Plaque Psoriasis
Conditions
Keywords
Phase 2, randomized, double-blind, placebo, plaque, psoriasis, safety, efficacy, JAK, janus kinase, moderate, severe
Brief summary
Study B7451005 is a Phase 2 study which will assess the efficacy and safety of PF-04965842 in patients with moderate to severe psoriasis. The study will include three PF-04965842 groups (200 mg daily, 400 mg daily and 200 mg twice daily) and a placebo group. The treatment period will be 4 weeks in duration and will be followed up by a 4 week follow up period.
Interventions
DRUGPF-04965842
Subjects will receive 200 mg PF 04965842 twice daily for 4 weeks
OTHERPlacebo
Subjects will receive placebo for 4 weeks
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Have a diagnosis of plaque psoriasis for at least 6 months prior to first study dose. 2. Have plaque type psoriasis covering at least 15% of total BSA at Day 1 (at the time of the first study dose). 3. Have a PASI score of 12 or greater at Day 1 (at the time of the first study dose). 4. Be a candidate for phototherapy or systemic treatment of psoriasis (either naïve or history of previous treatment).
Exclusion criteria
1. Currently have non plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis. 2. 3\. Have current drug induced psoriasis, eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, antimalarial drugs or lithium. 3. Have received any of the following treatment regimens specified in the timeframes outlined below: Within 9 months of first dose of study drug: • Ustekinumab (Stelara). Within 12 weeks of first dose of study drug: • Any experimental therapy for psoriasis or rheumatoid arthritis. Within 4 8 weeks of first dose of study drug: * Biologic therapies for psoriasis have discontinuation periods determined from approximately 5x half life of the respective biologic: * 4 weeks: etanercept (Enbrel). * 8 weeks: infliximab (Remicade), adalimumab (Humira). Within 4 weeks of first dose of study drug: * Systemic treatments other than biologics that could affect psoriasis (eg, oral or injectable corticosteroids, retinoids, methotrexate, cyclosporine, fumaric acid derivatives, sulfasalazine, hydroxycarbamide (hydroxyurea), azathioprine). * Phototherapy and psoralen plus ultraviolet A therapy (PUVA). * Other - intramuscular gold, immunization with any live virus vaccination (eg, FluMist), herbal medications. Within 2 weeks of first dose of study drug: * Topical treatments that could affect psoriasis (eg, corticosteroids, tars, keratolytics, anthralin, vitamin D analogs, and retinoids). * Phototherapy with ultraviolet B (UVB) (narrowband or broadband).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 4 | Baseline, 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 | Baseline, Week 1, 2, 3, 5, 6, 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). |
| Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Baseline, Week 1, 2, 3, 4, 5, 6, 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. |
| Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | Baseline, Week 1, 2, 3, 4, 5, 6, 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. |
| Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination) | 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. |
| Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | Week 1, 2, 3, 4, 5, 6, 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. |
| Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Baseline, Week 2, 4, 8 (early termination) | 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. |
| Change From Baseline in Lipid Ratios at Week 2, 4 and 8 | Baseline, Week 2, 4, 8 (early termination) | The ratio of LDL-C/HDL-C was reported. |
| Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 | Baseline, Week 1, 2, 3, 4, 8 (early termination) | 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. |
| Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Baseline, Week 1, 2, 3, 4, 5, 6, 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). |
| Number of Participants Reporting Clinically Significant Change From Baseline in Cytomegalovirus (CMV) Values | Baseline up to Week 8 (early termination) | 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. |
| Number of Participants Reporting Clinically Significant Change From Baseline in Herpes Simplex Virus Deoxyribonucleic Acid (HSV DNA) Values | Baseline up to Week 8 (early termination) | 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. |
| Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination) | — |
| Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination) | — |
| Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination) | — |
| Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination) | — |
| Number of Participants Reporting Clinically Significant Change From Baseline in Heart Rate | Baseline up to Week 8 (early termination) | — |
| Number of Participants Reporting Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters | Baseline up to Week 8 (early termination) | 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. |
| Number of Participants Reporting Clinically Significant Change From Baseline in Epstein-Barr Virus (EBV) Values | Baseline up to Week 8 (early termination) | 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28. | 14 |
| PF-04965842 200 Milligram (mg) Once Daily Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28. | 15 |
| PF-04965842 400 mg Once Daily Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28. | 16 |
| PF-04965842 200 mg Twice Daily Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28. | 14 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 | 1 | 0 |
| Overall Study | Insufficient clinical response | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 2 | 0 |
| Overall Study | No longer meets eligibility criteria | 0 | 0 | 0 | 2 |
| Overall Study | Other | 1 | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo | PF-04965842 200 Milligram (mg) Once Daily | PF-04965842 400 mg Once Daily | PF-04965842 200 mg Twice Daily | Total |
|---|---|---|---|---|---|
| Age, Continuous | 45.4 years STANDARD_DEVIATION 10.8 | 42.9 years STANDARD_DEVIATION 12.3 | 42.8 years STANDARD_DEVIATION 11.6 | 52.1 years STANDARD_DEVIATION 9.7 | 45.7 years STANDARD_DEVIATION 11.5 |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 5 Participants | 6 Participants | 19 Participants |
| Sex: Female, Male Male | 11 Participants | 10 Participants | 11 Participants | 8 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 14 | 7 / 15 | 14 / 16 | 11 / 14 |
| serious Total, serious adverse events | 1 / 14 | 0 / 15 | 0 / 16 | 0 / 14 |
Outcome results
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).
Time frame: Baseline, Week 4
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 4 | Baseline (n= 14, 15, 16, 14) | 20.05 units on a scale | Standard Deviation 3.993 |
| Placebo | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 4 | Change at Week 4 (n= 12, 12, 12, 10) | -6.61 units on a scale | Standard Deviation 7.252 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 4 | Baseline (n= 14, 15, 16, 14) | 20.34 units on a scale | Standard Deviation 7.089 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 4 | Change at Week 4 (n= 12, 12, 12, 10) | -11.73 units on a scale | Standard Deviation 6.658 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 4 | Change at Week 4 (n= 12, 12, 12, 10) | -13.09 units on a scale | Standard Deviation 7.979 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 4 | Baseline (n= 14, 15, 16, 14) | 19.21 units on a scale | Standard Deviation 4.426 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 4 | Baseline (n= 14, 15, 16, 14) | 18.01 units on a scale | Standard Deviation 5.507 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 4 | Change at Week 4 (n= 12, 12, 12, 10) | -13.71 units on a scale | Standard Deviation 6.248 |
Comparison: 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.90% CI: [-9.15, -1.01]
Comparison: PF-04965842 400 mg vs Placebo: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-9.61, -1.62]
Comparison: PF-04965842 200 mg vs Placebo: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-14.19, -5.77]
Secondary
Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP: Change at Week 3 (n=12,12,14,10) | -0.7 millimeter of mercury (mmHg) | Standard Deviation 8.17 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP: Change at Week 6 (n=11,12,12,10) | 0.5 millimeter of mercury (mmHg) | Standard Deviation 5.91 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Change at Week 1 (n= 14, 15, 16, 14) | -2.1 millimeter of mercury (mmHg) | Standard Deviation 9.64 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP: Baseline (n=14,15,16,14) | 77.1 millimeter of mercury (mmHg) | Standard Deviation 7.39 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP: Change at Week 8 (n= 14,14,13,13) | -1.1 millimeter of mercury (mmHg) | Standard Deviation 8.12 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP: Change at Week 2 (n=13,13,14,10) | 0.6 millimeter of mercury (mmHg) | Standard Deviation 8.08 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Change at Week 2 (n= 13, 13, 14, 10) | -0.3 millimeter of mercury (mmHg) | Standard Deviation 6.73 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Change at Week 8 (n= 14, 14, 13, 13) | -2.3 millimeter of mercury (mmHg) | Standard Deviation 12.96 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP: Change at Week 1 (n=14,15,16,14) | 0.0 millimeter of mercury (mmHg) | Standard Deviation 6.88 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP: Change at Week 5 (n= 11, 12, 12, 9) | 0.8 millimeter of mercury (mmHg) | Standard Deviation 5.13 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Change at Week 4 (n= 12, 12, 12, 10) | -2.3 millimeter of mercury (mmHg) | Standard Deviation 5.66 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Change at Week 6 (n= 11, 12, 12, 10) | -5.7 millimeter of mercury (mmHg) | Standard Deviation 8.95 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Baseline (n= 14,15,16,14) | 125.4 millimeter of mercury (mmHg) | Standard Deviation 11.77 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP Change at Week 4 (n=12,12,12,10) | -2.5 millimeter of mercury (mmHg) | Standard Deviation 8.21 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Change at Week 5 (n= 11, 12, 12, 9) | -2.9 millimeter of mercury (mmHg) | Standard Deviation 9.98 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Change at Week 3 (n= 12, 12, 14, 10) | -4.5 millimeter of mercury (mmHg) | Standard Deviation 7.09 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Change at Week 5 (n= 11, 12, 12, 9) | -0.8 millimeter of mercury (mmHg) | Standard Deviation 8.29 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Change at Week 6 (n= 11, 12, 12, 10) | -1.3 millimeter of mercury (mmHg) | Standard Deviation 7.99 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP: Change at Week 6 (n=11,12,12,10) | 2.1 millimeter of mercury (mmHg) | Standard Deviation 6.36 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP: Change at Week 3 (n=12,12,14,10) | -0.9 millimeter of mercury (mmHg) | Standard Deviation 7.5 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Change at Week 8 (n= 14, 14, 13, 13) | -2.1 millimeter of mercury (mmHg) | Standard Deviation 9.61 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Change at Week 2 (n= 13, 13, 14, 10) | -1.6 millimeter of mercury (mmHg) | Standard Deviation 9.46 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP: Change at Week 2 (n=13,13,14,10) | 1.5 millimeter of mercury (mmHg) | Standard Deviation 8.96 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP: Baseline (n=14,15,16,14) | 76.5 millimeter of mercury (mmHg) | Standard Deviation 6.84 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Baseline (n= 14,15,16,14) | 125.5 millimeter of mercury (mmHg) | Standard Deviation 11.46 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP: Change at Week 8 (n= 14,14,13,13) | -0.6 millimeter of mercury (mmHg) | Standard Deviation 6.08 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Change at Week 1 (n= 14, 15, 16, 14) | -1.5 millimeter of mercury (mmHg) | Standard Deviation 10.94 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP: Change at Week 5 (n= 11, 12, 12, 9) | 0.0 millimeter of mercury (mmHg) | Standard Deviation 5.64 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Change at Week 3 (n= 12, 12, 14, 10) | -3.3 millimeter of mercury (mmHg) | Standard Deviation 7.82 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Change at Week 4 (n= 12, 12, 12, 10) | -5.8 millimeter of mercury (mmHg) | Standard Deviation 12.4 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP: Change at Week 1 (n=14,15,16,14) | 0.9 millimeter of mercury (mmHg) | Standard Deviation 6.97 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP Change at Week 4 (n=12,12,12,10) | -2.3 millimeter of mercury (mmHg) | Standard Deviation 6.61 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Change at Week 8 (n= 14, 14, 13, 13) | -2.1 millimeter of mercury (mmHg) | Standard Deviation 7.12 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Change at Week 2 (n= 13, 13, 14, 10) | 3.9 millimeter of mercury (mmHg) | Standard Deviation 8.01 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP: Baseline (n=14,15,16,14) | 77.4 millimeter of mercury (mmHg) | Standard Deviation 9.85 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP: Change at Week 1 (n=14,15,16,14) | 0.8 millimeter of mercury (mmHg) | Standard Deviation 9.99 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP: Change at Week 2 (n=13,13,14,10) | -0.4 millimeter of mercury (mmHg) | Standard Deviation 9.13 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Baseline (n= 14,15,16,14) | 124.7 millimeter of mercury (mmHg) | Standard Deviation 12.97 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Change at Week 1 (n= 14, 15, 16, 14) | 0.6 millimeter of mercury (mmHg) | Standard Deviation 8.87 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Change at Week 3 (n= 12, 12, 14, 10) | 6.7 millimeter of mercury (mmHg) | Standard Deviation 16.82 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Change at Week 4 (n= 12, 12, 12, 10) | 0.2 millimeter of mercury (mmHg) | Standard Deviation 7.44 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Change at Week 5 (n= 11, 12, 12, 9) | -0.3 millimeter of mercury (mmHg) | Standard Deviation 10.37 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Change at Week 6 (n= 11, 12, 12, 10) | -2.0 millimeter of mercury (mmHg) | Standard Deviation 8.86 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP: Change at Week 3 (n=12,12,14,10) | 1.1 millimeter of mercury (mmHg) | Standard Deviation 7.76 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP Change at Week 4 (n=12,12,12,10) | 1.2 millimeter of mercury (mmHg) | Standard Deviation 5.46 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP: Change at Week 5 (n= 11, 12, 12, 9) | 0.4 millimeter of mercury (mmHg) | Standard Deviation 5.62 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP: Change at Week 6 (n=11,12,12,10) | -2.8 millimeter of mercury (mmHg) | Standard Deviation 5.67 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP: Change at Week 8 (n= 14,14,13,13) | 1.5 millimeter of mercury (mmHg) | Standard Deviation 9.77 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Change at Week 5 (n= 11, 12, 12, 9) | 2.0 millimeter of mercury (mmHg) | Standard Deviation 18.08 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Change at Week 4 (n= 12, 12, 12, 10) | 1.7 millimeter of mercury (mmHg) | Standard Deviation 15.44 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP: Baseline (n=14,15,16,14) | 79.9 millimeter of mercury (mmHg) | Standard Deviation 10.73 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP Change at Week 4 (n=12,12,12,10) | 2.4 millimeter of mercury (mmHg) | Standard Deviation 9.58 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Change at Week 3 (n= 12, 12, 14, 10) | -1.0 millimeter of mercury (mmHg) | Standard Deviation 13.65 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Change at Week 1 (n= 14, 15, 16, 14) | 2.0 millimeter of mercury (mmHg) | Standard Deviation 10.88 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Change at Week 2 (n= 13, 13, 14, 10) | -0.4 millimeter of mercury (mmHg) | Standard Deviation 7.68 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP: Change at Week 5 (n= 11, 12, 12, 9) | 1.8 millimeter of mercury (mmHg) | Standard Deviation 10.32 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Baseline (n= 14,15,16,14) | 128.0 millimeter of mercury (mmHg) | Standard Deviation 11.5 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP: Change at Week 1 (n=14,15,16,14) | 2.0 millimeter of mercury (mmHg) | Standard Deviation 10.02 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP: Change at Week 8 (n= 14,14,13,13) | 1.4 millimeter of mercury (mmHg) | Standard Deviation 9.26 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP: Change at Week 2 (n=13,13,14,10) | 2.5 millimeter of mercury (mmHg) | Standard Deviation 6.08 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Change at Week 8 (n= 14, 14, 13, 13) | 3.5 millimeter of mercury (mmHg) | Standard Deviation 11.49 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Systolic BP: Change at Week 6 (n= 11, 12, 12, 10) | -0.2 millimeter of mercury (mmHg) | Standard Deviation 11.37 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP: Change at Week 6 (n=11,12,12,10) | 0.9 millimeter of mercury (mmHg) | Standard Deviation 7.49 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 | Diastolic BP: Change at Week 3 (n=12,12,14,10) | 0.3 millimeter of mercury (mmHg) | Standard Deviation 10.7 |
Secondary
Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 5 (n= 11, 12, 12, 9) | 0.21 degree celsius | Standard Deviation 0.316 |
| Placebo | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 6 (n= 10, 12, 12, 10) | 0.05 degree celsius | Standard Deviation 0.328 |
| Placebo | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 8 (n= 14, 14, 13, 13) | 0.10 degree celsius | Standard Deviation 0.332 |
| Placebo | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Baseline (n= 14, 15, 16, 14) | 36.49 degree celsius | Standard Deviation 0.363 |
| Placebo | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 3 (n= 12, 12, 14, 10) | -0.04 degree celsius | Standard Deviation 0.391 |
| Placebo | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 1 (n= 14, 15, 16, 14) | -0.01 degree celsius | Standard Deviation 0.264 |
| Placebo | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 4 (n= 12, 12, 12, 10) | -0.07 degree celsius | Standard Deviation 0.467 |
| Placebo | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 2 (n= 13, 13, 14, 10) | -0.04 degree celsius | Standard Deviation 0.366 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 4 (n= 12, 12, 12, 10) | -0.21 degree celsius | Standard Deviation 0.362 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 5 (n= 11, 12, 12, 9) | 0.07 degree celsius | Standard Deviation 0.318 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Baseline (n= 14, 15, 16, 14) | 36.59 degree celsius | Standard Deviation 0.274 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 2 (n= 13, 13, 14, 10) | -0.22 degree celsius | Standard Deviation 0.397 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 3 (n= 12, 12, 14, 10) | -0.21 degree celsius | Standard Deviation 0.51 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 6 (n= 10, 12, 12, 10) | -0.00 degree celsius | Standard Deviation 0.292 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 8 (n= 14, 14, 13, 13) | -0.01 degree celsius | Standard Deviation 0.361 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 1 (n= 14, 15, 16, 14) | -0.03 degree celsius | Standard Deviation 0.322 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 2 (n= 13, 13, 14, 10) | -0.05 degree celsius | Standard Deviation 0.509 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 3 (n= 12, 12, 14, 10) | -0.11 degree celsius | Standard Deviation 0.287 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 8 (n= 14, 14, 13, 13) | -0.05 degree celsius | Standard Deviation 0.326 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 1 (n= 14, 15, 16, 14) | 0.00 degree celsius | Standard Deviation 0.265 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Baseline (n= 14, 15, 16, 14) | 36.67 degree celsius | Standard Deviation 0.282 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 4 (n= 12, 12, 12, 10) | -0.02 degree celsius | Standard Deviation 0.346 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 5 (n= 11, 12, 12, 9) | 0.01 degree celsius | Standard Deviation 0.305 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 6 (n= 10, 12, 12, 10) | -0.07 degree celsius | Standard Deviation 0.269 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 6 (n= 10, 12, 12, 10) | 0.00 degree celsius | Standard Deviation 0.39 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 1 (n= 14, 15, 16, 14) | -0.17 degree celsius | Standard Deviation 0.271 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 2 (n= 13, 13, 14, 10) | -0.05 degree celsius | Standard Deviation 0.273 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 8 (n= 14, 14, 13, 13) | 0.07 degree celsius | Standard Deviation 0.426 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 3 (n= 12, 12, 14, 10) | 0.09 degree celsius | Standard Deviation 0.501 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 4 (n= 12, 12, 12, 10) | -0.12 degree celsius | Standard Deviation 0.477 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 5 (n= 11, 12, 12, 9) | 0.13 degree celsius | Standard Deviation 0.443 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 | Baseline (n= 14, 15, 16, 14) | 36.57 degree celsius | Standard Deviation 0.433 |
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.
Time frame: Baseline, Week 2, 4, 8 (early termination)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | LDL-C: Change at Week 8 (n= 7, 11, 10, 8) | 7.14 milligram per deciliter (mg/dL) | Standard Deviation 20.659 |
| Placebo | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Triglycerides: Baseline (n= 14, 15, 16, 14) | 116.64 milligram per deciliter (mg/dL) | Standard Deviation 47.49 |
| Placebo | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | HDL-C: Change at Week 2 (n= 13, 14, 14, 12) | -1.54 milligram per deciliter (mg/dL) | Standard Deviation 7.881 |
| Placebo | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | LDL-C: Change at Week 2 (n= 13, 14, 14, 12) | -6.31 milligram per deciliter (mg/dL) | Standard Deviation 16.825 |
| Placebo | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Baseline: (n= 14, 15. 16, 14) | 119.07 milligram per deciliter (mg/dL) | Standard Deviation 24.78 |
| Placebo | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Triglycerides: Change at Week 4 (n=12, 12, 12, 10) | 0.67 milligram per deciliter (mg/dL) | Standard Deviation 42.47 |
| Placebo | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | LDL-C: Change at Week 4 (n= 12, 12, 12, 10) | -2.50 milligram per deciliter (mg/dL) | Standard Deviation 11.35 |
| Placebo | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Triglycerides: Change at Week 8 (n= 7, 11, 10, 8) | 48.71 milligram per deciliter (mg/dL) | Standard Deviation 102.301 |
| Placebo | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Cholesterol: Change at Week 2 (n= 13, 14, 14 12) | -0.77 milligram per deciliter (mg/dL) | Standard Deviation 14.8 |
| Placebo | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Cholesterol: Baseline (n= 14, 15, 16, 14) | 195.43 milligram per deciliter (mg/dL) | Standard Deviation 30.137 |
| Placebo | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Cholesterol: Change at Week 4 (n= 12, 12, 12, 10) | -3.50 milligram per deciliter (mg/dL) | Standard Deviation 20.174 |
| Placebo | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Triglycerides: Change at Week 2 (n= 13, 14, 14 12) | 35.85 milligram per deciliter (mg/dL) | Standard Deviation 49.173 |
| Placebo | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | HDL-C: Change at Week 8 (n= 7, 11, 10, 8) | -2.43 milligram per deciliter (mg/dL) | Standard Deviation 10.737 |
| Placebo | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | HDL-C: Change at Week 4 (n= 12, 12, 12, 10) | -1.00 milligram per deciliter (mg/dL) | Standard Deviation 6.238 |
| Placebo | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Cholesterol: Change at Week 8 (n= 7, 11, 10, 8) | 9.86 milligram per deciliter (mg/dL) | Standard Deviation 24.361 |
| Placebo | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | HDL-C: Baseline (n= 14, 15, 16, 14) | 52.93 milligram per deciliter (mg/dL) | Standard Deviation 12.64 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Triglycerides: Change at Week 8 (n= 7, 11, 10, 8) | 41.09 milligram per deciliter (mg/dL) | Standard Deviation 68.405 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Baseline: (n= 14, 15. 16, 14) | 105.27 milligram per deciliter (mg/dL) | Standard Deviation 28.632 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | LDL-C: Change at Week 4 (n= 12, 12, 12, 10) | 26.75 milligram per deciliter (mg/dL) | Standard Deviation 26.455 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | HDL-C: Change at Week 2 (n= 13, 14, 14, 12) | 10.00 milligram per deciliter (mg/dL) | Standard Deviation 5.533 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Cholesterol: Change at Week 4 (n= 12, 12, 12, 10) | 40.08 milligram per deciliter (mg/dL) | Standard Deviation 25.062 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Cholesterol: Change at Week 8 (n= 7, 11, 10, 8) | 7.45 milligram per deciliter (mg/dL) | Standard Deviation 14.733 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Triglycerides: Change at Week 2 (n= 13, 14, 14 12) | 23.79 milligram per deciliter (mg/dL) | Standard Deviation 72.638 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Triglycerides: Change at Week 4 (n=12, 12, 12, 10) | 35.67 milligram per deciliter (mg/dL) | Standard Deviation 80.714 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | LDL-C: Change at Week 2 (n= 13, 14, 14, 12) | 18.50 milligram per deciliter (mg/dL) | Standard Deviation 31.035 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | LDL-C: Change at Week 8 (n= 7, 11, 10, 8) | 6.00 milligram per deciliter (mg/dL) | Standard Deviation 16.529 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | HDL-C: Baseline (n= 14, 15, 16, 14) | 46.47 milligram per deciliter (mg/dL) | Standard Deviation 11.23 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | HDL-C: Change at Week 4 (n= 12, 12, 12, 10) | 9.25 milligram per deciliter (mg/dL) | Standard Deviation 6.717 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | HDL-C: Change at Week 8 (n= 7, 11, 10, 8) | -2.36 milligram per deciliter (mg/dL) | Standard Deviation 2.73 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Cholesterol: Baseline (n= 14, 15, 16, 14) | 186.80 milligram per deciliter (mg/dL) | Standard Deviation 25.741 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Cholesterol: Change at Week 2 (n= 13, 14, 14 12) | 29.57 milligram per deciliter (mg/dL) | Standard Deviation 31.329 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Triglycerides: Baseline (n= 14, 15, 16, 14) | 175.00 milligram per deciliter (mg/dL) | Standard Deviation 74.971 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | HDL-C: Baseline (n= 14, 15, 16, 14) | 49.06 milligram per deciliter (mg/dL) | Standard Deviation 15.058 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Cholesterol: Baseline (n= 14, 15, 16, 14) | 188.75 milligram per deciliter (mg/dL) | Standard Deviation 32.298 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Cholesterol: Change at Week 8 (n= 7, 11, 10, 8) | -1.20 milligram per deciliter (mg/dL) | Standard Deviation 20.395 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | HDL-C: Change at Week 8 (n= 7, 11, 10, 8) | -0.40 milligram per deciliter (mg/dL) | Standard Deviation 6.275 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Triglycerides: Change at Week 8 (n= 7, 11, 10, 8) | 12.20 milligram per deciliter (mg/dL) | Standard Deviation 44.434 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Cholesterol: Change at Week 2 (n= 13, 14, 14 12) | 21.00 milligram per deciliter (mg/dL) | Standard Deviation 34.005 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | HDL-C: Change at Week 4 (n= 12, 12, 12, 10) | 12.25 milligram per deciliter (mg/dL) | Standard Deviation 10.437 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | LDL-C: Change at Week 4 (n= 12, 12, 12, 10) | 10.17 milligram per deciliter (mg/dL) | Standard Deviation 22.143 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | HDL-C: Change at Week 2 (n= 13, 14, 14, 12) | 10.64 milligram per deciliter (mg/dL) | Standard Deviation 9.295 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Baseline: (n= 14, 15. 16, 14) | 114.56 milligram per deciliter (mg/dL) | Standard Deviation 28.317 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Cholesterol: Change at Week 4 (n= 12, 12, 12, 10) | 27.25 milligram per deciliter (mg/dL) | Standard Deviation 22.919 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Triglycerides: Change at Week 2 (n= 13, 14, 14 12) | 35.86 milligram per deciliter (mg/dL) | Standard Deviation 47.337 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Triglycerides: Change at Week 4 (n=12, 12, 12, 10) | 24.00 milligram per deciliter (mg/dL) | Standard Deviation 66.766 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | LDL-C: Change at Week 2 (n= 13, 14, 14, 12) | 3.21 milligram per deciliter (mg/dL) | Standard Deviation 25.097 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | LDL-C: Change at Week 8 (n= 7, 11, 10, 8) | -3.20 milligram per deciliter (mg/dL) | Standard Deviation 12.072 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Triglycerides: Baseline (n= 14, 15, 16, 14) | 125.50 milligram per deciliter (mg/dL) | Standard Deviation 50.552 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Cholesterol: Change at Week 8 (n= 7, 11, 10, 8) | -10.88 milligram per deciliter (mg/dL) | Standard Deviation 23.991 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | LDL-C: Change at Week 8 (n= 7, 11, 10, 8) | -15.13 milligram per deciliter (mg/dL) | Standard Deviation 20.301 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Triglycerides: Baseline (n= 14, 15, 16, 14) | 134.21 milligram per deciliter (mg/dL) | Standard Deviation 53.903 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | HDL-C: Baseline (n= 14, 15, 16, 14) | 50.29 milligram per deciliter (mg/dL) | Standard Deviation 10.163 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | HDL-C: Change at Week 2 (n= 13, 14, 14, 12) | 14.00 milligram per deciliter (mg/dL) | Standard Deviation 8.113 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Cholesterol: Change at Week 4 (n= 12, 12, 12, 10) | 26.40 milligram per deciliter (mg/dL) | Standard Deviation 29.22 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | LDL-C: Change at Week 2 (n= 13, 14, 14, 12) | 26.92 milligram per deciliter (mg/dL) | Standard Deviation 24.748 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | HDL-C: Change at Week 4 (n= 12, 12, 12, 10) | 12.80 milligram per deciliter (mg/dL) | Standard Deviation 10.075 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | HDL-C: Change at Week 8 (n= 7, 11, 10, 8) | -5.00 milligram per deciliter (mg/dL) | Standard Deviation 6.234 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Triglycerides: Change at Week 4 (n=12, 12, 12, 10) | -7.30 milligram per deciliter (mg/dL) | Standard Deviation 44.144 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Cholesterol: Baseline (n= 14, 15, 16, 14) | 191.14 milligram per deciliter (mg/dL) | Standard Deviation 36.469 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Cholesterol: Change at Week 2 (n= 13, 14, 14 12) | 44.08 milligram per deciliter (mg/dL) | Standard Deviation 23.469 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Triglycerides: Change at Week 2 (n= 13, 14, 14 12) | 15.83 milligram per deciliter (mg/dL) | Standard Deviation 43.151 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Baseline: (n= 14, 15. 16, 14) | 113.93 milligram per deciliter (mg/dL) | Standard Deviation 31.77 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | Triglycerides: Change at Week 8 (n= 7, 11, 10, 8) | 46.50 milligram per deciliter (mg/dL) | Standard Deviation 62.198 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Fasting Lipids at Week 2, 4 and 8 | LDL-C: Change at Week 4 (n= 12, 12, 12, 10) | 15.20 milligram per deciliter (mg/dL) | Standard Deviation 30.904 |
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.
Time frame: Baseline, Week 1, 2, 3, 4, 8 (early termination)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 | Baseline (n= 14, 15, 16, 14) | 0.6056 mg/dL | Standard Deviation 1.0528 |
| Placebo | Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 | Change at Week 1 (n= 14, 15, 16, 14) | -0.1451 mg/dL | Standard Deviation 0.37322 |
| Placebo | Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 | Change at Week 4 (n= 11, 12, 12, 10) | -0.0284 mg/dL | Standard Deviation 0.64387 |
| Placebo | Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 | Change at Week 2 (n= 13, 14, 14, 12) | -0.1712 mg/dL | Standard Deviation 0.49223 |
| Placebo | Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 | Change at Week 3 (n= 12, 12, 15, 11) | 0.0323 mg/dL | Standard Deviation 0.61746 |
| Placebo | Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 | Change at Week 8 (n= 7, 11, 11, 8) | -0.5996 mg/dL | Standard Deviation 1.17921 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 | Change at Week 8 (n= 7, 11, 11, 8) | -0.2473 mg/dL | Standard Deviation 0.94249 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 | Change at Week 2 (n= 13, 14, 14, 12) | -0.4540 mg/dL | Standard Deviation 0.80459 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 | Baseline (n= 14, 15, 16, 14) | 0.6718 mg/dL | Standard Deviation 0.71527 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 | Change at Week 4 (n= 11, 12, 12, 10) | -0.4093 mg/dL | Standard Deviation 0.83169 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 | Change at Week 3 (n= 12, 12, 15, 11) | 1.2447 mg/dL | Standard Deviation 5.21627 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 | Change at Week 1 (n= 14, 15, 16, 14) | -0.5495 mg/dL | Standard Deviation 0.66033 |
| PF-04965842 400 mg Once Daily | Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 | Change at Week 8 (n= 7, 11, 11, 8) | 0.2521 mg/dL | Standard Deviation 0.53698 |
| PF-04965842 400 mg Once Daily | Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 | Baseline (n= 14, 15, 16, 14) | 0.3325 mg/dL | Standard Deviation 0.28854 |
| PF-04965842 400 mg Once Daily | Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 | Change at Week 1 (n= 14, 15, 16, 14) | -0.2288 mg/dL | Standard Deviation 0.26512 |
| PF-04965842 400 mg Once Daily | Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 | Change at Week 2 (n= 13, 14, 14, 12) | -0.1783 mg/dL | Standard Deviation 0.27518 |
| PF-04965842 400 mg Once Daily | Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 | Change at Week 3 (n= 12, 12, 15, 11) | -0.0471 mg/dL | Standard Deviation 0.45332 |
| PF-04965842 400 mg Once Daily | Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 | Change at Week 4 (n= 11, 12, 12, 10) | 0.1162 mg/dL | Standard Deviation 0.95838 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 | Change at Week 4 (n= 11, 12, 12, 10) | -0.0850 mg/dL | Standard Deviation 0.6341 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 | Change at Week 3 (n= 12, 12, 15, 11) | -0.2214 mg/dL | Standard Deviation 0.48102 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 | Change at Week 1 (n= 14, 15, 16, 14) | -0.3807 mg/dL | Standard Deviation 0.49723 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 | Change at Week 8 (n= 7, 11, 11, 8) | -0.0081 mg/dL | Standard Deviation 0.16782 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 | Baseline (n= 14, 15, 16, 14) | 0.4994 mg/dL | Standard Deviation 0.43345 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 | Change at Week 2 (n= 13, 14, 14, 12) | -0.3374 mg/dL | Standard Deviation 0.49736 |
Secondary
Change From Baseline in Lipid Ratios at Week 2, 4 and 8
The ratio of LDL-C/HDL-C was reported.
Time frame: Baseline, Week 2, 4, 8 (early termination)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Lipid Ratios at Week 2, 4 and 8 | LDL-C: HDL C; Change at Week 2 (n=13,14,14,12) | 0.02 ratio | Standard Deviation 0.449 |
| Placebo | Change From Baseline in Lipid Ratios at Week 2, 4 and 8 | LDL C: HDL C; Change at Week 8 (n=7,11,10, 8) | 0.37 ratio | Standard Deviation 0.381 |
| Placebo | Change From Baseline in Lipid Ratios at Week 2, 4 and 8 | LDL-C: HDL C; Baseline (n= 14,15,16,14) | 2.35 ratio | Standard Deviation 0.745 |
| Placebo | Change From Baseline in Lipid Ratios at Week 2, 4 and 8 | LDL C: HDL C; Change at Week 4 (n= 12, 12, 12, 10) | 0.01 ratio | Standard Deviation 0.218 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Lipid Ratios at Week 2, 4 and 8 | LDL C: HDL C; Change at Week 8 (n=7,11,10, 8) | 0.32 ratio | Standard Deviation 0.439 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Lipid Ratios at Week 2, 4 and 8 | LDL C: HDL C; Change at Week 4 (n= 12, 12, 12, 10) | 0.11 ratio | Standard Deviation 0.552 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Lipid Ratios at Week 2, 4 and 8 | LDL-C: HDL C; Change at Week 2 (n=13,14,14,12) | -0.05 ratio | Standard Deviation 0.593 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Lipid Ratios at Week 2, 4 and 8 | LDL-C: HDL C; Baseline (n= 14,15,16,14) | 2.39 ratio | Standard Deviation 0.915 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Lipid Ratios at Week 2, 4 and 8 | LDL C: HDL C; Change at Week 4 (n= 12, 12, 12, 10) | -0.30 ratio | Standard Deviation 0.468 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Lipid Ratios at Week 2, 4 and 8 | LDL C: HDL C; Change at Week 8 (n=7,11,10, 8) | -0.07 ratio | Standard Deviation 0.324 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Lipid Ratios at Week 2, 4 and 8 | LDL-C: HDL C; Change at Week 2 (n=13,14,14,12) | -0.33 ratio | Standard Deviation 0.384 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Lipid Ratios at Week 2, 4 and 8 | LDL-C: HDL C; Baseline (n= 14,15,16,14) | 2.48 ratio | Standard Deviation 0.735 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Lipid Ratios at Week 2, 4 and 8 | LDL C: HDL C; Change at Week 4 (n= 12, 12, 12, 10) | -0.07 ratio | Standard Deviation 0.813 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Lipid Ratios at Week 2, 4 and 8 | LDL-C: HDL C; Baseline (n= 14,15,16,14) | 2.37 ratio | Standard Deviation 0.912 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Lipid Ratios at Week 2, 4 and 8 | LDL C: HDL C; Change at Week 8 (n=7,11,10, 8) | -0.04 ratio | Standard Deviation 0.362 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Lipid Ratios at Week 2, 4 and 8 | LDL-C: HDL C; Change at Week 2 (n=13,14,14,12) | -0.03 ratio | Standard Deviation 0.367 |
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).
Time frame: Baseline, Week 1, 2, 3, 5, 6, 8
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 | Change at Week 8 (n= 8, 11, 11, 8) | -9.33 units on a scale | Standard Deviation 6.745 |
| Placebo | Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 | Change at Week 5 (n= 11, 12, 12, 9) | -8.69 units on a scale | Standard Deviation 5.314 |
| Placebo | Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 | Change at Week 1 (n= 14, 15, 16, 14) | -2.96 units on a scale | Standard Deviation 4.306 |
| Placebo | Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 | Change at Week 3 (n= 13, 12, 15, 11) | -5.38 units on a scale | Standard Deviation 7.033 |
| Placebo | Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 | Change at Week 6 (n= 11, 11, 10, 10) | -8.05 units on a scale | Standard Deviation 6.989 |
| Placebo | Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 | Change at Week 2 (n= 14, 14, 13, 12) | -5.26 units on a scale | Standard Deviation 5.205 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 | Change at Week 6 (n= 11, 11, 10, 10) | -12.00 units on a scale | Standard Deviation 4.901 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 | Change at Week 8 (n= 8, 11, 11, 8) | -8.38 units on a scale | Standard Deviation 4.933 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 | Change at Week 2 (n= 14, 14, 13, 12) | -5.80 units on a scale | Standard Deviation 4.915 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 | Change at Week 1 (n= 14, 15, 16, 14) | -5.13 units on a scale | Standard Deviation 4.902 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 | Change at Week 3 (n= 13, 12, 15, 11) | -7.44 units on a scale | Standard Deviation 5.824 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 | Change at Week 5 (n= 11, 12, 12, 9) | -11.68 units on a scale | Standard Deviation 5.262 |
| PF-04965842 400 mg Once Daily | Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 | Change at Week 2 (n= 14, 14, 13, 12) | -8.33 units on a scale | Standard Deviation 7.103 |
| PF-04965842 400 mg Once Daily | Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 | Change at Week 6 (n= 11, 11, 10, 10) | -12.13 units on a scale | Standard Deviation 9.576 |
| PF-04965842 400 mg Once Daily | Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 | Change at Week 5 (n= 11, 12, 12, 9) | -11.77 units on a scale | Standard Deviation 8.421 |
| PF-04965842 400 mg Once Daily | Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 | Change at Week 1 (n= 14, 15, 16, 14) | -4.79 units on a scale | Standard Deviation 4.9 |
| PF-04965842 400 mg Once Daily | Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 | Change at Week 8 (n= 8, 11, 11, 8) | -10.04 units on a scale | Standard Deviation 8.287 |
| PF-04965842 400 mg Once Daily | Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 | Change at Week 3 (n= 13, 12, 15, 11) | -10.77 units on a scale | Standard Deviation 8.048 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 | Change at Week 8 (n= 8, 11, 11, 8) | -10.75 units on a scale | Standard Deviation 6.382 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 | Change at Week 1 (n= 14, 15, 16, 14) | -5.46 units on a scale | Standard Deviation 4.965 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 | Change at Week 2 (n= 14, 14, 13, 12) | -8.51 units on a scale | Standard Deviation 5.86 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 | Change at Week 5 (n= 11, 12, 12, 9) | -14.17 units on a scale | Standard Deviation 6.483 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 | Change at Week 6 (n= 11, 11, 10, 10) | -11.80 units on a scale | Standard Deviation 6.678 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 | Change at Week 3 (n= 13, 12, 15, 11) | -12.61 units on a scale | Standard Deviation 4.461 |
Comparison: PF-04965842 200 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-4.73, 0.72]
Comparison: PF-04965842 400 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-4.99, 0.38]
Comparison: PF-04965842 200 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-6.45, -0.86]
Comparison: PF-04965842 200 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-4.49, 2.32]
Comparison: PF-04965842 400 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-7.23, -0.49]
Comparison: PF-04965842 200 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-8.65, -1.67]
Comparison: PF-04965842 200 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-6.07, 1.39]
Comparison: PF-04965842 400 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-9.78, -2.47]
Comparison: PF-04965842 200 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-13.22, -5.56]
Comparison: PF-04965842 200 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-6.71, 0.21]
Comparison: PF-04965842 400 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-6.4, 0.45]
Comparison: PF-04965842 200 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-12.24, -4.95]
Comparison: PF-04965842 200 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-7.89, -0.08]
Comparison: PF-04965842 400 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-7.68, 0.07]
Comparison: PF-04965842 200 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-11, -2.89]
Comparison: PF-04965842 200 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-5.65, 3.11]
Comparison: PF-04965842 400 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-7.18, 1.51]
Comparison: PF-04965842 200 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-11.15, -1.89]
Secondary
Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 5 (n= 11, 12, 12, 9) | 5.2 beats per minute (bpm) | Standard Deviation 12.75 |
| Placebo | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 4 (n= 12, 12, 12, 10) | -1.3 beats per minute (bpm) | Standard Deviation 9.69 |
| Placebo | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 8 (n= 14, 14, 13, 13) | 0.9 beats per minute (bpm) | Standard Deviation 11.96 |
| Placebo | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 2 (n= 13, 13, 14, 10) | 2.8 beats per minute (bpm) | Standard Deviation 9.97 |
| Placebo | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 6 (n= 11, 12, 12, 10) | 4.5 beats per minute (bpm) | Standard Deviation 12.36 |
| Placebo | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 3 (n= 12, 12, 14, 10) | 4.1 beats per minute (bpm) | Standard Deviation 15.09 |
| Placebo | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Baseline (n= 14, 15, 16, 14) | 67.6 beats per minute (bpm) | Standard Deviation 7.87 |
| Placebo | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 1 (n= 14, 15, 16, 14) | 1.0 beats per minute (bpm) | Standard Deviation 6.5 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Baseline (n= 14, 15, 16, 14) | 71.8 beats per minute (bpm) | Standard Deviation 11.85 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 2 (n= 13, 13, 14, 10) | -4.7 beats per minute (bpm) | Standard Deviation 9.39 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 1 (n= 14, 15, 16, 14) | -0.2 beats per minute (bpm) | Standard Deviation 8.51 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 6 (n= 11, 12, 12, 10) | -1.8 beats per minute (bpm) | Standard Deviation 11.46 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 3 (n= 12, 12, 14, 10) | -1.3 beats per minute (bpm) | Standard Deviation 10.76 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 8 (n= 14, 14, 13, 13) | -0.6 beats per minute (bpm) | Standard Deviation 13.87 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 5 (n= 11, 12, 12, 9) | 2.7 beats per minute (bpm) | Standard Deviation 10.44 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 4 (n= 12, 12, 12, 10) | -1.3 beats per minute (bpm) | Standard Deviation 12.89 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Baseline (n= 14, 15, 16, 14) | 72.2 beats per minute (bpm) | Standard Deviation 11.54 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 5 (n= 11, 12, 12, 9) | -0.8 beats per minute (bpm) | Standard Deviation 10.34 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 6 (n= 11, 12, 12, 10) | 2.4 beats per minute (bpm) | Standard Deviation 8.53 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 8 (n= 14, 14, 13, 13) | -5.3 beats per minute (bpm) | Standard Deviation 11.29 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 4 (n= 12, 12, 12, 10) | -4.7 beats per minute (bpm) | Standard Deviation 10.87 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 1 (n= 14, 15, 16, 14) | 0.0 beats per minute (bpm) | Standard Deviation 10.56 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 2 (n= 13, 13, 14, 10) | -2.4 beats per minute (bpm) | Standard Deviation 8.5 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 3 (n= 12, 12, 14, 10) | -1.5 beats per minute (bpm) | Standard Deviation 11.06 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 5 (n= 11, 12, 12, 9) | 7.8 beats per minute (bpm) | Standard Deviation 11.11 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 2 (n= 13, 13, 14, 10) | -2.8 beats per minute (bpm) | Standard Deviation 8.48 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 8 (n= 14, 14, 13, 13) | -1.2 beats per minute (bpm) | Standard Deviation 8.12 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 6 (n= 11, 12, 12, 10) | 4.7 beats per minute (bpm) | Standard Deviation 9.15 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 4 (n= 12, 12, 12, 10) | 0.5 beats per minute (bpm) | Standard Deviation 9.37 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 3 (n= 12, 12, 14, 10) | -2.3 beats per minute (bpm) | Standard Deviation 6.88 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 1 (n= 14, 15, 16, 14) | -4.3 beats per minute (bpm) | Standard Deviation 7.43 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Baseline (n= 14, 15, 16, 14) | 72.6 beats per minute (bpm) | Standard Deviation 9.64 |
Secondary
Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Baseline (n= 14, 15, 16, 13) | 16.2 respiration per minute (resp/min) | Standard Deviation 1.58 |
| Placebo | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 1 (n= 14, 15, 16, 13) | -0.5 respiration per minute (resp/min) | Standard Deviation 1.7 |
| Placebo | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 5 (n= 11, 12, 12, 8) | 0.1 respiration per minute (resp/min) | Standard Deviation 1.45 |
| Placebo | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 2 (n= 13, 13, 14, 9) | -0.5 respiration per minute (resp/min) | Standard Deviation 1.45 |
| Placebo | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 3 (n= 12, 12, 14, 9) | -0.3 respiration per minute (resp/min) | Standard Deviation 0.87 |
| Placebo | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 4 (n= 12, 12, 12, 9) | 0.2 respiration per minute (resp/min) | Standard Deviation 2.12 |
| Placebo | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 6 (n= 11, 12, 12, 9) | -0.4 respiration per minute (resp/min) | Standard Deviation 0.81 |
| Placebo | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 8 (n= 14, 14, 13, 12) | -0.3 respiration per minute (resp/min) | Standard Deviation 1.49 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Baseline (n= 14, 15, 16, 13) | 17.1 respiration per minute (resp/min) | Standard Deviation 3.67 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 3 (n= 12, 12, 14, 9) | -0.6 respiration per minute (resp/min) | Standard Deviation 1.51 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 1 (n= 14, 15, 16, 13) | 0.9 respiration per minute (resp/min) | Standard Deviation 1.98 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 5 (n= 11, 12, 12, 8) | 0.3 respiration per minute (resp/min) | Standard Deviation 2.3 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 8 (n= 14, 14, 13, 12) | -0.2 respiration per minute (resp/min) | Standard Deviation 2.01 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 2 (n= 13, 13, 14, 9) | 0.4 respiration per minute (resp/min) | Standard Deviation 1.71 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 4 (n= 12, 12, 12, 9) | -0.7 respiration per minute (resp/min) | Standard Deviation 1.72 |
| PF-04965842 200 Milligram (mg) Once Daily | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 6 (n= 11, 12, 12, 9) | 0.2 respiration per minute (resp/min) | Standard Deviation 1.34 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 4 (n= 12, 12, 12, 9) | -1.2 respiration per minute (resp/min) | Standard Deviation 1.75 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 6 (n= 11, 12, 12, 9) | -0.8 respiration per minute (resp/min) | Standard Deviation 1.54 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 1 (n= 14, 15, 16, 13) | -0.1 respiration per minute (resp/min) | Standard Deviation 0.81 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 2 (n= 13, 13, 14, 9) | -0.6 respiration per minute (resp/min) | Standard Deviation 1.82 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 3 (n= 12, 12, 14, 9) | -0.4 respiration per minute (resp/min) | Standard Deviation 1.69 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 5 (n= 11, 12, 12, 8) | -0.9 respiration per minute (resp/min) | Standard Deviation 1.78 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 8 (n= 14, 14, 13, 12) | -0.8 respiration per minute (resp/min) | Standard Deviation 1.3 |
| PF-04965842 400 mg Once Daily | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Baseline (n= 14, 15, 16, 13) | 16.3 respiration per minute (resp/min) | Standard Deviation 2.44 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 1 (n= 14, 15, 16, 13) | -0.3 respiration per minute (resp/min) | Standard Deviation 1.6 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 8 (n= 14, 14, 13, 12) | -1.0 respiration per minute (resp/min) | Standard Deviation 1.6 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 4 (n= 12, 12, 12, 9) | 0.0 respiration per minute (resp/min) | Standard Deviation 1.41 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Baseline (n= 14, 15, 16, 13) | 17.0 respiration per minute (resp/min) | Standard Deviation 2.16 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 2 (n= 13, 13, 14, 9) | 0.7 respiration per minute (resp/min) | Standard Deviation 2.65 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 3 (n= 12, 12, 14, 9) | 0.2 respiration per minute (resp/min) | Standard Deviation 1.56 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 6 (n= 11, 12, 12, 9) | -0.2 respiration per minute (resp/min) | Standard Deviation 1.2 |
| PF-04965842 200 mg Twice Daily | Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 5 (n= 11, 12, 12, 8) | -0.6 respiration per minute (resp/min) | Standard Deviation 1.92 |
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.
Time frame: Baseline up to Week 8 (early termination)
Population: The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Reporting Clinically Significant Change From Baseline in Cytomegalovirus (CMV) Values | 0 participants |
| PF-04965842 200 Milligram (mg) Once Daily | Number of Participants Reporting Clinically Significant Change From Baseline in Cytomegalovirus (CMV) Values | 0 participants |
| PF-04965842 400 mg Once Daily | Number of Participants Reporting Clinically Significant Change From Baseline in Cytomegalovirus (CMV) Values | 0 participants |
| PF-04965842 200 mg Twice Daily | Number of Participants Reporting Clinically Significant Change From Baseline in Cytomegalovirus (CMV) Values | 0 participants |
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.
Time frame: Baseline up to Week 8 (early termination)
Population: The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Reporting Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters | 0 participants |
| PF-04965842 200 Milligram (mg) Once Daily | Number of Participants Reporting Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters | 0 participants |
| PF-04965842 400 mg Once Daily | Number of Participants Reporting Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters | 0 participants |
| PF-04965842 200 mg Twice Daily | Number of Participants Reporting Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters | 0 participants |
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.
Time frame: Baseline up to Week 8 (early termination)
Population: The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Reporting Clinically Significant Change From Baseline in Epstein-Barr Virus (EBV) Values | 0 participants |
| PF-04965842 200 Milligram (mg) Once Daily | Number of Participants Reporting Clinically Significant Change From Baseline in Epstein-Barr Virus (EBV) Values | 0 participants |
| PF-04965842 400 mg Once Daily | Number of Participants Reporting Clinically Significant Change From Baseline in Epstein-Barr Virus (EBV) Values | 0 participants |
| PF-04965842 200 mg Twice Daily | Number of Participants Reporting Clinically Significant Change From Baseline in Epstein-Barr Virus (EBV) Values | 0 participants |
Secondary
Number of Participants Reporting Clinically Significant Change From Baseline in Heart Rate
Time frame: Baseline up to Week 8 (early termination)
Population: The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Reporting Clinically Significant Change From Baseline in Heart Rate | 0 bpm |
| PF-04965842 200 Milligram (mg) Once Daily | Number of Participants Reporting Clinically Significant Change From Baseline in Heart Rate | 0 bpm |
| PF-04965842 400 mg Once Daily | Number of Participants Reporting Clinically Significant Change From Baseline in Heart Rate | 0 bpm |
| PF-04965842 200 mg Twice Daily | Number of Participants Reporting Clinically Significant Change From Baseline in Heart Rate | 0 bpm |
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.
Time frame: Baseline up to Week 8 (early termination)
Population: The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Reporting Clinically Significant Change From Baseline in Herpes Simplex Virus Deoxyribonucleic Acid (HSV DNA) Values | 0 participants |
| PF-04965842 200 Milligram (mg) Once Daily | Number of Participants Reporting Clinically Significant Change From Baseline in Herpes Simplex Virus Deoxyribonucleic Acid (HSV DNA) Values | 0 participants |
| PF-04965842 400 mg Once Daily | Number of Participants Reporting Clinically Significant Change From Baseline in Herpes Simplex Virus Deoxyribonucleic Acid (HSV DNA) Values | 0 participants |
| PF-04965842 200 mg Twice Daily | Number of Participants Reporting Clinically Significant Change From Baseline in Herpes Simplex Virus Deoxyribonucleic Acid (HSV DNA) Values | 0 participants |
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.
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 8
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 3 (n= 13, 12, 15, 11) | 23.1 percentage of participants |
| Placebo | Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 2 (n= 14, 14, 13, 12) | 21.4 percentage of participants |
| Placebo | Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 1 (n= 14, 15, 16, 14) | 7.1 percentage of participants |
| Placebo | Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 6 (n= 11, 11, 10, 10) | 45.5 percentage of participants |
| Placebo | Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 5 (n= 11, 12, 12, 9) | 54.5 percentage of participants |
| Placebo | Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 4 (n= 12, 12, 12, 10) | 25.0 percentage of participants |
| Placebo | Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 8 (n= 8, 11, 11, 8) | 50.0 percentage of participants |
| PF-04965842 200 Milligram (mg) Once Daily | Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 1 (n= 14, 15, 16, 14) | 6.7 percentage of participants |
| PF-04965842 200 Milligram (mg) Once Daily | Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 2 (n= 14, 14, 13, 12) | 7.1 percentage of participants |
| PF-04965842 200 Milligram (mg) Once Daily | Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 6 (n= 11, 11, 10, 10) | 81.8 percentage of participants |
| PF-04965842 200 Milligram (mg) Once Daily | Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 3 (n= 13, 12, 15, 11) | 25.0 percentage of participants |
| PF-04965842 200 Milligram (mg) Once Daily | Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 4 (n= 12, 12, 12, 10) | 66.7 percentage of participants |
| PF-04965842 200 Milligram (mg) Once Daily | Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 5 (n= 11, 12, 12, 9) | 66.7 percentage of participants |
| PF-04965842 200 Milligram (mg) Once Daily | Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 8 (n= 8, 11, 11, 8) | 45.5 percentage of participants |
| PF-04965842 400 mg Once Daily | Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 2 (n= 14, 14, 13, 12) | 23.1 percentage of participants |
| PF-04965842 400 mg Once Daily | Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 4 (n= 12, 12, 12, 10) | 66.7 percentage of participants |
| PF-04965842 400 mg Once Daily | Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 5 (n= 11, 12, 12, 9) | 58.3 percentage of participants |
| PF-04965842 400 mg Once Daily | Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 8 (n= 8, 11, 11, 8) | 63.6 percentage of participants |
| PF-04965842 400 mg Once Daily | Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 3 (n= 13, 12, 15, 11) | 46.7 percentage of participants |
| PF-04965842 400 mg Once Daily | Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 1 (n= 14, 15, 16, 14) | 25.0 percentage of participants |
| PF-04965842 400 mg Once Daily | Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 6 (n= 11, 11, 10, 10) | 60.0 percentage of participants |
| PF-04965842 200 mg Twice Daily | Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 1 (n= 14, 15, 16, 14) | 21.4 percentage of participants |
| PF-04965842 200 mg Twice Daily | Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 2 (n= 14, 14, 13, 12) | 41.7 percentage of participants |
| PF-04965842 200 mg Twice Daily | Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 3 (n= 13, 12, 15, 11) | 90.9 percentage of participants |
| PF-04965842 200 mg Twice Daily | Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 5 (n= 11, 12, 12, 9) | 100.0 percentage of participants |
| PF-04965842 200 mg Twice Daily | Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 8 (n= 8, 11, 11, 8) | 62.5 percentage of participants |
| PF-04965842 200 mg Twice Daily | Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 6 (n= 11, 11, 10, 10) | 70.0 percentage of participants |
| PF-04965842 200 mg Twice Daily | Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 4 (n= 12, 12, 12, 10) | 80.0 percentage of participants |
Comparison: PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-21.5, 19.6]
Comparison: PF-04965842 400 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-5.9, 40.3]
Comparison: PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-9.3, 38]Difference in Percentage Analysed using
Comparison: PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-38, 9.3]
Comparison: PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-25.4, 29.1]
Comparison: PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-10.2, 48.3]
Comparison: PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-26.7, 31]
Comparison: PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-6.9, 49.8]
Comparison: PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [36.4, 85.3]
Comparison: PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [7.6, 67.1]
Comparison: PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [7.6, 67.1]
Comparison: PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [19.7, 77.6]
Comparison: PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-21.4, 43.4]
Comparison: PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-29.4, 36.4]
Comparison: PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [17.1, 69]
Comparison: PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [1.9, 63.4]
Comparison: PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-21.4, 47]
Comparison: PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-11.8, 54.9]
Comparison: PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-40.4, 32.3]
Comparison: PF-04965842 400 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-23.7, 48.2]
Comparison: PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-28, 49.3]
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.
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 8
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | Week 2 (n= 14, 14, 13, 12) | 7.1 percentage of participants |
| Placebo | Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | Week 5 (n= 11, 12, 12, 9) | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | Week 4 (n= 12, 12, 12, 10) | 16.7 percentage of participants |
| Placebo | Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | Week 8 (n= 8, 11, 11, 8) | 25.0 percentage of participants |
| Placebo | Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | Week 1 (n= 14, 15, 16, 14) | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | Week 6 (n= 11, 11, 10, 10) | 18.2 percentage of participants |
| Placebo | Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | Week 3 (n= 13, 12, 15, 11) | 7.7 percentage of participants |
| PF-04965842 200 Milligram (mg) Once Daily | Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | Week 8 (n= 8, 11, 11, 8) | 9.1 percentage of participants |
| PF-04965842 200 Milligram (mg) Once Daily | Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | Week 2 (n= 14, 14, 13, 12) | 0.0 percentage of participants |
| PF-04965842 200 Milligram (mg) Once Daily | Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | Week 1 (n= 14, 15, 16, 14) | 0.0 percentage of participants |
| PF-04965842 200 Milligram (mg) Once Daily | Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | Week 4 (n= 12, 12, 12, 10) | 16.7 percentage of participants |
| PF-04965842 200 Milligram (mg) Once Daily | Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | Week 5 (n= 11, 12, 12, 9) | 25.0 percentage of participants |
| PF-04965842 200 Milligram (mg) Once Daily | Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | Week 6 (n= 11, 11, 10, 10) | 9.1 percentage of participants |
| PF-04965842 200 Milligram (mg) Once Daily | Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | Week 3 (n= 13, 12, 15, 11) | 0.0 percentage of participants |
| PF-04965842 400 mg Once Daily | Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | Week 3 (n= 13, 12, 15, 11) | 40.0 percentage of participants |
| PF-04965842 400 mg Once Daily | Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | Week 2 (n= 14, 14, 13, 12) | 15.4 percentage of participants |
| PF-04965842 400 mg Once Daily | Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | Week 5 (n= 11, 12, 12, 9) | 50.0 percentage of participants |
| PF-04965842 400 mg Once Daily | Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | Week 1 (n= 14, 15, 16, 14) | 0.0 percentage of participants |
| PF-04965842 400 mg Once Daily | Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | Week 4 (n= 12, 12, 12, 10) | 50.0 percentage of participants |
| PF-04965842 400 mg Once Daily | Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | Week 6 (n= 11, 11, 10, 10) | 60.0 percentage of participants |
| PF-04965842 400 mg Once Daily | Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | Week 8 (n= 8, 11, 11, 8) | 18.2 percentage of participants |
| PF-04965842 200 mg Twice Daily | Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | Week 5 (n= 11, 12, 12, 9) | 66.7 percentage of participants |
| PF-04965842 200 mg Twice Daily | Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | Week 1 (n= 14, 15, 16, 14) | 7.1 percentage of participants |
| PF-04965842 200 mg Twice Daily | Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | Week 2 (n= 14, 14, 13, 12) | 25.0 percentage of participants |
| PF-04965842 200 mg Twice Daily | Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | Week 8 (n= 8, 11, 11, 8) | 25.0 percentage of participants |
| PF-04965842 200 mg Twice Daily | Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | Week 6 (n= 11, 11, 10, 10) | 50.0 percentage of participants |
| PF-04965842 200 mg Twice Daily | Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | Week 4 (n= 12, 12, 12, 10) | 60.0 percentage of participants |
| PF-04965842 200 mg Twice Daily | Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 | Week 3 (n= 13, 12, 15, 11) | 36.4 percentage of participants |
Comparison: PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [0.8, 55.3]
Comparison: PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-10.2, 27]
Comparison: PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-27, 10.2]
Comparison: PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-14.4, 32.2]
Comparison: PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-6.7, 43.6]
Comparison: PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-28.8, 12.1]
Comparison: PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [5.4, 55.4]
Comparison: PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-27.3, 27.3]
Comparison: PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [1, 59.8]
Comparison: PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [8.8, 69.3]
Comparison: PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [2.1, 49.3]
Comparison: PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [25.4, 71.8]
Comparison: PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [39.2, 86.1]
Comparison: PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-36.3, 18.3]
Comparison: PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [6.2, 68.5]
Comparison: PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-2.9, 60.5]
Comparison: PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-47.8, 13.7]
Comparison: PF-04965842 400 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-40.6, 24.8]
Comparison: PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-36.4, 36.4]
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.
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 2 (n= 14, 14, 13, 12) | 7.1 percentage of participants |
| Placebo | Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 3 (n= 13, 12, 15, 11) | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 6 (n= 11, 11, 10, 10) | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 8 (n= 8, 11, 11, 8) | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 5 (n= 11, 12, 12, 9) | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 1 (n= 14, 15, 16, 14) | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 4 (n= 12, 12, 12, 10) | 0.0 percentage of participants |
| PF-04965842 200 Milligram (mg) Once Daily | Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 1 (n= 14, 15, 16, 14) | 0.0 percentage of participants |
| PF-04965842 200 Milligram (mg) Once Daily | Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 2 (n= 14, 14, 13, 12) | 0.0 percentage of participants |
| PF-04965842 200 Milligram (mg) Once Daily | Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 4 (n= 12, 12, 12, 10) | 0.0 percentage of participants |
| PF-04965842 200 Milligram (mg) Once Daily | Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 5 (n= 11, 12, 12, 9) | 0.0 percentage of participants |
| PF-04965842 200 Milligram (mg) Once Daily | Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 8 (n= 8, 11, 11, 8) | 0.0 percentage of participants |
| PF-04965842 200 Milligram (mg) Once Daily | Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 6 (n= 11, 11, 10, 10) | 0.0 percentage of participants |
| PF-04965842 200 Milligram (mg) Once Daily | Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 3 (n= 13, 12, 15, 11) | 0.0 percentage of participants |
| PF-04965842 400 mg Once Daily | Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 1 (n= 14, 15, 16, 14) | 0.0 percentage of participants |
| PF-04965842 400 mg Once Daily | Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 5 (n= 11, 12, 12, 9) | 25.0 percentage of participants |
| PF-04965842 400 mg Once Daily | Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 2 (n= 14, 14, 13, 12) | 7.7 percentage of participants |
| PF-04965842 400 mg Once Daily | Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 3 (n= 13, 12, 15, 11) | 13.3 percentage of participants |
| PF-04965842 400 mg Once Daily | Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 4 (n= 12, 12, 12, 10) | 33.3 percentage of participants |
| PF-04965842 400 mg Once Daily | Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 6 (n= 11, 11, 10, 10) | 20.0 percentage of participants |
| PF-04965842 400 mg Once Daily | Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 8 (n= 8, 11, 11, 8) | 0.0 percentage of participants |
| PF-04965842 200 mg Twice Daily | Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 6 (n= 11, 11, 10, 10) | 30.0 percentage of participants |
| PF-04965842 200 mg Twice Daily | Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 4 (n= 12, 12, 12, 10) | 60.0 percentage of participants |
| PF-04965842 200 mg Twice Daily | Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 8 (n= 8, 11, 11, 8) | 25.0 percentage of participants |
| PF-04965842 200 mg Twice Daily | Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 2 (n= 14, 14, 13, 12) | 8.3 percentage of participants |
| PF-04965842 200 mg Twice Daily | Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 1 (n= 14, 15, 16, 14) | 7.1 percentage of participants |
| PF-04965842 200 mg Twice Daily | Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 5 (n= 11, 12, 12, 9) | 44.4 percentage of participants |
| PF-04965842 200 mg Twice Daily | Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Week 3 (n= 13, 12, 15, 11) | 36.4 percentage of participants |
Comparison: PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-10.2, 27]
Comparison: PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-27, 10.2]
Comparison: PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-20.7, 22.8]
Comparison: PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-20.3, 24.8]
Comparison: PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-5.6, 33.8]
Comparison: PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [15.3, 61.1]
Comparison: PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [11.3, 57.3]
Comparison: PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [34.7, 80.9]
Comparison: PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [2.1, 49.3]
Comparison: PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [19.4, 70.2]
Comparison: PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-2.7, 46.6]
Comparison: PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [6.4, 56.4]
Comparison: PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-4.9, 54.9]
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.
Time frame: Week 1, 2, 3, 4, 5, 6, 8
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | Week 1 (n= 14, 15, 16, 14) | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | Week 8 (n= 8, 11, 11, 8) | 25.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | Week 3 (n= 13, 12, 15, 11) | 15.4 percentage of participants |
| Placebo | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | Week 2 (n= 14, 14, 13, 12) | 7.1 percentage of participants |
| Placebo | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | Week 6 (n= 11, 11, 10, 10) | 36.4 percentage of participants |
| Placebo | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | Week 4 (n= 12, 12, 12, 10) | 16.7 percentage of participants |
| Placebo | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | Week 5 (n= 11, 12, 12, 9) | 27.3 percentage of participants |
| PF-04965842 200 Milligram (mg) Once Daily | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | Week 2 (n= 14, 14, 13, 12) | 28.6 percentage of participants |
| PF-04965842 200 Milligram (mg) Once Daily | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | Week 1 (n= 14, 15, 16, 14) | 13.3 percentage of participants |
| PF-04965842 200 Milligram (mg) Once Daily | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | Week 8 (n= 8, 11, 11, 8) | 27.3 percentage of participants |
| PF-04965842 200 Milligram (mg) Once Daily | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | Week 5 (n= 11, 12, 12, 9) | 33.3 percentage of participants |
| PF-04965842 200 Milligram (mg) Once Daily | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | Week 4 (n= 12, 12, 12, 10) | 41.7 percentage of participants |
| PF-04965842 200 Milligram (mg) Once Daily | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | Week 3 (n= 13, 12, 15, 11) | 33.3 percentage of participants |
| PF-04965842 200 Milligram (mg) Once Daily | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | Week 6 (n= 11, 11, 10, 10) | 45.5 percentage of participants |
| PF-04965842 400 mg Once Daily | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | Week 5 (n= 11, 12, 12, 9) | 41.7 percentage of participants |
| PF-04965842 400 mg Once Daily | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | Week 2 (n= 14, 14, 13, 12) | 23.1 percentage of participants |
| PF-04965842 400 mg Once Daily | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | Week 3 (n= 13, 12, 15, 11) | 46.7 percentage of participants |
| PF-04965842 400 mg Once Daily | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | Week 4 (n= 12, 12, 12, 10) | 58.3 percentage of participants |
| PF-04965842 400 mg Once Daily | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | Week 1 (n= 14, 15, 16, 14) | 12.5 percentage of participants |
| PF-04965842 400 mg Once Daily | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | Week 6 (n= 11, 11, 10, 10) | 40.0 percentage of participants |
| PF-04965842 400 mg Once Daily | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | Week 8 (n= 8, 11, 11, 8) | 45.5 percentage of participants |
| PF-04965842 200 mg Twice Daily | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | Week 1 (n= 14, 15, 16, 14) | 7.1 percentage of participants |
| PF-04965842 200 mg Twice Daily | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | Week 4 (n= 12, 12, 12, 10) | 70.0 percentage of participants |
| PF-04965842 200 mg Twice Daily | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | Week 3 (n= 13, 12, 15, 11) | 45.5 percentage of participants |
| PF-04965842 200 mg Twice Daily | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | Week 2 (n= 14, 14, 13, 12) | 41.7 percentage of participants |
| PF-04965842 200 mg Twice Daily | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | Week 6 (n= 11, 11, 10, 10) | 50.0 percentage of participants |
| PF-04965842 200 mg Twice Daily | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | Week 5 (n= 11, 12, 12, 9) | 77.8 percentage of participants |
| PF-04965842 200 mg Twice Daily | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 | Week 8 (n= 8, 11, 11, 8) | 37.5 percentage of participants |
Comparison: PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-4.4, 33.8]
Comparison: PF-04965842 400 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-5.2, 32]
Comparison: PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-10.2, 27]
Comparison: PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-3.2, 45.5]
Comparison: PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-8.1, 40.7]
Comparison: PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [7.3, 59.4]
Comparison: PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-11.2, 45.5]
Comparison: PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [1.7, 55.7]
Comparison: PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-1.2, 57.4]Difference in Percentage Analysed using
Comparison: PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-6.4, 52.5]
Comparison: PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [8.7, 66.7]
Comparison: PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [18.5, 76.6]
Comparison: PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-26.1, 36.6]
Comparison: PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-18.9, 44.5]
Comparison: PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [12.9, 75.3]
Comparison: PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-25.2, 41.4]
Comparison: PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-30.5, 37.3]
Comparison: PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-21.9, 46.2]
Comparison: PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-33.2, 34.6]
Comparison: PF-04965842 400 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-17.6, 51.9]
Comparison: PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.90% CI: [-26.4, 48.1]
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).
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 8
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 1 (n= 14, 15, 16, 14) | -13.68 percent change | Standard Deviation 18.527 |
| Placebo | Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 6 (n= 11, 11, 10, 10) | -39.85 percent change | Standard Deviation 28.661 |
| Placebo | Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 5 (n= 11, 12, 12, 9) | -42.62 percent change | Standard Deviation 21.228 |
| Placebo | Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 2 (n= 14, 14, 13, 12) | -26.68 percent change | Standard Deviation 25.776 |
| Placebo | Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 8 (n= 8, 11, 11, 8) | -44.62 percent change | Standard Deviation 26.616 |
| Placebo | Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 3 (n= 13, 12, 15, 11) | -27.06 percent change | Standard Deviation 31.22 |
| Placebo | Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 4 (n= 12, 12, 12, 10) | -33.59 percent change | Standard Deviation 31.574 |
| PF-04965842 200 Milligram (mg) Once Daily | Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 6 (n= 11, 11, 10, 10) | -61.02 percent change | Standard Deviation 11.655 |
| PF-04965842 200 Milligram (mg) Once Daily | Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 4 (n= 12, 12, 12, 10) | -57.61 percent change | Standard Deviation 21.594 |
| PF-04965842 200 Milligram (mg) Once Daily | Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 3 (n= 13, 12, 15, 11) | -33.96 percent change | Standard Deviation 19.793 |
| PF-04965842 200 Milligram (mg) Once Daily | Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 5 (n= 11, 12, 12, 9) | -58.63 percent change | Standard Deviation 16.015 |
| PF-04965842 200 Milligram (mg) Once Daily | Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 8 (n= 8, 11, 11, 8) | -44.28 percent change | Standard Deviation 27.486 |
| PF-04965842 200 Milligram (mg) Once Daily | Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 1 (n= 14, 15, 16, 14) | -23.27 percent change | Standard Deviation 18.796 |
| PF-04965842 200 Milligram (mg) Once Daily | Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 2 (n= 14, 14, 13, 12) | -27.96 percent change | Standard Deviation 20.161 |
| PF-04965842 400 mg Once Daily | Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 4 (n= 12, 12, 12, 10) | -64.46 percent change | Standard Deviation 32.175 |
| PF-04965842 400 mg Once Daily | Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 2 (n= 14, 14, 13, 12) | -41.54 percent change | Standard Deviation 28.779 |
| PF-04965842 400 mg Once Daily | Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 1 (n= 14, 15, 16, 14) | -24.07 percent change | Standard Deviation 22.272 |
| PF-04965842 400 mg Once Daily | Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 3 (n= 13, 12, 15, 11) | -53.18 percent change | Standard Deviation 33.326 |
| PF-04965842 400 mg Once Daily | Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 5 (n= 11, 12, 12, 9) | -57.76 percent change | Standard Deviation 37.397 |
| PF-04965842 400 mg Once Daily | Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 6 (n= 11, 11, 10, 10) | -56.94 percent change | Standard Deviation 39.558 |
| PF-04965842 400 mg Once Daily | Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 8 (n= 8, 11, 11, 8) | -48.63 percent change | Standard Deviation 35.373 |
| PF-04965842 200 mg Twice Daily | Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 3 (n= 13, 12, 15, 11) | -73.37 percent change | Standard Deviation 22.569 |
| PF-04965842 200 mg Twice Daily | Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 8 (n= 8, 11, 11, 8) | -61.67 percent change | Standard Deviation 29.352 |
| PF-04965842 200 mg Twice Daily | Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 6 (n= 11, 11, 10, 10) | -69.15 percent change | Standard Deviation 26.871 |
| PF-04965842 200 mg Twice Daily | Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 2 (n= 14, 14, 13, 12) | -49.09 percent change | Standard Deviation 30.153 |
| PF-04965842 200 mg Twice Daily | Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 1 (n= 14, 15, 16, 14) | -30.99 percent change | Standard Deviation 28.557 |
| PF-04965842 200 mg Twice Daily | Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 5 (n= 11, 12, 12, 9) | -80.80 percent change | Standard Deviation 20.279 |
| PF-04965842 200 mg Twice Daily | Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 | Change at Week 4 (n= 12, 12, 12, 10) | -80.96 percent change | Standard Deviation 23.155 |
Comparison: PF-04965842 200 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-23.19, 4.56]
Comparison: PF-04965842 400 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-24.87, 2.5]
Comparison: PF-04965842 200 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-33.45, -4.99]
Comparison: PF-04965842 200 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-21.71, 13.11]
Comparison: PF-04965842 400 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-35.25, -0.82]
Comparison: PF-04965842 200 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-44.9, -9.23]
Comparison: PF-04965842 200 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-28.53, 8.39]
Comparison: PF-04965842 400 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-47.33, -11.13]
Comparison: PF-04965842 200 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-68.92, -31.05]
Comparison: PF-04965842 200 mg vs Placebo at Week 4: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-43.26, -5.24]
Comparison: PF-04965842 400 mg vs Placebo at Week 4: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-46.18, -8.75]
Comparison: PF-04965842 200 mg vs Placebo at Week 4: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-72.24, -33.02]
Comparison: PF-04965842 200 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-35.8, -0.15]LANCOVA
Comparison: PF-04965842 400 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-32.44, 2.88]
Comparison: PF-04965842 200 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-66.61, -29.27]
Comparison: PF-04965842 200 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-41, -2.49]
Comparison: PF-04965842 400 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-36.92, 1.42]
Comparison: PF-04965842 200 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-55.85, -15.9]
Comparison: PF-04965842 200 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-32.57, 11.07]
Comparison: PF-04965842 400 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-34.71, 8.64]
Comparison: PF-04965842 200 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.90% CI: [-57.44, -11.48]