standard Deviation 28.7 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD16/56 | 1.73 percent change | Standard Deviation 52.8 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD16/56 | -28.06 percent change | Standard Deviation 32.3 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD16/56 | -6.44 percent change | Standard Deviation 38 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD19 | 69.43 percent change | Standard Deviation 75.9 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD3 | 7.07 percent change | Standard Deviation 33 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD4 | 9.86 percent change | Standard Deviation 41.2 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD19 | 117.56 percent change | Standard Deviation 52.4 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD4 | 22.68 percent change | Standard Deviation 24.8 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD8 | -3.36 percent change | Standard Deviation 23.6 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD8 | 16.37 percent change | Standard Deviation 16.9 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD3 | 19.79 percent change | Standard Deviation 23.1 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD8 | 10.68 percent change | Standard Deviation 30.9 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD19 | 95.87 percent change | Standard Deviation 86.6 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD16/56 | -43.06 percent change | Standard Deviation 21.4 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD4 | 14.80 percent change | Standard Deviation 32.3 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD3 | 40.85 percent change | Standard Deviation 36.7 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD19 | 68.14 percent change | Standard Deviation 72.2 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD3 | 14.91 percent change | Standard Deviation 32.1 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD16/56 | -8.75 percent change | Standard Deviation 46.5 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD8 | 40.38 percent change | Standard Deviation 34.4 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD4 | 38.65 percent change | Standard Deviation 36.7 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD8 | 42.59 percent change | Standard Deviation 59.2 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD19 | 60.99 percent change | Standard Deviation 151.4 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD8 | 17.58 percent change | Standard Deviation 42.4 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD19 | 78.60 percent change | Standard Deviation 94 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD3 | 10.74 percent change | Standard Deviation 37.1 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD4 | 9.67 percent change | Standard Deviation 49.1 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD16/56 | -20.03 percent change | Standard Deviation 44.6 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD16/56 | 45.94 percent change | Standard Deviation 114.4 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD3 | 44.08 percent change | Standard Deviation 61.6 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD4 | 57.94 percent change | Standard Deviation 91.5 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD19 | 116.93 percent change | Standard Deviation 215.8 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD3 | 15.64 percent change | Standard Deviation 32.3 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD8 | 31.87 percent change | Standard Deviation 86.9 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD16/56 | -14.38 percent change | Standard Deviation 37.9 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD4 | 17.69 percent change | Standard Deviation 46.8 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD4 | 19.21 percent change | Standard Deviation 30.4 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD8 | 9.89 percent change | Standard Deviation 35.5 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD16/56 | -42.70 percent change | Standard Deviation 35 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD3 | 12.69 percent change | Standard Deviation 43.9 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD19 | 152.66 percent change | Standard Deviation 263.6 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD16/56 | -4.09 percent change | Standard Deviation 34 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD16/56 | -6.49 percent change | Standard Deviation 25.4 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD19 | -16.04 percent change | Standard Deviation 33.1 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD8 | -14.21 percent change | Standard Deviation 20.2 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD4 | -5.88 percent change | Standard Deviation 23.1 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD4 | -15.51 percent change | Standard Deviation 25.1 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD3 | -7.20 percent change | Standard Deviation 20.7 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD8 | -6.94 percent change | Standard Deviation 18.9 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 8 hr post dose on Day 14: CD19 | 2.53 percent change | Standard Deviation 36.2 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14 | Change at 0 hr post dose on Day 14: CD3 | -15.05 percent change | Standard Deviation 21.7 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD19 | 16.98 percent change | Standard Deviation 50.8 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD3 | 13.89 percent change | Standard Deviation 27.9 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD8 | 17.52 percent change | Standard Deviation 32.7 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD16/56 | 11.58 percent change | Standard Deviation 31.5 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD4 | 12.44 percent change | Standard Deviation 29.6 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD4 | -13.35 percent change | Standard Deviation 24.9 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD19 | -15.78 percent change | Standard Deviation 15.9 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD16/56 | -7.64 percent change | Standard Deviation 73.7 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD8 | -9.18 percent change | Standard Deviation 44.1 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD3 | -14.04 percent change | Standard Deviation 30.6 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD4 | -7.80 percent change | Standard Deviation 21.5 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD3 | -10.24 percent change | Standard Deviation 21.3 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD8 | -12.38 percent change | Standard Deviation 23.1 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD16/56 | -21.03 percent change | Standard Deviation 46 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD19 | 13.95 percent change | Standard Deviation 32.5 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD8 | -18.76 percent change | Standard Deviation 24 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD4 | -8.89 percent change | Standard Deviation 17.4 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD3 | -10.65 percent change | Standard Deviation 18.5 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD19 | 22.65 percent change | Standard Deviation 45.8 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD16/56 | -48.63 percent change | Standard Deviation 63.5 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD16/56 | -17.13 percent change | Standard Deviation 45.7 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD8 | -13.47 percent change | Standard Deviation 8 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD3 | -14.54 percent change | Standard Deviation 13.5 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD19 | -8.14 percent change | Standard Deviation 35.6 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD4 | -13.66 percent change | Standard Deviation 19.1 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD19 | -29.44 percent change | Standard Deviation 25.4 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD16/56 | -76.21 percent change | Standard Deviation 28.2 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD8 | -51.68 percent change | Standard Deviation 18.1 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD3 | -46.69 percent change | Standard Deviation 17.5 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD4 | -42.60 percent change | Standard Deviation 18.8 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD4 | 7.17 percent change | Standard Deviation 17.1 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD3 | 3.91 percent change | Standard Deviation 20 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD16/56 | -0.68 percent change | Standard Deviation 22.4 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD19 | -4.67 percent change | Standard Deviation 25.8 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18 | Change at Day 18: CD8 | 4.70 percent change | Standard Deviation 15.9 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD16/56 | 18.27 percent change | Standard Deviation 30.4 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD3 | 8.88 percent change | Standard Deviation 24 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD19 | 7.58 percent change | Standard Deviation 40.3 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD8 | 12.67 percent change | Standard Deviation 19.3 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD4 | 8.58 percent change | Standard Deviation 26.7 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD19 | 9.56 percent change | Standard Deviation 30.5 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD16/56 | 61.26 percent change | Standard Deviation 47.8 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD8 | 32.68 percent change | Standard Deviation 30.1 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD3 | 34.74 percent change | Standard Deviation 27.4 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD4 | 33.29 percent change | Standard Deviation 25.4 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD19 | 17.40 percent change | Standard Deviation 24.5 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD8 | 19.68 percent change | Standard Deviation 29.3 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD4 | 26.73 percent change | Standard Deviation 31.9 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD3 | 23.93 percent change | Standard Deviation 31.1 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD16/56 | 52.84 percent change | Standard Deviation 54.8 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD3 | 46.07 percent change | Standard Deviation 31.4 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD16/56 | 63.21 percent change | Standard Deviation 45.1 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD4 | 44.17 percent change | Standard Deviation 33.9 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD19 | 30.39 percent change | Standard Deviation 11.3 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD8 | 43.04 percent change | Standard Deviation 29.1 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD16/56 | 0.61 percent change | Standard Deviation 37.7 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD3 | 14.05 percent change | Standard Deviation 24.4 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD8 | 16.96 percent change | Standard Deviation 25.1 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD4 | 18.85 percent change | Standard Deviation 34.9 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD19 | 7.04 percent change | Standard Deviation 33.5 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD16/56 | 103.79 percent change | Standard Deviation 45.8 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD3 | 52.43 percent change | Standard Deviation 34.3 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD8 | 50.97 percent change | Standard Deviation 30.4 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD4 | 55.80 percent change | Standard Deviation 35.5 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD19 | 45.72 percent change | Standard Deviation 44.4 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD8 | -4.17 percent change | Standard Deviation 20.2 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD4 | -6.85 percent change | Standard Deviation 18 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD3 | -5.18 percent change | Standard Deviation 17.4 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD19 | -4.22 percent change | Standard Deviation 24.4 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2 | Change at Day 2: CD16/56 | 5.61 percent change | Standard Deviation 35.7 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD16/56 | -7.23 percent change | Standard Deviation 23.5 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD3 | -25.48 percent change | Standard Deviation 10.5 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD19 | -20.90 percent change | Standard Deviation 25.4 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD8 | -19.51 percent change | Standard Deviation 14 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD4 | -29.75 percent change | Standard Deviation 9.6 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD3 | -6.38 percent change | Standard Deviation 14.8 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD16/56 | -9.21 percent change | Standard Deviation 63.8 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD8 | -6.00 percent change | Standard Deviation 31.1 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD19 | -14.61 percent change | Standard Deviation 26.7 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD4 | -2.88 percent change | Standard Deviation 7.4 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD8 | -43.55 percent change | Standard Deviation 28.9 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD3 | -42.27 percent change | Standard Deviation 23.9 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD16/56 | -47.87 percent change | Standard Deviation 30.7 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD19 | -22.60 percent change | Standard Deviation 26.6 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD4 | -41.01 percent change | Standard Deviation 24.4 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD8 | -23.78 percent change | Standard Deviation 21.1 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD3 | -14.82 percent change | Standard Deviation 20.2 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD19 | -7.67 percent change | Standard Deviation 34.8 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD16/56 | -48.04 percent change | Standard Deviation 19 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD4 | -11.01 percent change | Standard Deviation 20.7 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD8 | -2.12 percent change | Standard Deviation 14.8 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD16/56 | 5.62 percent change | Standard Deviation 35.4 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD19 | -17.50 percent change | Standard Deviation 27.7 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD3 | -7.93 percent change | Standard Deviation 13.5 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD4 | -9.41 percent change | Standard Deviation 16.5 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD3 | -27.37 percent change | Standard Deviation 13.3 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD19 | -12.51 percent change | Standard Deviation 22.9 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD16/56 | -66.94 percent change | Standard Deviation 19.2 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD8 | -32.49 percent change | Standard Deviation 15.6 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD4 | -22.38 percent change | Standard Deviation 13.1 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD8 | -4.01 percent change | Standard Deviation 17.8 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD19 | 0.98 percent change | Standard Deviation 24.3 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD3 | -1.12 percent change | Standard Deviation 17.8 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD16/56 | -2.22 percent change | Standard Deviation 44.1 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21 | Change at Day 21: CD4 | 1.16 percent change | Standard Deviation 19.8 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD3 | -18.11 percent change | Standard Deviation 10 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD4 | -21.29 percent change | Standard Deviation 13.3 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD8 | -11.96 percent change | Standard Deviation 9 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD16/56 | 5.13 percent change | Standard Deviation 35.9 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD19 | -7.96 percent change | Standard Deviation 24.3 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD3 | 9.29 percent change | Standard Deviation 24.5 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD8 | 11.58 percent change | Standard Deviation 18.8 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD19 | 21.29 percent change | Standard Deviation 23.5 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD16/56 | 21.93 percent change | Standard Deviation 51.3 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD4 | 10.97 percent change | Standard Deviation 29.8 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD4 | 1.02 percent change | Standard Deviation 35.2 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD19 | 1.96 percent change | Standard Deviation 42.3 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD3 | 0.38 percent change | Standard Deviation 34.1 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD8 | -2.84 percent change | Standard Deviation 35 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD16/56 | -10.27 percent change | Standard Deviation 31.2 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD16/56 | -28.52 percent change | Standard Deviation 51.6 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD8 | -9.33 percent change | Standard Deviation 18.5 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD4 | -5.90 percent change | Standard Deviation 15.7 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD19 | -6.53 percent change | Standard Deviation 21.8 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD3 | -4.60 percent change | Standard Deviation 17.9 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD16/56 | 11.21 percent change | Standard Deviation 55.9 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD19 | -16.50 percent change | Standard Deviation 28.3 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD8 | -6.13 percent change | Standard Deviation 21.8 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD3 | -7.60 percent change | Standard Deviation 23.3 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD4 | -11.51 percent change | Standard Deviation 19.8 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD4 | -19.90 percent change | Standard Deviation 6.3 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD19 | -11.58 percent change | Standard Deviation 22.1 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD8 | -23.56 percent change | Standard Deviation 13.7 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD3 | -22.08 percent change | Standard Deviation 9.7 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD16/56 | -26.96 percent change | Standard Deviation 39.4 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD16/56 | 13.32 percent change | Standard Deviation 50.8 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD8 | -1.56 percent change | Standard Deviation 26.7 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD19 | -12.51 percent change | Standard Deviation 19.1 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD4 | -2.86 percent change | Standard Deviation 24.9 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28 | Change at Day 28: CD3 | -2.57 percent change | Standard Deviation 25 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD8 | -10.94 percent change | Standard Deviation 17.8 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD4 | -15.87 percent change | Standard Deviation 22.4 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD16/56 | -23.08 percent change | Standard Deviation 22.5 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD19 | -12.59 percent change | Standard Deviation 27.2 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD3 | -15.29 percent change | Standard Deviation 21.1 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD16/56 | 90.73 percent change | Standard Deviation 41.6 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD3 | 51.71 percent change | Standard Deviation 31.4 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD4 | 43.87 percent change | Standard Deviation 22 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD8 | 56.72 percent change | Standard Deviation 43.5 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD19 | 41.44 percent change | Standard Deviation 18.2 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD8 | 18.18 percent change | Standard Deviation 41.7 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD3 | 29.11 percent change | Standard Deviation 49 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD19 | 53.84 percent change | Standard Deviation 71.8 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD16/56 | 10.67 percent change | Standard Deviation 44.3 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD4 | 30.90 percent change | Standard Deviation 51.7 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD4 | 72.02 percent change | Standard Deviation 43.1 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD3 | 71.55 percent change | Standard Deviation 44.5 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD8 | 61.61 percent change | Standard Deviation 41.4 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD16/56 | 24.27 percent change | Standard Deviation 55.5 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD19 | 56.27 percent change | Standard Deviation 35.1 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD8 | 31.95 percent change | Standard Deviation 32.6 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD16/56 | -5.23 percent change | Standard Deviation 43.2 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD4 | 42.50 percent change | Standard Deviation 56.7 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD3 | 34.28 percent change | Standard Deviation 41.8 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD19 | 44.76 percent change | Standard Deviation 55.7 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD16/56 | -1.66 percent change | Standard Deviation 44.8 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD19 | 77.25 percent change | Standard Deviation 50.7 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD8 | 29.81 percent change | Standard Deviation 33.5 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD4 | 39.46 percent change | Standard Deviation 27.2 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD3 | 32.81 percent change | Standard Deviation 28 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD8 | -0.31 percent change | Standard Deviation 24.8 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD16/56 | 7.18 percent change | Standard Deviation 59.8 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD19 | -2.55 percent change | Standard Deviation 37.5 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD4 | 6.08 percent change | Standard Deviation 31.3 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4 | Change at Day 4: CD3 | 3.80 percent change | Standard Deviation 28.2 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD8 | -12.74 percent change | Standard Deviation 29.1 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD19 | -31.86 percent change | Standard Deviation 30.9 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD4 | -25.65 percent change | Standard Deviation 30.3 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD3 | -20.79 percent change | Standard Deviation 29 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD16/56 | -9.01 percent change | Standard Deviation 25.4 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD19 | 6.43 percent change | Standard Deviation 33.6 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD16/56 | 21.15 percent change | Standard Deviation 70.8 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD4 | -19.27 percent change | Standard Deviation 29.2 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD8 | -10.04 percent change | Standard Deviation 37.2 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD3 | -15.72 percent change | Standard Deviation 29.9 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD19 | -9.39 percent change | Standard Deviation 29.2 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD16/56 | -2.32 percent change | Standard Deviation 27.9 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD8 | -12.93 percent change | Standard Deviation 33.9 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD3 | -11.58 percent change | Standard Deviation 30 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD4 | -11.42 percent change | Standard Deviation 30 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD3 | -1.60 percent change | Standard Deviation 19.5 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD4 | -4.08 percent change | Standard Deviation 17.5 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD8 | -5.60 percent change | Standard Deviation 19.8 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD16/56 | 2.87 percent change | Standard Deviation 76.1 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD19 | -10.22 percent change | Standard Deviation 27.3 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD16/56 | 24.08 percent change | Standard Deviation 35.8 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD19 | -20.20 percent change | Standard Deviation 30 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD4 | -12.27 percent change | Standard Deviation 24.6 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD8 | -3.24 percent change | Standard Deviation 17.6 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD3 | -9.17 percent change | Standard Deviation 21.5 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD4 | -3.81 percent change | Standard Deviation 12 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD8 | 4.19 percent change | Standard Deviation 31.4 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD16/56 | -4.54 percent change | Standard Deviation 37.4 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD3 | -1.63 percent change | Standard Deviation 20.2 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD19 | -8.30 percent change | Standard Deviation 16.8 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD16/56 | 19.90 percent change | Standard Deviation 41.5 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD4 | 0.96 percent change | Standard Deviation 35.7 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD3 | 0.19 percent change | Standard Deviation 32.6 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD8 | 3.57 percent change | Standard Deviation 33.5 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42 | Change at Day 42: CD19 | -3.93 percent change | Standard Deviation 52.5 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD4 | 6.52 percent change | Standard Deviation 22.6 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD3 | 5.72 percent change | Standard Deviation 20.6 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD16/56 | -10.57 percent change | Standard Deviation 14.3 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD8 | 6.76 percent change | Standard Deviation 18.5 |
| CP-690,550 5 mg (Cohort 1) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD19 | 13.01 percent change | Standard Deviation 36.3 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD8 | 31.50 percent change | Standard Deviation 42.3 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD19 | 34.47 percent change | Standard Deviation 24.6 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD16/56 | 29.97 percent change | Standard Deviation 56.6 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD3 | 28.15 percent change | Standard Deviation 26 |
| CP-690,550 10 mg (Cohort 2) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD4 | 29.39 percent change | Standard Deviation 22.2 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD8 | 7.21 percent change | Standard Deviation 50.1 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD3 | 13.47 percent change | Standard Deviation 55.4 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD16/56 | 17.02 percent change | Standard Deviation 83 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD19 | 55.54 percent change | Standard Deviation 83.2 |
| CP-690,550 20 mg (Cohort 3) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD4 | 14.99 percent change | Standard Deviation 56.6 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD3 | 25.51 percent change | Standard Deviation 38.9 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD4 | 24.48 percent change | Standard Deviation 39.3 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD19 | 72.86 percent change | Standard Deviation 67.4 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD16/56 | -1.43 percent change | Standard Deviation 40 |
| CP-690,550 30 mg (Cohort 4) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD8 | 21.74 percent change | Standard Deviation 37.5 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD3 | 1.61 percent change | Standard Deviation 26 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD16/56 | -2.37 percent change | Standard Deviation 56.4 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD8 | 1.74 percent change | Standard Deviation 25.2 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD19 | 15.14 percent change | Standard Deviation 46 |
| CP-690,550 60 mg (Cohort 5) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD4 | 0.91 percent change | Standard Deviation 26.6 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD8 | 30.95 percent change | Standard Deviation 27.8 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD19 | 98.64 percent change | Standard Deviation 102.9 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD16/56 | -7.95 percent change | Standard Deviation 30.2 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD3 | 34.77 percent change | Standard Deviation 33.1 |
| CP-690,550 50 mg (Cohort 6) | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD4 | 37.42 percent change | Standard Deviation 33.1 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD3 | -3.08 percent change | Standard Deviation 17.3 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD8 | -3.10 percent change | Standard Deviation 19.8 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD19 | -2.40 percent change | Standard Deviation 22.3 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD4 | -3.28 percent change | Standard Deviation 17.8 |
| Placebo | Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7 | Change at Day 7: CD16/56 | 2.26 percent change | Standard Deviation 35.2 |
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.
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 1 | 0.50 hr |
| CP-690,550 10 mg (Cohort 2) | Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 1 | 0.50 hr |
| CP-690,550 20 mg (Cohort 3) | Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 1 | 0.50 hr |
| CP-690,550 30 mg (Cohort 4) | Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 1 | 0.50 hr |
| CP-690,550 60 mg (Cohort 5) | Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 1 | 1.00 hr |
| CP-690,550 50 mg (Cohort 6) | Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 1 | 1.00 hr |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 14 | 0.50 hr |
| CP-690,550 10 mg (Cohort 2) | Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 14 | 1.00 hr |
| CP-690,550 20 mg (Cohort 3) | Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 14 | 0.50 hr |
| CP-690,550 30 mg (Cohort 4) | Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 14 | 1.00 hr |
| CP-690,550 60 mg (Cohort 5) | Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 14 | 1.00 hr |
| CP-690,550 50 mg (Cohort 6) | Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 14 | 1.00 hr |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Gene Expression in Peripheral Blood | BAX (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 Blood | IFN-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 Blood | CD 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 Blood | TNF-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 Blood | TNF-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 Blood | iNOS (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 Blood | BCL2 (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 Blood | Granzyme 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 Blood | BCL2 (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 Blood | BAX (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 Blood | iNOS (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 Blood | CD 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 Blood | Granzyme 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 Blood | IFN-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 Blood | TNF-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 Blood | TNF-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 Blood | CD 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 Blood | TNF-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 Blood | BAX (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 Blood | IFN-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 Blood | TNF-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 Blood | BCL2 (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 Blood | iNOS (n=2,1,1) | 0.02 relative expression unit (REU) | — |
| CP-690,550 20 mg (Cohort 3) | Gene Expression in Peripheral Blood | Granzyme B (n=9,9,6) | 1.58 relative expression unit (REU) | Standard Deviation 1.13 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Gene Expression in Psoriatic Plaque Biopsies | Perforin | 2.80 relative expression unit (REU) | Standard Deviation 2.56 |
| CP-690,550 5 mg (Cohort 1) | Gene Expression in Psoriatic Plaque Biopsies | PCNA | 2.09 relative expression unit (REU) | Standard Deviation 0.77 |
| CP-690,550 5 mg (Cohort 1) | Gene Expression in Psoriatic Plaque Biopsies | CD25 | 7.34 relative expression unit (REU) | Standard Deviation 2.33 |
| CP-690,550 5 mg (Cohort 1) | Gene Expression in Psoriatic Plaque Biopsies | IL-2 | 0.98 relative expression unit (REU) | Standard Deviation 0.16 |
| CP-690,550 5 mg (Cohort 1) | Gene Expression in Psoriatic Plaque Biopsies | CXCL10 | 15.03 relative expression unit (REU) | Standard Deviation 5.75 |
| CP-690,550 5 mg (Cohort 1) | Gene Expression in Psoriatic Plaque Biopsies | BCL-2 | 0.47 relative expression unit (REU) | Standard Deviation 0.09 |
| CP-690,550 5 mg (Cohort 1) | Gene Expression in Psoriatic Plaque Biopsies | IL-8 | 556.12 relative expression unit (REU) | Standard Deviation 754.91 |
| CP-690,550 5 mg (Cohort 1) | Gene Expression in Psoriatic Plaque Biopsies | TNF-FasL | 0.95 relative expression unit (REU) | Standard Deviation 0.24 |
| CP-690,550 5 mg (Cohort 1) | Gene Expression in Psoriatic Plaque Biopsies | K-16 | 69.04 relative expression unit (REU) | Standard Deviation 7.6 |
| CP-690,550 5 mg (Cohort 1) | Gene Expression in Psoriatic Plaque Biopsies | Granzyme B | 42.71 relative expression unit (REU) | Standard Deviation 18.54 |
| CP-690,550 5 mg (Cohort 1) | Gene Expression in Psoriatic Plaque Biopsies | INF-gamma | 2.26 relative expression unit (REU) | Standard Deviation 1.49 |
| CP-690,550 5 mg (Cohort 1) | Gene Expression in Psoriatic Plaque Biopsies | INOS | 77.79 relative expression unit (REU) | Standard Deviation 40.1 |
| CP-690,550 5 mg (Cohort 1) | Gene Expression in Psoriatic Plaque Biopsies | BAX | 1.16 relative expression unit (REU) | Standard Deviation 0.21 |
| CP-690,550 5 mg (Cohort 1) | Gene Expression in Psoriatic Plaque Biopsies | IL-15 | 0.51 relative expression unit (REU) | Standard Deviation 0.01 |
| CP-690,550 5 mg (Cohort 1) | Gene Expression in Psoriatic Plaque Biopsies | IL-7 | 0.85 relative expression unit (REU) | Standard Deviation 0.11 |
| CP-690,550 10 mg (Cohort 2) | Gene Expression in Psoriatic Plaque Biopsies | IL-15 | 0.70 relative expression unit (REU) | Standard Deviation 0.06 |
| CP-690,550 10 mg (Cohort 2) | Gene Expression in Psoriatic Plaque Biopsies | IL-7 | 1.26 relative expression unit (REU) | Standard Deviation 0.51 |
| CP-690,550 10 mg (Cohort 2) | Gene Expression in Psoriatic Plaque Biopsies | BAX | 0.83 relative expression unit (REU) | Standard Deviation 0.28 |
| CP-690,550 10 mg (Cohort 2) | Gene Expression in Psoriatic Plaque Biopsies | K-16 | 5.18 relative expression unit (REU) | Standard Deviation 2.63 |
| CP-690,550 10 mg (Cohort 2) | Gene Expression in Psoriatic Plaque Biopsies | CD25 | 1.05 relative expression unit (REU) | Standard Deviation 0.27 |
| CP-690,550 10 mg (Cohort 2) | Gene Expression in Psoriatic Plaque Biopsies | PCNA | 1.15 relative expression unit (REU) | Standard Deviation 0.06 |
| CP-690,550 10 mg (Cohort 2) | Gene Expression in Psoriatic Plaque Biopsies | Perforin | 0.65 relative expression unit (REU) | Standard Deviation 0.17 |
| CP-690,550 10 mg (Cohort 2) | Gene Expression in Psoriatic Plaque Biopsies | TNF-FasL | 1.24 relative expression unit (REU) | Standard Deviation 0.86 |
| CP-690,550 10 mg (Cohort 2) | Gene Expression in Psoriatic Plaque Biopsies | CXCL10 | 0.44 relative expression unit (REU) | Standard Deviation 0.45 |
| CP-690,550 10 mg (Cohort 2) | Gene Expression in Psoriatic Plaque Biopsies | INOS | 0.97 relative expression unit (REU) | Standard Deviation 0.08 |
| CP-690,550 10 mg (Cohort 2) | Gene Expression in Psoriatic Plaque Biopsies | Granzyme B | 1.20 relative expression unit (REU) | Standard Deviation 0.07 |
| CP-690,550 10 mg (Cohort 2) | Gene Expression in Psoriatic Plaque Biopsies | IL-2 | 0.87 relative expression unit (REU) | Standard Deviation 0.02 |
| CP-690,550 10 mg (Cohort 2) | Gene Expression in Psoriatic Plaque Biopsies | IL-8 | 14.66 relative expression unit (REU) | — |
| CP-690,550 10 mg (Cohort 2) | Gene Expression in Psoriatic Plaque Biopsies | BCL-2 | 0.36 relative expression unit (REU) | Standard Deviation 0.14 |
| CP-690,550 10 mg (Cohort 2) | Gene Expression in Psoriatic Plaque Biopsies | INF-gamma | 0.90 relative expression unit (REU) | Standard Deviation 0.09 |
| CP-690,550 20 mg (Cohort 3) | Gene Expression in Psoriatic Plaque Biopsies | INF-gamma | 0.22 relative expression unit (REU) | — |
| CP-690,550 20 mg (Cohort 3) | Gene Expression in Psoriatic Plaque Biopsies | IL-15 | 0.86 relative expression unit (REU) | — |
| CP-690,550 20 mg (Cohort 3) | Gene Expression in Psoriatic Plaque Biopsies | BCL-2 | 2.29 relative expression unit (REU) | — |
| CP-690,550 20 mg (Cohort 3) | Gene Expression in Psoriatic Plaque Biopsies | CD25 | 0.16 relative expression unit (REU) | — |
| CP-690,550 20 mg (Cohort 3) | Gene Expression in Psoriatic Plaque Biopsies | CXCL10 | 0.04 relative expression unit (REU) | — |
| CP-690,550 20 mg (Cohort 3) | Gene Expression in Psoriatic Plaque Biopsies | Granzyme B | 0.03 relative expression unit (REU) | — |
| CP-690,550 20 mg (Cohort 3) | Gene Expression in Psoriatic Plaque Biopsies | IL-2 | 0.75 relative expression unit (REU) | — |
| CP-690,550 20 mg (Cohort 3) | Gene Expression in Psoriatic Plaque Biopsies | IL-8 | 0.00 relative expression unit (REU) | — |
| CP-690,550 20 mg (Cohort 3) | Gene Expression in Psoriatic Plaque Biopsies | INOS | 0.02 relative expression unit (REU) | — |
| CP-690,550 20 mg (Cohort 3) | Gene Expression in Psoriatic Plaque Biopsies | BAX | 0.68 relative expression unit (REU) | — |
| CP-690,550 20 mg (Cohort 3) | Gene Expression in Psoriatic Plaque Biopsies | IL-7 | 1.19 relative expression unit (REU) | — |
| CP-690,550 20 mg (Cohort 3) | Gene Expression in Psoriatic Plaque Biopsies | K-16 | 0.04 relative expression unit (REU) | — |
| CP-690,550 20 mg (Cohort 3) | Gene Expression in Psoriatic Plaque Biopsies | PCNA | 0.41 relative expression unit (REU) | — |
| CP-690,550 20 mg (Cohort 3) | Gene Expression in Psoriatic Plaque Biopsies | Perforin | 0.23 relative expression unit (REU) | — |
| CP-690,550 20 mg (Cohort 3) | Gene Expression in Psoriatic Plaque Biopsies | TNF-FasL | 0.64 relative expression unit (REU) | — |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Immunohistochemistry From Psoriatic Plaque Biopsies | Baseline: Absolute CD16/56 (n=0,0,0,0) | NA cells/microliter (cells/μL) | — |
| CP-690,550 5 mg (Cohort 1) | Immunohistochemistry From Psoriatic Plaque Biopsies | Day 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 Biopsies | Day 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 Biopsies | Day 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 Biopsies | Day 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 Biopsies | Baseline: CD3 epidermal (n=1,1,4,2) | 115.00 cells/microliter (cells/μL) | — |
| CP-690,550 5 mg (Cohort 1) | Immunohistochemistry From Psoriatic Plaque Biopsies | Baseline: CD3 dermal (n=1,1,4,2) | 189.00 cells/microliter (cells/μL) | — |
| CP-690,550 5 mg (Cohort 1) | Immunohistochemistry From Psoriatic Plaque Biopsies | Baseline: CD83 dermal (n=1,1,4,2) | 11.00 cells/microliter (cells/μL) | — |
| CP-690,550 5 mg (Cohort 1) | Immunohistochemistry From Psoriatic Plaque Biopsies | Day 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 Biopsies | Day 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 Biopsies | Baseline: CD8 dermal (n=1,1,4,2) | 23.00 cells/microliter (cells/μL) | — |
| CP-690,550 5 mg (Cohort 1) | Immunohistochemistry From Psoriatic Plaque Biopsies | Baseline: CD83 epidermal (n=1,1,4,2) | 13.00 cells/microliter (cells/μL) | — |
| CP-690,550 5 mg (Cohort 1) | Immunohistochemistry From Psoriatic Plaque Biopsies | Baseline: CD8 epidermal (n=1,1,4,2) | 66.00 cells/microliter (cells/μL) | — |
| CP-690,550 5 mg (Cohort 1) | Immunohistochemistry From Psoriatic Plaque Biopsies | Day 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 Biopsies | Day 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 Biopsies | Baseline: Absolute CD16/56 (n=0,0,0,0) | NA cells/microliter (cells/μL) | — |
| CP-690,550 10 mg (Cohort 2) | Immunohistochemistry From Psoriatic Plaque Biopsies | Day 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 Biopsies | Day 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 Biopsies | Day 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 Biopsies | Day 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 Biopsies | Baseline: CD8 epidermal (n=1,1,4,2) | 55.00 cells/microliter (cells/μL) | — |
| CP-690,550 10 mg (Cohort 2) | Immunohistochemistry From Psoriatic Plaque Biopsies | Day 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 Biopsies | Baseline: CD83 epidermal (n=1,1,4,2) | 44.00 cells/microliter (cells/μL) | — |
| CP-690,550 10 mg (Cohort 2) | Immunohistochemistry From Psoriatic Plaque Biopsies | Day 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 Biopsies | Baseline: CD83 dermal (n=1,1,4,2) | 78.00 cells/microliter (cells/μL) | — |
| CP-690,550 10 mg (Cohort 2) | Immunohistochemistry From Psoriatic Plaque Biopsies | Baseline: CD3 epidermal (n=1,1,4,2) | 108.00 cells/microliter (cells/μL) | — |
| CP-690,550 10 mg (Cohort 2) | Immunohistochemistry From Psoriatic Plaque Biopsies | Baseline: CD8 dermal (n=1,1,4,2) | 53.00 cells/microliter (cells/μL) | — |
| CP-690,550 10 mg (Cohort 2) | Immunohistochemistry From Psoriatic Plaque Biopsies | Baseline: CD3 dermal (n=1,1,4,2) | 135.00 cells/microliter (cells/μL) | — |
| CP-690,550 20 mg (Cohort 3) | Immunohistochemistry From Psoriatic Plaque Biopsies | Baseline: 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 Biopsies | Baseline: 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 Biopsies | Day 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 Biopsies | Day 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 Biopsies | Baseline: 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 Biopsies | Baseline: 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 Biopsies | Baseline: 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 Biopsies | Baseline: 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 Biopsies | Baseline: Absolute CD16/56 (n=0,0,0,0) | NA cells/microliter (cells/μL) | — |
| CP-690,550 20 mg (Cohort 3) | Immunohistochemistry From Psoriatic Plaque Biopsies | Day 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 Biopsies | Day 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 Biopsies | Day 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 Biopsies | Day 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 Biopsies | Day 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 Biopsies | Baseline: 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 Biopsies | Day 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 Biopsies | Baseline: 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 Biopsies | Baseline: 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 Biopsies | Day 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 Biopsies | Baseline: 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 Biopsies | Baseline: 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 Biopsies | Baseline: 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 Biopsies | Day 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 Biopsies | Day 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 Biopsies | Day 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 Biopsies | Day 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 Biopsies | Day 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 Biopsies | Baseline: Absolute CD16/56 (n=0,0,0,0) | NA cells/microliter (cells/μL) | — |
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.
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Keratin 16 (K16) Expression | Baseline | 1 participants |
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Keratin 16 (K16) Expression | Day 14 | 1 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Keratin 16 (K16) Expression | Day 14 | 1 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Keratin 16 (K16) Expression | Baseline | 1 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Keratin 16 (K16) Expression | Day 14 | 4 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Keratin 16 (K16) Expression | Baseline | 4 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Keratin 16 (K16) Expression | Baseline | 2 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Keratin 16 (K16) Expression | Day 14 | 2 participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 4 | 0 participants |
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 1 | 2 participants |
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 0 | 0 participants |
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 4 | 0 participants |
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 3 | 0 participants |
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 1 | 3 participants |
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 3 | 0 participants |
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 2 | 2 participants |
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 1 | 3 participants |
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 2 | 1 participants |
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 0 | 1 participants |
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 0 | 0 participants |
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 4 | 0 participants |
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 3 | 1 participants |
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 2 | 2 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 4 | 0 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 1 | 3 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 1 | 2 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 0 | 1 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 4 | 0 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 0 | 0 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 3 | 0 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 4 | 0 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 2 | 1 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 3 | 0 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 2 | 1 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 3 | 0 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 1 | 4 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 0 | 1 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 2 | 2 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 1 | 8 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 3 | 0 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 4 | 0 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 0 | 0 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 2 | 1 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 0 | 3 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 1 | 5 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 2 | 1 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 3 | 0 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 4 | 0 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 0 | 1 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 1 | 6 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 2 | 2 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 3 | 0 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 4 | 0 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 2 | 2 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 2 | 2 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 4 | 0 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 1 | 7 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 1 | 3 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 1 | 7 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 3 | 0 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 3 | 0 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 4 | 0 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 0 | 4 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 0 | 2 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 4 | 0 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 3 | 0 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 2 | 0 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 0 | 0 participants |
| CP-690,550 60 mg (Cohort 5) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 4 | 0 participants |
| CP-690,550 60 mg (Cohort 5) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 3 | 0 participants |
| CP-690,550 60 mg (Cohort 5) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 4 | 0 participants |
| CP-690,550 60 mg (Cohort 5) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 2 | 2 participants |
| CP-690,550 60 mg (Cohort 5) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 1 | 6 participants |
| CP-690,550 60 mg (Cohort 5) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 2 | 4 participants |
| CP-690,550 60 mg (Cohort 5) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 1 | 3 participants |
| CP-690,550 60 mg (Cohort 5) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 3 | 0 participants |
| CP-690,550 60 mg (Cohort 5) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 4 | 0 participants |
| CP-690,550 60 mg (Cohort 5) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 1 | 4 participants |
| CP-690,550 60 mg (Cohort 5) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 0 | 1 participants |
| CP-690,550 60 mg (Cohort 5) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 3 | 0 participants |
| CP-690,550 60 mg (Cohort 5) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 2 | 3 participants |
| CP-690,550 60 mg (Cohort 5) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 0 | 2 participants |
| CP-690,550 60 mg (Cohort 5) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 0 | 2 participants |
| CP-690,550 50 mg (Cohort 6) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 3 | 0 participants |
| CP-690,550 50 mg (Cohort 6) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 1 | 0 participants |
| CP-690,550 50 mg (Cohort 6) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 3 | 0 participants |
| CP-690,550 50 mg (Cohort 6) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 2 | 2 participants |
| CP-690,550 50 mg (Cohort 6) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 4 | 0 participants |
| CP-690,550 50 mg (Cohort 6) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 3 | 0 participants |
| CP-690,550 50 mg (Cohort 6) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 2 | 0 participants |
| CP-690,550 50 mg (Cohort 6) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 0 | 5 participants |
| CP-690,550 50 mg (Cohort 6) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 1 | 4 participants |
| CP-690,550 50 mg (Cohort 6) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 1 | 2 participants |
| CP-690,550 50 mg (Cohort 6) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 2 | 1 participants |
| CP-690,550 50 mg (Cohort 6) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 0 | 4 participants |
| CP-690,550 50 mg (Cohort 6) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 4 | 0 participants |
| CP-690,550 50 mg (Cohort 6) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 4 | 0 participants |
| CP-690,550 50 mg (Cohort 6) | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 0 | 6 participants |
| Placebo | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 2 | 4 participants |
| Placebo | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 0 | 0 participants |
| Placebo | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 0 | 1 participants |
| Placebo | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 3 | 1 participants |
| Placebo | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 4 | 0 participants |
| Placebo | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 4 | 0 participants |
| Placebo | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 3 | 0 participants |
| Placebo | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 2 | 9 participants |
| Placebo | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 3 | 1 participants |
| Placebo | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 2 | 9 participants |
| Placebo | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 1 | 8 participants |
| Placebo | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Erythema: 1 | 4 participants |
| Placebo | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 0 | 0 participants |
| Placebo | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Scaling: 4 | 0 participants |
| Placebo | Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14 | Induration: 1 | 2 participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:4 | 0 participants |
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:3 | 3 participants |
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:5 | 1 participants |
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:6 | 0 participants |
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:1 | 0 participants |
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:7 | 0 participants |
| CP-690,550 5 mg (Cohort 1) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:2 | 1 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:4 | 3 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:5 | 0 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:2 | 0 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:6 | 1 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:3 | 1 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:7 | 0 participants |
| CP-690,550 10 mg (Cohort 2) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:1 | 0 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:3 | 3 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:6 | 2 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:5 | 2 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:7 | 0 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:1 | 0 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:2 | 0 participants |
| CP-690,550 20 mg (Cohort 3) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:4 | 2 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:6 | 2 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:7 | 0 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:3 | 2 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:2 | 0 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:4 | 1 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:5 | 4 participants |
| CP-690,550 30 mg (Cohort 4) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:1 | 0 participants |
| CP-690,550 60 mg (Cohort 5) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:3 | 0 participants |
| CP-690,550 60 mg (Cohort 5) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:7 | 1 participants |
| CP-690,550 60 mg (Cohort 5) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:5 | 3 participants |
| CP-690,550 60 mg (Cohort 5) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:6 | 0 participants |
| CP-690,550 60 mg (Cohort 5) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:2 | 1 participants |
| CP-690,550 60 mg (Cohort 5) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:1 | 0 participants |
| CP-690,550 60 mg (Cohort 5) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:4 | 4 participants |
| CP-690,550 50 mg (Cohort 6) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:1 | 0 participants |
| CP-690,550 50 mg (Cohort 6) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:6 | 4 participants |
| CP-690,550 50 mg (Cohort 6) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:2 | 0 participants |
| CP-690,550 50 mg (Cohort 6) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:3 | 0 participants |
| CP-690,550 50 mg (Cohort 6) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:4 | 2 participants |
| CP-690,550 50 mg (Cohort 6) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:5 | 0 participants |
| CP-690,550 50 mg (Cohort 6) | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:7 | 2 participants |
| Placebo | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:5 | 5 participants |
| Placebo | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:4 | 2 participants |
| Placebo | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:3 | 5 participants |
| Placebo | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:2 | 1 participants |
| Placebo | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:1 | 0 participants |
| Placebo | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:7 | 0 participants |
| Placebo | Number of Participants With Physician's Global Assessment (PGA) of Psoriasis | PGA:6 | 1 participants |