Psoriasis
Conditions
Keywords
chronic plaque psoriasis, topical treatment
Brief summary
Study will test effectiveness of an experimental drug applied once or twice daily to two psoriasis plaques. Requires 1 clinic visit each week for 5 weeks.
Interventions
DRUGCP-690,550
Topical treatment once daily for 28 days
DRUGPlacebo Vehicle
Topical treatment once daily for 28 days
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Having chronic plaque psoriasis for at least 6 months * Able to withdraw all prior psoriasis treatments * Must agree to avoid prolonged exposure to the sun and avoid use of tanning booths or other ultraviolet light sources during the study
Exclusion criteria
* Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis * Pregnant or lactating women * Unwilling to use appropriate contraceptive methods
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 | Baseline, Week 4 | TPSS: all target lesions were scored individually by the investigator for signs of induration, scaling, and erythema. For large target lesions only a portion of the lesion was treated and only the treated portion was rated. Each of the 3 signs was rated on a 5-point severity scale: 0 = none; 1 = slight; 2 = moderate; 3 = marked; 4 = very marked. Total score range for TPSS was 0 to 12, higher score indicated greater severity of disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Week 4 | PGA of Psoriasis: The investigator scored each target lesion on a 5-point scale, reflecting the erythema, induration and scaling separately for each target lesions. Each parameter was scored from 0 to 4, with appropriate morphologic descriptors. The 5-point scale for PGA was: 0, clear; 1, almost clear; 2, mild; 3, moderate; 4 severe. The sum of the 3 scores was divided by 3 to obtain a final PGA score. Total score range: 0 to 4, higher score indicated greater severity of disease. Success was considered as PGA response of clear and almost clear. |
| Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3 | Baseline, Week 1, 2, 3 | TPSS: all target lesions were scored individually by the investigator for signs of induration, scaling, and erythema. For large target lesions only a portion of the lesion was treated and only the treated portion was rated. Each of the 3 signs was rated on a 5-point scale: 0 = none; 1 = slight; 2 = moderate; 3 = marked; 4 = very marked. Total score range for TPSS was 0 to 12, higher score indicated greater severity of disease. |
| Number of Participants With Administration Site Adverse Events | Baseline up to 7 to 10 days after last dose of study treatment (maximum up to 38 days) | An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug. Administration site adverse event included documentation of any clinically significant local reaction, such as erosion, vesicles or scabbing. |
| Drug Plasma Concentrations of CP-690,555 | 0 hour (pre-dose) on Day 14 and 0 hour (pre-dose), 1, 2, 9 hours post-dose on Day 28 | Concentrations below the limit of quantification (LOQ) were not estimable. The LOQ was 0.1 ng/mL. |
| Skin Biopsy Drug Concentrations | Day 28 | Skin biopsy drug concentrations was measured via drug levels in dermis and expressed as nanogram of drug per milligram (mg) of dermis weight. Tissue concentration (ng/mg) = (ng drug/mL extraction solvent multiplied by mL extraction solvent) divided by mg tissue weight; 1 mL of extraction solvent was used. |
Countries
Canada, United States
Participant flow
Recruitment details
During the study, enrollment into the 4 once daily dosing regimen treatment groups was discontinued in order to decrease the overall total number of participants to be enrolled.
Participants by arm
| Arm | Count |
|---|---|
| 2% CP-690,550 Once Daily CP-690,550 2.0 percent (%) (50 microgram per square centimeter \[mcg/cm\^2\]) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28. | 6 |
| 0.2% CP-690,550 Once Daily CP-690,550 0.2% (5 mcg/cm\^2), gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28. | 6 |
| 0.02% CP-690,550 Once Daily CP-690,550 0.02% (0.5 mcg/cm\^2) gel (active), applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, once daily up to Day 28. | 8 |
| Placebo Once Daily CP-690,550 matching placebo vehicle applied topically on 2 target plaque areas, once daily up to Day 28. | 4 |
| 2% CP-690,550 Twice Daily CP-690,550 2.0% (50 mcg/cm\^2), gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28. | 17 |
| 0.2% CP-690,550 Twice Daily CP-690,550 0.2% (5 mcg/cm\^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28. | 17 |
| 0.02% CP-690,550 Twice Daily CP-690,550 0.02% (0.5 mcg/cm\^2) gel (active) applied topically on 1 target plaque area, along with matching placebo vehicle on another target plaque area, twice daily up to Day 28. | 15 |
| Placebo Twice Daily CP-690,550 matching placebo vehicle applied topically on 2 target plaque areas twice daily up to Day 28. | 8 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | 2% CP-690,550 Once Daily | 0.2% CP-690,550 Once Daily | 0.02% CP-690,550 Once Daily | Placebo Once Daily | 2% CP-690,550 Twice Daily | 0.2% CP-690,550 Twice Daily | 0.02% CP-690,550 Twice Daily | Placebo Twice Daily | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 51.8 Years STANDARD_DEVIATION 7.3 | 45.7 Years STANDARD_DEVIATION 11.6 | 50.3 Years STANDARD_DEVIATION 17 | 52.5 Years STANDARD_DEVIATION 13.1 | 45.9 Years STANDARD_DEVIATION 10.5 | 43.2 Years STANDARD_DEVIATION 15.8 | 47.4 Years STANDARD_DEVIATION 13 | 41.1 Years STANDARD_DEVIATION 17 | 46.3 Years STANDARD_DEVIATION 13.5 |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 4 Participants | 5 Participants | 2 Participants | 1 Participants | 15 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 8 Participants | 3 Participants | 13 Participants | 12 Participants | 13 Participants | 7 Participants | 66 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 | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 6 | 2 / 6 | 5 / 8 | 3 / 4 | 6 / 17 | 11 / 17 | 7 / 15 | 4 / 8 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 8 | 0 / 4 | 0 / 17 | 0 / 17 | 0 / 15 | 0 / 8 |
Outcome results
Primary
Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4
TPSS: all target lesions were scored individually by the investigator for signs of induration, scaling, and erythema. For large target lesions only a portion of the lesion was treated and only the treated portion was rated. Each of the 3 signs was rated on a 5-point severity scale: 0 = none; 1 = slight; 2 = moderate; 3 = marked; 4 = very marked. Total score range for TPSS was 0 to 12, higher score indicated greater severity of disease.
Time frame: Baseline, Week 4
Population: Full analysis set (FAS) population included all randomized participants who received at least 1 dose of study medication and had a valid baseline with at least one valid post-baseline value for efficacy parameter. N (number of participants analyzed) is signifying those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2% CP-690,550 Once Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 | 2.38 Percent Change | Standard Deviation 5.83 |
| 0.2% CP-690,550 Once Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 | -4.76 Percent Change | Standard Deviation 11.66 |
| 0.02% CP-690,550 Once Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 | 2.48 Percent Change | Standard Deviation 11.5 |
| Placebo Once Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 | -4.17 Percent Change | Standard Deviation 8.33 |
| 2% CP-690,550 Twice Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 | -4.46 Percent Change | Standard Deviation 9.23 |
| 0.2% CP-690,550 Twice Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 | -1.77 Percent Change | Standard Deviation 20.87 |
| 0.02% CP-690,550 Twice Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 | -3.29 Percent Change | Standard Deviation 21.34 |
| Placebo Twice Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 | -7.14 Percent Change | Standard Deviation 20.11 |
Secondary
Drug Plasma Concentrations of CP-690,555
Concentrations below the limit of quantification (LOQ) were not estimable. The LOQ was 0.1 ng/mL.
Time frame: 0 hour (pre-dose) on Day 14 and 0 hour (pre-dose), 1, 2, 9 hours post-dose on Day 28
Population: FAS: all randomized participants who received at least 1 dose of study medication; had a valid baseline with at least 1 valid post-baseline efficacy assessment of CP-690,550. Participants of reporting groups 2%, 0.2% and 0.02% CP-690,550 Once Daily regimen had no post-baseline measurable concentration of CP-690,550. Overall number of participants analyzed = who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2% CP-690,550 Once Daily | Drug Plasma Concentrations of CP-690,555 | 0 hour post-dose | 0.183 nanogram per milliliter (ng/mL) | Standard Deviation 0.054 |
| 2% CP-690,550 Once Daily | Drug Plasma Concentrations of CP-690,555 | 1 hour post-dose | 0.174 nanogram per milliliter (ng/mL) | Standard Deviation 0.046 |
| 2% CP-690,550 Once Daily | Drug Plasma Concentrations of CP-690,555 | 2 hour post-dose | 0.191 nanogram per milliliter (ng/mL) | Standard Deviation 0.059 |
| 2% CP-690,550 Once Daily | Drug Plasma Concentrations of CP-690,555 | 9 hour post-dose | 0.160 nanogram per milliliter (ng/mL) | Standard Deviation 0.039 |
| 0.2% CP-690,550 Once Daily | Drug Plasma Concentrations of CP-690,555 | 9 hour post-dose | NA nanogram per milliliter (ng/mL) | — |
| 0.2% CP-690,550 Once Daily | Drug Plasma Concentrations of CP-690,555 | 0 hour post-dose | 0.116 nanogram per milliliter (ng/mL) | Standard Deviation 0.02 |
| 0.2% CP-690,550 Once Daily | Drug Plasma Concentrations of CP-690,555 | 2 hour post-dose | NA nanogram per milliliter (ng/mL) | — |
| 0.2% CP-690,550 Once Daily | Drug Plasma Concentrations of CP-690,555 | 1 hour post-dose | NA nanogram per milliliter (ng/mL) | — |
| 0.02% CP-690,550 Once Daily | Drug Plasma Concentrations of CP-690,555 | 9 hour post-dose | 0.102 nanogram per milliliter (ng/mL) | — |
| 0.02% CP-690,550 Once Daily | Drug Plasma Concentrations of CP-690,555 | 1 hour post-dose | 0.126 nanogram per milliliter (ng/mL) | — |
| 0.02% CP-690,550 Once Daily | Drug Plasma Concentrations of CP-690,555 | 2 hour post-dose | 0.115 nanogram per milliliter (ng/mL) | — |
| 0.02% CP-690,550 Once Daily | Drug Plasma Concentrations of CP-690,555 | 0 hour post-dose | NA nanogram per milliliter (ng/mL) | — |
Secondary
Number of Participants With Administration Site Adverse Events
An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug. Administration site adverse event included documentation of any clinically significant local reaction, such as erosion, vesicles or scabbing.
Time frame: Baseline up to 7 to 10 days after last dose of study treatment (maximum up to 38 days)
Population: FAS population included participants who received at least 1 dose of study medication and had a valid baseline with at least one valid post-baseline value for efficacy assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2% CP-690,550 Once Daily | Number of Participants With Administration Site Adverse Events | Active | 0 Participants |
| 2% CP-690,550 Once Daily | Number of Participants With Administration Site Adverse Events | Vehicle | 0 Participants |
| 0.2% CP-690,550 Once Daily | Number of Participants With Administration Site Adverse Events | Active | 0 Participants |
| 0.2% CP-690,550 Once Daily | Number of Participants With Administration Site Adverse Events | Vehicle | 0 Participants |
| 0.02% CP-690,550 Once Daily | Number of Participants With Administration Site Adverse Events | Active | 0 Participants |
| 0.02% CP-690,550 Once Daily | Number of Participants With Administration Site Adverse Events | Vehicle | 0 Participants |
| Placebo Once Daily | Number of Participants With Administration Site Adverse Events | Active | 1 Participants |
| Placebo Once Daily | Number of Participants With Administration Site Adverse Events | Vehicle | 1 Participants |
| 2% CP-690,550 Twice Daily | Number of Participants With Administration Site Adverse Events | Active | 0 Participants |
| 2% CP-690,550 Twice Daily | Number of Participants With Administration Site Adverse Events | Vehicle | 0 Participants |
| 0.2% CP-690,550 Twice Daily | Number of Participants With Administration Site Adverse Events | Active | 0 Participants |
| 0.2% CP-690,550 Twice Daily | Number of Participants With Administration Site Adverse Events | Vehicle | 1 Participants |
| 0.02% CP-690,550 Twice Daily | Number of Participants With Administration Site Adverse Events | Vehicle | 1 Participants |
| 0.02% CP-690,550 Twice Daily | Number of Participants With Administration Site Adverse Events | Active | 1 Participants |
| Placebo Twice Daily | Number of Participants With Administration Site Adverse Events | Active | 0 Participants |
| Placebo Twice Daily | Number of Participants With Administration Site Adverse Events | Vehicle | 0 Participants |
Secondary
Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions
PGA of Psoriasis: The investigator scored each target lesion on a 5-point scale, reflecting the erythema, induration and scaling separately for each target lesions. Each parameter was scored from 0 to 4, with appropriate morphologic descriptors. The 5-point scale for PGA was: 0, clear; 1, almost clear; 2, mild; 3, moderate; 4 severe. The sum of the 3 scores was divided by 3 to obtain a final PGA score. Total score range: 0 to 4, higher score indicated greater severity of disease. Success was considered as PGA response of clear and almost clear.
Time frame: Week 4
Population: FAS population included participants who received at least 1 dose of study medication and had a valid baseline with at least one valid post-baseline value for efficacy assessment. N (number of participants analyzed) is signifying those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2% CP-690,550 Once Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Active, Clear | 0.0 Percentage of Participants |
| 2% CP-690,550 Once Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Active, Almost Clear | 0.0 Percentage of Participants |
| 2% CP-690,550 Once Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Vehicle, Clear | 0.0 Percentage of Participants |
| 2% CP-690,550 Once Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Vehicle, Almost Clear | 0.0 Percentage of Participants |
| 0.2% CP-690,550 Once Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Vehicle, Almost Clear | 0.0 Percentage of Participants |
| 0.2% CP-690,550 Once Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Active, Almost Clear | 0.0 Percentage of Participants |
| 0.2% CP-690,550 Once Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Active, Clear | 0.0 Percentage of Participants |
| 0.2% CP-690,550 Once Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Vehicle, Clear | 0.0 Percentage of Participants |
| 0.02% CP-690,550 Once Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Active, Clear | 0.0 Percentage of Participants |
| 0.02% CP-690,550 Once Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Vehicle, Almost Clear | 0.0 Percentage of Participants |
| 0.02% CP-690,550 Once Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Active, Almost Clear | 0.0 Percentage of Participants |
| 0.02% CP-690,550 Once Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Vehicle, Clear | 0.0 Percentage of Participants |
| Placebo Once Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Active, Clear | 0.0 Percentage of Participants |
| Placebo Once Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Active, Almost Clear | 0.0 Percentage of Participants |
| Placebo Once Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Vehicle, Clear | 0.0 Percentage of Participants |
| Placebo Once Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Vehicle, Almost Clear | 0.0 Percentage of Participants |
| 2% CP-690,550 Twice Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Vehicle, Almost Clear | 26.7 Percentage of Participants |
| 2% CP-690,550 Twice Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Vehicle, Clear | 0.0 Percentage of Participants |
| 2% CP-690,550 Twice Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Active, Almost Clear | 13.3 Percentage of Participants |
| 2% CP-690,550 Twice Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Active, Clear | 6.7 Percentage of Participants |
| 0.2% CP-690,550 Twice Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Vehicle, Almost Clear | 25.0 Percentage of Participants |
| 0.2% CP-690,550 Twice Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Vehicle, Clear | 0.0 Percentage of Participants |
| 0.2% CP-690,550 Twice Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Active, Almost Clear | 25.0 Percentage of Participants |
| 0.2% CP-690,550 Twice Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Active, Clear | 0.0 Percentage of Participants |
| 0.02% CP-690,550 Twice Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Vehicle, Almost Clear | 13.3 Percentage of Participants |
| 0.02% CP-690,550 Twice Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Active, Clear | 0.0 Percentage of Participants |
| 0.02% CP-690,550 Twice Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Vehicle, Clear | 0.0 Percentage of Participants |
| 0.02% CP-690,550 Twice Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Active, Almost Clear | 33.3 Percentage of Participants |
| Placebo Twice Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Active, Almost Clear | 14.3 Percentage of Participants |
| Placebo Twice Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Vehicle, Clear | 0.0 Percentage of Participants |
| Placebo Twice Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Vehicle, Almost Clear | 0.0 Percentage of Participants |
| Placebo Twice Daily | Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions | Active, Clear | 0.0 Percentage of Participants |
Secondary
Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3
TPSS: all target lesions were scored individually by the investigator for signs of induration, scaling, and erythema. For large target lesions only a portion of the lesion was treated and only the treated portion was rated. Each of the 3 signs was rated on a 5-point scale: 0 = none; 1 = slight; 2 = moderate; 3 = marked; 4 = very marked. Total score range for TPSS was 0 to 12, higher score indicated greater severity of disease.
Time frame: Baseline, Week 1, 2, 3
Population: FAS: all randomized participants who received at least 1 dose of study medication; had a valid baseline with at least 1 valid post-baseline efficacy assessment. Here 'N' (number of participants analyzed)= participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2% CP-690,550 Once Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3 | Week 1 | 0.00 percent change | Standard Deviation 0 |
| 2% CP-690,550 Once Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3 | Week 3 | 0.00 percent change | Standard Deviation 0 |
| 2% CP-690,550 Once Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3 | Week 2 | -5.56 percent change | Standard Deviation 8.61 |
| 0.2% CP-690,550 Once Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3 | Week 3 | 2.78 percent change | Standard Deviation 6.8 |
| 0.2% CP-690,550 Once Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3 | Week 2 | 0.93 percent change | Standard Deviation 8.9 |
| 0.2% CP-690,550 Once Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3 | Week 1 | 5.56 percent change | Standard Deviation 13.61 |
| 0.02% CP-690,550 Once Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3 | Week 3 | 8.73 percent change | Standard Deviation 13.52 |
| 0.02% CP-690,550 Once Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3 | Week 1 | -1.39 percent change | Standard Deviation 9.74 |
| 0.02% CP-690,550 Once Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3 | Week 2 | 0.69 percent change | Standard Deviation 8.63 |
| Placebo Once Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3 | Week 1 | -16.67 percent change | Standard Deviation 33.33 |
| Placebo Once Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3 | Week 2 | 0.00 percent change | Standard Deviation 0 |
| Placebo Once Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3 | Week 3 | -16.67 percent change | Standard Deviation 28.87 |
| 2% CP-690,550 Twice Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3 | Week 2 | -3.49 percent change | Standard Deviation 16.24 |
| 2% CP-690,550 Twice Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3 | Week 1 | -1.59 percent change | Standard Deviation 28.97 |
| 2% CP-690,550 Twice Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3 | Week 3 | -4.66 percent change | Standard Deviation 13.47 |
| 0.2% CP-690,550 Twice Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3 | Week 2 | 0.25 percent change | Standard Deviation 9.82 |
| 0.2% CP-690,550 Twice Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3 | Week 1 | 4.24 percent change | Standard Deviation 16.3 |
| 0.2% CP-690,550 Twice Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3 | Week 3 | 3.06 percent change | Standard Deviation 22.74 |
| 0.02% CP-690,550 Twice Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3 | Week 2 | -4.55 percent change | Standard Deviation 16.11 |
| 0.02% CP-690,550 Twice Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3 | Week 1 | 2.13 percent change | Standard Deviation 11.59 |
| 0.02% CP-690,550 Twice Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3 | Week 3 | -2.99 percent change | Standard Deviation 16.38 |
| Placebo Twice Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3 | Week 1 | -3.87 percent change | Standard Deviation 7.19 |
| Placebo Twice Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3 | Week 2 | -4.42 percent change | Standard Deviation 13.45 |
| Placebo Twice Daily | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3 | Week 3 | -2.83 percent change | Standard Deviation 16 |
Secondary
Skin Biopsy Drug Concentrations
Skin biopsy drug concentrations was measured via drug levels in dermis and expressed as nanogram of drug per milligram (mg) of dermis weight. Tissue concentration (ng/mg) = (ng drug/mL extraction solvent multiplied by mL extraction solvent) divided by mg tissue weight; 1 mL of extraction solvent was used.
Time frame: Day 28
Population: FAS population included participants who received at least 1 dose of study medication and had a valid baseline with at least one valid post-baseline value for efficacy assessment. Overall number of participants analyzed = participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2% CP-690,550 Once Daily | Skin Biopsy Drug Concentrations | 3.4145 ng/mg | Standard Deviation 2.9877 |
| 0.2% CP-690,550 Once Daily | Skin Biopsy Drug Concentrations | 2.2320 ng/mg | Standard Deviation 2.7257 |
| 0.02% CP-690,550 Once Daily | Skin Biopsy Drug Concentrations | 0.3242 ng/mg | Standard Deviation 0.6343 |
| Placebo Once Daily | Skin Biopsy Drug Concentrations | 0 ng/mg | — |
| 2% CP-690,550 Twice Daily | Skin Biopsy Drug Concentrations | 8.2810 ng/mg | Standard Deviation 10.27 |
| 0.2% CP-690,550 Twice Daily | Skin Biopsy Drug Concentrations | 0.2957 ng/mg | Standard Deviation 0.3675 |
| 0.02% CP-690,550 Twice Daily | Skin Biopsy Drug Concentrations | 0.0847 ng/mg | Standard Deviation 0.1252 |
| Placebo Twice Daily | Skin Biopsy Drug Concentrations | 0 ng/mg | — |