Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Dose-Finding Study of GSK2894512 Cream in Subjects With Plaque 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: NCT02564042
Recruitment Status : Completed
First Posted : September 30, 2015
Results First Posted : November 13, 2017
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Drug: GSK2894512 1% Cream
Drug: GSK2894512 0.5% Cream
Drug: Vehicle cream
Enrollment 227
Recruitment Details This was a randomized, double-blind, dose-finding study of GSK2894512 in adult participants with psoriasis. The study consisted of 3 periods: 4 weeks screening, 12 weeks double-blind treatment, and 4 weeks post-treatment follow-up. The total duration of study for a participant was 16-20 weeks.
Pre-assignment Details A total of 290 participants were screened of which 63 failed screening and 227 participants were randomized into the study. Participants in the treatment phase were randomized to receive GSK2894512 cream (0.5 or 1 percent) or vehicle control once daily (QD) or twice daily (BID).
Arm/Group Title GSK2894512 1% BID GSK2894512 1% QD GSK2894512 0.5% BID GSK2894512 0.5% QD Vehicle BID Vehicle QD
Hide Arm/Group Description The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
Period Title: Overall Study
Started 38 38 38 38 37 38
Completed 27 30 32 35 26 24
Not Completed 11 8 6 3 11 14
Reason Not Completed
Adverse Event             4             4             3             0             0             1
Lost to Follow-up             1             1             1             0             1             1
Physician Decision             1             0             0             1             0             0
Withdrawal by Subject             5             3             2             2             10             12
Arm/Group Title GSK2894512 1% BID GSK2894512 1% QD GSK2894512 0.5% BID GSK2894512 0.5% QD Vehicle BID Vehicle QD Total
Hide Arm/Group Description The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. Total of all reporting groups
Overall Number of Baseline Participants 38 38 38 38 37 38 227
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 38 participants 38 participants 38 participants 37 participants 38 participants 227 participants
45.9  (11.93) 48.5  (10.56) 49.6  (10.93) 48.7  (9.72) 46.7  (12.62) 46.4  (10.16) 47.6  (10.99)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 38 participants 38 participants 38 participants 37 participants 38 participants 227 participants
Female
12
  31.6%
12
  31.6%
14
  36.8%
13
  34.2%
14
  37.8%
9
  23.7%
74
  32.6%
Male
26
  68.4%
26
  68.4%
24
  63.2%
25
  65.8%
23
  62.2%
29
  76.3%
153
  67.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race, Customized Number Analyzed 38 participants 38 participants 38 participants 38 participants 37 participants 38 participants 227 participants
American Indian (Amer Ind)/Alaska Native (Ala Nat)
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.6%
0
   0.0%
0
   0.0%
1
   0.4%
Asian/South East Asian Descent/Japanese Descent
10
  26.3%
9
  23.7%
8
  21.1%
6
  15.8%
9
  24.3%
6
  15.8%
48
  21.1%
Black/African American (Afr Amer)
1
   2.6%
2
   5.3%
3
   7.9%
1
   2.6%
3
   8.1%
0
   0.0%
10
   4.4%
White/Caucasian
26
  68.4%
27
  71.1%
26
  68.4%
30
  78.9%
25
  67.6%
32
  84.2%
166
  73.1%
Amer Ind/Ala Nat & Black/Afr Amer &White/Caucasian
0
   0.0%
0
   0.0%
1
   2.6%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.4%
Black/Afr Amer & White/Caucasian
1
   2.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.4%
1.Primary Outcome
Title Percentage of Participants Who Have a Physician Global Assessment (PGA) Score of 0 or 1 at Week 12 and a Minimum 2-grade Improvement in PGA Score From Baseline to Week 12
Hide Description The PGA is a clinical tool for assessing the current state/severity of a participant’s psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual ‘average’ of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of responders that is, participants who achieved a PGA score of 0 or 1 and a minimum 2-grade improvement from Baseline were summarized. Baseline was defined as the latest assessment prior to the first dose. The analysis was performed on modified intent-to-treat (mITT) Population which comprised of all randomized participants except those enrolled at center ID 220008.
Time Frame Baseline and up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title GSK2894512 1% BID GSK2894512 1% QD GSK2894512 0.5% BID GSK2894512 0.5% QD Vehicle BID Vehicle QD
Hide Arm/Group Description:
The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
Overall Number of Participants Analyzed 23 25 26 28 19 20
Measure Type: Number
Unit of Measure: Percentage of participants
65 56 46 36 11 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 54.7
Confidence Interval (2-Sided) 95%
25.9 to 76.6
Estimation Comments Difference between GSK2894512 1% BID and Vehicle BID has been presented
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% QD, Vehicle QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 51.0
Confidence Interval (2-Sided) 95%
22.2 to 73.2
Estimation Comments Difference between GSK2894512 1% QD and Vehicle QD has been presented
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK2894512 0.5% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 35.6
Confidence Interval (2-Sided) 95%
6.3 to 60.5
Estimation Comments Difference between GSK2894512 0.5% BID and Vehicle BID has been presented
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GSK2894512 0.5% QD, Vehicle QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 30.7
Confidence Interval (2-Sided) 95%
1.6 to 55.9
Estimation Comments Difference between GSK2894512 0.5% QD and Vehicle QD has been presented
2.Secondary Outcome
Title Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit
Hide Description The PASI is a standard clinical tool for assessing the severity of psoriasis based on severity of erythema, thickness and scale, as well as the extent of body surface area (BSA) affected with psoriasis. The 3 clinical signs were graded on a 5 point scale (0 to 4) and the % BSA affected was scored on a 7-point scale (0 to 6) for each of the 4 specified body regions (head, upper extremities, trunk and lower extremities). The individual scores were multiplied by a weighted factor for each body region. The sum of these scores gave the overall PASI score. Higher scores indicated more severe disease. The percentage of participants with >=75% improvement in PASI from Baseline were summarized. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame Baseline and up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title GSK2894512 1% BID GSK2894512 1% QD GSK2894512 0.5% BID GSK2894512 0.5% QD Vehicle BID Vehicle QD
Hide Arm/Group Description:
The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
Overall Number of Participants Analyzed 34 35 32 32 30 33
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1, n=32, 35, 31, 32, 28, 32 Number Analyzed 32 participants 35 participants 31 participants 32 participants 28 participants 32 participants
0 3 0 0 0 0
Week 2, n=32, 33, 30, 32, 24, 30 Number Analyzed 32 participants 33 participants 30 participants 32 participants 24 participants 30 participants
6 15 3 3 0 0
Week 4, n=28, 31, 29, 32, 22, 26 Number Analyzed 28 participants 31 participants 29 participants 32 participants 22 participants 26 participants
32 26 14 6 5 0
Week 8, n=26, 27, 27, 32, 20, 20 Number Analyzed 26 participants 27 participants 27 participants 32 participants 20 participants 20 participants
50 37 37 34 5 0
Week 12, n=23, 25, 26, 28, 19, 20 Number Analyzed 23 participants 25 participants 26 participants 28 participants 19 participants 20 participants
65 56 46 46 16 5
Week 14, n=23, 26, 24, 27, 19, 19 Number Analyzed 23 participants 26 participants 24 participants 27 participants 19 participants 19 participants
65 65 46 48 16 5
Week 16, n=24, 26, 26, 28, 19, 19 Number Analyzed 24 participants 26 participants 26 participants 28 participants 19 participants 19 participants
63 58 46 54 11 5
Early withdrawal (EW), n=10, 7, 4, 2, 10, 9 Number Analyzed 10 participants 7 participants 4 participants 2 participants 10 participants 9 participants
10 43 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% QD, Vehicle QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 2.9
Confidence Interval (2-Sided) 95%
-21.0 to 26.6
Estimation Comments Difference between GSK2894512 1% QD and Vehicle QD at Week 1 has been presented
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 6.3
Confidence Interval 95%
-20.5 to 32.4
Estimation Comments Difference between GSK2894512 1% BID and Vehicle BID at Week 2 has been presented
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% QD, Vehicle QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 15.2
Confidence Interval (2-Sided) 95%
-9.6 to 39.1
Estimation Comments Difference between GSK2894512 1% QD and Vehicle QD at Week 2 has been presented
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GSK2894512 0.5% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 3.3
Confidence Interval (2-Sided) 95%
-23.6 to 29.9
Estimation Comments Difference between GSK2894512 0.5% BID and Vehicle BID at Week 2 has been presented
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection GSK2894512 0.5% QD, Vehicle QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 3.1
Confidence Interval (2-Sided) 95%
-22.2 to 28.1
Estimation Comments Difference between GSK2894512 0.5% QD and Vehicle QD at Week 2 has been presented
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 27.6
Confidence Interval (2-Sided) 95%
-0.5 to 52.4
Estimation Comments Difference between GSK2894512 1% BID and Vehicle BID at Week 4 has been presented
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% QD, Vehicle QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 25.8
Confidence Interval (2-Sided) 95%
-0.4 to 49.3
Estimation Comments Difference between GSK2894512 1% QD and Vehicle QD at Week 4 has been presented
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection GSK2894512 0.5% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 9.2
Confidence Interval (2-Sided) 95%
-18.4 to 35.7
Estimation Comments Difference between GSK2894512 0.5% BID and Vehicle BID at Week 4 has been presented
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection GSK2894512 0.5% QD, Vehicle QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 6.3
Confidence Interval (2-Sided) 95%
-19.7 to 31.7
Estimation Comments Difference between GSK2894512 0.5% QD and Vehicle QD at Week 4 has been presented
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 45.0
Confidence Interval (2-Sided) 95%
16.6 to 68.4
Estimation Comments Difference between GSK2894512 1% BID and Vehicle BID at Week 8 has been presented
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% QD, Vehicle QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 37.0
Confidence Interval (2-Sided) 95%
8.7 to 61.3
Estimation Comments Difference between GSK2894512 1% QD and Vehicle QD at Week 8 has been presented
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection GSK2894512 0.5% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 32.0
Confidence Interval (2-Sided) 95%
3.5 to 57.2
Estimation Comments Difference between GSK2894512 0.5% BID and Vehicle BID at Week 8 has been presented
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection GSK2894512 0.5% QD, Vehicle QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 34.4
Confidence Interval (2-Sided) 95%
6.3 to 58.7
Estimation Comments Difference between GSK2894512 0.5% QD and Vehicle QD at Week 8 has been presented
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 49.4
Confidence Interval (2-Sided) 95%
20.1 to 72.4
Estimation Comments Difference between GSK2894512 1% BID and Vehicle BID at Week 12 has been presented
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% QD, Vehicle QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 51.0
Confidence Interval (2-Sided) 95%
22.2 to 73.2
Estimation Comments Difference between GSK2894512 1% QD and Vehicle QD at Week 12 has been presented
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection GSK2894512 0.5% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 30.4
Confidence Interval (2-Sided) 95%
1.0 to 56.1
Estimation Comments Difference between GSK2894512 0.5% BID and Vehicle BID at Week 12 has been presented
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection GSK2894512 0.5% QD, Vehicle QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 41.4
Confidence Interval (2-Sided) 95%
12.7 to 65.0
Estimation Comments Difference between GSK2894512 0.5% QD and Vehicle QD at Week 12 has been presented
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 49.4
Confidence Interval (2-Sided) 95%
20.1 to 72.4
Estimation Comments Difference between GSK2894512 1% BID and Vehicle BID at Week 14 has been presented
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% QD, Vehicle QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 60.1
Confidence Interval (2-Sided) 95%
33.2 to 80.1
Estimation Comments Difference between GSK2894512 1% QD and Vehicle QD at Week 14 has been presented
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection GSK2894512 0.5% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 30.0
Confidence Interval (2-Sided) 95%
0.2 to 56.5
Estimation Comments Difference between GSK2894512 0.5% BID and Vehicle BID at Week 14 has been presented
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection GSK2894512 0.5% QD, Vehicle QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 42.9
Confidence Interval (2-Sided) 95%
14.4 to 66.5
Estimation Comments Difference between GSK2894512 0.5% QD and Vehicle QD at Week 14 has been presented
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 52.0
Confidence Interval (2-Sided) 95%
23.2 to 74.4
Estimation Comments Difference between GSK2894512 1% BID and Vehicle BID at Week 16 has been presented
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% QD, Vehicle QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 52.4
Confidence Interval (2-Sided) 95%
24.4 to 74.0
Estimation Comments Difference between GSK2894512 1% QD and Vehicle QD at Week 16 has been presented
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection GSK2894512 0.5% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 35.6
Confidence Interval (2-Sided) 95%
6.3 to 60.5
Estimation Comments Difference between GSK2894512 0.5% BID and Vehicle BID at Week 16 has been presented
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection GSK2894512 0.5% QD, Vehicle QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 48.3
Confidence Interval (2-Sided) 95%
19.7 to 71.1
Estimation Comments Difference between GSK2894512 0.5% QD and Vehicle QD at Week 16 has been presented
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 10.0
Confidence Interval (2-Sided) 95%
-36.9 to 53.9
Estimation Comments Difference between GSK2894512 1% BID and Vehicle BID at EW has been presented
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% QD, Vehicle QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 42.9
Confidence Interval (2-Sided) 95%
-6.3 to 81.6
Estimation Comments Difference between GSK2894512 1% QD and Vehicle QD at EW has been presented
3.Secondary Outcome
Title Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit
Hide Description The PGA is a clinical tool for assessing the current state/severity of a participant’s psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual ‘average’ of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of participants who achieved a minimum 2-grade improvement from Baseline for each study visit were summarized. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame Baseline and up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title GSK2894512 1% BID GSK2894512 1% QD GSK2894512 0.5% BID GSK2894512 0.5% QD Vehicle BID Vehicle QD
Hide Arm/Group Description:
The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
Overall Number of Participants Analyzed 34 35 32 32 30 33
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1, n=32, 35, 31, 32, 28, 32 Number Analyzed 32 participants 35 participants 31 participants 32 participants 28 participants 32 participants
0 0 6 0 4 0
Week 2, n=32, 33, 30, 32, 24, 30 Number Analyzed 32 participants 33 participants 30 participants 32 participants 24 participants 30 participants
13 12 13 6 0 0
Week 4, n=28, 31, 29, 32, 22, 26 Number Analyzed 28 participants 31 participants 29 participants 32 participants 22 participants 26 participants
21 23 24 13 5 0
Week 8, n=26, 27, 27, 32, 20, 20 Number Analyzed 26 participants 27 participants 27 participants 32 participants 20 participants 20 participants
46 37 41 41 0 0
Week 12, n=23, 25, 26, 28, 19, 20 Number Analyzed 23 participants 25 participants 26 participants 28 participants 19 participants 20 participants
65 56 50 36 11 5
Week 14, n=23, 26, 24, 27, 19, 19 Number Analyzed 23 participants 26 participants 24 participants 27 participants 19 participants 19 participants
61 62 38 37 5 0
Week 16, n=24, 26, 26, 28, 19, 19 Number Analyzed 24 participants 26 participants 26 participants 28 participants 19 participants 19 participants
58 54 38 36 5 0
EW, n=10, 7, 4, 2, 10, 9 Number Analyzed 10 participants 7 participants 4 participants 2 participants 10 participants 9 participants
20 43 25 0 0 0
4.Secondary Outcome
Title Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit
Hide Description The PGA is a clinical tool for assessing the current state/severity of a participant’s psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual ‘average’ of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of participants who achieved a PGA score of 0 or 1 from Baseline at each study visit was summarized. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame Up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title GSK2894512 1% BID GSK2894512 1% QD GSK2894512 0.5% BID GSK2894512 0.5% QD Vehicle BID Vehicle QD
Hide Arm/Group Description:
The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
Overall Number of Participants Analyzed 34 35 32 32 30 33
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1, n=32, 35, 31, 32, 28, 32 Number Analyzed 32 participants 35 participants 31 participants 32 participants 28 participants 32 participants
0 9 3 0 4 0
Week 2, n=32, 33, 30, 32, 24, 30 Number Analyzed 32 participants 33 participants 30 participants 32 participants 24 participants 30 participants
16 18 10 6 0 0
Week 4, n=28, 31, 29, 32, 22, 26 Number Analyzed 28 participants 31 participants 29 participants 32 participants 22 participants 26 participants
21 42 24 16 5 4
Week 8, n=26, 27, 27, 32, 20, 20 Number Analyzed 26 participants 27 participants 27 participants 32 participants 20 participants 20 participants
54 56 44 41 0 5
Week 12, n=23, 25, 26, 28, 19, 20 Number Analyzed 23 participants 25 participants 26 participants 28 participants 19 participants 20 participants
70 72 54 39 11 10
Week 14, n=23, 26, 24, 27, 19, 19 Number Analyzed 23 participants 26 participants 24 participants 27 participants 19 participants 19 participants
61 69 42 41 5 5
Week 16, n=24, 26, 26, 28, 19, 19 Number Analyzed 24 participants 26 participants 26 participants 28 participants 19 participants 19 participants
58 65 50 43 5 5
EW, n=10, 7, 4, 2, 10, 9 Number Analyzed 10 participants 7 participants 4 participants 2 participants 10 participants 9 participants
10 57 25 0 0 0
5.Secondary Outcome
Title Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit
Hide Description The extent of BSA affected by psoriasis is a general indicator of disease severity and was measured throughout the study. The extent of BSA to which study treatment was applied was also recorded. For the purpose of approximate clinical estimation, the total palmar surface of the palm plus 5 digits was assumed to be approximately equivalent to 1 percent BSA. Assessment of BSA affected with psoriasis was performed separately for four body surface regions: the head, the upper extremities, the trunk and the lower extremities, corresponding to 10, 20, 30 and 40 percent of the total body area, respectively. The mean change in percent BSA affected from Baseline was summarized for each study visit. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame Baseline and up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title GSK2894512 1% BID GSK2894512 1% QD GSK2894512 0.5% BID GSK2894512 0.5% QD Vehicle BID Vehicle QD
Hide Arm/Group Description:
The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
Overall Number of Participants Analyzed 34 35 32 32 30 33
Mean (Standard Deviation)
Unit of Measure: Percentage of BSA
Week 1, n=32, 35, 31, 32, 28, 32 Number Analyzed 32 participants 35 participants 31 participants 32 participants 28 participants 32 participants
-0.53  (1.136) -0.30  (0.990) -0.35  (0.774) 0.02  (0.773) -0.05  (0.510) 0.01  (0.277)
Week 2, n=32, 33, 30, 32, 24, 30 Number Analyzed 32 participants 33 participants 30 participants 32 participants 24 participants 30 participants
-1.06  (1.496) -0.75  (1.789) -0.79  (1.350) -0.51  (1.157) -0.18  (0.657) -0.13  (1.159)
Week 4, n=28, 31, 29, 32, 22, 26 Number Analyzed 28 participants 31 participants 29 participants 32 participants 22 participants 26 participants
-2.14  (3.275) -2.13  (2.529) -1.93  (2.951) -0.80  (1.468) -0.60  (1.332) -0.17  (1.432)
Week 8, n=26, 27, 27, 32, 20, 20 Number Analyzed 26 participants 27 participants 27 participants 32 participants 20 participants 20 participants
-3.37  (3.590) -3.60  (3.220) -3.51  (3.756) -1.77  (2.800) -1.05  (1.823) -0.65  (1.435)
Week 12, n=23, 25, 26, 28, 19, 20 Number Analyzed 23 participants 25 participants 26 participants 28 participants 19 participants 20 participants
-4.88  (4.211) -4.28  (3.508) -4.29  (3.882) -3.59  (3.931) -1.57  (2.380) -0.98  (3.335)
Week 14, n=23, 26, 24, 27, 19, 19 Number Analyzed 23 participants 26 participants 24 participants 27 participants 19 participants 19 participants
-5.01  (4.108) -4.63  (3.548) -4.26  (4.172) -3.59  (4.201) -1.33  (2.475) -0.58  (3.634)
Week 16, n=24, 26, 26, 28, 19, 19 Number Analyzed 24 participants 26 participants 26 participants 28 participants 19 participants 19 participants
-5.30  (4.468) -4.47  (3.833) -4.34  (4.299) -3.56  (4.716) -1.18  (2.490) -1.10  (3.627)
EW, n=10, 7, 4, 2, 10, 9 Number Analyzed 10 participants 7 participants 4 participants 2 participants 10 participants 9 participants
-1.92  (2.218) -2.31  (3.465) 0.25  (1.893) 1.25  (9.546) 0.74  (1.536) 1.17  (2.094)
6.Secondary Outcome
Title Mean Change in PASI Score From Baseline to Each Study Visit
Hide Description The PASI is a standard clinical tool for assessing the severity of psoriasis based on severity of erythema, thickness and scale, as well as the extent of BSA affected with psoriasis. The 3 clinical signs were graded on a 5 point scale (0=None to 4=Severe) and the percent of BSA affected is scored on a 7-point scale (0=0% involvement to 6=90-100%) for each of 4 specified body regions (head, upper extremities, trunk and lower extremities). The individual scores were multiplied by a weighted factor for each body region. The sum of these scores gave the overall PASI score. PASI score ranged from 0=no psoriasis to 72=worse psoriasis. The mean change in PASI score from Baseline was summarized for each study visit. Baseline was the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame Baseline and up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title GSK2894512 1% BID GSK2894512 1% QD GSK2894512 0.5% BID GSK2894512 0.5% QD Vehicle BID Vehicle QD
Hide Arm/Group Description:
The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
Overall Number of Participants Analyzed 34 35 32 32 30 33
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Week 1, n=32, 35, 31, 32, 28, 32 Number Analyzed 32 participants 35 participants 31 participants 32 participants 28 participants 32 participants
-2.22  (2.795) -1.73  (2.374) -1.11  (2.083) -1.33  (1.807) -0.85  (1.203) -0.28  (1.165)
Week 2, n=32, 33, 30, 32, 24, 30 Number Analyzed 32 participants 33 participants 30 participants 32 participants 24 participants 30 participants
-4.10  (3.756) -3.07  (3.016) -2.39  (3.118) -2.49  (2.316) -1.78  (2.826) -0.61  (1.644)
Week 4, n=28, 31, 29, 32, 22, 26 Number Analyzed 28 participants 31 participants 29 participants 32 participants 22 participants 26 participants
-6.07  (5.051) -4.45  (3.072) -3.83  (3.827) -3.31  (2.796) -2.88  (3.308) -1.08  (2.026)
Week 8, n=26, 27, 27, 32, 20, 20 Number Analyzed 26 participants 27 participants 27 participants 32 participants 20 participants 20 participants
-7.52  (5.612) -5.77  (3.556) -5.79  (5.055) -4.58  (3.902) -2.82  (4.081) -1.34  (2.288)
Week 12, n=23, 25, 26, 28, 19, 20 Number Analyzed 23 participants 25 participants 26 participants 28 participants 19 participants 20 participants
-8.70  (5.617) -6.62  (3.709) -6.30  (5.138) -5.41  (4.424) -2.77  (4.291) -1.54  (2.970)
Week 14, n=23, 26, 24, 27, 19, 19 Number Analyzed 23 participants 26 participants 24 participants 27 participants 19 participants 19 participants
-8.61  (5.328) -6.65  (3.973) -5.67  (5.100) -5.28  (4.422) -2.60  (4.491) -1.29  (3.280)
Week 16, n=24, 26, 26, 28, 19, 19 Number Analyzed 24 participants 26 participants 26 participants 28 participants 19 participants 19 participants
-8.46  (5.432) -6.63  (4.067) -5.65  (5.646) -5.13  (4.712) -2.41  (4.285) -1.09  (3.914)
EW, n=10, 7, 4, 2, 10, 9 Number Analyzed 10 participants 7 participants 4 participants 2 participants 10 participants 9 participants
-3.70  (3.391) -4.00  (3.636) -1.18  (1.167) 1.50  (8.627) -0.06  (2.784) 0.12  (2.742)
7.Secondary Outcome
Title PGA Scores at Each Study Visit
Hide Description The PGA is a clinical tool for assessing the current state/severity of a participant’s psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual ‘average’ of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The mean of PGA scores at each study visit was summarized. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame Up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title GSK2894512 1% BID GSK2894512 1% QD GSK2894512 0.5% BID GSK2894512 0.5% QD Vehicle BID Vehicle QD
Hide Arm/Group Description:
The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
Overall Number of Participants Analyzed 34 35 32 32 30 33
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline, n=34, 35, 32, 32, 30, 33 Number Analyzed 34 participants 35 participants 32 participants 32 participants 30 participants 33 participants
2.9  (0.42) 2.7  (0.51) 3.0  (0.54) 2.9  (0.39) 3.0  (0.26) 2.8  (0.44)
Week 1, n=32, 35, 31, 32, 28, 32 Number Analyzed 32 participants 35 participants 31 participants 32 participants 28 participants 32 participants
2.7  (0.59) 2.4  (0.65) 2.7  (0.65) 2.6  (0.56) 2.9  (0.52) 2.8  (0.51)
Week 2, n=32, 33, 30, 32, 24, 30 Number Analyzed 32 participants 33 participants 30 participants 32 participants 24 participants 30 participants
2.3  (0.77) 2.2  (0.71) 2.4  (0.67) 2.5  (0.62) 2.6  (0.50) 2.6  (0.49)
Week 4, n=28, 31, 29, 32, 22, 26 Number Analyzed 28 participants 31 participants 29 participants 32 participants 22 participants 26 participants
2.0  (0.67) 1.6  (0.71) 2.1  (0.77) 2.1  (0.78) 2.4  (0.59) 2.6  (0.64)
Week 8, n=26, 27, 27, 32, 20, 20 Number Analyzed 26 participants 27 participants 27 participants 32 participants 20 participants 20 participants
1.5  (0.86) 1.4  (0.80) 1.6  (0.75) 1.7  (0.85) 2.5  (0.51) 2.5  (0.61)
Week 12, n=23, 25, 26, 28, 19, 20 Number Analyzed 23 participants 25 participants 26 participants 28 participants 19 participants 20 participants
1.1  (0.92) 1.1  (0.81) 1.3  (1.01) 1.6  (0.78) 2.4  (0.69) 2.5  (0.69)
Week 14, n=23, 26, 24, 27, 19, 19 Number Analyzed 23 participants 26 participants 24 participants 27 participants 19 participants 19 participants
1.3  (1.01) 1.1  (0.99) 1.6  (0.88) 1.7  (0.94) 2.5  (0.61) 2.5  (0.61)
Week 16, n=24, 26, 26, 28, 19, 19 Number Analyzed 24 participants 26 participants 26 participants 28 participants 19 participants 19 participants
1.3  (1.08) 1.2  (1.01) 1.5  (0.90) 1.7  (1.06) 2.5  (0.61) 2.6  (0.69)
EW, n=10, 7, 4, 2, 10, 9 Number Analyzed 10 participants 7 participants 4 participants 2 participants 10 participants 9 participants
2.5  (1.08) 1.6  (1.40) 2.0  (1.41) 2.5  (0.71) 3.1  (0.57) 3.1  (0.60)
8.Secondary Outcome
Title Mean Change in PGA Score From Baseline to Each Study Visit
Hide Description The PGA is a clinical tool for assessing the current state/severity of a participant’s psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual ‘average’ of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The mean change in PGA scores from Baseline was summarized for each study visit. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame Baseline and up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title GSK2894512 1% BID GSK2894512 1% QD GSK2894512 0.5% BID GSK2894512 0.5% QD Vehicle BID Vehicle QD
Hide Arm/Group Description:
The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
Overall Number of Participants Analyzed 34 35 32 32 30 33
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Week 1, n=32, 35, 31, 32, 28, 32 Number Analyzed 32 participants 35 participants 31 participants 32 participants 28 participants 32 participants
-0.3  (0.44) -0.3  (0.48) -0.3  (0.69) -0.3  (0.47) -0.1  (0.52) -0.1  (0.30)
Week 2, n=32, 33, 30, 32, 24, 30 Number Analyzed 32 participants 33 participants 30 participants 32 participants 24 participants 30 participants
-0.7  (0.75) -0.6  (0.70) -0.6  (0.77) -0.4  (0.62) -0.4  (0.49) -0.2  (0.50)
Week 4, n=28, 31, 29, 32, 22, 26 Number Analyzed 28 participants 31 participants 29 participants 32 participants 22 participants 26 participants
-1.0  (0.69) -1.1  (0.70) -0.9  (0.83) -0.8  (0.78) -0.5  (0.60) -0.2  (0.51)
Week 8, n=26, 27, 27, 32, 20, 20 Number Analyzed 26 participants 27 participants 27 participants 32 participants 20 participants 20 participants
-1.4  (0.90) -1.3  (0.88) -1.4  (0.84) -1.2  (0.97) -0.5  (0.60) -0.4  (0.49)
Week 12, n=23, 25, 26, 28, 19, 20 Number Analyzed 23 participants 25 participants 26 participants 28 participants 19 participants 20 participants
-1.8  (0.90) -1.7  (1.03) -1.7  (1.06) -1.3  (0.81) -0.5  (0.77) -0.4  (0.67)
Week 14, n=23, 26, 24, 27, 19, 19 Number Analyzed 23 participants 26 participants 24 participants 27 participants 19 participants 19 participants
-1.7  (0.93) -1.6  (1.20) -1.4  (0.88) -1.2  (0.92) -0.5  (0.70) -0.4  (0.50)
Week 16, n=24, 26, 26, 28, 19, 19 Number Analyzed 24 participants 26 participants 26 participants 28 participants 19 participants 19 participants
-1.6  (1.01) -1.6  (1.24) -1.4  (0.90) -1.3  (1.00) -0.4  (0.69) -0.3  (0.56)
EW, n=10, 7, 4, 2, 10, 9 Number Analyzed 10 participants 7 participants 4 participants 2 participants 10 participants 9 participants
-0.5  (1.18) -1.3  (1.38) -1.0  (1.41) 0.0  (1.41) 0.0  (0.47) 0.1  (0.60)
9.Secondary Outcome
Title Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit
Hide Description A single target lesion of at least 3 centimeter (cm) x 3 cm was selected at Baseline. For the selected lesion, the severity of erythema, scaling and plaque thickness (induration) was assessed by the investigator on a 5-point scale ranging from 0=none to 4=severe. The mean change in individual grading scores from Baseline was summarized for each study visit. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame Baseline and up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title GSK2894512 1% BID GSK2894512 1% QD GSK2894512 0.5% BID GSK2894512 0.5% QD Vehicle BID Vehicle QD
Hide Arm/Group Description:
The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
Overall Number of Participants Analyzed 34 35 32 32 30 33
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Scaling; Week 1, n=32, 35, 31, 32, 28, 32 Number Analyzed 32 participants 35 participants 31 participants 32 participants 28 participants 32 participants
-0.7  (0.70) -0.7  (0.90) -0.4  (0.76) -0.6  (0.56) -0.5  (0.69) -0.3  (0.44)
Scaling; Week 2, n=32, 33, 30, 32, 24, 30 Number Analyzed 32 participants 33 participants 30 participants 32 participants 24 participants 30 participants
-0.9  (0.78) -1.0  (1.07) -0.9  (0.87) -1.0  (0.84) -1.0  (0.75) -0.3  (0.80)
Scaling; Week 4, n=28, 31, 29, 32, 22, 26 Number Analyzed 28 participants 31 participants 29 participants 32 participants 22 participants 26 participants
-1.5  (0.88) -1.5  (1.21) -1.4  (0.95) -1.4  (0.98) -1.0  (0.84) -0.4  (0.80)
Scaling; Week 8, n=26, 27, 27, 32, 20, 20 Number Analyzed 26 participants 27 participants 27 participants 32 participants 20 participants 20 participants
-2.0  (1.11) -2.0  (1.19) -1.7  (1.07) -1.9  (1.03) -1.2  (0.93) -0.4  (0.81)
Scaling; Week 12, n=23, 25, 26, 29, 19, 20 Number Analyzed 23 participants 25 participants 26 participants 29 participants 19 participants 20 participants
-2.3  (0.96) -2.4  (1.15) -2.1  (1.07) -2.0  (1.05) -1.0  (1.11) -0.7  (0.81)
Scaling; Week 14, n=23, 26, 24, 27, 19, 19 Number Analyzed 23 participants 26 participants 24 participants 27 participants 19 participants 19 participants
-2.1  (1.20) -2.2  (1.43) -1.7  (1.17) -1.8  (1.37) -0.7  (1.05) -0.5  (0.77)
Scaling; Week 16, n=24, 26, 26, 28, 19, 19 Number Analyzed 24 participants 26 participants 26 participants 28 participants 19 participants 19 participants
-2.1  (1.19) -2.2  (1.24) -1.6  (1.45) -1.8  (1.29) -0.6  (1.07) -0.3  (0.67)
Scaling; EW, n=10, 7, 4, 2, 10, 9 Number Analyzed 10 participants 7 participants 4 participants 2 participants 10 participants 9 participants
-1.5  (1.27) -1.6  (1.27) -1.3  (1.50) -0.5  (0.71) -0.5  (0.97) 0.0  (0.71)
Erythema; Week 1, n=32, 35, 31, 32, 28, 32 Number Analyzed 32 participants 35 participants 31 participants 32 participants 28 participants 32 participants
-0.4  (0.66) -0.5  (0.78) -0.3  (0.64) -0.4  (0.50) -0.2  (0.48) -0.1  (0.39)
Erythema; Week 2, n=32, 33, 30, 32, 24, 30 Number Analyzed 32 participants 33 participants 30 participants 32 participants 24 participants 30 participants
-0.8  (0.83) -1.1  (0.97) -0.7  (0.94) -0.8  (0.74) -0.3  (0.75) -0.2  (0.48)
Erythema; Week 4, n=28, 31, 29, 32, 22, 26 Number Analyzed 28 participants 31 participants 29 participants 32 participants 22 participants 26 participants
-1.3  (0.90) -1.5  (0.89) -1.3  (0.85) -1.1  (0.80) -0.6  (0.85) -0.4  (0.64)
Erythema; Week 8, n=26, 27, 27, 32, 20, 20 Number Analyzed 26 participants 27 participants 27 participants 32 participants 20 participants 20 participants
-1.8  (1.10) -2.0  (1.04) -1.9  (0.95) -1.5  (0.92) -0.8  (0.85) -0.5  (0.76)
Erythema; Week 12, n=23, 25, 26, 29, 19, 20 Number Analyzed 23 participants 25 participants 26 participants 29 participants 19 participants 20 participants
-2.3  (1.10) -2.5  (1.08) -2.2  (1.01) -1.9  (1.13) -0.5  (1.07) -0.8  (0.97)
Erythema; Week 14, n=23, 26, 24, 27, 19, 19 Number Analyzed 23 participants 26 participants 24 participants 27 participants 19 participants 19 participants
-2.1  (1.28) -2.2  (1.21) -1.9  (0.95) -1.7  (1.27) -0.6  (1.12) -0.9  (0.91)
Erythema; Week 16, n=24, 26, 26, 28, 19, 19 Number Analyzed 24 participants 26 participants 26 participants 28 participants 19 participants 19 participants
-2.1  (1.23) -2.3  (1.09) -1.8  (1.10) -2.0  (1.26) -0.6  (0.96) -0.5  (0.90)
Erythema; EW, n=10, 7, 4, 2, 10, 9 Number Analyzed 10 participants 7 participants 4 participants 2 participants 10 participants 9 participants
-1.3  (1.06) -1.4  (1.40) -0.8  (1.50) 0.0  (1.41) -0.5  (0.97) -0.1  (0.60)
Plaque thickness; Week 1, n=32,35,31,32,28,32 Number Analyzed 32 participants 35 participants 31 participants 32 participants 28 participants 32 participants
-0.5  (0.67) -0.5  (0.82) -0.4  (0.56) -0.3  (0.60) -0.4  (0.50) -0.2  (0.45)
Plaque thickness; Week 2, n=32,33,30,32,24,30 Number Analyzed 32 participants 33 participants 30 participants 32 participants 24 participants 30 participants
-0.9  (0.84) -0.9  (1.01) -0.9  (0.94) -0.8  (0.80) -0.7  (0.76) -0.3  (0.66)
Plaque thickness; Week 4, n=28,31,29,32,22,26 Number Analyzed 28 participants 31 participants 29 participants 32 participants 22 participants 26 participants
-1.4  (1.03) -1.5  (1.26) -1.3  (1.00) -1.2  (0.93) -1.0  (0.65) -0.4  (0.64)
Plaque thickness; Week 8, n=26,27,27,32,20,20 Number Analyzed 26 participants 27 participants 27 participants 32 participants 20 participants 20 participants
-1.8  (1.17) -1.8  (1.15) -1.8  (1.09) -1.7  (1.12) -0.9  (0.88) -0.5  (0.60)
Plaque thickness; Week 12, n=23,25,26,29,19,20 Number Analyzed 23 participants 25 participants 26 participants 29 participants 19 participants 20 participants
-2.3  (0.93) -2.1  (1.19) -1.9  (1.20) -1.9  (1.13) -1.0  (0.94) -0.7  (0.80)
Plaque thickness; Week 14, n=23,26,24,27,19,19 Number Analyzed 23 participants 26 participants 24 participants 27 participants 19 participants 19 participants
-2.1  (1.16) -2.1  (1.20) -1.8  (1.19) -1.7  (1.32) -0.9  (1.13) -0.7  (0.87)
Plaque thickness; Week 16, n=24,26 26,28,19,19 Number Analyzed 24 participants 26 participants 26 participants 28 participants 19 participants 19 participants
-2.1  (1.19) -2.1  (1.32) -1.6  (1.39) -1.8  (1.31) -0.7  (1.10) -0.4  (0.69)
Plaque thickness; EW, n=10,7,4,2,10,9 Number Analyzed 10 participants 7 participants 4 participants 2 participants 10 participants 9 participants
-1.3  (1.06) -1.9  (1.21) -1.0  (1.41) 0.0  (0.00) -0.6  (1.07) 0.4  (0.73)
10.Secondary Outcome
Title Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit
Hide Description The participant reported itch severity was obtained from the response of the participants to the itch NRS item in the psoriasis symptom diary (PSD). PSD was developed to assess daily self-reports of psoriasis symptoms and the functional impact related to the underlying pathophysiology of the disease. The participants answered questions related to the severity and impact of the signs and symptoms daily using a 11 point NRS with scores ranging from 0 (absent) to 10 (worst imaginable). Mean change in itch/pruritis NRS from Baseline to each study visit was presented. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the post dose weekly average value minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame Baseline and up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title GSK2894512 1% BID GSK2894512 1% QD GSK2894512 0.5% BID GSK2894512 0.5% QD Vehicle BID Vehicle QD
Hide Arm/Group Description:
The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
Overall Number of Participants Analyzed 34 35 32 32 30 33
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Week 1, n=28, 33, 21, 31, 21, 29 Number Analyzed 28 participants 33 participants 21 participants 31 participants 21 participants 29 participants
-0.66  (1.800) -0.17  (2.007) -1.00  (2.038) -0.32  (1.710) -1.31  (1.689) -0.63  (1.612)
Week 2, n=27, 30, 22, 32, 20, 25 Number Analyzed 27 participants 30 participants 22 participants 32 participants 20 participants 25 participants
-1.62  (2.334) -0.85  (1.870) -1.97  (2.366) -1.24  (1.949) -1.66  (2.444) -1.12  (2.147)
Week 4, n=20, 25, 21, 30, 17, 24 Number Analyzed 20 participants 25 participants 21 participants 30 participants 17 participants 24 participants
-2.35  (3.057) -1.78  (2.402) -3.13  (2.075) -1.91  (2.723) -1.67  (2.727) -1.31  (2.338)
Week 8, n=18, 22, 20, 29, 16, 20 Number Analyzed 18 participants 22 participants 20 participants 29 participants 16 participants 20 participants
-3.66  (3.248) -1.93  (2.543) -3.29  (2.605) -2.06  (2.842) -1.98  (3.239) -1.43  (2.664)
Week 12, n=14, 20, 21, 24, 15, 18 Number Analyzed 14 participants 20 participants 21 participants 24 participants 15 participants 18 participants
-3.53  (2.933) -2.59  (2.923) -3.65  (2.605) -2.73  (2.922) -2.46  (3.389) -1.43  (2.765)
Week 14, n=13, 14, 15, 24, 15, 13 Number Analyzed 13 participants 14 participants 15 participants 24 participants 15 participants 13 participants
-3.56  (2.698) -3.52  (2.489) -3.58  (2.296) -2.24  (3.067) -1.90  (2.643) -2.19  (2.898)
Week 16, n=10, 9, 12, 19, 13, 10 Number Analyzed 10 participants 9 participants 12 participants 19 participants 13 participants 10 participants
-3.67  (3.766) -2.19  (2.695) -3.66  (2.059) -2.25  (2.992) -2.36  (2.837) -2.06  (3.225)
EW, n=6, 3, 2, 0, 5, 5 Number Analyzed 6 participants 3 participants 2 participants 0 participants 5 participants 5 participants
-1.77  (1.647) -0.07  (1.501) -5.67  (6.128) -1.79  (1.654) -0.51  (1.391)
11.Secondary Outcome
Title Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit
Hide Description The PGA is a clinical tool for assessing the current state/severity of a participant’s psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual ‘average’ of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of responders that is, participants who achieved a PGA score of 0 or 1 and a minimum 2-grade improvement from baseline were summarized. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame Baseline and up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title GSK2894512 1% BID GSK2894512 1% QD GSK2894512 0.5% BID GSK2894512 0.5% QD Vehicle BID Vehicle QD
Hide Arm/Group Description:
The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
Overall Number of Participants Analyzed 34 35 32 32 30 33
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1, n=32, 35, 31, 32, 28, 32 Number Analyzed 32 participants 35 participants 31 participants 32 participants 28 participants 32 participants
0 0 3 0 4 0
Week 2, n=32, 33, 30, 32, 24, 30 Number Analyzed 32 participants 33 participants 30 participants 32 participants 24 participants 30 participants
9 9 10 6 0 0
Week 4, n=28, 31, 29, 32, 22, 26 Number Analyzed 28 participants 31 participants 29 participants 32 participants 22 participants 26 participants
14 19 17 13 5 0
Week 8, n=26, 27, 27, 32, 20, 20 Number Analyzed 26 participants 27 participants 27 participants 32 participants 20 participants 20 participants
42 37 33 41 0 0
Week 12, n=23, 25, 26, 28, 19, 20 Number Analyzed 23 participants 25 participants 26 participants 28 participants 19 participants 20 participants
65 56 46 36 11 5
Week 14, n=23, 26, 24, 27, 19, 19 Number Analyzed 23 participants 26 participants 24 participants 27 participants 19 participants 19 participants
57 62 29 37 5 0
Week 16, n=24, 26, 26, 28, 19, 19 Number Analyzed 24 participants 26 participants 26 participants 28 participants 19 participants 19 participants
58 54 35 36 5 0
EW, n=10, 7, 4, 2, 10, 9 Number Analyzed 10 participants 7 participants 4 participants 2 participants 10 participants 9 participants
10 43 25 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value -3.6
Confidence Interval (2-Sided) 95%
-28.8 to 21.9
Estimation Comments Difference between GSK2894512 1% BID and Vehicle BID at Week 1 has been presented
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK2894512 0.5% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-25.4 to 25.1
Estimation Comments Difference between GSK2894512 0.5% BID and Vehicle BID at Week 1 has been presented
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 9.4
Confidence Interval (2-Sided) 95%
-17.5 to 35.3
Estimation Comments Difference between GSK2894512 1% BID and Vehicle BID at Week 2 has been presented
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% QD, Vehicle QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 9.1
Confidence Interval (2-Sided) 95%
-15.4 to 33.3
Estimation Comments Difference between GSK2894512 1% QD and Vehicle QD at Week 2 has been presented .
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection GSK2894512 0.5% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 10.0
Confidence Interval (2-Sided) 95%
-17.1 to 36.1
Estimation Comments Difference between GSK2894512 0.5% BID and Vehicle BID at Week 2 has been presented .
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection GSK2894512 0.5% QD, Vehicle QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 6.3
Confidence Interval (2-Sided) 95%
-19.3 to 31.0
Estimation Comments Difference between GSK2894512 0.5% QD and Vehicle QD at Week 2 has been presented
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 9.7
Confidence Interval (2-Sided) 95%
-18.2 to 36.7
Estimation Comments Difference between GSK2894512 1% BID and Vehicle BID at Week 4 has been presented
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% QD, Vehicle QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 19.4
Confidence Interval (2-Sided) 95%
-6.9 to 43.6
Estimation Comments Difference between GSK2894512 1% QD and Vehicle QD at Week 4 has been presented .
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection GSK2894512 0.5% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 12.7
Confidence Interval (2-Sided) 95%
-15.1 to 38.9
Estimation Comments Difference between GSK2894512 0.5% BID and Vehicle BID at Week 4 has been presented
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection GSK2894512 0.5% QD, Vehicle QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 12.5
Confidence Interval (2-Sided) 95%
-13.6 to 37.4
Estimation Comments Difference between GSK2894512 0.5% QD and Vehicle QD at Week 4 has been presented .
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 42.3
Confidence Interval (2-Sided) 95%
13.8 to 66.0
Estimation Comments Difference between GSK2894512 1% BID and Vehicle BID at Week 8 has been presented
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% QD, Vehicle QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 37.0
Confidence Interval (2-Sided) 95%
8.7 to 61.3
Estimation Comments Difference between GSK2894512 1% QD and Vehicle QD at Week 8 has been presented
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection GSK2894512 0.5% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 33.3
Confidence Interval (2-Sided) 95%
4.8 to 58.2
Estimation Comments Difference between GSK2894512 0.5% BID and Vehicle BID at Week 8 has been presented .
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection GSK2894512 0.5% QD, Vehicle QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 40.6
Confidence Interval (2-Sided) 95%
12.8 to 63.9
Estimation Comments Difference between GSK2894512 0.5% QD and Vehicle QD at Week 8 has been presented.
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 54.7
Confidence Interval (2-Sided) 95%
25.9 to 76.6
Estimation Comments Difference between GSK2894512 1% BID and Vehicle BID at Week 12 has been presented.
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% QD, Vehicle QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 51.0
Confidence Interval (2-Sided) 95%
22.2 to 73.2
Estimation Comments Difference between GSK2894512 1% QD and Vehicle QD at Week 12 has been presented
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection GSK2894512 0.5% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 35.6
Confidence Interval (2-Sided) 95%
6.3 to 60.5
Estimation Comments Difference between GSK2894512 0.5% BID and Vehicle BID at Week 12 has been presented
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection GSK2894512 0.5% QD, Vehicle QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 30.7
Confidence Interval (2-Sided) 95%
1.6 to 55.9
Estimation Comments Difference between GSK2894512 0.5% QD and Vehicle QD at Week 12 has been presented
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 51.3
Confidence Interval (2-Sided) 95%
22.0 to 74.0
Estimation Comments Difference between GSK2894512 1% BID and Vehicle BID at Week 14 has been presented
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% QD, Vehicle QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 61.5
Confidence Interval (2-Sided) 95%
34.6 to 81.0
Estimation Comments Difference between GSK2894512 1% QD and Vehicle QD at Week 14 has been presented
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection GSK2894512 0.5% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 23.9
Confidence Interval (2-Sided) 95%
-6.1 to 51.0
Estimation Comments Difference between GSK2894512 0.5% BID and Vehicle BID at Week 14 has been presented
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection GSK2894512 0.5% QD, Vehicle QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 37.0
Confidence Interval (2-Sided) 95%
7.8 to 61.6
Estimation Comments Difference between GSK2894512 0.5% QD and Vehicle QD at Week 14 has been presented
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 53.1
Confidence Interval (2-Sided) 95%
24.7 to 75.6
Estimation Comments Difference between GSK2894512 1% BID and Vehicle BID at Week 16 has been presented
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% QD, Vehicle QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 53.8
Confidence Interval (2-Sided) 95%
25.8 to 75.5
Estimation Comments Difference between GSK2894512 1% QD and Vehicle QD at Week 16 has been presented
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection GSK2894512 0.5% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 29.4
Confidence Interval (2-Sided) 95%
-0.3 to 55.0
Estimation Comments Difference between GSK2894512 0.5% BID and Vehicle BID at Week 16 has been presented
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection GSK2894512 0.5% QD, Vehicle QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 35.7
Confidence Interval (2-Sided) 95%
6.5 to 60.2
Estimation Comments Difference between GSK2894512 0.5% QD and Vehicle QD at Week 16 has been presented
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 10.0
Confidence Interval (2-Sided) 95%
-36.9 to 53.9
Estimation Comments Difference between GSK2894512 1% BID and Vehicle BID at EW has been presented
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection GSK2894512 1% QD, Vehicle QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 42.9
Confidence Interval (2-Sided) 95%
-6.3 to 81.6
Estimation Comments Difference between GSK2894512 1% QD and Vehicle QD at EW has been presented
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection GSK2894512 0.5% BID, Vehicle BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 25.0
Confidence Interval (2-Sided) 95%
-35.7 to 80.6
Estimation Comments Difference between GSK2894512 0.5% BID and Vehicle BID at EW has been presented
12.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Hide Description An AE is defined as any untoward medical occurrence in a participant under clinical investigation, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. A TEAE is defined as an AE which occurred on or after study treatment start date and on or before the last visit. Number of participants with AEs and SAEs were presented. The analysis was performed on safety Population which comprised of all participants who received at least one dose of study treatment.
Time Frame Up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title GSK2894512 1% BID GSK2894512 1% QD GSK2894512 0.5% BID GSK2894512 0.5% QD Vehicle BID Vehicle QD
Hide Arm/Group Description:
The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
Overall Number of Participants Analyzed 38 38 38 38 37 38
Measure Type: Number
Unit of Measure: Participants
TEAEs 26 20 22 17 9 10
serious TEAEs 1 3 3 0 0 0
13.Secondary Outcome
Title Number of Participants With Reported Local Tolerability Scores
Hide Description The assessment of the presence and degree of burning/stinging and itching at the application site following application of the study treatment was done at each specified study visit using a 5 point tolerability scale. The scores ranged from 0 to 4 where 0=None and 4=Strong/Severe. The score represented an average across all application sites. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame Up to Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title GSK2894512 1% BID GSK2894512 1% QD GSK2894512 0.5% BID GSK2894512 0.5% QD Vehicle BID Vehicle QD
Hide Arm/Group Description:
The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
Overall Number of Participants Analyzed 38 38 38 38 37 38
Measure Type: Number
Unit of Measure: Participants
Week 1, none, n=36, 38, 37,38, 35, 37 Number Analyzed 36 participants 38 participants 37 participants 38 participants 35 participants 37 participants
19 17 18 26 19 26
Week 1, slight, n=36, 38, 37,38, 35, 37 Number Analyzed 36 participants 38 participants 37 participants 38 participants 35 participants 37 participants
4 8 7 1 6 8
Week 1, mild, n=36, 38, 37,38, 35, 37 Number Analyzed 36 participants 38 participants 37 participants 38 participants 35 participants 37 participants
8 9 5 8 6 2
Week 1, moderate, n=36, 38, 37,38, 35, 37 Number Analyzed 36 participants 38 participants 37 participants 38 participants 35 participants 37 participants
4 4 6 3 2 1
Week 1, strong/severe, n=36, 38, 37,38, 35, 37 Number Analyzed 36 participants 38 participants 37 participants 38 participants 35 participants 37 participants
1 0 1 0 2 0
Week 2, none, n=36, 36, 36,38, 31, 35 Number Analyzed 36 participants 36 participants 36 participants 38 participants 31 participants 35 participants
24 28 20 31 23 26
Week 2, slight, n=36, 36, 36,38, 31, 35 Number Analyzed 36 participants 36 participants 36 participants 38 participants 31 participants 35 participants
4 4 7 4 4 5
Week 2, mild, n=36, 36, 36,38, 31, 35 Number Analyzed 36 participants 36 participants 36 participants 38 participants 31 participants 35 participants
7 4 3 2 1 4
Week 2, moderate, n=36, 36, 36,38, 31, 35 Number Analyzed 36 participants 36 participants 36 participants 38 participants 31 participants 35 participants
1 0 6 1 1 0
Week 2, strong/severe, n=36, 36, 36,38, 31, 35 Number Analyzed 36 participants 36 participants 36 participants 38 participants 31 participants 35 participants
0 0 0 0 2 0
Week 4, none, n=32, 34, 35,38, 29, 31 Number Analyzed 32 participants 34 participants 35 participants 38 participants 29 participants 31 participants
19 24 23 32 21 26
Week 4, slight, n=32, 34, 35,38, 29, 31 Number Analyzed 32 participants 34 participants 35 participants 38 participants 29 participants 31 participants
7 5 4 2 3 3
Week 4, mild, n=32, 34, 35,38, 29, 31 Number Analyzed 32 participants 34 participants 35 participants 38 participants 29 participants 31 participants
4 4 5 3 3 1
Week 4, moderate, n=32, 34, 35,38, 29, 31 Number Analyzed 32 participants 34 participants 35 participants 38 participants 29 participants 31 participants
2 1 3 1 1 1
Week 4, strong/severe, n=32, 34, 35,38, 29, 31 Number Analyzed 32 participants 34 participants 35 participants 38 participants 29 participants 31 participants
0 0 0 0 1 0
Week 8, none, n=30, 31, 33,38, 27, 26 Number Analyzed 30 participants 31 participants 33 participants 38 participants 27 participants 26 participants
24 24 24 33 24 22
Week 8, slight, n=30, 31, 33,38, 27, 26 Number Analyzed 30 participants 31 participants 33 participants 38 participants 27 participants 26 participants
4 7 5 3 3 2
Week 8, mild, n=30, 31, 33,38, 27, 26 Number Analyzed 30 participants 31 participants 33 participants 38 participants 27 participants 26 participants
1 0 3 1 0 0
Week 8, moderate, n=30, 31, 33,38, 27, 26 Number Analyzed 30 participants 31 participants 33 participants 38 participants 27 participants 26 participants
1 0 1 1 0 2
Week 8, strong/severe, n=30, 31, 33,38, 27, 26 Number Analyzed 30 participants 31 participants 33 participants 38 participants 27 participants 26 participants
0 0 0 0 0 0
Week 12, none, n=27, 29, 32,35, 26, 25 Number Analyzed 27 participants 29 participants 32 participants 35 participants 26 participants 25 participants
20 24 25 31 24 23
Week 12, slight, n=27, 29, 32,35, 26, 25 Number Analyzed 27 participants 29 participants 32 participants 35 participants 26 participants 25 participants
4 2 3 3 2 1
Week 12, mild, n=27, 29, 32,35, 26, 25 Number Analyzed 27 participants 29 participants 32 participants 35 participants 26 participants 25 participants
2 3 3 1 0 0
Week 12, moderate, n=27, 29, 32,35, 26, 25 Number Analyzed 27 participants 29 participants 32 participants 35 participants 26 participants 25 participants
1 0 1 0 0 1
Week 12, strong/severe, n=27, 29, 32,35, 26, 25 Number Analyzed 27 participants 29 participants 32 participants 35 participants 26 participants 25 participants
0 0 0 0 0 0
Week 14, none, n=27, 30, 33, 33, 27, 24 Number Analyzed 27 participants 30 participants 33 participants 33 participants 27 participants 24 participants
24 25 25 31 25 23
Week 14, slight, n=27, 30, 33, 33, 27, 24 Number Analyzed 27 participants 30 participants 33 participants 33 participants 27 participants 24 participants
1 3 3 2 1 0
Week 14, mild, n=27, 30, 33, 33, 27, 24 Number Analyzed 27 participants 30 participants 33 participants 33 participants 27 participants 24 participants
1 1 3 0 1 0
Week 14, moderate, n=27, 30, 33, 33, 27, 24 Number Analyzed 27 participants 30 participants 33 participants 33 participants 27 participants 24 participants
1 1 2 0 0 1
Week 14, strong/severe, n=27, 30, 33, 33, 27, 24 Number Analyzed 27 participants 30 participants 33 participants 33 participants 27 participants 24 participants
0 0 0 0 0 0
EW, none, n=9, 7, 4, 2, 10, 9 Number Analyzed 9 participants 7 participants 4 participants 2 participants 10 participants 9 participants
4 2 0 2 4 8
EW, slight, n=9, 7, 4, 2, 10, 9 Number Analyzed 9 participants 7 participants 4 participants 2 participants 10 participants 9 participants
1 2 1 0 2 0
EW, mild, n=9, 7, 4, 2, 10, 9 Number Analyzed 9 participants 7 participants 4 participants 2 participants 10 participants 9 participants
0 0 2 0 2 0
EW, moderate, n=9, 7, 4, 2, 10, 9 Number Analyzed 9 participants 7 participants 4 participants 2 participants 10 participants 9 participants
2 1 0 0 1 1
EW, strong/severe, n=9,7,4, 2, 10, 9 Number Analyzed 9 participants 7 participants 4 participants 2 participants 10 participants 9 participants
2 2 1 0 1 0
14.Secondary Outcome
Title Change From Baseline in Albumin and Protein Level
Hide Description Blood samples were collected for the evaluation of change in albumin and protein levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame Baseline and up to Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title GSK2894512 1% BID GSK2894512 1% QD GSK2894512 0.5% BID GSK2894512 0.5% QD Vehicle BID Vehicle QD
Hide Arm/Group Description:
The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
Overall Number of Participants Analyzed 38 38 38 38 37 38
Mean (Standard Deviation)
Unit of Measure: grams/liter (g/L)
Albumin, Week 2, n=35, 36, 35, 37, 29, 34 Number Analyzed 35 participants 36 participants 35 participants 37 participants 29 participants 34 participants
-0.9  (2.11) -1.1  (2.70) -0.9  (2.83) -1.1  (2.33) -0.9  (3.37) -0.6  (2.76)
Albumin, Week 4, n=32, 34, 33, 37, 29, 30 Number Analyzed 32 participants 34 participants 33 participants 37 participants 29 participants 30 participants
-1.3  (2.10) -1.2  (2.52) -1.0  (3.57) -0.4  (1.99) -0.8  (3.53) -0.2  (3.23)
Albumin, Week 8, n=30, 31, 32, 37, 27, 26 Number Analyzed 30 participants 31 participants 32 participants 37 participants 27 participants 26 participants
-1.0  (1.65) -0.6  (2.33) -1.0  (3.33) -1.0  (2.49) -0.6  (3.19) -1.0  (2.36)
Albumin, Week 12, n=27, 30, 32, 36, 26, 24 Number Analyzed 27 participants 30 participants 32 participants 36 participants 26 participants 24 participants
-0.8  (2.19) -0.5  (3.31) -1.3  (3.39) -1.2  (1.67) -0.6  (3.14) -1.1  (2.85)
Albumin, Week 14, n=29, 31, 33, 34, 27, 24 Number Analyzed 29 participants 31 participants 33 participants 34 participants 27 participants 24 participants
-1.3  (2.74) -1.1  (2.72) -1.5  (2.71) -1.1  (2.81) -1.6  (4.24) -2.0  (2.40)
Albumin, EW, n=10, 6, 3, 2, 10, 9 Number Analyzed 10 participants 6 participants 3 participants 2 participants 10 participants 9 participants
-0.3  (2.06) -1.7  (2.50) 0.0  (3.46) -3.5  (3.54) -0.8  (1.99) -0.2  (2.54)
Protein, Week 2, n=35, 36, 35, 37, 29, 34 Number Analyzed 35 participants 36 participants 35 participants 37 participants 29 participants 34 participants
-1.1  (3.84) -2.5  (3.95) -1.3  (4.25) -1.5  (3.07) -1.8  (4.21) -1.0  (4.25)
Protein, Week 4, n=32, 34, 33, 37, 29, 30 Number Analyzed 32 participants 34 participants 33 participants 37 participants 29 participants 30 participants
-2.3  (3.23) -2.9  (3.41) -0.9  (4.94) -0.7  (3.37) -1.9  (4.99) -0.3  (4.70)
Protein, Week 8, n=30, 31, 32, 37, 27, 26 Number Analyzed 30 participants 31 participants 32 participants 37 participants 27 participants 26 participants
-2.1  (3.28) -1.7  (3.74) -1.9  (4.88) -1.3  (3.89) -1.5  (4.42) -1.4  (3.30)
Protein, Week 12, n=27, 30, 32, 36, 26, 24 Number Analyzed 27 participants 30 participants 32 participants 36 participants 26 participants 24 participants
-1.3  (2.73) -2.5  (3.72) -2.4  (4.23) -1.7  (3.27) -1.8  (4.05) -1.5  (3.84)
Protein, Week 14, n=29, 31, 33, 34, 27, 24 Number Analyzed 29 participants 31 participants 33 participants 34 participants 27 participants 24 participants
-2.1  (3.06) -2.9  (3.61) -2.4  (4.34) -1.9  (4.01) -3.0  (4.32) -2.6  (2.81)
Protein, EW, n=10, 6, 3, 2, 10, 9 Number Analyzed 10 participants 6 participants 3 participants 2 participants 10 participants 9 participants
-0.8  (2.66) -3.5  (3.83) -3.0  (5.00) -3.5  (2.12) -1.2  (3.52) -0.2  (3.42)
15.Secondary Outcome
Title Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels.
Hide Description Blood samples were collected for the evaluation of change in levels of alk phos, ALT, AST and GGT from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame Baseline and up to Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title GSK2894512 1% BID GSK2894512 1% QD GSK2894512 0.5% BID GSK2894512 0.5% QD Vehicle BID Vehicle QD
Hide Arm/Group Description:
The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
Overall Number of Participants Analyzed 38 38 38 38 37 38
Mean (Standard Deviation)
Unit of Measure: International Units (IU)/L
Alk. Phos, Week 2, n=35, 36, 35, 37, 29, 34 Number Analyzed 35 participants 36 participants 35 participants 37 participants 29 participants 34 participants
-0.6  (10.83) -0.9  (8.44) -0.7  (13.47) -2.9  (10.93) 0.7  (18.06) -2.1  (7.02)
Alk. Phos, Week 4, n=32, 34, 33, 37, 29, 30 Number Analyzed 32 participants 34 participants 33 participants 37 participants 29 participants 30 participants
-0.2  (20.50) -0.6  (7.03) 0.1  (13.51) 0.4  (11.33) -0.0  (14.42) -2.9  (8.69)
Alk. Phos, Week 8, n=30, 31, 32, 37, 27, 26 Number Analyzed 30 participants 31 participants 32 participants 37 participants 27 participants 26 participants
-4.1  (17.59) -1.2  (11.06) -0.1  (9.53) -3.9  (9.54) 0.0  (12.56) 2.3  (11.25)
Alk. Phos, Week 12, n=27, 30, 32, 36, 26, 24 Number Analyzed 27 participants 30 participants 32 participants 36 participants 26 participants 24 participants
-5.7  (18.74) -3.1  (10.45) -1.7  (9.29) -2.3  (8.30) -1.7  (15.72) 1.2  (13.29)
Alk. Phos, Week 14, n=29, 31, 33, 34, 27, 24 Number Analyzed 29 participants 31 participants 33 participants 34 participants 27 participants 24 participants
-2.3  (15.62) -4.1  (10.56) -3.1  (12.34) -4.9  (13.20) -2.4  (16.98) -2.8  (13.62)
Alk. Phos, EW, n=10, 6, 3, 2, 10, 9 Number Analyzed 10 participants 6 participants 3 participants 2 participants 10 participants 9 participants
-3.7  (7.27) 2.7  (10.95) 7.7  (16.80) -13.5  (6.36) -3.4  (10.51) -1.8  (9.13)
ALT, Week 2, n=35, 36, 35, 37, 29, 34 Number Analyzed 35 participants 36 participants 35 participants 37 participants 29 participants 34 participants
-2.1  (7.98) -2.6  (7.95) -2.3  (6.18) -2.9  (9.75) -2.7  (13.45) -1.3  (4.54)
ALT, Week 4, n=32, 34, 33, 37, 29, 30 Number Analyzed 32 participants 34 participants 33 participants 37 participants 29 participants 30 participants
0.3  (22.68) -2.7  (5.99) -3.7  (13.21) -2.9  (9.91) -2.4  (11.83) 2.3  (9.10)
ALT, Week 8, n=30, 31, 32, 37, 27, 26 Number Analyzed 30 participants 31 participants 32 participants 37 participants 27 participants 26 participants
-1.5  (10.37) -3.9  (12.47) 0.1  (11.68) -4.4  (10.88) 0.3  (14.28) -0.4  (10.21)
ALT, Week 12, n=27, 30, 32, 36, 26, 24 Number Analyzed 27 participants 30 participants 32 participants 36 participants 26 participants 24 participants
-1.8  (15.35) -2.2  (8.25) -0.1  (13.72) -5.4  (9.54) -2.6  (14.93) 1.5  (20.39)
ALT, Week 14, n=29, 31, 33, 34, 27, 24 Number Analyzed 29 participants 31 participants 33 participants 34 participants 27 participants 24 participants
-3.8  (17.42) -3.5  (10.37) -1.8  (12.99) -6.5  (10.33) -1.4  (19.63) -1.7  (9.27)
ALT, EW, n=10, 6, 3, 2, 10, 9 Number Analyzed 10 participants 6 participants 3 participants 2 participants 10 participants 9 participants
-1.1  (5.02) -2.2  (7.31) 5.0  (16.64) -5.0  (7.07) -8.2  (12.16) -1.3  (5.52)
AST, Week 2, n=35, 36, 35, 37, 29, 34 Number Analyzed 35 participants 36 participants 35 participants 37 participants 29 participants 34 participants
-0.6  (4.91) -1.2  (5.09) 0.5  (3.71) -1.8  (11.91) -2.3  (10.76) -1.0  (5.70)
AST, Week 4, n=32, 34, 33, 37, 29, 30 Number Analyzed 32 participants 34 participants 33 participants 37 participants 29 participants 30 participants
0.2  (9.76) -1.9  (3.21) -1.0  (5.22) -3.1  (11.61) -1.9  (9.05) 0.5  (6.66)
AST, Week 8, n=30, 31, 32, 37, 27, 26 Number Analyzed 30 participants 31 participants 32 participants 37 participants 27 participants 26 participants
-1.0  (4.22) -2.2  (6.32) 2.6  (11.60) -4.2  (11.50) -0.3  (10.52) -1.7  (8.47)
AST, Week 12, n=27, 30, 32, 36, 26, 24 Number Analyzed 27 participants 30 participants 32 participants 36 participants 26 participants 24 participants
0.6  (9.09) -2.2  (7.49) 1.9  (8.89) -4.1  (9.90) -1.6  (12.75) -0.3  (8.45)
AST, Week 14, n=29, 31, 33, 34, 27, 24 Number Analyzed 29 participants 31 participants 33 participants 34 participants 27 participants 24 participants
-0.4  (7.55) -2.7  (8.76) 0.7  (8.39) -5.1  (11.36) -1.3  (13.40) -1.0  (6.92)
AST, EW, n=10, 6, 3, 2, 10, 9 Number Analyzed 10 participants 6 participants 3 participants 2 participants 10 participants 9 participants
-1.0  (4.24) 5.2  (15.84) 1.7  (9.07) -1.0  (4.24) -3.7  (7.73) -0.3  (7.48)
GGT, Week 2, n=35, 36, 35, 37, 29, 34 Number Analyzed 35 participants 36 participants 35 participants 37 participants 29 participants 34 participants
-1.0  (6.63) -2.1  (8.38) -0.4  (17.64) -1.6  (14.39) -3.1  (15.17) -4.5  (9.92)
GGT, Week 4, n=32, 34, 33, 37, 29, 30 Number Analyzed 32 participants 34 participants 33 participants 37 participants 29 participants 30 participants
8.5  (56.71) -3.5  (17.84) -4.6  (22.06) 0.3  (15.40) -2.5  (18.08) -2.1  (11.77)
GGT, Week 8, n=30, 31, 32, 37, 27, 26 Number Analyzed 30 participants 31 participants 32 participants 37 participants 27 participants 26 participants
1.9  (20.56) -7.6  (32.91) -1.2  (21.11) -3.2  (20.11) -3.1  (23.93) -0.4  (13.61)
GGT, Week 12, n=27, 30, 32, 36, 26, 24 Number Analyzed 27 participants 30 participants 32 participants 36 participants 26 participants 24 participants
-0.1  (24.48) -2.4  (12.78) 2.1  (20.03) -5.9  (12.56) -3.7  (30.64) 3.3  (23.10)
GGT, Week 14, n=29, 31, 33, 34, 27, 24 Number Analyzed 29 participants 31 participants 33 participants 34 participants 27 participants 24 participants
-1.9  (16.31) -2.5  (11.69) -0.1  (16.58) -5.9  (17.67) -0.5  (38.93) -1.3  (11.15)
GGT, EW, n=10, 6, 3, 2, 10, 9 Number Analyzed 10 participants 6 participants 3 participants 2 participants 10 participants 9 participants
-2.0  (6.25) -5.3  (7.42) -2.0  (6.56) -2.5  (7.78) -2.6  (4.65) -10.1  (25.73)
16.Secondary Outcome
Title Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate.
Hide Description Blood samples were collected for the evaluation of change in levels of direct bil, bil, creatinine and urate from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame Baseline and up to Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title GSK2894512 1% BID GSK2894512 1% QD GSK2894512 0.5% BID GSK2894512 0.5% QD Vehicle BID Vehicle QD
Hide Arm/Group Description:
The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
Overall Number of Participants Analyzed 38 38 38 38 37 38
Mean (Standard Deviation)
Unit of Measure: micromoles (µmol)/L
Direct bil, Week 2, n=35, 36, 35, 37, 29, 34 Number Analyzed 35 participants 36 participants 35 participants 37 participants 29 participants 34 participants
-0.2  (0.81) -0.4  (1.36) 0.0  (1.08) -0.1  (1.24) -0.1  (1.51) 0.0  (0.85)
Direct bil, Week 4, n=32, 34, 33, 37, 29, 30 Number Analyzed 32 participants 34 participants 33 participants 37 participants 29 participants 30 participants
-0.3  (0.67) -0.5  (1.50) -0.1  (1.17) -0.2  (0.99) -0.1  (1.36) -0.1  (1.17)
Direct bil, Week 8, n=30, 31, 32, 37, 27, 26 Number Analyzed 30 participants 31 participants 32 participants 37 participants 27 participants 26 participants
-0.4  (0.97) -0.3  (1.24) -0.2  (0.93) -0.2  (1.03) -0.1  (1.35) -0.5  (1.33)
Direct bil, Week 12, n=27, 30, 32, 36, 26, 24 Number Analyzed 27 participants 30 participants 32 participants 36 participants 26 participants 24 participants
-0.2  (0.64) -0.3  (1.26) -0.2  (1.18) -0.4  (1.15) 0.0  (1.26) -0.1  (1.10)
Direct bil, Week 14, n=29, 31, 33, 34, 27, 24 Number Analyzed 29 participants 31 participants 33 participants 34 participants 27 participants 24 participants
0.1  (1.19) -0.3  (1.28) -0.1  (1.06) -0.1  (1.04) 0.1  (1.52) -0.2  (0.82)
Direct bil, EW, n=10, 6, 3, 2, 10, 9 Number Analyzed 10 participants 6 participants 3 participants 2 participants 10 participants 9 participants
0.2  (1.14) 0.0  (0.00) 0.0  (0.00) 2.0  (0.00) -0.4  (1.26) -0.2  (1.20)
Bil, Week 2, n=35, 36, 35, 37, 29, 34 Number Analyzed 35 participants 36 participants 35 participants 37 participants 29 participants 34 participants
-0.7  (3.03) -1.4  (3.24) -0.6  (2.98) -0.3  (2.56) -0.3  (4.40) 0.8  (4.15)
Bil, Week 4, n=32, 34, 33, 37, 29, 30 Number Analyzed 32 participants 34 participants 33 participants 37 participants 29 participants 30 participants
-0.4  (3.50) -1.2  (3.42) 0.4  (4.34) -0.6  (2.87) -0.6  (4.84) 1.7  (4.29)
Bil, Week 8, n=30, 31, 32, 37, 27, 26 Number Analyzed 30 participants 31 participants 32 participants 37 participants 27 participants 26 participants
-0.3  (2.86) 0.1  (2.73) -0.8  (2.48) -0.3  (3.06) -0.9  (4.27) 0.2  (3.81)
Bil, Week 12, n=27, 30, 32, 36, 26, 24 Number Analyzed 27 participants 30 participants 32 participants 36 participants 26 participants 24 participants
-0.2  (2.10) -0.7  (2.70) -0.9  (3.13) -0.4  (3.13) -0.4  (4.93) 0.6  (4.02)
Bil, Week 14, n=29, 31, 33, 34, 27, 24 Number Analyzed 29 participants 31 participants 33 participants 34 participants 27 participants 24 participants
0.6  (3.70) -0.7  (4.34) -0.9  (2.74) -0.5  (3.56) -0.8  (4.84) 0.5  (2.96)
Bil, EW, n=10, 6, 3, 2, 10, 9 Number Analyzed 10 participants 6 participants 3 participants 2 participants 10 participants 9 participants
-0.8  (2.53) 0.0  (2.19) 2.7  (3.06) -1.0  (1.41) 0.4  (3.10) -0.2  (3.23)
Creatinine, Week 2, n=35, 36, 35, 37, 29, 34 Number Analyzed 35 participants 36 participants 35 participants 37 participants 29 participants 34 participants
-0.26  (7.565) 0.86  (9.588) 1.14  (7.202) 0.27  (9.708) -1.65  (5.812) 1.22  (6.632)
Creatinine, Week 4, n=32, 34, 33, 37, 29, 30 Number Analyzed 32 participants 34 participants 33 participants 37 participants 29 participants 30 participants
-2.27  (6.493) 0.12  (8.469) 0.97  (7.802) 1.81  (7.510) -2.38  (6.095) 1.57  (10.282)
Creatinine, Week 8, n=30, 31, 32, 37, 27, 26 Number Analyzed 30 participants 31 participants 32 participants 37 participants 27 participants 26 participants
-0.09  (6.792) 0.55  (7.030) 0.48  (7.086) 2.82  (11.713) -2.89  (7.566) 1.40  (8.515)
Creatinine, Week 12, n=27, 30, 32, 36, 26, 24 Number Analyzed 27 participants 30 participants 32 participants 36 participants 26 participants 24 participants
2.39  (7.526) 0.14  (6.543) 0.34  (6.852) 0.37  (11.501) -4.35  (10.528) 1.49  (7.718)
Creatinine, Week 14, n=29, 31, 33, 34, 27, 24 Number Analyzed 29 participants 31 participants 33 participants 34 participants 27 participants 24 participants
1.74  (5.748) 1.67  (7.316) 3.41  (7.309) 1.67  (14.096) -2.33  (9.715) 3.06  (8.970)
Creatinine, EW, n=10, 6, 3, 2, 10, 9 Number Analyzed 10 participants 6 participants 3 participants 2 participants 10 participants 9 participants
-0.80  (8.570) -5.02  (9.374) 21.77  (31.832) -1.80  (0.000) -1.58  (6.009) -2.36  (5.544)
Urate, Week 2, n=35, 36, 35, 37, 29, 34 Number Analyzed 35 participants 36 participants 35 participants 37 participants 29 participants 34 participants
-6.0  (55.26) -7.8  (40.29) 15.4  (41.96) 6.2  (61.07) -8.3  (62.91) -0.3  (62.06)
Urate, Week 4, n=32, 34, 33, 37, 29, 30 Number Analyzed 32 participants 34 participants 33 participants 37 participants 29 participants 30 participants
-12.5  (34.36) -7.9  (43.82) 11.2  (48.01) 5.7  (49.36) -10.7  (54.11) 2.7  (52.06)
Urate, Week 8, n=30, 31, 32, 37, 27, 26 Number Analyzed 30 participants 31 participants 32 participants 37 participants 27 participants 26 participants
-5.0  (37.30) -8.7  (37.13) -3.8  (32.30) -0.3  (45.43) -6.3  (73.54) -4.2  (75.80)
Urate, Week 12, n=27, 30, 32, 36, 26, 24 Number Analyzed 27 participants 30 participants 32 participants 36 participants 26 participants 24 participants
-6.3  (28.44) 5.7  (34.51) 1.6  (35.21) -1.7  (55.01) 0.4  (88.79) 15.4  (66.27)
Urate, Week 14, n=29, 31, 33, 34, 27, 24 Number Analyzed 29 participants 31 participants 33 participants 34 participants 27 participants 24 participants
3.1  (41.15) 19.4  (71.04) 16.4  (48.98) -5.9  (54.72) -14.1  (59.37) -2.5  (65.62)
Urate, EW, n=10, 6, 3, 2, 10, 9 Number Analyzed 10 participants 6 participants 3 participants 2 participants 10 participants 9 participants
-2.0  (35.21) -38.3  (31.89) 76.7  (98.15) -10.0  (14.14) -13.0  (33.68) -13.3  (52.92)
17.Secondary Outcome
Title Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Hide Description Blood samples were collected for the evaluation of change in levels of calcium, chloride, CO2, glucose, potassium, sodium, and urea from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame Baseline and up to Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title GSK2894512 1% BID GSK2894512 1% QD GSK2894512 0.5% BID GSK2894512 0.5% QD Vehicle BID Vehicle QD
Hide Arm/Group Description:
The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
Overall Number of Participants Analyzed 38 38 38 38 37 38
Mean (Standard Deviation)
Unit of Measure: millimoles (mmol)/L
Calcium, Week 2, n=35, 36, 35, 37, 29, 34 Number Analyzed 35 participants 36 participants 35 participants 37 participants 29 participants 34 participants
-0.036  (0.1241) -0.036  (0.0935) -0.041  (0.1411) -0.036  (0.0967) -0.048  (0.1239) -0.006  (0.0887)
Calcium, Week 4, n=32, 34, 33, 37, 29, 30 Number Analyzed 32 participants 34 participants 33 participants 37 participants 29 participants 30 participants
-0.037  (0.1003) -0.045  (0.0788) -0.033  (0.1306) -0.014  (0.0899) -0.036  (0.1451) 0.003  (0.0830)
Calcium, Week 8, n=30, 31, 32, 37, 27, 26 Number Analyzed 30 participants 31 participants 32 participants 37 participants 27 participants 26 participants
-0.034  (0.1205) -0.015  (0.0853) -0.036  (0.0951) -0.010  (0.1000) -0.039  (0.1131) -0.017  (0.0948)
Calcium, Week 12, n=27, 30, 32, 36, 26, 24 Number Analyzed 27 participants 30 participants 32 participants 36 participants 26 participants 24 participants
-0.019  (0.0910) -0.013  (0.0934) -0.034  (0.0845) -0.021  (0.1129) -0.032  (0.0988) 0.011  (0.1127)
Calcium, Week 14, n=29, 31, 33, 34, 27, 24 Number Analyzed 29 participants 31 participants 33 participants 34 participants 27 participants 24 participants
-0.028  (0.0912) -0.030  (0.1067) -0.029  (0.0930) -0.025  (0.0935) -0.045  (0.1270) -0.020  (0.1052)
Calcium, EW, n=10, 6, 3, 2, 10, 9 Number Analyzed 10 participants 6 participants 3 participants 2 participants 10 participants 9 participants
-0.024  (0.0717) -0.020  (0.0632) 0.007  (0.1286) -0.030  (0.0990) -0.014  (0.0366) 0.004  (0.0691)
Chloride, Week 2, n=35, 36, 35, 37, 29, 34 Number Analyzed 35 participants 36 participants 35 participants 37 participants 29 participants 34 participants
-0.1  (2.30) 0.3  (2.00) -0.3  (1.98) 0.1  (2.05) 0.3  (2.44) -0.0  (2.29)
Chloride, Week 4, n=32, 34, 33, 37, 29, 30 Number Analyzed 32 participants 34 participants 33 participants 37 participants 29 participants 30 participants
-0.1  (1.66) 0.5  (1.97) -0.4  (2.56) -0.5  (1.83) 0.1  (2.62) -0.7  (2.74)
Chloride, Week 8, n=30, 31, 32, 37, 27, 26 Number Analyzed 30 participants 31 participants 32 participants 37 participants 27 participants 26 participants
0.3  (1.73) 0.6  (1.89) -0.3  (2.02) 0.3  (2.03) -0.1  (2.13) -0.3  (3.07)
Chloride, Week 12, n=27, 30, 32, 36, 26, 24 Number Analyzed 27 participants 30 participants 32 participants 36 participants 26 participants 24 participants
-0.4  (2.62) 0.7  (2.00) 0.1  (2.29) -0.2  (2.35) 0.7  (2.37) -0.7  (2.80)
Chloride, Week 14, n=29, 31, 33, 34, 27, 24 Number Analyzed 29 participants 31 p