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Trial record 12 of 811 for:    Psoriasis 4

Study to Evaluate PF-04965842 in Patients With Moderate to Severe Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02201524
Recruitment Status : Terminated (Study terminated 26 June 2015 due to changes in the drug development portfolio. This study was not terminated for reasons of safety and/or efficacy)
First Posted : July 28, 2014
Results First Posted : October 5, 2016
Last Update Posted : October 5, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Interventions Drug: PF-04965842
Other: Placebo
Enrollment 59
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo PF-04965842 200 Milligram (mg) Once Daily PF-04965842 400 mg Once Daily PF-04965842 200 mg Twice Daily
Hide Arm/Group Description Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28. Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28. Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28. Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
Period Title: Overall Study
Started 14 15 16 14
Completed 12 12 12 10
Not Completed 2 3 4 4
Reason Not Completed
Adverse Event             0             2             1             0
Insufficient clinical response             1             0             0             0
Lost to Follow-up             0             0             2             0
No longer meets eligibility criteria             0             0             0             2
Protocol Violation             0             0             0             1
Withdrawal by Subject             0             0             1             1
Other             1             1             0             0
Arm/Group Title Placebo PF-04965842 200 Milligram (mg) Once Daily PF-04965842 400 mg Once Daily PF-04965842 200 mg Twice Daily Total
Hide Arm/Group Description Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28. Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28. Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28. Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28. Total of all reporting groups
Overall Number of Baseline Participants 14 15 16 14 59
Hide Baseline Analysis Population Description
The full analysis set (FAS) included all randomized participants who received at least 1 dose of the randomized study drug (PF-04965842 or placebo).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 15 participants 16 participants 14 participants 59 participants
45.4  (10.8) 42.9  (12.3) 42.8  (11.6) 52.1  (9.7) 45.7  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 16 participants 14 participants 59 participants
Female
3
  21.4%
5
  33.3%
5
  31.3%
6
  42.9%
19
  32.2%
Male
11
  78.6%
10
  66.7%
11
  68.8%
8
  57.1%
40
  67.8%
1.Primary Outcome
Title Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo PF-04965842 200 Milligram (mg) Once Daily PF-04965842 400 mg Once Daily PF-04965842 200 mg Twice Daily
Hide Arm/Group Description:
Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
Overall Number of Participants Analyzed 14 15 16 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n= 14, 15, 16, 14) 20.05  (3.993) 20.34  (7.089) 19.21  (4.426) 18.01  (5.507)
Change at Week 4 (n= 12, 12, 12, 10) -6.61  (7.252) -11.73  (6.658) -13.09  (7.979) -13.71  (6.248)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square (LS) mean difference
Estimated Value -5.08
Confidence Interval (2-Sided) 90%
-9.15 to -1.01
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.420
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments PF-04965842 400 mg vs Placebo: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -5.61
Confidence Interval (2-Sided) 90%
-9.61 to -1.62
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.375
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments PF-04965842 200 mg vs Placebo: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -9.98
Confidence Interval (2-Sided) 90%
-14.19 to -5.77
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.506
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo PF-04965842 200 Milligram (mg) Once Daily PF-04965842 400 mg Once Daily PF-04965842 200 mg Twice Daily
Hide Arm/Group Description:
Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
Overall Number of Participants Analyzed 14 15 16 14
Mean (Standard Deviation)
Unit of Measure: percent change
Change at Week 1 (n= 14, 15, 16, 14) -13.68  (18.527) -23.27  (18.796) -24.07  (22.272) -30.99  (28.557)
Change at Week 2 (n= 14, 14, 13, 12) -26.68  (25.776) -27.96  (20.161) -41.54  (28.779) -49.09  (30.153)
Change at Week 3 (n= 13, 12, 15, 11) -27.06  (31.220) -33.96  (19.793) -53.18  (33.326) -73.37  (22.569)
Change at Week 4 (n= 12, 12, 12, 10) -33.59  (31.574) -57.61  (21.594) -64.46  (32.175) -80.96  (23.155)
Change at Week 5 (n= 11, 12, 12, 9) -42.62  (21.228) -58.63  (16.015) -57.76  (37.397) -80.80  (20.279)
Change at Week 6 (n= 11, 11, 10, 10) -39.85  (28.661) -61.02  (11.655) -56.94  (39.558) -69.15  (26.871)
Change at Week 8 (n= 8, 11, 11, 8) -44.62  (26.616) -44.28  (27.486) -48.63  (35.373) -61.67  (29.352)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -9.32
Confidence Interval (2-Sided) 90%
-23.19 to 4.56
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.291
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -11.19
Confidence Interval (2-Sided) 90%
-24.87 to 2.50
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.177
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -19.22
Confidence Interval (2-Sided) 90%
-33.45 to -4.99
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.504
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -4.30
Confidence Interval (2-Sided) 90%
-21.71 to 13.11
Parameter Dispersion
Type: Standard Error of the mean
Value: 10.387
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -18.04
Confidence Interval (2-Sided) 90%
-35.25 to -0.82
Parameter Dispersion
Type: Standard Error of the mean
Value: 10.273
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -27.07
Confidence Interval (2-Sided) 90%
-44.90 to -9.23
Parameter Dispersion
Type: Standard Error of the mean
Value: 10.646
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -10.07
Confidence Interval (2-Sided) 90%
-28.53 to 8.39
Parameter Dispersion
Type: Standard Error of the mean
Value: 11.013
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -29.23
Confidence Interval (2-Sided) 90%
-47.33 to -11.13
Parameter Dispersion
Type: Standard Error of the mean
Value: 10.793
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -49.99
Confidence Interval (2-Sided) 90%
-68.92 to -31.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 11.299
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -24.25
Confidence Interval (2-Sided) 90%
-43.26 to -5.24
Parameter Dispersion
Type: Standard Error of the mean
Value: 11.330
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -27.47
Confidence Interval (2-Sided) 90%
-46.18 to -8.75
Parameter Dispersion
Type: Standard Error of the mean
Value: 11.155
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -52.63
Confidence Interval (2-Sided) 90%
-72.24 to -33.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 11.697
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method LANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -17.98
Confidence Interval (2-Sided) 90%
-35.80 to -0.15
Parameter Dispersion
Type: Standard Error of the mean
Value: 10.605
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -14.78
Confidence Interval (2-Sided) 90%
-32.44 to 2.88
Parameter Dispersion
Type: Standard Error of the mean
Value: 10.513
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -47.94
Confidence Interval (2-Sided) 90%
-66.61 to -29.27
Parameter Dispersion
Type: Standard Error of the mean
Value: 11.125
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean
Estimated Value -21.75
Confidence Interval (2-Sided) 90%
-41.00 to -2.49
Parameter Dispersion
Type: Standard Error of the mean
Value: 11.459
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -17.75
Confidence Interval (2-Sided) 90%
-36.92 to 1.42
Parameter Dispersion
Type: Standard Error of the mean
Value: 11.416
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -35.88
Confidence Interval (2-Sided) 90%
-55.85 to -15.90
Parameter Dispersion
Type: Standard Error of the mean
Value: 11.893
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -10.75
Confidence Interval (2-Sided) 90%
-32.57 to 11.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 12.985
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -13.03
Confidence Interval (2-Sided) 90%
-34.71 to 8.64
Parameter Dispersion
Type: Standard Error of the mean
Value: 12.902
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -34.46
Confidence Interval (2-Sided) 90%
-57.44 to -11.48
Parameter Dispersion
Type: Standard Error of the mean
Value: 13.690
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo PF-04965842 200 Milligram (mg) Once Daily PF-04965842 400 mg Once Daily PF-04965842 200 mg Twice Daily
Hide Arm/Group Description:
Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
Overall Number of Participants Analyzed 14 15 16 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Week 1 (n= 14, 15, 16, 14) -2.96  (4.306) -5.13  (4.902) -4.79  (4.900) -5.46  (4.965)
Change at Week 2 (n= 14, 14, 13, 12) -5.26  (5.205) -5.80  (4.915) -8.33  (7.103) -8.51  (5.860)
Change at Week 3 (n= 13, 12, 15, 11) -5.38  (7.033) -7.44  (5.824) -10.77  (8.048) -12.61  (4.461)
Change at Week 5 (n= 11, 12, 12, 9) -8.69  (5.314) -11.68  (5.262) -11.77  (8.421) -14.17  (6.483)
Change at Week 6 (n= 11, 11, 10, 10) -8.05  (6.989) -12.00  (4.901) -12.13  (9.576) -11.80  (6.678)
Change at Week 8 (n= 8, 11, 11, 8) -9.33  (6.745) -8.38  (4.933) -10.04  (8.287) -10.75  (6.382)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -2.01
Confidence Interval (2-Sided) 90%
-4.73 to 0.72
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.626
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -2.31
Confidence Interval (2-Sided) 90%
-4.99 to 0.38
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.603
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -3.65
Confidence Interval (2-Sided) 90%
-6.45 to -0.86
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.668
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.08
Confidence Interval (2-Sided) 90%
-4.49 to 2.32
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.032
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -3.86
Confidence Interval (2-Sided) 90%
-7.23 to -0.49
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.011
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -5.16
Confidence Interval (2-Sided) 90%
-8.65 to -1.67
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.084
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -2.34
Confidence Interval (2-Sided) 90%
-6.07 to 1.39
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.224
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -6.12
Confidence Interval (2-Sided) 90%
-9.78 to -2.47
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.177
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -9.39
Confidence Interval (2-Sided) 90%
-13.22 to -5.56
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.286
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -3.25
Confidence Interval (2-Sided) 90%
-6.71 to 0.21
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.054
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -2.98
Confidence Interval (2-Sided) 90%
-6.40 to 0.45
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.035
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -8.59
Confidence Interval (2-Sided) 90%
-12.24 to -4.95
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.167
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -3.98
Confidence Interval (2-Sided) 90%
-7.89 to -0.08
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.321
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -3.80
Confidence Interval (2-Sided) 90%
-7.68 to 0.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.304
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -6.94
Confidence Interval (2-Sided) 90%
-11.00 to -2.89
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.412
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.27
Confidence Interval (2-Sided) 90%
-5.65 to 3.11
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.607
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -2.83
Confidence Interval (2-Sided) 90%
-7.18 to 1.51
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.586
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -6.52
Confidence Interval (2-Sided) 90%
-11.15 to -1.89
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.758
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo PF-04965842 200 Milligram (mg) Once Daily PF-04965842 400 mg Once Daily PF-04965842 200 mg Twice Daily
Hide Arm/Group Description:
Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
Overall Number of Participants Analyzed 14 15 16 14
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
Week 1 (n= 14, 15, 16, 14)
7.1
(0.4 to 29.7)
6.7
(0.3 to 27.9)
25.0
(9.0 to 48.4)
21.4
(6.1 to 46.6)
Week 2 (n= 14, 14, 13, 12)
21.4
(6.1 to 46.6)
7.1
(0.4 to 29.7)
23.1
(6.6 to 49.5)
41.7
(18.1 to 68.5)
Week 3 (n= 13, 12, 15, 11)
23.1
(6.6 to 49.5)
25.0
(7.2 to 52.7)
46.7
(24.4 to 70.0)
90.9
(63.6 to 99.5)
Week 4 (n= 12, 12, 12, 10)
25.0
(7.2 to 52.7)
66.7
(39.1 to 87.7)
66.7
(39.1 to 87.7)
80.0
(49.3 to 96.3)
Week 5 (n= 11, 12, 12, 9)
54.5
(27.1 to 80.0)
66.7
(39.1 to 87.7)
58.3
(31.5 to 81.9)
100.0
(71.7 to 100)
Week 6 (n= 11, 11, 10, 10)
45.5
(20.0 to 72.9)
81.8
(53.0 to 96.7)
60.0
(30.4 to 85.0)
70.0
(39.3 to 91.3)
Week 8 (n= 8, 11, 11, 8)
50.0
(19.3 to 80.7)
45.5
(20.0 to 72.9)
63.6
(35.0 to 86.5)
62.5
(28.9 to 88.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -0.5
Confidence Interval (2-Sided) 90%
-21.5 to 19.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments PF-04965842 400 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 17.9
Confidence Interval (2-Sided) 90%
-5.9 to 40.3
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Difference in Percentage Analysed using
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 14.3
Confidence Interval (2-Sided) 90%
-9.3 to 38.0
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -14.3
Confidence Interval (2-Sided) 90%
-38.0 to 9.3
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 1.6
Confidence Interval (2-Sided) 90%
-25.4 to 29.1
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 20.2
Confidence Interval (2-Sided) 90%
-10.2 to 48.3
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 1.9
Confidence Interval (2-Sided) 90%
-26.7 to 31.0
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 23.6
Confidence Interval (2-Sided) 90%
-6.9 to 49.8
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 67.8
Confidence Interval (2-Sided) 90%
36.4 to 85.3
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 41.7
Confidence Interval (2-Sided) 90%
7.6 to 67.1
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 41.7
Confidence Interval (2-Sided) 90%
7.6 to 67.1
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 55.0
Confidence Interval (2-Sided) 90%
19.7 to 77.6
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 12.1
Confidence Interval (2-Sided) 90%
-21.4 to 43.4
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 3.8
Confidence Interval (2-Sided) 90%
-29.4 to 36.4
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 45.5
Confidence Interval (2-Sided) 90%
17.1 to 69.0
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 36.4
Confidence Interval (2-Sided) 90%
1.9 to 63.4
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 14.5
Confidence Interval (2-Sided) 90%
-21.4 to 47.0
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 24.5
Confidence Interval (2-Sided) 90%
-11.8 to 54.9
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -4.5
Confidence Interval (2-Sided) 90%
-40.4 to 32.3
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments PF-04965842 400 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 13.6
Confidence Interval (2-Sided) 90%
-23.7 to 48.2
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 12.5
Confidence Interval (2-Sided) 90%
-28.0 to 49.3
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo PF-04965842 200 Milligram (mg) Once Daily PF-04965842 400 mg Once Daily PF-04965842 200 mg Twice Daily
Hide Arm/Group Description:
Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
Overall Number of Participants Analyzed 14 15 16 14
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
Week 1 (n= 14, 15, 16, 14)
0.0
(0.0 to 19.3)
0.0
(0.0 to 18.1)
0.0
(0.0 to 17.1)
7.1
(0.4 to 29.7)
Week 2 (n= 14, 14, 13, 12)
7.1
(0.4 to 29.7)
0.0
(0.0 to 19.3)
15.4
(2.8 to 41.0)
25.0
(7.2 to 52.7)
Week 3 (n= 13, 12, 15, 11)
7.7
(0.4 to 31.6)
0.0
(0.0 to 22.1)
40.0
(19.1 to 64.0)
36.4
(13.5 to 65.0)
Week 4 (n= 12, 12, 12, 10)
16.7
(3.0 to 43.8)
16.7
(3.0 to 43.8)
50.0
(24.5 to 75.5)
60.0
(30.4 to 85.0)
Week 5 (n= 11, 12, 12, 9)
0.0
(0.0 to 23.8)
25.0
(7.2 to 52.7)
50.0
(24.5 to 75.5)
66.7
(34.5 to 90.2)
Week 6 (n= 11, 11, 10, 10)
18.2
(3.3 to 47.0)
9.1
(0.5 to 36.4)
60.0
(30.4 to 85.0)
50.0
(22.2 to 77.8)
Week 8 (n= 8, 11, 11, 8)
25.0
(4.6 to 60.0)
9.1
(0.5 to 36.4)
18.2
(3.3 to 47.0)
25.0
(4.6 to 60.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 7.1
Confidence Interval (2-Sided) 90%
-10.2 to 27.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -7.1
Confidence Interval (2-Sided) 90%
-27.0 to 10.2
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 8.2
Confidence Interval (2-Sided) 90%
-14.4 to 32.2
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 17.9
Confidence Interval (2-Sided) 90%
-6.7 to 43.6
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -7.7
Confidence Interval (2-Sided) 90%
-28.8 to 12.1
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 32.3
Confidence Interval (2-Sided) 90%
5.4 to 55.4
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 28.7
Confidence Interval (2-Sided) 90%
0.8 to 55.3
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 0.0
Confidence Interval (2-Sided) 90%
-27.3 to 27.3
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 33.3
Confidence Interval (2-Sided) 90%
1.0 to 59.8
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 43.3
Confidence Interval (2-Sided) 90%
8.8 to 69.3
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 25.0
Confidence Interval (2-Sided) 90%
2.1 to 49.3
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 50.0
Confidence Interval (2-Sided) 90%
25.4 to 71.8
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 66.7
Confidence Interval (2-Sided) 90%
39.2 to 86.1
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -9.1
Confidence Interval (2-Sided) 90%
-36.3 to 18.3
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 41.8
Confidence Interval (2-Sided) 90%
6.2 to 68.5
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 31.8
Confidence Interval (2-Sided) 90%
-2.9 to 60.5
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -15.9
Confidence Interval (2-Sided) 90%
-47.8 to 13.7
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments PF-04965842 400 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -6.8
Confidence Interval (2-Sided) 90%
-40.6 to 24.8
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 0.0
Confidence Interval (2-Sided) 90%
-36.4 to 36.4
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo PF-04965842 200 Milligram (mg) Once Daily PF-04965842 400 mg Once Daily PF-04965842 200 mg Twice Daily
Hide Arm/Group Description:
Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
Overall Number of Participants Analyzed 14 15 16 14
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
Week 1 (n= 14, 15, 16, 14)
0.0
(0.0 to 19.3)
0.0
(0.0 to 18.1)
0.0
(0.0 to 17.1)
7.1
(0.4 to 29.7)
Week 2 (n= 14, 14, 13, 12)
7.1
(0.4 to 29.7)
0.0
(0.0 to 19.3)
7.7
(0.4 to 31.6)
8.3
(0.4 to 33.9)
Week 3 (n= 13, 12, 15, 11)
0.0
(0.0 to 20.6)
0.0
(0.0 to 22.1)
13.3
(2.4 to 36.3)
36.4
(13.5 to 65.0)
Week 4 (n= 12, 12, 12, 10)
0.0
(0.0 to 22.1)
0.0
(0.0 to 22.1)
33.3
(12.3 to 60.9)
60.0
(30.4 to 85.0)
Week 5 (n= 11, 12, 12, 9)
0.0
(0.0 to 23.8)
0.0
(0.0 to 22.1)
25.0
(7.2 to 52.7)
44.4
(16.9 to 74.9)
Week 6 (n= 11, 11, 10, 10)
0.0
(0.0 to 23.8)
0.0
(0.0 to 23.8)
20.0
(3.7 to 50.7)
30.0
(8.7 to 60.7)
Week 8 (n= 8, 11, 11, 8)
0.0
(0.0 to 31.2)
0.0
(0.0 to 23.8)
0.0
(0.0 to 23.8)
25.0
(4.6 to 60.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 7.1
Confidence Interval (2-Sided) 90%
-10.2 to 27.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -7.1
Confidence Interval (2-Sided) 90%
-27.0 to 10.2
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 0.5
Confidence Interval (2-Sided) 90%
-20.7 to 22.8
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 1.2
Confidence Interval (2-Sided) 90%
-20.3 to 24.8
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 13.3
Confidence Interval (2-Sided) 90%
-5.6 to 33.8
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 36.4
Confidence Interval (2-Sided) 90%
15.3 to 61.1
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 33.3
Confidence Interval (2-Sided) 90%
11.3 to 57.3
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 60.0
Confidence Interval (2-Sided) 90%
34.7 to 80.9
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 25.0
Confidence Interval (2-Sided) 90%
2.1 to 49.3
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 44.4
Confidence Interval (2-Sided) 90%
19.4 to 70.2
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 20.0
Confidence Interval (2-Sided) 90%
-2.7 to 46.6
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 30.0
Confidence Interval (2-Sided) 90%
6.4 to 56.4
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 25.0
Confidence Interval (2-Sided) 90%
-4.9 to 54.9
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo PF-04965842 200 Milligram (mg) Once Daily PF-04965842 400 mg Once Daily PF-04965842 200 mg Twice Daily
Hide Arm/Group Description:
Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
Overall Number of Participants Analyzed 14 15 16 14
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
Week 1 (n= 14, 15, 16, 14)
0.0
(0.0 to 19.3)
13.3
(2.4 to 36.3)
12.5
(2.3 to 34.4)
7.1
(0.4 to 29.7)
Week 2 (n= 14, 14, 13, 12)
7.1
(0.4 to 29.7)
28.6
(10.4 to 54.0)
23.1
(6.6 to 49.5)
41.7
(18.1 to 68.5)
Week 3 (n= 13, 12, 15, 11)
15.4
(2.8 to 41.0)
33.3
(12.3 to 60.9)
46.7
(24.4 to 70.0)
45.5
(20.0 to 72.9)
Week 4 (n= 12, 12, 12, 10)
16.7
(3.0 to 43.8)
41.7
(18.1 to 68.5)
58.3
(31.5 to 81.9)
70.0
(39.3 to 91.3)
Week 5 (n= 11, 12, 12, 9)
27.3
(7.9 to 56.4)
33.3
(12.3 to 60.9)
41.7
(18.1 to 68.5)
77.8
(45.0 to 95.9)
Week 6 (n= 11, 11, 10, 10)
36.4
(13.5 to 65.0)
45.5
(20.0 to 72.9)
40.0
(15.0 to 69.6)
50.0
(22.2 to 77.8)
Week 8 (n= 8, 11, 11, 8)
25.0
(4.6 to 60.0)
27.3
(7.9 to 56.4)
45.5
(20.0 to 72.9)
37.5
(11.1 to 71.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 13.3
Confidence Interval (2-Sided) 90%
-4.4 to 33.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments PF-04965842 400 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 12.5
Confidence Interval (2-Sided) 90%
-5.2 to 32.0
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 7.1
Confidence Interval (2-Sided) 90%
-10.2 to 27.0
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 21.4
Confidence Interval (2-Sided) 90%
-3.2 to 45.5
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 15.9
Confidence Interval (2-Sided) 90%
-8.1 to 40.7
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 34.5
Confidence Interval (2-Sided) 90%
7.3 to 59.4
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 17.9
Confidence Interval (2-Sided) 90%
-11.2 to 45.5
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 31.3
Confidence Interval (2-Sided) 90%
1.7 to 55.7
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Difference in Percentage Analysed using
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 30.1
Confidence Interval (2-Sided) 90%
-1.2 to 57.4
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 25.0
Confidence Interval (2-Sided) 90%
-6.4 to 52.5
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 41.7
Confidence Interval (2-Sided) 90%
8.7 to 66.7
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 53.3
Confidence Interval (2-Sided) 90%
18.5 to 76.6
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 6.1
Confidence Interval (2-Sided) 90%
-26.1 to 36.6
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 14.4
Confidence Interval (2-Sided) 90%
-18.9 to 44.5
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 50.5
Confidence Interval (2-Sided) 90%
12.9 to 75.3
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 9.1
Confidence Interval (2-Sided) 90%
-25.2 to 41.4
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 3.6
Confidence Interval (2-Sided) 90%
-30.5 to 37.3
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 13.6
Confidence Interval (2-Sided) 90%
-21.9 to 46.2
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 Milligram (mg) Once Daily
Comments PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 2.3
Confidence Interval (2-Sided) 90%
-33.2 to 34.6
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 400 mg Once Daily
Comments PF-04965842 400 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 20.5
Confidence Interval (2-Sided) 90%
-17.6 to 51.9
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200 mg Twice Daily
Comments PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 12.5
Confidence Interval (2-Sided) 90%
-26.4 to 48.1
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Fasting Lipids at Week 2, 4 and 8
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo PF-04965842 200 Milligram (mg) Once Daily PF-04965842 400 mg Once Daily PF-04965842 200 mg Twice Daily
Hide Arm/Group Description:
Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
Overall Number of Participants Analyzed 14 15 16 14
Mean (Standard Deviation)
Unit of Measure: milligram per deciliter (mg/dL)
Baseline: (n= 14, 15. 16, 14) 119.07  (24.780) 105.27  (28.632) 114.56  (28.317) 113.93  (31.770)
LDL-C: Change at Week 2 (n= 13, 14, 14, 12) -6.31  (16.825) 18.50  (31.035) 3.21  (25.097) 26.92  (24.748)
LDL-C: Change at Week 4 (n= 12, 12, 12, 10) -2.50  (11.350) 26.75  (26.455) 10.17  (22.143) 15.20  (30.904)
LDL-C: Change at Week 8 (n= 7, 11, 10, 8) 7.14  (20.659) 6.00  (16.529) -3.20  (12.072) -15.13  (20.301)
HDL-C: Baseline (n= 14, 15, 16, 14) 52.93  (12.640) 46.47  (11.230) 49.06  (15.058) 50.29  (10.163)
HDL-C: Change at Week 2 (n= 13, 14, 14, 12) -1.54  (7.881) 10.00  (5.533) 10.64  (9.295) 14.00  (8.113)
HDL-C: Change at Week 4 (n= 12, 12, 12, 10) -1.00  (6.238) 9.25  (6.717) 12.25  (10.437) 12.80  (10.075)
HDL-C: Change at Week 8 (n= 7, 11, 10, 8) -2.43  (10.737) -2.36  (2.730) -0.40  (6.275) -5.00  (6.234)
Cholesterol: Baseline (n= 14, 15, 16, 14) 195.43  (30.137) 186.80  (25.741) 188.75  (32.298) 191.14  (36.469)
Cholesterol: Change at Week 2 (n= 13, 14, 14 12) -0.77  (14.800) 29.57  (31.329) 21.00  (34.005) 44.08  (23.469)
Cholesterol: Change at Week 4 (n= 12, 12, 12, 10) -3.50  (20.174) 40.08  (25.062) 27.25  (22.919) 26.40  (29.220)
Cholesterol: Change at Week 8 (n= 7, 11, 10, 8) 9.86  (24.361) 7.45  (14.733) -1.20  (20.395) -10.88  (23.991)
Triglycerides: Baseline (n= 14, 15, 16, 14) 116.64  (47.490) 175.00  (74.971) 125.50  (50.552) 134.21  (53.903)
Triglycerides: Change at Week 2 (n= 13, 14, 14 12) 35.85  (49.173) 23.79  (72.638) 35.86  (47.337) 15.83  (43.151)
Triglycerides: Change at Week 4 (n=12, 12, 12, 10) 0.67  (42.470) 35.67  (80.714) 24.00  (66.766) -7.30  (44.144)
Triglycerides: Change at Week 8 (n= 7, 11, 10, 8) 48.71  (102.301) 41.09  (68.405) 12.20  (44.434) 46.50  (62.198)
9.Secondary Outcome
Title Change From Baseline in Lipid Ratios at Week 2, 4 and 8
Hide Description The ratio of LDL-C/HDL-C was reported.
Time Frame Baseline, Week 2, 4, 8 (early termination)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo PF-04965842 200 Milligram (mg) Once Daily PF-04965842 400 mg Once Daily PF-04965842 200 mg Twice Daily
Hide Arm/Group Description:
Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
Overall Number of Participants Analyzed 14 15 16 14
Mean (Standard Deviation)
Unit of Measure: ratio
LDL-C: HDL C; Baseline (n= 14,15,16,14) 2.35  (0.745) 2.39  (0.915) 2.48  (0.735) 2.37  (0.912)
LDL-C: HDL C; Change at Week 2 (n=13,14,14,12) 0.02  (0.449) -0.05  (0.593) -0.33  (0.384) -0.03  (0.367)
LDL C: HDL C; Change at Week 4 (n= 12, 12, 12, 10) 0.01  (0.218) 0.11  (0.552) -0.30  (0.468) -0.07  (0.813)
LDL C: HDL C; Change at Week 8 (n=7,11,10, 8) 0.37  (0.381) 0.32  (0.439) -0.07  (0.324) -0.04  (0.362)
10.Secondary Outcome
Title Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo PF-04965842 200 Milligram (mg) Once Daily PF-04965842 400 mg Once Daily PF-04965842 200 mg Twice Daily
Hide Arm/Group Description:
Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
Overall Number of Participants Analyzed 14 15 16 14
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (n= 14, 15, 16, 14) 0.6056  (1.05280) 0.6718  (0.71527) 0.3325  (0.28854) 0.4994  (0.43345)
Change at Week 1 (n= 14, 15, 16, 14) -0.1451  (0.37322) -0.5495  (0.66033) -0.2288  (0.26512) -0.3807  (0.49723)
Change at Week 2 (n= 13, 14, 14, 12) -0.1712  (0.49223) -0.4540  (0.80459) -0.1783  (0.27518) -0.3374  (0.49736)
Change at Week 3 (n= 12, 12, 15, 11) 0.0323  (0.61746) 1.2447  (5.21627) -0.0471  (0.45332) -0.2214  (0.48102)
Change at Week 4 (n= 11, 12, 12, 10) -0.0284  (0.64387) -0.4093  (0.83169) 0.1162  (0.95838) -0.0850  (0.63410)
Change at Week 8 (n= 7, 11, 11, 8) -0.5996  (1.17921) -0.2473  (0.94249) 0.2521  (0.53698) -0.0081  (0.16782)
11.Secondary Outcome
Title Number of Participants Reporting Clinically Significant Change From Baseline in Epstein-Barr Virus (EBV) Values
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.
Arm/Group Title Placebo PF-04965842 200 Milligram (mg) Once Daily PF-04965842 400 mg Once Daily PF-04965842 200 mg Twice Daily
Hide Arm/Group Description:
Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
Overall Number of Participants Analyzed 14 15 16 14
Measure Type: Number
Unit of Measure: participants
0 0 0 0
12.Secondary Outcome
Title Number of Participants Reporting Clinically Significant Change From Baseline in Cytomegalovirus (CMV) Values
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.
Arm/Group Title Placebo PF-04965842 200 Milligram (mg) Once Daily PF-04965842 400 mg Once Daily PF-04965842 200 mg Twice Daily
Hide Arm/Group Description:
Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
Overall Number of Participants Analyzed 14 15 16 14
Measure Type: Number
Unit of Measure: participants
0 0 0 0
13.Secondary Outcome
Title Number of Participants Reporting Clinically Significant Change From Baseline in Herpes Simplex Virus Deoxyribonucleic Acid (HSV DNA) Values
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.
Arm/Group Title Placebo PF-04965842 200 Milligram (mg) Once Daily PF-04965842 400 mg Once Daily PF-04965842 200 mg Twice Daily
Hide Arm/Group Description:
Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
Overall Number of Participants Analyzed 14 15 16 14
Measure Type: Number
Unit of Measure: participants
0 0 0 0
14.Secondary Outcome
Title Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8
Hide Description [Not Specified]
Time Frame Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo PF-04965842 200 Milligram (mg) Once Daily PF-04965842 400 mg Once Daily PF-04965842 200 mg Twice Daily
Hide Arm/Group Description:
Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
Overall Number of Participants Analyzed 14 15 16 14
Mean (Standard Deviation)
Unit of Measure: millimeter of mercury (mmHg)
Systolic BP: Baseline (n= 14,15,16,14) 125.4  (11.77) 125.5  (11.46) 124.7  (12.97) 128.0  (11.50)
Systolic BP: Change at Week 1 (n= 14, 15, 16, 14) -2.1  (9.64) -1.5  (10.94) 0.6  (8.87) 2.0  (10.88)
Systolic BP: Change at Week 2 (n= 13, 13, 14, 10) -0.3  (6.73) -1.6  (9.46) 3.9  (8.01) -0.4  (7.68)
Systolic BP: Change at Week 3 (n= 12, 12, 14, 10) -4.5  (7.09) -3.3  (7.82) 6.7  (16.82) -1.0  (13.65)
Systolic BP: Change at Week 4 (n= 12, 12, 12, 10) -2.3  (5.66) -5.8  (12.40) 0.2  (7.44) 1.7  (15.44)
Systolic BP: Change at Week 5 (n= 11, 12, 12, 9) -2.9  (9.98) -0.8  (8.29) -0.3  (10.37) 2.0  (18.08)
Systolic BP: Change at Week 6 (n= 11, 12, 12, 10) -5.7  (8.95) -1.3  (7.99) -2.0  (8.86) -0.2  (11.37)
Systolic BP: Change at Week 8 (n= 14, 14, 13, 13) -2.3  (12.96) -2.1  (9.61) -2.1  (7.12) 3.5  (11.49)
Diastolic BP: Baseline (n=14,15,16,14) 77.1  (7.39) 76.5  (6.84) 77.4  (9.85) 79.9  (10.73)
Diastolic BP: Change at Week 1 (n=14,15,16,14) 0.0  (6.88) 0.9  (6.97) 0.8  (9.99) 2.0  (10.02)
Diastolic BP: Change at Week 2 (n=13,13,14,10) 0.6  (8.08) 1.5  (8.96) -0.4  (9.13) 2.5  (6.08)
Diastolic BP: Change at Week 3 (n=12,12,14,10) -0.7  (8.17) -0.9  (7.50) 1.1  (7.76) 0.3  (10.70)
Diastolic BP Change at Week 4 (n=12,12,12,10) -2.5  (8.21) -2.3  (6.61) 1.2  (5.46) 2.4  (9.58)
Diastolic BP: Change at Week 5 (n= 11, 12, 12, 9) 0.8  (5.13) 0.0  (5.64) 0.4  (5.62) 1.8  (10.32)
Diastolic BP: Change at Week 6 (n=11,12,12,10) 0.5  (5.91) 2.1  (6.36) -2.8  (5.67) 0.9  (7.49)
Diastolic BP: Change at Week 8 (n= 14,14,13,13) -1.1  (8.12) -0.6  (6.08) 1.5  (9.77) 1.4  (9.26)
15.Secondary Outcome
Title Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8
Hide Description [Not Specified]
Time Frame Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo PF-04965842 200 Milligram (mg) Once Daily PF-04965842 400 mg Once Daily PF-04965842 200 mg Twice Daily
Hide Arm/Group Description:
Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
Overall Number of Participants Analyzed 14 15 16 14
Mean (Standard Deviation)
Unit of Measure: beats per minute (bpm)
Baseline (n= 14, 15, 16, 14) 67.6  (7.87) 71.8  (11.85) 72.2  (11.54) 72.6  (9.64)
Change at Week 1 (n= 14, 15, 16, 14) 1.0  (6.50) -0.2  (8.51) 0.0  (10.56) -4.3  (7.43)
Change at Week 2 (n= 13, 13, 14, 10) 2.8  (9.97) -4.7  (9.39) -2.4  (8.50) -2.8  (8.48)
Change at Week 3 (n= 12, 12, 14, 10) 4.1  (15.09) -1.3  (10.76) -1.5  (11.06) -2.3  (6.88)
Change at Week 4 (n= 12, 12, 12, 10) -1.3  (9.69) -1.3  (12.89) -4.7  (10.87) 0.5  (9.37)
Change at Week 5 (n= 11, 12, 12, 9) 5.2  (12.75) 2.7  (10.44) -0.8  (10.34) 7.8  (11.11)
Change at Week 6 (n= 11, 12, 12, 10) 4.5  (12.36) -1.8  (11.46) 2.4  (8.53) 4.7  (9.15)
Change at Week 8 (n= 14, 14, 13, 13) 0.9  (11.96) -0.6  (13.87) -5.3  (11.29) -1.2  (8.12)
16.Secondary Outcome
Title Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8
Hide Description [Not Specified]
Time Frame Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo PF-04965842 200 Milligram (mg) Once Daily PF-04965842 400 mg Once Daily PF-04965842 200 mg Twice Daily
Hide Arm/Group Description:
Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
Overall Number of Participants Analyzed 14 15 16 14
Mean (Standard Deviation)
Unit of Measure: respiration per minute (resp/min)
Baseline (n= 14, 15, 16, 13) 16.2  (1.58) 17.1  (3.67) 16.3  (2.44) 17.0  (2.16)
Change at Week 1 (n= 14, 15, 16, 13) -0.5  (1.70) 0.9  (1.98) -0.1  (0.81) -0.3  (1.60)
Change at Week 2 (n= 13, 13, 14, 9) -0.5  (1.45) 0.4  (1.71) -0.6  (1.82) 0.7  (2.65)
Change at Week 3 (n= 12, 12, 14, 9) -0.3  (0.87) -0.6  (1.51) -0.4  (1.69) 0.2  (1.56)
Change at Week 4 (n= 12, 12, 12, 9) 0.2  (2.12) -0.7  (1.72) -1.2  (1.75) 0.0  (1.41)
Change at Week 5 (n= 11, 12, 12, 8) 0.1  (1.45) 0.3  (2.30) -0.9  (1.78) -0.6  (1.92)
Change at Week 6 (n= 11, 12, 12, 9) -0.4  (0.81) 0.2  (1.34) -0.8  (1.54) -0.2  (1.20)
Change at Week 8 (n= 14, 14, 13, 12) -0.3  (1.49) -0.2  (2.01) -0.8  (1.30) -1.0  (1.60)
17.Secondary Outcome
Title Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8
Hide Description [Not Specified]
Time Frame Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo PF-04965842 200 Milligram (mg) Once Daily PF-04965842 400 mg Once Daily PF-04965842 200 mg Twice Daily
Hide Arm/Group Description:
Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
Overall Number of Participants Analyzed 14 15 16 14
Mean (Standard Deviation)
Unit of Measure: degree celsius
Baseline (n= 14, 15, 16, 14) 36.49  (0.363) 36.59  (0.274) 36.67  (0.282) 36.57  (0.433)
Change at Week 1 (n= 14, 15, 16, 14) -0.01  (0.264) -0.03  (0.322) 0.00  (0.265) -0.17  (0.271)
Change at Week 2 (n= 13, 13, 14, 10) -0.04  (0.366) -0.22  (0.397) -0.05  (0.509) -0.05  (0.273)
Change at Week 3 (n= 12, 12, 14, 10) -0.04  (0.391) -0.21  (0.510) -0.11  (0.287) 0.09  (0.501)
Change at Week 4 (n= 12, 12, 12, 10) -0.07  (0.467) -0.21  (0.362) -0.02  (0.346) -0.12  (0.477)
Change at Week 5 (n= 11, 12, 12, 9) 0.21  (0.316) 0.07  (0.318) 0.01  (0.305) 0.13  (0.443)
Change at Week 6 (n= 10, 12, 12, 10) 0.05  (0.328) -0.00  (0.292) -0.07  (0.269) 0.00  (0.390)
Change at Week 8 (n= 14, 14, 13, 13) 0.10  (0.332) -0.01  (0.361) -0.05  (0.326) 0.07  (0.426)
18.Secondary Outcome
Title Number of Participants Reporting Clinically Significant Change From Baseline in Heart Rate
Hide Description [Not Specified]
Time Frame Baseline up to Week 8 (early termination)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.
Arm/Group Title Placebo PF-04965842 200 Milligram (mg) Once Daily PF-04965842 400 mg Once Daily PF-04965842 200 mg Twice Daily
Hide Arm/Group Description:
Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
Overall Number of Participants Analyzed 14 15 16 14
Measure Type: Number
Unit of Measure: bpm
0 0 0 0
19.Secondary Outcome
Title Number of Participants Reporting Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.
Arm/Group Title Placebo PF-04965842 200 Milligram (mg) Once Daily PF-04965842 400 mg Once Daily PF-04965842 200 mg Twice Daily
Hide Arm/Group Description:
Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
Overall Number of Participants Analyzed 14 15 16 14
Measure Type: Number
Unit of Measure: participants
0 0 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Placebo PF-04965842 200 Milligram (mg) Once Daily PF-04965842 400 mg Once Daily PF-04965842 200 mg Twice Daily
Hide Arm/Group Description Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28. Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28. Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28. Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
All-Cause Mortality
Placebo PF-04965842 200 Milligram (mg) Once Daily PF-04965842 400 mg Once Daily PF-04965842 200 mg Twice Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo PF-04965842 200 Milligram (mg) Once Daily PF-04965842 400 mg Once Daily PF-04965842 200 mg Twice Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/14 (7.14%)   0/15 (0.00%)   0/16 (0.00%)   0/14 (0.00%) 
Nervous system disorders         
Transient ischaemic attack * 1  1/14 (7.14%)  0/15 (0.00%)  0/16 (0.00%)  0/14 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events