| Primary | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 4 | PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4). | The modified intent to treat (mITT) analysis set included all randomized participants who received at least 1 dose of the randomized study drug (PF-04965842 or placebo). Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28. | | OG001 | PF-04965842 200 Milligram (mg) Once Daily | Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28. | | OG002 | PF-04965842 400 mg Once Daily | Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28. | | OG003 | PF-04965842 200 mg Twice Daily | Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28. |
| | Units | Counts |
|---|
| Participants | - OG00014
- OG00115
- OG00216
- OG003
|
| | Title | Denominators | Categories |
|---|
| Baseline (n= 14, 15, 16, 14) | | | Title | Measurements |
|---|
| - OG00020.05± 3.993
- OG00120.34± 7.089
- OG00219.21± 4.426
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| PF-04965842 200 mg vs Placebo: Longitudinal analysis of covariance (LANCOVA) model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix. | | | | | Least square (LS) mean difference | -5.08 | Standard Error of the Mean | 2.420 | 2-Sided | 90 | -9.15 | -1.01 | | | | No | Superiority or Other | | | |
|
| Secondary | Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4). | The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Week 1, 2, 3, 4, 5, 6, 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28. | | OG001 | PF-04965842 200 Milligram (mg) Once Daily | Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28. |
|
| Secondary | Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 | PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4). | The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 1, 2, 3, 5, 6, 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28. | | OG001 | PF-04965842 200 Milligram (mg) Once Daily | Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28. |
|
| Secondary | Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | PASI score is combined assessment of lesion severity and area affected into single score range:0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated:0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4). Participants who had at least 50 percent reduction in PASI score relative to baseline PASI Score are reported. 90 percent confidence intervals are calculated using clopper-pearson (exact) method. | The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Number | 90% Confidence Interval | percentage of participants | | Baseline, Week 1, 2, 3, 4, 5, 6, 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28. | | OG001 |
|
| Secondary | Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | PASI score is combined assessment of lesion severity and area affected into single score range:0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated:0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4). Participants who had at least 75 percent reduction in PASI score relative to baseline PASI Score are reported. 90 percent confidence intervals are calculated using clopper-pearson (exact) method. | The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Number | 90% Confidence Interval | percentage of participants | | Baseline, Week 1, 2, 3, 4, 5, 6, 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28. | | OG001 |
|
| Secondary | Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | PASI score is combined assessment of lesion severity and area affected into single score range:0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated:0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4). Participants who had at least 90 percent reduction in PASI score relative to baseline PASI Score are reported. 90 percent confidence intervals are calculated using clopper-pearson (exact) method. | The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Number | 90% Confidence Interval | percentage of participants | | Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28. | | OG001 |
|
| Secondary | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema (E), induration (I), and scaling (S) across all psoriatic lesions. The severity rating scores (erythema: 0= no evidence of erythema to 4= dark, deep red; Induration: 0= no evidence of plaque elevation to 4= marked plaque elevation, hard/sharp borders; Scaling: 0= no evidence of scaling to 4= thick, coarse scale predominates) were summed (E + I + S= total) and the average (total/3) was taken. The total average was rounded to the nearest whole number score to determine the PGA. The 5-point scale for PGA was: 0= clear; 1= almost clear; 2= mild; 3= moderate; 4= severe, where higher score indicating more severity. Participants with response of clear and almost clear were reported. 90 percent confidence intervals were calculated using clopper-pearson (exact) method. | The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Number | 90% Confidence Interval | percentage of participants | | Week 1, 2, 3, 4, 5, 6, 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28. | | OG001 | PF-04965842 200 Milligram (mg) Once Daily | |
|
| Secondary | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Participants were required to fast 9 hours prior to sampling for lipid profile which included following parameters: low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C), cholesterol, triglycerides. | The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Mean | Standard Deviation | milligram per deciliter (mg/dL) | | Baseline, Week 2, 4, 8 (early termination) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28. | | OG001 | PF-04965842 200 Milligram (mg) Once Daily | Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28. | | OG002 | PF-04965842 400 mg Once Daily | Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28. | | OG003 | PF-04965842 200 mg Twice Daily |
|
| Secondary | Change From Baseline in Lipid Ratios at Week 2, 4 and 8 | The ratio of LDL-C/HDL-C was reported. | The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Mean | Standard Deviation | ratio | | Baseline, Week 2, 4, 8 (early termination) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28. | | OG001 | PF-04965842 200 Milligram (mg) Once Daily | Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28. | | OG002 | PF-04965842 400 mg Once Daily | Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28. | | OG003 | PF-04965842 200 mg Twice Daily | Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28. |
|
| Secondary | Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Reference range for measurements is 0-0.5 mg/dL and lower limit of detection is less than (<) 0.015 mg/dL. Any value <0.015 mg/dL is imputed as 0.0075 mg/dL. | The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, Week 1, 2, 3, 4, 8 (early termination) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28. | | OG001 | PF-04965842 200 Milligram (mg) Once Daily | Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28. | | OG002 | PF-04965842 400 mg Once Daily | Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28. | |
|
| Secondary | Number of Participants Reporting Clinically Significant Change From Baseline in Epstein-Barr Virus (EBV) Values | EBV samples were collected and changes from baseline were evaluated by the principal investigator (PI) for clinical significance. Clinical significance is levels outside of the normal range (abnormal levels) with clinically apparent viral disease, or that resulted in adverse event (AEs) or required follow-up. | The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. | Posted | | Number | | participants | | Baseline up to Week 8 (early termination) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28. | | OG001 | PF-04965842 200 Milligram (mg) Once Daily | Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28. | | OG002 | PF-04965842 400 mg Once Daily | Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28. | | OG003 | PF-04965842 200 mg Twice Daily |
|
| Secondary | Number of Participants Reporting Clinically Significant Change From Baseline in Cytomegalovirus (CMV) Values | CMV samples were collected and changes from baseline were evaluated by the PI for clinical significance. Clinical significance is levels outside of the normal range (abnormal levels) with clinically apparent viral disease, or that resulted in AEs or required follow-up. | The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. | Posted | | Number | | participants | | Baseline up to Week 8 (early termination) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28. | | OG001 | PF-04965842 200 Milligram (mg) Once Daily | Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28. | | OG002 | PF-04965842 400 mg Once Daily | Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28. | | OG003 | PF-04965842 200 mg Twice Daily | |
|
| Secondary | Number of Participants Reporting Clinically Significant Change From Baseline in Herpes Simplex Virus Deoxyribonucleic Acid (HSV DNA) Values | HSV DNA samples were collected and changes from baseline were evaluated by the PI for clinical significance. Clinical significance is levels outside of the normal range (abnormal levels) with clinically apparent viral disease, or that resulted in AEs or required follow-up. | The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. | Posted | | Number | | participants | | Baseline up to Week 8 (early termination) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28. | | OG001 | PF-04965842 200 Milligram (mg) Once Daily | Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28. | | OG002 | PF-04965842 400 mg Once Daily | Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28. | | OG003 | PF-04965842 200 mg Twice Daily |
|
| Secondary | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | | The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Mean | Standard Deviation | millimeter of mercury (mmHg) | | Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28. | | OG001 | PF-04965842 200 Milligram (mg) Once Daily | Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28. | | OG002 | PF-04965842 400 mg Once Daily | Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28. | | OG003 | PF-04965842 200 mg Twice Daily | Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28. |
| |
| Secondary | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | | The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Mean | Standard Deviation | beats per minute (bpm) | | Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28. | | OG001 | PF-04965842 200 Milligram (mg) Once Daily | Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28. | | OG002 | PF-04965842 400 mg Once Daily | Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28. | | OG003 | PF-04965842 200 mg Twice Daily | Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28. |
| |
| Secondary | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | | The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Mean | Standard Deviation | respiration per minute (resp/min) | | Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28. | | OG001 | PF-04965842 200 Milligram (mg) Once Daily | Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28. | | OG002 | PF-04965842 400 mg Once Daily | Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28. | | OG003 | PF-04965842 200 mg Twice Daily | Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28. |
| |
| Secondary | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | | The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Mean | Standard Deviation | degree celsius | | Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28. | | OG001 | PF-04965842 200 Milligram (mg) Once Daily | Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28. | | OG002 | PF-04965842 400 mg Once Daily | Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28. | | OG003 | PF-04965842 200 mg Twice Daily | Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28. |
| |
| Secondary | Number of Participants Reporting Clinically Significant Change From Baseline in Heart Rate | | The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. | Posted | | Number | | bpm | | Baseline up to Week 8 (early termination) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28. | | OG001 | PF-04965842 200 Milligram (mg) Once Daily | Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28. | | OG002 | PF-04965842 400 mg Once Daily | Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28. | | OG003 | PF-04965842 200 mg Twice Daily | Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28. |
| |
| Secondary | Number of Participants Reporting Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters | ECG change data was reported as qualitative results, as per change in planned analysis. It was categorized as: normal; abnormal, not clinically significant or abnormal, clinically significant. | The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. | Posted | | Number | | participants | | Baseline up to Week 8 (early termination) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28. | | OG001 | PF-04965842 200 Milligram (mg) Once Daily | Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28. | | OG002 | PF-04965842 400 mg Once Daily | Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28. | | OG003 | PF-04965842 200 mg Twice Daily | Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28. |
|