PsoriasisPhase 1NCT01736696

Multiple Dose Escalation Study In Medically Stable Subjects With Psoriasis

A Phase 1 study testing tofacitinib in people with Psoriasis and Immunomodulation, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Psoriasis, Immunomodulation
What is being tested?: tofacitinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 59 participants
Where: 1 siteUnited States
Study dates: Nov 2002to Apr 2004
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer Investigational Site
Little Rock, Arkansas, 72202

Other trials in United States

About this study

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

Conditions: Psoriasis, Immunomodulation
Being tested: tofacitinib
Keywords: Psoriasis, PASI, plaques, skin biopsy, immunomodulation
Medical subject headings: Psoriasis, Plaque, Amyloid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tofacitinibDrug
5 mg BID For 13 days and once on Day 14
tofacitinibDrug
10 mg BID for 13 days and once on Day 14*
tofacitinibDrug
20 mg BID for 13 days and once on Day 14
tofacitinibDrug
30 mg BID for 13 days and once on Day 14
tofacitinibDrug
60 mg tablet once a day (QD) for 14 days
tofacitinibDrug
50 mg tablets two times a day (BID) for 13 days and once on day 14

Study groups in NCT01736696
Study group	Role	What they receive
5 mg BID	Experimental	5 mg BID for 13 days and once on Day 14 Receives: Drug: tofacitinib
10 mg BID	Experimental	10 mg BID for13 days and once on Day 14* Receives: Drug: tofacitinib
20 mg BID	Experimental	20 mg BID for 13 days and once on Day 14 Receives: Drug: tofacitinib
30 mg BID	Experimental	30 mg BID for 13 days and once on Day 14 Receives: Drug: tofacitinib
60 mg QD	Experimental	60 mg QD for 14 days Receives: Drug: tofacitinib
50 mg BID	Experimental	50 mg BID x 13 days and once on day 14 Receives: Drug: tofacitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 23 hours (hrs) prior to morning dose on Day 1 (Baseline for HPD 1), 1 hour (hr) post morning dose on Day 1
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.
Measured: 22 hrs prior to morning dose on Day 1 (Baseline for HPD 2), 2 hrs post morning dose on Day 1
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.
Measured: 20 hrs prior to morning dose on Day 1 (Baseline for HPD 4), 4 hrs post morning dose on Day 1
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.
Measured: 16 hrs prior to morning dose on Day 1 (Baseline for HPD 8), 8 hrs post morning dose on Day 1
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.
Measured: 12 hrs prior to morning dose on Day 1 (Baseline for HPD 12), 12 hrs post morning dose on Day 1
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.
Measured: 8 hrs prior to morning dose on Day 1 (Baseline for HPD 16), 16 hrs post morning dose on Day 1
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.
Measured: Hour 0 (pre-dose) on Day 1 (Baseline for HPD 0), 0 hr on Day 14
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.
Measured: 23 hrs prior to morning dose on Day 1 (Baseline for HPD 1), 1 hr post morning dose on Day 14
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.
Measured: 22 hrs prior to morning dose on Day 1 (Baseline for HPD 2), 2 hrs post morning dose on Day 14
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.
Measured: 20 hrs prior to morning dose on Day 1 (Baseline for HPD 4), 4 hrs post morning dose on Day 14
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.
Measured: 16 hrs prior to morning dose on Day 1 (Baseline for HPD 8), 8 hrs post morning dose on Day 14
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.
Measured: 12 hrs prior to morning dose on Day 1 (Baseline for HPD 12), 12 hrs post morning dose on Day 14
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.
Measured: 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
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.
Measured: 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
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.
Measured: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1
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.
Measured: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 14
Maximum Observed Plasma Concentration (Cmax) at Day 1
Measured: 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
Measured: 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
Measured: 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
Measured: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 14
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.
Measured: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1 and Day 14
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.
Measured: Baseline, 1 hr post-dose on Day 1
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.
Measured: Baseline, hr 0 on Day 2
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.
Measured: Baseline, hr 0 on Day 4
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.
Measured: Baseline, hr 0 on Day 7
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.
Measured: Baseline, hr 0 on Day 10
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.
Measured: Baseline; hr 0, 8 hr post-dose on Day 14
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.
Measured: Baseline, Hour 0 on Day 18
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.
Measured: Baseline, hr 0 on Day 21
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.
Measured: Baseline, hr 0 on Day 28
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.
Measured: Baseline, hr 0 on Day 42
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.
Measured: Baseline (Within 7 days prior to Day 1), Day 14
Change From Baseline in Reticulocyte Count at Day 2
Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.
Measured: Baseline (Within 7 days prior to Day 1), Day 2
Change From Baseline in Reticulocyte Count at Day 4
Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.
Measured: Baseline (Within 7 days prior to Day 1), Day 4
Change From Baseline in Reticulocyte Count at Day 7
Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.
Measured: Baseline (Within 7 days prior to Day 1), Day 7
Change From Baseline in Reticulocyte Count at Day 10
Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.
Measured: Baseline (Within 7 days prior to Day 1), Day 10
Change From Baseline in Reticulocyte Count at Day 15
Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.
Measured: Baseline (Within 7 days prior to Day 1), Day 15
Change From Baseline in Reticulocyte Count at Day 21
Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.
Measured: Baseline (Within 7 days prior to Day 1), Day 21
Change From Baseline in Reticulocyte Count at Day 28
Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.
Measured: Baseline (Within 7 days prior to Day 1), Day 28
Change From Baseline in Reticulocyte Count at Day 42
Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.
Measured: Baseline (Within 7 days prior to Day 1), Day 42
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
Measured: Day 0 (pre-dose), 1, 2, 4, 7, 10, 14, 15, 18, 21, 28, 42
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.
Measured: Day 14

Secondary outcomes (7)

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.
Measured: Baseline (Within 7 days prior to Day 1) up to Day 14
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).
Measured: Baseline (Within 7 days prior to Day 1) up to Day 14
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.
Measured: Day 14
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.
Measured: Baseline (within 7 days prior to Day 1), Day 14
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.
Measured: Baseline (within 7 days prior to Day 1) up to Day 14
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.
Measured: Baseline (within 7 days prior to Day 1) up to Day 14
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).
Measured: Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2002Apr 2004

First posted29 Nov 2012 (estimated)
Study startNov 2002
Primary completionApr 2004
Study completionApr 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PsoriasisStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01736696
Sponsor's protocol ID: A3921003
Status last verified: Jan 2013
First submitted: 26 Nov 2012
Last updated: 20 Feb 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1, Investigator-Blind, Subject-Blind, Sponsor-Open, Placebo-Controlled, Two-Week, Multiple Dose Escalation Study In Medically Stable Subjects With Psoriasis To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of CP-690,550
ClinicalTrials.gov ID: NCT01736696
Acronym / sponsor ID: A3921003
Conditions: Psoriasis, Immunomodulation
Keywords: Psoriasis, PASI, plaques, skin biopsy, immunomodulation
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 59 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Nov 2002
Primary completion: Apr 2004 (actual)
Study completion: Apr 2004 (actual)
First posted: 29 Nov 2012 (estimated)
Results: Posted 20 Feb 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 6

Arm	Type	Receives
5 mg BID	Experimental	Drug: tofacitinib5 mg BID for 13 days and once on Day 14
10 mg BID	Experimental	Drug: tofacitinib10 mg BID for13 days and once on Day 14*
20 mg BID	Experimental	Drug: tofacitinib20 mg BID for 13 days and once on Day 14
30 mg BID	Experimental	Drug: tofacitinib30 mg BID for 13 days and once on Day 14
60 mg QD	Experimental	Drug: tofacitinib60 mg QD for 14 days
50 mg BID	Experimental	Drug: tofacitinib50 mg BID x 13 days and once on day 14

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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).

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
tofacitinib5 mg BID For 13 days and once on Day 14	Drug	5 mg BID
tofacitinib10 mg BID for 13 days and once on Day 14*	Drug	10 mg BID
tofacitinib20 mg BID for 13 days and once on Day 14	Drug	20 mg BID
tofacitinib30 mg BID for 13 days and once on Day 14	Drug	30 mg BID
tofacitinib60 mg tablet once a day (QD) for 14 days	Drug	60 mg QD
tofacitinib50 mg tablets two times a day (BID) for 13 days and once on day 14	Drug	50 mg BID

Primary outcome

Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1
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
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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
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
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
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 14
Accumulation Ratio (R0)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline (Within 7 days prior to Day 1), Day 4
Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.
Change From Baseline in Reticulocyte Count at Day 7
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 0 (pre-dose), 1, 2, 4, 7, 10, 14, 15, 18, 21, 28, 42
Half Maximal Effective Area Under the Concentration-Time Curve 50 (EAUC 50)
Time frame: 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.

7 secondary outcomes

Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14
Time frame: Baseline (Within 7 days prior to Day 1) up to Day 14
Number of Participants With Physician's Global Assessment (PGA) of Psoriasis
Time frame: Baseline (Within 7 days prior to Day 1) up to Day 14
Gene Expression in Psoriatic Plaque Biopsies
Time frame: Day 14
Immunohistochemistry From Psoriatic Plaque Biopsies
Time frame: Baseline (within 7 days prior to Day 1), Day 14
Number of Participants With Keratin 16 (K16) Expression
Time frame: Baseline (within 7 days prior to Day 1) up to Day 14
Number of Participants With Intracellular Adhesion Molecule (ICAM-1) by Epidermal Keratinocytes Expression
Time frame: Baseline (within 7 days prior to Day 1) up to Day 14
Gene Expression in Peripheral Blood
Time frame: Day 14

Results and safety

Results posted to the registry on 20 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CP-690,550 5 mg (Cohort 1)	5	5
CP-690,550 10 mg (Cohort 2)	5	5
CP-690,550 20 mg (Cohort 3)	10	9
CP-690,550 30 mg (Cohort 4)	9	9
CP-690,550 60 mg (Cohort 5)	9	9
CP-690,550 50 mg (Cohort 6)	8	8
Placebo	13	13

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

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. Mean (Standard Deviation). Unit: millisecond (msec)

Measure	CP-690,550 5 mg (Cohort 1) n = 5	CP-690,550 10 mg (Cohort 2) n = 5	CP-690,550 20 mg (Cohort 3) n = 10	CP-690,550 30 mg (Cohort 4) n = 9	CP-690,550 60 mg (Cohort 5) n = 9	CP-690,550 50 mg (Cohort 6) n = 8	Placebo n = 13
Baseline for HPD 1	372.20 (34.3)	348.47 (23.52)	369.40 (19.47)	375.74 (24.65)	383.96 (18.10)	371.29 (28.33)	370.95 (18.00)
Change at HPD 1 on Day 1	-6.33 (25.91)	15.73 (9.04)	-6.33 (21.67)	2.70 (14.54)	1.63 (14.09)	-2.79 (13.28)	-4.21 (12.61)

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

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

Time frame: 22 hrs prior to morning dose on Day 1 (Baseline for HPD 2), 2 hrs post morning dose on Day 1. Mean (Standard Deviation). Unit: msec

Measure	CP-690,550 5 mg (Cohort 1) n = 5	CP-690,550 10 mg (Cohort 2) n = 5	CP-690,550 20 mg (Cohort 3) n = 10	CP-690,550 30 mg (Cohort 4) n = 9	CP-690,550 60 mg (Cohort 5) n = 9	CP-690,550 50 mg (Cohort 6) n = 8	Placebo n = 13
Baseline for HPD 2	369.67 (33.78)	350.27 (20.76)	372.87 (21.10)	377.48 (24.26)	387.00 (18.81)	374.00 (26.75)	369.87 (17.53)
Change at HPD 2 on Day 1	-0.40 (26.39)	9.80 (13.71)	-6.90 (22.22)	-0.15 (12.82)	-0.07 (9.40)	-1.58 (13.66)	-2.05 (16.76)

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

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

Time frame: 20 hrs prior to morning dose on Day 1 (Baseline for HPD 4), 4 hrs post morning dose on Day 1. Mean (Standard Deviation). Unit: msec

Measure	CP-690,550 5 mg (Cohort 1) n = 5	CP-690,550 10 mg (Cohort 2) n = 5	CP-690,550 20 mg (Cohort 3) n = 10	CP-690,550 30 mg (Cohort 4) n = 9	CP-690,550 60 mg (Cohort 5) n = 9	CP-690,550 50 mg (Cohort 6) n = 8	Placebo n = 13
Baseline for HPD 4 (n=5,5,10,9,9,8,13)	373.73 (31.71)	348.07 (23.34)	373.20 (21.78)	373.15 (20.46)	381.44 (20.02)	381.17 (26.96)	368.00 (18.04)
Change at HPD 4 on Day 1 (n=5,5,9,9,9,8,13)	-4.53 (23.17)	11.53 (12.32)	2.19 (20.98)	2.96 (17.94)	7.74 (14.69)	-8.17 (14.32)	-2.82 (10.82)

Population analysed: 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.

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

Time frame: 16 hrs prior to morning dose on Day 1 (Baseline for HPD 8), 8 hrs post morning dose on Day 1. Mean (Standard Deviation). Unit: msec

Measure	CP-690,550 5 mg (Cohort 1) n = 5	CP-690,550 10 mg (Cohort 2) n = 5	CP-690,550 20 mg (Cohort 3) n = 10	CP-690,550 30 mg (Cohort 4) n = 9	CP-690,550 60 mg (Cohort 5) n = 9	CP-690,550 50 mg (Cohort 6) n = 8	Placebo n = 13
Baseline for HPD 8 (n=5,5,10,9,9,8,13)	364.13 (36.00)	356.73 (25.62)	366.90 (22.02)	374.56 (22.73)	378.15 (23.91)	372.25 (28.29)	367.56 (17.95)
Change at HPD 8 on Day 1 (n=5,5,9,9,9,8,13)	-1.27 (15.93)	-6.60 (10.71)	-3.96 (18.54)	-3.44 (12.75)	7.67 (16.08)	-9.83 (15.12)	-9.03 (11.52)

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CP-690,550 5 mg (Cohort 1)	0 of 5 (0%)	0 of 5 (0%)	Not reported
CP-690,550 10 mg (Cohort 2)	1 of 5 (20%)	1 of 5 (20%)	Not reported
CP-690,550 20 mg (Cohort 3)	0 of 10 (0%)	3 of 10 (30%)	Not reported
CP-690,550 30 mg (Cohort 4)	0 of 9 (0%)	1 of 9 (11.1%)	Not reported
CP-690,550 60 mg (Cohort 5)	0 of 9 (0%)	2 of 9 (22.2%)	Not reported
CP-690,550 50 mg (Cohort 6)	0 of 8 (0%)	2 of 8 (25%)	Not reported
Placebo	0 of 13 (0%)	2 of 13 (15.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing tofacitinib in people with Psoriasis and Immunomodulation, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1 (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). The study lists 42 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01736696.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2013; AzTrials last refreshed its copy on 27 Oct 2026.