Trial Outcomes & Findings for A Dose-Finding Study of GSK2894512 Cream in Subjects With Plaque Psoriasis (NCT NCT02564042)
NCT ID: NCT02564042
Last Updated: 2017-11-13
Results Overview
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.
COMPLETED
PHASE2
227 participants
Baseline and up to Week 12
2017-11-13
Participant Flow
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.
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).
Participant milestones
| Measure |
GSK2894512 1% BID
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.
|
GSK2894512 1% QD
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.
|
GSK2894512 0.5% BID
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.
|
GSK2894512 0.5% QD
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.
|
Vehicle BID
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.
|
Vehicle QD
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 Study
STARTED
|
38
|
38
|
38
|
38
|
37
|
38
|
|
Overall Study
COMPLETED
|
27
|
30
|
32
|
35
|
26
|
24
|
|
Overall Study
NOT COMPLETED
|
11
|
8
|
6
|
3
|
11
|
14
|
Reasons for withdrawal
| Measure |
GSK2894512 1% BID
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.
|
GSK2894512 1% QD
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.
|
GSK2894512 0.5% BID
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.
|
GSK2894512 0.5% QD
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.
|
Vehicle BID
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.
|
Vehicle QD
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 Study
Adverse Event
|
4
|
4
|
3
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
0
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
2
|
2
|
10
|
12
|
Baseline Characteristics
A Dose-Finding Study of GSK2894512 Cream in Subjects With Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
GSK2894512 1% BID
n=38 Participants
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.
|
GSK2894512 1% QD
n=38 Participants
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.
|
GSK2894512 0.5% BID
n=38 Participants
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.
|
GSK2894512 0.5% QD
n=38 Participants
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.
|
Vehicle BID
n=37 Participants
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.
|
Vehicle QD
n=38 Participants
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
n=227 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
45.9 Years
STANDARD_DEVIATION 11.93 • n=5 Participants
|
48.5 Years
STANDARD_DEVIATION 10.56 • n=7 Participants
|
49.6 Years
STANDARD_DEVIATION 10.93 • n=5 Participants
|
48.7 Years
STANDARD_DEVIATION 9.72 • n=4 Participants
|
46.7 Years
STANDARD_DEVIATION 12.62 • n=21 Participants
|
46.4 Years
STANDARD_DEVIATION 10.16 • n=8 Participants
|
47.6 Years
STANDARD_DEVIATION 10.99 • n=8 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
74 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
153 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race, Customized · American Indian (Amer Ind)/Alaska Native (Ala Nat)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race, Customized · Asian/South East Asian Descent/Japanese Descent
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
48 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race, Customized · Black/African American (Afr Amer)
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race, Customized · White/Caucasian
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
166 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race, Customized · Amer Ind/Ala Nat & Black/Afr Amer &White/Caucasian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race, Customized · Black/Afr Amer & White/Caucasian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to Week 12Population: mITT Population
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.
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=28 Participants
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.
|
Vehicle BID
n=19 Participants
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.
|
Vehicle QD
n=20 Participants
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.
|
GSK2894512 1% BID
n=23 Participants
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.
|
GSK2894512 0.5% BID
n=26 Participants
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.
|
GSK2894512 1% QD
n=25 Participants
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.
|
|---|---|---|---|---|---|---|
|
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
|
36 Percentage of participants
|
11 Percentage of participants
|
5 Percentage of participants
|
65 Percentage of participants
|
46 Percentage of participants
|
56 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and up to Week 16Population: mITT Population
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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=32 Participants
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.
|
Vehicle BID
n=30 Participants
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.
|
Vehicle QD
n=33 Participants
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.
|
GSK2894512 1% BID
n=34 Participants
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.
|
GSK2894512 0.5% BID
n=32 Participants
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.
|
GSK2894512 1% QD
n=35 Participants
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit
Week 1, n=32, 35, 31, 32, 28, 32
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
3 Percentage of participants
|
|
Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit
Week 2, n=32, 33, 30, 32, 24, 30
|
3 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
6 Percentage of participants
|
3 Percentage of participants
|
15 Percentage of participants
|
|
Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit
Week 4, n=28, 31, 29, 32, 22, 26
|
6 Percentage of participants
|
5 Percentage of participants
|
0 Percentage of participants
|
32 Percentage of participants
|
14 Percentage of participants
|
26 Percentage of participants
|
|
Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit
Week 8, n=26, 27, 27, 32, 20, 20
|
34 Percentage of participants
|
5 Percentage of participants
|
0 Percentage of participants
|
50 Percentage of participants
|
37 Percentage of participants
|
37 Percentage of participants
|
|
Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit
Week 12, n=23, 25, 26, 28, 19, 20
|
46 Percentage of participants
|
16 Percentage of participants
|
5 Percentage of participants
|
65 Percentage of participants
|
46 Percentage of participants
|
56 Percentage of participants
|
|
Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit
Week 14, n=23, 26, 24, 27, 19, 19
|
48 Percentage of participants
|
16 Percentage of participants
|
5 Percentage of participants
|
65 Percentage of participants
|
46 Percentage of participants
|
65 Percentage of participants
|
|
Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit
Week 16, n=24, 26, 26, 28, 19, 19
|
54 Percentage of participants
|
11 Percentage of participants
|
5 Percentage of participants
|
63 Percentage of participants
|
46 Percentage of participants
|
58 Percentage of participants
|
|
Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit
Early withdrawal (EW), n=10, 7, 4, 2, 10, 9
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
10 Percentage of participants
|
0 Percentage of participants
|
43 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and up to Week 16Population: mITT Population
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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=32 Participants
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.
|
Vehicle BID
n=30 Participants
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.
|
Vehicle QD
n=33 Participants
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.
|
GSK2894512 1% BID
n=34 Participants
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.
|
GSK2894512 0.5% BID
n=32 Participants
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.
|
GSK2894512 1% QD
n=35 Participants
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit
Week 1, n=32, 35, 31, 32, 28, 32
|
0 Percentage of participants
|
4 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
6 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit
Week 2, n=32, 33, 30, 32, 24, 30
|
6 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
13 Percentage of participants
|
13 Percentage of participants
|
12 Percentage of participants
|
|
Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit
Week 4, n=28, 31, 29, 32, 22, 26
|
13 Percentage of participants
|
5 Percentage of participants
|
0 Percentage of participants
|
21 Percentage of participants
|
24 Percentage of participants
|
23 Percentage of participants
|
|
Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit
Week 8, n=26, 27, 27, 32, 20, 20
|
41 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
46 Percentage of participants
|
41 Percentage of participants
|
37 Percentage of participants
|
|
Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit
Week 12, n=23, 25, 26, 28, 19, 20
|
36 Percentage of participants
|
11 Percentage of participants
|
5 Percentage of participants
|
65 Percentage of participants
|
50 Percentage of participants
|
56 Percentage of participants
|
|
Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit
Week 14, n=23, 26, 24, 27, 19, 19
|
37 Percentage of participants
|
5 Percentage of participants
|
0 Percentage of participants
|
61 Percentage of participants
|
38 Percentage of participants
|
62 Percentage of participants
|
|
Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit
Week 16, n=24, 26, 26, 28, 19, 19
|
36 Percentage of participants
|
5 Percentage of participants
|
0 Percentage of participants
|
58 Percentage of participants
|
38 Percentage of participants
|
54 Percentage of participants
|
|
Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit
EW, n=10, 7, 4, 2, 10, 9
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
20 Percentage of participants
|
25 Percentage of participants
|
43 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 16Population: mITT Population
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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=32 Participants
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.
|
Vehicle BID
n=30 Participants
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.
|
Vehicle QD
n=33 Participants
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.
|
GSK2894512 1% BID
n=34 Participants
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.
|
GSK2894512 0.5% BID
n=32 Participants
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.
|
GSK2894512 1% QD
n=35 Participants
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit
Week 4, n=28, 31, 29, 32, 22, 26
|
16 Percentage of participants
|
5 Percentage of participants
|
4 Percentage of participants
|
21 Percentage of participants
|
24 Percentage of participants
|
42 Percentage of participants
|
|
Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit
Week 1, n=32, 35, 31, 32, 28, 32
|
0 Percentage of participants
|
4 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
3 Percentage of participants
|
9 Percentage of participants
|
|
Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit
Week 2, n=32, 33, 30, 32, 24, 30
|
6 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
16 Percentage of participants
|
10 Percentage of participants
|
18 Percentage of participants
|
|
Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit
Week 8, n=26, 27, 27, 32, 20, 20
|
41 Percentage of participants
|
0 Percentage of participants
|
5 Percentage of participants
|
54 Percentage of participants
|
44 Percentage of participants
|
56 Percentage of participants
|
|
Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit
Week 12, n=23, 25, 26, 28, 19, 20
|
39 Percentage of participants
|
11 Percentage of participants
|
10 Percentage of participants
|
70 Percentage of participants
|
54 Percentage of participants
|
72 Percentage of participants
|
|
Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit
Week 14, n=23, 26, 24, 27, 19, 19
|
41 Percentage of participants
|
5 Percentage of participants
|
5 Percentage of participants
|
61 Percentage of participants
|
42 Percentage of participants
|
69 Percentage of participants
|
|
Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit
Week 16, n=24, 26, 26, 28, 19, 19
|
43 Percentage of participants
|
5 Percentage of participants
|
5 Percentage of participants
|
58 Percentage of participants
|
50 Percentage of participants
|
65 Percentage of participants
|
|
Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit
EW, n=10, 7, 4, 2, 10, 9
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
10 Percentage of participants
|
25 Percentage of participants
|
57 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and up to Week 16Population: mITT Population
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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=32 Participants
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.
|
Vehicle BID
n=30 Participants
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.
|
Vehicle QD
n=33 Participants
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.
|
GSK2894512 1% BID
n=34 Participants
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.
|
GSK2894512 0.5% BID
n=32 Participants
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.
|
GSK2894512 1% QD
n=35 Participants
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.
|
|---|---|---|---|---|---|---|
|
Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit
Week 1, n=32, 35, 31, 32, 28, 32
|
0.02 Percentage of BSA
Standard Deviation 0.773
|
-0.05 Percentage of BSA
Standard Deviation 0.510
|
0.01 Percentage of BSA
Standard Deviation 0.277
|
-0.53 Percentage of BSA
Standard Deviation 1.136
|
-0.35 Percentage of BSA
Standard Deviation 0.774
|
-0.30 Percentage of BSA
Standard Deviation 0.990
|
|
Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit
Week 2, n=32, 33, 30, 32, 24, 30
|
-0.51 Percentage of BSA
Standard Deviation 1.157
|
-0.18 Percentage of BSA
Standard Deviation 0.657
|
-0.13 Percentage of BSA
Standard Deviation 1.159
|
-1.06 Percentage of BSA
Standard Deviation 1.496
|
-0.79 Percentage of BSA
Standard Deviation 1.350
|
-0.75 Percentage of BSA
Standard Deviation 1.789
|
|
Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit
Week 4, n=28, 31, 29, 32, 22, 26
|
-0.80 Percentage of BSA
Standard Deviation 1.468
|
-0.60 Percentage of BSA
Standard Deviation 1.332
|
-0.17 Percentage of BSA
Standard Deviation 1.432
|
-2.14 Percentage of BSA
Standard Deviation 3.275
|
-1.93 Percentage of BSA
Standard Deviation 2.951
|
-2.13 Percentage of BSA
Standard Deviation 2.529
|
|
Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit
Week 8, n=26, 27, 27, 32, 20, 20
|
-1.77 Percentage of BSA
Standard Deviation 2.800
|
-1.05 Percentage of BSA
Standard Deviation 1.823
|
-0.65 Percentage of BSA
Standard Deviation 1.435
|
-3.37 Percentage of BSA
Standard Deviation 3.590
|
-3.51 Percentage of BSA
Standard Deviation 3.756
|
-3.60 Percentage of BSA
Standard Deviation 3.220
|
|
Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit
Week 12, n=23, 25, 26, 28, 19, 20
|
-3.59 Percentage of BSA
Standard Deviation 3.931
|
-1.57 Percentage of BSA
Standard Deviation 2.380
|
-0.98 Percentage of BSA
Standard Deviation 3.335
|
-4.88 Percentage of BSA
Standard Deviation 4.211
|
-4.29 Percentage of BSA
Standard Deviation 3.882
|
-4.28 Percentage of BSA
Standard Deviation 3.508
|
|
Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit
Week 14, n=23, 26, 24, 27, 19, 19
|
-3.59 Percentage of BSA
Standard Deviation 4.201
|
-1.33 Percentage of BSA
Standard Deviation 2.475
|
-0.58 Percentage of BSA
Standard Deviation 3.634
|
-5.01 Percentage of BSA
Standard Deviation 4.108
|
-4.26 Percentage of BSA
Standard Deviation 4.172
|
-4.63 Percentage of BSA
Standard Deviation 3.548
|
|
Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit
Week 16, n=24, 26, 26, 28, 19, 19
|
-3.56 Percentage of BSA
Standard Deviation 4.716
|
-1.18 Percentage of BSA
Standard Deviation 2.490
|
-1.10 Percentage of BSA
Standard Deviation 3.627
|
-5.30 Percentage of BSA
Standard Deviation 4.468
|
-4.34 Percentage of BSA
Standard Deviation 4.299
|
-4.47 Percentage of BSA
Standard Deviation 3.833
|
|
Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit
EW, n=10, 7, 4, 2, 10, 9
|
1.25 Percentage of BSA
Standard Deviation 9.546
|
0.74 Percentage of BSA
Standard Deviation 1.536
|
1.17 Percentage of BSA
Standard Deviation 2.094
|
-1.92 Percentage of BSA
Standard Deviation 2.218
|
0.25 Percentage of BSA
Standard Deviation 1.893
|
-2.31 Percentage of BSA
Standard Deviation 3.465
|
SECONDARY outcome
Timeframe: Baseline and up to Week 16Population: mITT Population
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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=32 Participants
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.
|
Vehicle BID
n=30 Participants
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.
|
Vehicle QD
n=33 Participants
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.
|
GSK2894512 1% BID
n=34 Participants
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.
|
GSK2894512 0.5% BID
n=32 Participants
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.
|
GSK2894512 1% QD
n=35 Participants
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.
|
|---|---|---|---|---|---|---|
|
Mean Change in PASI Score From Baseline to Each Study Visit
Week 4, n=28, 31, 29, 32, 22, 26
|
-3.31 Scores on a scale
Standard Deviation 2.796
|
-2.88 Scores on a scale
Standard Deviation 3.308
|
-1.08 Scores on a scale
Standard Deviation 2.026
|
-6.07 Scores on a scale
Standard Deviation 5.051
|
-3.83 Scores on a scale
Standard Deviation 3.827
|
-4.45 Scores on a scale
Standard Deviation 3.072
|
|
Mean Change in PASI Score From Baseline to Each Study Visit
Week 8, n=26, 27, 27, 32, 20, 20
|
-4.58 Scores on a scale
Standard Deviation 3.902
|
-2.82 Scores on a scale
Standard Deviation 4.081
|
-1.34 Scores on a scale
Standard Deviation 2.288
|
-7.52 Scores on a scale
Standard Deviation 5.612
|
-5.79 Scores on a scale
Standard Deviation 5.055
|
-5.77 Scores on a scale
Standard Deviation 3.556
|
|
Mean Change in PASI Score From Baseline to Each Study Visit
Week 12, n=23, 25, 26, 28, 19, 20
|
-5.41 Scores on a scale
Standard Deviation 4.424
|
-2.77 Scores on a scale
Standard Deviation 4.291
|
-1.54 Scores on a scale
Standard Deviation 2.970
|
-8.70 Scores on a scale
Standard Deviation 5.617
|
-6.30 Scores on a scale
Standard Deviation 5.138
|
-6.62 Scores on a scale
Standard Deviation 3.709
|
|
Mean Change in PASI Score From Baseline to Each Study Visit
Week 14, n=23, 26, 24, 27, 19, 19
|
-5.28 Scores on a scale
Standard Deviation 4.422
|
-2.60 Scores on a scale
Standard Deviation 4.491
|
-1.29 Scores on a scale
Standard Deviation 3.280
|
-8.61 Scores on a scale
Standard Deviation 5.328
|
-5.67 Scores on a scale
Standard Deviation 5.100
|
-6.65 Scores on a scale
Standard Deviation 3.973
|
|
Mean Change in PASI Score From Baseline to Each Study Visit
Week 16, n=24, 26, 26, 28, 19, 19
|
-5.13 Scores on a scale
Standard Deviation 4.712
|
-2.41 Scores on a scale
Standard Deviation 4.285
|
-1.09 Scores on a scale
Standard Deviation 3.914
|
-8.46 Scores on a scale
Standard Deviation 5.432
|
-5.65 Scores on a scale
Standard Deviation 5.646
|
-6.63 Scores on a scale
Standard Deviation 4.067
|
|
Mean Change in PASI Score From Baseline to Each Study Visit
EW, n=10, 7, 4, 2, 10, 9
|
1.50 Scores on a scale
Standard Deviation 8.627
|
-0.06 Scores on a scale
Standard Deviation 2.784
|
0.12 Scores on a scale
Standard Deviation 2.742
|
-3.70 Scores on a scale
Standard Deviation 3.391
|
-1.18 Scores on a scale
Standard Deviation 1.167
|
-4.00 Scores on a scale
Standard Deviation 3.636
|
|
Mean Change in PASI Score From Baseline to Each Study Visit
Week 1, n=32, 35, 31, 32, 28, 32
|
-1.33 Scores on a scale
Standard Deviation 1.807
|
-0.85 Scores on a scale
Standard Deviation 1.203
|
-0.28 Scores on a scale
Standard Deviation 1.165
|
-2.22 Scores on a scale
Standard Deviation 2.795
|
-1.11 Scores on a scale
Standard Deviation 2.083
|
-1.73 Scores on a scale
Standard Deviation 2.374
|
|
Mean Change in PASI Score From Baseline to Each Study Visit
Week 2, n=32, 33, 30, 32, 24, 30
|
-2.49 Scores on a scale
Standard Deviation 2.316
|
-1.78 Scores on a scale
Standard Deviation 2.826
|
-0.61 Scores on a scale
Standard Deviation 1.644
|
-4.10 Scores on a scale
Standard Deviation 3.756
|
-2.39 Scores on a scale
Standard Deviation 3.118
|
-3.07 Scores on a scale
Standard Deviation 3.016
|
SECONDARY outcome
Timeframe: Up to Week 16Population: mITT Population
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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=32 Participants
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.
|
Vehicle BID
n=30 Participants
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.
|
Vehicle QD
n=33 Participants
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.
|
GSK2894512 1% BID
n=34 Participants
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.
|
GSK2894512 0.5% BID
n=32 Participants
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.
|
GSK2894512 1% QD
n=35 Participants
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.
|
|---|---|---|---|---|---|---|
|
PGA Scores at Each Study Visit
Baseline, n=34, 35, 32, 32, 30, 33
|
2.9 Scores on a scale
Standard Deviation 0.39
|
3.0 Scores on a scale
Standard Deviation 0.26
|
2.8 Scores on a scale
Standard Deviation 0.44
|
2.9 Scores on a scale
Standard Deviation 0.42
|
3.0 Scores on a scale
Standard Deviation 0.54
|
2.7 Scores on a scale
Standard Deviation 0.51
|
|
PGA Scores at Each Study Visit
Week 1, n=32, 35, 31, 32, 28, 32
|
2.6 Scores on a scale
Standard Deviation 0.56
|
2.9 Scores on a scale
Standard Deviation 0.52
|
2.8 Scores on a scale
Standard Deviation 0.51
|
2.7 Scores on a scale
Standard Deviation 0.59
|
2.7 Scores on a scale
Standard Deviation 0.65
|
2.4 Scores on a scale
Standard Deviation 0.65
|
|
PGA Scores at Each Study Visit
Week 2, n=32, 33, 30, 32, 24, 30
|
2.5 Scores on a scale
Standard Deviation 0.62
|
2.6 Scores on a scale
Standard Deviation 0.50
|
2.6 Scores on a scale
Standard Deviation 0.49
|
2.3 Scores on a scale
Standard Deviation 0.77
|
2.4 Scores on a scale
Standard Deviation 0.67
|
2.2 Scores on a scale
Standard Deviation 0.71
|
|
PGA Scores at Each Study Visit
Week 4, n=28, 31, 29, 32, 22, 26
|
2.1 Scores on a scale
Standard Deviation 0.78
|
2.4 Scores on a scale
Standard Deviation 0.59
|
2.6 Scores on a scale
Standard Deviation 0.64
|
2.0 Scores on a scale
Standard Deviation 0.67
|
2.1 Scores on a scale
Standard Deviation 0.77
|
1.6 Scores on a scale
Standard Deviation 0.71
|
|
PGA Scores at Each Study Visit
Week 8, n=26, 27, 27, 32, 20, 20
|
1.7 Scores on a scale
Standard Deviation 0.85
|
2.5 Scores on a scale
Standard Deviation 0.51
|
2.5 Scores on a scale
Standard Deviation 0.61
|
1.5 Scores on a scale
Standard Deviation 0.86
|
1.6 Scores on a scale
Standard Deviation 0.75
|
1.4 Scores on a scale
Standard Deviation 0.80
|
|
PGA Scores at Each Study Visit
Week 12, n=23, 25, 26, 28, 19, 20
|
1.6 Scores on a scale
Standard Deviation 0.78
|
2.4 Scores on a scale
Standard Deviation 0.69
|
2.5 Scores on a scale
Standard Deviation 0.69
|
1.1 Scores on a scale
Standard Deviation 0.92
|
1.3 Scores on a scale
Standard Deviation 1.01
|
1.1 Scores on a scale
Standard Deviation 0.81
|
|
PGA Scores at Each Study Visit
Week 14, n=23, 26, 24, 27, 19, 19
|
1.7 Scores on a scale
Standard Deviation 0.94
|
2.5 Scores on a scale
Standard Deviation 0.61
|
2.5 Scores on a scale
Standard Deviation 0.61
|
1.3 Scores on a scale
Standard Deviation 1.01
|
1.6 Scores on a scale
Standard Deviation 0.88
|
1.1 Scores on a scale
Standard Deviation 0.99
|
|
PGA Scores at Each Study Visit
Week 16, n=24, 26, 26, 28, 19, 19
|
1.7 Scores on a scale
Standard Deviation 1.06
|
2.5 Scores on a scale
Standard Deviation 0.61
|
2.6 Scores on a scale
Standard Deviation 0.69
|
1.3 Scores on a scale
Standard Deviation 1.08
|
1.5 Scores on a scale
Standard Deviation 0.90
|
1.2 Scores on a scale
Standard Deviation 1.01
|
|
PGA Scores at Each Study Visit
EW, n=10, 7, 4, 2, 10, 9
|
2.5 Scores on a scale
Standard Deviation 0.71
|
3.1 Scores on a scale
Standard Deviation 0.57
|
3.1 Scores on a scale
Standard Deviation 0.60
|
2.5 Scores on a scale
Standard Deviation 1.08
|
2.0 Scores on a scale
Standard Deviation 1.41
|
1.6 Scores on a scale
Standard Deviation 1.40
|
SECONDARY outcome
Timeframe: Baseline and up to Week 16Population: mITT Population
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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=32 Participants
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.
|
Vehicle BID
n=30 Participants
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.
|
Vehicle QD
n=33 Participants
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.
|
GSK2894512 1% BID
n=34 Participants
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.
|
GSK2894512 0.5% BID
n=32 Participants
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.
|
GSK2894512 1% QD
n=35 Participants
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.
|
|---|---|---|---|---|---|---|
|
Mean Change in PGA Score From Baseline to Each Study Visit
Week 1, n=32, 35, 31, 32, 28, 32
|
-0.3 Scores on a scale
Standard Deviation 0.47
|
-0.1 Scores on a scale
Standard Deviation 0.52
|
-0.1 Scores on a scale
Standard Deviation 0.30
|
-0.3 Scores on a scale
Standard Deviation 0.44
|
-0.3 Scores on a scale
Standard Deviation 0.69
|
-0.3 Scores on a scale
Standard Deviation 0.48
|
|
Mean Change in PGA Score From Baseline to Each Study Visit
Week 2, n=32, 33, 30, 32, 24, 30
|
-0.4 Scores on a scale
Standard Deviation 0.62
|
-0.4 Scores on a scale
Standard Deviation 0.49
|
-0.2 Scores on a scale
Standard Deviation 0.50
|
-0.7 Scores on a scale
Standard Deviation 0.75
|
-0.6 Scores on a scale
Standard Deviation 0.77
|
-0.6 Scores on a scale
Standard Deviation 0.70
|
|
Mean Change in PGA Score From Baseline to Each Study Visit
Week 4, n=28, 31, 29, 32, 22, 26
|
-0.8 Scores on a scale
Standard Deviation 0.78
|
-0.5 Scores on a scale
Standard Deviation 0.60
|
-0.2 Scores on a scale
Standard Deviation 0.51
|
-1.0 Scores on a scale
Standard Deviation 0.69
|
-0.9 Scores on a scale
Standard Deviation 0.83
|
-1.1 Scores on a scale
Standard Deviation 0.70
|
|
Mean Change in PGA Score From Baseline to Each Study Visit
Week 8, n=26, 27, 27, 32, 20, 20
|
-1.2 Scores on a scale
Standard Deviation 0.97
|
-0.5 Scores on a scale
Standard Deviation 0.60
|
-0.4 Scores on a scale
Standard Deviation 0.49
|
-1.4 Scores on a scale
Standard Deviation 0.90
|
-1.4 Scores on a scale
Standard Deviation 0.84
|
-1.3 Scores on a scale
Standard Deviation 0.88
|
|
Mean Change in PGA Score From Baseline to Each Study Visit
Week 12, n=23, 25, 26, 28, 19, 20
|
-1.3 Scores on a scale
Standard Deviation 0.81
|
-0.5 Scores on a scale
Standard Deviation 0.77
|
-0.4 Scores on a scale
Standard Deviation 0.67
|
-1.8 Scores on a scale
Standard Deviation 0.90
|
-1.7 Scores on a scale
Standard Deviation 1.06
|
-1.7 Scores on a scale
Standard Deviation 1.03
|
|
Mean Change in PGA Score From Baseline to Each Study Visit
Week 14, n=23, 26, 24, 27, 19, 19
|
-1.2 Scores on a scale
Standard Deviation 0.92
|
-0.5 Scores on a scale
Standard Deviation 0.70
|
-0.4 Scores on a scale
Standard Deviation 0.50
|
-1.7 Scores on a scale
Standard Deviation 0.93
|
-1.4 Scores on a scale
Standard Deviation 0.88
|
-1.6 Scores on a scale
Standard Deviation 1.20
|
|
Mean Change in PGA Score From Baseline to Each Study Visit
Week 16, n=24, 26, 26, 28, 19, 19
|
-1.3 Scores on a scale
Standard Deviation 1.00
|
-0.4 Scores on a scale
Standard Deviation 0.69
|
-0.3 Scores on a scale
Standard Deviation 0.56
|
-1.6 Scores on a scale
Standard Deviation 1.01
|
-1.4 Scores on a scale
Standard Deviation 0.90
|
-1.6 Scores on a scale
Standard Deviation 1.24
|
|
Mean Change in PGA Score From Baseline to Each Study Visit
EW, n=10, 7, 4, 2, 10, 9
|
0.0 Scores on a scale
Standard Deviation 1.41
|
0.0 Scores on a scale
Standard Deviation 0.47
|
0.1 Scores on a scale
Standard Deviation 0.60
|
-0.5 Scores on a scale
Standard Deviation 1.18
|
-1.0 Scores on a scale
Standard Deviation 1.41
|
-1.3 Scores on a scale
Standard Deviation 1.38
|
SECONDARY outcome
Timeframe: Baseline and up to Week 16Population: mITT Population
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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=32 Participants
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.
|
Vehicle BID
n=30 Participants
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.
|
Vehicle QD
n=33 Participants
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.
|
GSK2894512 1% BID
n=34 Participants
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.
|
GSK2894512 0.5% BID
n=32 Participants
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.
|
GSK2894512 1% QD
n=35 Participants
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.
|
|---|---|---|---|---|---|---|
|
Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit
Scaling; Week 14, n=23, 26, 24, 27, 19, 19
|
-1.8 Scores on a scale
Standard Deviation 1.37
|
-0.7 Scores on a scale
Standard Deviation 1.05
|
-0.5 Scores on a scale
Standard Deviation 0.77
|
-2.1 Scores on a scale
Standard Deviation 1.20
|
-1.7 Scores on a scale
Standard Deviation 1.17
|
-2.2 Scores on a scale
Standard Deviation 1.43
|
|
Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit
Plaque thickness; Week 16, n=24,26 26,28,19,19
|
-1.8 Scores on a scale
Standard Deviation 1.31
|
-0.7 Scores on a scale
Standard Deviation 1.10
|
-0.4 Scores on a scale
Standard Deviation 0.69
|
-2.1 Scores on a scale
Standard Deviation 1.19
|
-1.6 Scores on a scale
Standard Deviation 1.39
|
-2.1 Scores on a scale
Standard Deviation 1.32
|
|
Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit
Erythema; Week 16, n=24, 26, 26, 28, 19, 19
|
-2.0 Scores on a scale
Standard Deviation 1.26
|
-0.6 Scores on a scale
Standard Deviation 0.96
|
-0.5 Scores on a scale
Standard Deviation 0.90
|
-2.1 Scores on a scale
Standard Deviation 1.23
|
-1.8 Scores on a scale
Standard Deviation 1.10
|
-2.3 Scores on a scale
Standard Deviation 1.09
|
|
Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit
Erythema; EW, n=10, 7, 4, 2, 10, 9
|
0.0 Scores on a scale
Standard Deviation 1.41
|
-0.5 Scores on a scale
Standard Deviation 0.97
|
-0.1 Scores on a scale
Standard Deviation 0.60
|
-1.3 Scores on a scale
Standard Deviation 1.06
|
-0.8 Scores on a scale
Standard Deviation 1.50
|
-1.4 Scores on a scale
Standard Deviation 1.40
|
|
Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit
Scaling; Week 1, n=32, 35, 31, 32, 28, 32
|
-0.6 Scores on a scale
Standard Deviation 0.56
|
-0.5 Scores on a scale
Standard Deviation 0.69
|
-0.3 Scores on a scale
Standard Deviation 0.44
|
-0.7 Scores on a scale
Standard Deviation 0.70
|
-0.4 Scores on a scale
Standard Deviation 0.76
|
-0.7 Scores on a scale
Standard Deviation 0.90
|
|
Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit
Scaling; Week 2, n=32, 33, 30, 32, 24, 30
|
-1.0 Scores on a scale
Standard Deviation 0.84
|
-1.0 Scores on a scale
Standard Deviation 0.75
|
-0.3 Scores on a scale
Standard Deviation 0.80
|
-0.9 Scores on a scale
Standard Deviation 0.78
|
-0.9 Scores on a scale
Standard Deviation 0.87
|
-1.0 Scores on a scale
Standard Deviation 1.07
|
|
Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit
Scaling; Week 4, n=28, 31, 29, 32, 22, 26
|
-1.4 Scores on a scale
Standard Deviation 0.98
|
-1.0 Scores on a scale
Standard Deviation 0.84
|
-0.4 Scores on a scale
Standard Deviation 0.80
|
-1.5 Scores on a scale
Standard Deviation 0.88
|
-1.4 Scores on a scale
Standard Deviation 0.95
|
-1.5 Scores on a scale
Standard Deviation 1.21
|
|
Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit
Scaling; Week 8, n=26, 27, 27, 32, 20, 20
|
-1.9 Scores on a scale
Standard Deviation 1.03
|
-1.2 Scores on a scale
Standard Deviation 0.93
|
-0.4 Scores on a scale
Standard Deviation 0.81
|
-2.0 Scores on a scale
Standard Deviation 1.11
|
-1.7 Scores on a scale
Standard Deviation 1.07
|
-2.0 Scores on a scale
Standard Deviation 1.19
|
|
Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit
Scaling; Week 12, n=23, 25, 26, 29, 19, 20
|
-2.0 Scores on a scale
Standard Deviation 1.05
|
-1.0 Scores on a scale
Standard Deviation 1.11
|
-0.7 Scores on a scale
Standard Deviation 0.81
|
-2.3 Scores on a scale
Standard Deviation 0.96
|
-2.1 Scores on a scale
Standard Deviation 1.07
|
-2.4 Scores on a scale
Standard Deviation 1.15
|
|
Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit
Scaling; Week 16, n=24, 26, 26, 28, 19, 19
|
-1.8 Scores on a scale
Standard Deviation 1.29
|
-0.6 Scores on a scale
Standard Deviation 1.07
|
-0.3 Scores on a scale
Standard Deviation 0.67
|
-2.1 Scores on a scale
Standard Deviation 1.19
|
-1.6 Scores on a scale
Standard Deviation 1.45
|
-2.2 Scores on a scale
Standard Deviation 1.24
|
|
Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit
Scaling; EW, n=10, 7, 4, 2, 10, 9
|
-0.5 Scores on a scale
Standard Deviation 0.71
|
-0.5 Scores on a scale
Standard Deviation 0.97
|
0.0 Scores on a scale
Standard Deviation 0.71
|
-1.5 Scores on a scale
Standard Deviation 1.27
|
-1.3 Scores on a scale
Standard Deviation 1.50
|
-1.6 Scores on a scale
Standard Deviation 1.27
|
|
Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit
Erythema; Week 1, n=32, 35, 31, 32, 28, 32
|
-0.4 Scores on a scale
Standard Deviation 0.50
|
-0.2 Scores on a scale
Standard Deviation 0.48
|
-0.1 Scores on a scale
Standard Deviation 0.39
|
-0.4 Scores on a scale
Standard Deviation 0.66
|
-0.3 Scores on a scale
Standard Deviation 0.64
|
-0.5 Scores on a scale
Standard Deviation 0.78
|
|
Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit
Erythema; Week 2, n=32, 33, 30, 32, 24, 30
|
-0.8 Scores on a scale
Standard Deviation 0.74
|
-0.3 Scores on a scale
Standard Deviation 0.75
|
-0.2 Scores on a scale
Standard Deviation 0.48
|
-0.8 Scores on a scale
Standard Deviation 0.83
|
-0.7 Scores on a scale
Standard Deviation 0.94
|
-1.1 Scores on a scale
Standard Deviation 0.97
|
|
Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit
Erythema; Week 4, n=28, 31, 29, 32, 22, 26
|
-1.1 Scores on a scale
Standard Deviation 0.80
|
-0.6 Scores on a scale
Standard Deviation 0.85
|
-0.4 Scores on a scale
Standard Deviation 0.64
|
-1.3 Scores on a scale
Standard Deviation 0.90
|
-1.3 Scores on a scale
Standard Deviation 0.85
|
-1.5 Scores on a scale
Standard Deviation 0.89
|
|
Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit
Plaque thickness; Week 1, n=32,35,31,32,28,32
|
-0.3 Scores on a scale
Standard Deviation 0.60
|
-0.4 Scores on a scale
Standard Deviation 0.50
|
-0.2 Scores on a scale
Standard Deviation 0.45
|
-0.5 Scores on a scale
Standard Deviation 0.67
|
-0.4 Scores on a scale
Standard Deviation 0.56
|
-0.5 Scores on a scale
Standard Deviation 0.82
|
|
Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit
Plaque thickness; Week 2, n=32,33,30,32,24,30
|
-0.8 Scores on a scale
Standard Deviation 0.80
|
-0.7 Scores on a scale
Standard Deviation 0.76
|
-0.3 Scores on a scale
Standard Deviation 0.66
|
-0.9 Scores on a scale
Standard Deviation 0.84
|
-0.9 Scores on a scale
Standard Deviation 0.94
|
-0.9 Scores on a scale
Standard Deviation 1.01
|
|
Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit
Erythema; Week 8, n=26, 27, 27, 32, 20, 20
|
-1.5 Scores on a scale
Standard Deviation 0.92
|
-0.8 Scores on a scale
Standard Deviation 0.85
|
-0.5 Scores on a scale
Standard Deviation 0.76
|
-1.8 Scores on a scale
Standard Deviation 1.10
|
-1.9 Scores on a scale
Standard Deviation 0.95
|
-2.0 Scores on a scale
Standard Deviation 1.04
|
|
Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit
Plaque thickness; Week 4, n=28,31,29,32,22,26
|
-1.2 Scores on a scale
Standard Deviation 0.93
|
-1.0 Scores on a scale
Standard Deviation 0.65
|
-0.4 Scores on a scale
Standard Deviation 0.64
|
-1.4 Scores on a scale
Standard Deviation 1.03
|
-1.3 Scores on a scale
Standard Deviation 1.00
|
-1.5 Scores on a scale
Standard Deviation 1.26
|
|
Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit
Erythema; Week 12, n=23, 25, 26, 29, 19, 20
|
-1.9 Scores on a scale
Standard Deviation 1.13
|
-0.5 Scores on a scale
Standard Deviation 1.07
|
-0.8 Scores on a scale
Standard Deviation 0.97
|
-2.3 Scores on a scale
Standard Deviation 1.10
|
-2.2 Scores on a scale
Standard Deviation 1.01
|
-2.5 Scores on a scale
Standard Deviation 1.08
|
|
Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit
Erythema; Week 14, n=23, 26, 24, 27, 19, 19
|
-1.7 Scores on a scale
Standard Deviation 1.27
|
-0.6 Scores on a scale
Standard Deviation 1.12
|
-0.9 Scores on a scale
Standard Deviation 0.91
|
-2.1 Scores on a scale
Standard Deviation 1.28
|
-1.9 Scores on a scale
Standard Deviation 0.95
|
-2.2 Scores on a scale
Standard Deviation 1.21
|
|
Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit
Plaque thickness; Week 8, n=26,27,27,32,20,20
|
-1.7 Scores on a scale
Standard Deviation 1.12
|
-0.9 Scores on a scale
Standard Deviation 0.88
|
-0.5 Scores on a scale
Standard Deviation 0.60
|
-1.8 Scores on a scale
Standard Deviation 1.17
|
-1.8 Scores on a scale
Standard Deviation 1.09
|
-1.8 Scores on a scale
Standard Deviation 1.15
|
|
Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit
Plaque thickness; Week 12, n=23,25,26,29,19,20
|
-1.9 Scores on a scale
Standard Deviation 1.13
|
-1.0 Scores on a scale
Standard Deviation 0.94
|
-0.7 Scores on a scale
Standard Deviation 0.80
|
-2.3 Scores on a scale
Standard Deviation 0.93
|
-1.9 Scores on a scale
Standard Deviation 1.20
|
-2.1 Scores on a scale
Standard Deviation 1.19
|
|
Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit
Plaque thickness; Week 14, n=23,26,24,27,19,19
|
-1.7 Scores on a scale
Standard Deviation 1.32
|
-0.9 Scores on a scale
Standard Deviation 1.13
|
-0.7 Scores on a scale
Standard Deviation 0.87
|
-2.1 Scores on a scale
Standard Deviation 1.16
|
-1.8 Scores on a scale
Standard Deviation 1.19
|
-2.1 Scores on a scale
Standard Deviation 1.20
|
|
Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit
Plaque thickness; EW, n=10,7,4,2,10,9
|
0.0 Scores on a scale
Standard Deviation 0.00
|
-0.6 Scores on a scale
Standard Deviation 1.07
|
0.4 Scores on a scale
Standard Deviation 0.73
|
-1.3 Scores on a scale
Standard Deviation 1.06
|
-1.0 Scores on a scale
Standard Deviation 1.41
|
-1.9 Scores on a scale
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: Baseline and up to Week 16Population: mITT Population
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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=32 Participants
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.
|
Vehicle BID
n=30 Participants
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.
|
Vehicle QD
n=33 Participants
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.
|
GSK2894512 1% BID
n=34 Participants
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.
|
GSK2894512 0.5% BID
n=32 Participants
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.
|
GSK2894512 1% QD
n=35 Participants
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.
|
|---|---|---|---|---|---|---|
|
Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit
Week 1, n=28, 33, 21, 31, 21, 29
|
-0.32 Scores on a scale
Standard Deviation 1.710
|
-1.31 Scores on a scale
Standard Deviation 1.689
|
-0.63 Scores on a scale
Standard Deviation 1.612
|
-0.66 Scores on a scale
Standard Deviation 1.800
|
-1.00 Scores on a scale
Standard Deviation 2.038
|
-0.17 Scores on a scale
Standard Deviation 2.007
|
|
Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit
Week 2, n=27, 30, 22, 32, 20, 25
|
-1.24 Scores on a scale
Standard Deviation 1.949
|
-1.66 Scores on a scale
Standard Deviation 2.444
|
-1.12 Scores on a scale
Standard Deviation 2.147
|
-1.62 Scores on a scale
Standard Deviation 2.334
|
-1.97 Scores on a scale
Standard Deviation 2.366
|
-0.85 Scores on a scale
Standard Deviation 1.870
|
|
Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit
Week 4, n=20, 25, 21, 30, 17, 24
|
-1.91 Scores on a scale
Standard Deviation 2.723
|
-1.67 Scores on a scale
Standard Deviation 2.727
|
-1.31 Scores on a scale
Standard Deviation 2.338
|
-2.35 Scores on a scale
Standard Deviation 3.057
|
-3.13 Scores on a scale
Standard Deviation 2.075
|
-1.78 Scores on a scale
Standard Deviation 2.402
|
|
Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit
Week 8, n=18, 22, 20, 29, 16, 20
|
-2.06 Scores on a scale
Standard Deviation 2.842
|
-1.98 Scores on a scale
Standard Deviation 3.239
|
-1.43 Scores on a scale
Standard Deviation 2.664
|
-3.66 Scores on a scale
Standard Deviation 3.248
|
-3.29 Scores on a scale
Standard Deviation 2.605
|
-1.93 Scores on a scale
Standard Deviation 2.543
|
|
Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit
Week 12, n=14, 20, 21, 24, 15, 18
|
-2.73 Scores on a scale
Standard Deviation 2.922
|
-2.46 Scores on a scale
Standard Deviation 3.389
|
-1.43 Scores on a scale
Standard Deviation 2.765
|
-3.53 Scores on a scale
Standard Deviation 2.933
|
-3.65 Scores on a scale
Standard Deviation 2.605
|
-2.59 Scores on a scale
Standard Deviation 2.923
|
|
Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit
Week 14, n=13, 14, 15, 24, 15, 13
|
-2.24 Scores on a scale
Standard Deviation 3.067
|
-1.90 Scores on a scale
Standard Deviation 2.643
|
-2.19 Scores on a scale
Standard Deviation 2.898
|
-3.56 Scores on a scale
Standard Deviation 2.698
|
-3.58 Scores on a scale
Standard Deviation 2.296
|
-3.52 Scores on a scale
Standard Deviation 2.489
|
|
Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit
Week 16, n=10, 9, 12, 19, 13, 10
|
-2.25 Scores on a scale
Standard Deviation 2.992
|
-2.36 Scores on a scale
Standard Deviation 2.837
|
-2.06 Scores on a scale
Standard Deviation 3.225
|
-3.67 Scores on a scale
Standard Deviation 3.766
|
-3.66 Scores on a scale
Standard Deviation 2.059
|
-2.19 Scores on a scale
Standard Deviation 2.695
|
|
Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit
EW, n=6, 3, 2, 0, 5, 5
|
—
|
-1.79 Scores on a scale
Standard Deviation 1.654
|
-0.51 Scores on a scale
Standard Deviation 1.391
|
-1.77 Scores on a scale
Standard Deviation 1.647
|
-5.67 Scores on a scale
Standard Deviation 6.128
|
-0.07 Scores on a scale
Standard Deviation 1.501
|
SECONDARY outcome
Timeframe: Baseline and up to Week 16Population: mITT Population
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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=32 Participants
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.
|
Vehicle BID
n=30 Participants
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.
|
Vehicle QD
n=33 Participants
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.
|
GSK2894512 1% BID
n=34 Participants
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.
|
GSK2894512 0.5% BID
n=32 Participants
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.
|
GSK2894512 1% QD
n=35 Participants
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit
Week 1, n=32, 35, 31, 32, 28, 32
|
0 Percentage of participants
|
4 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
3 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit
Week 2, n=32, 33, 30, 32, 24, 30
|
6 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
9 Percentage of participants
|
10 Percentage of participants
|
9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit
Week 4, n=28, 31, 29, 32, 22, 26
|
13 Percentage of participants
|
5 Percentage of participants
|
0 Percentage of participants
|
14 Percentage of participants
|
17 Percentage of participants
|
19 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit
Week 8, n=26, 27, 27, 32, 20, 20
|
41 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
42 Percentage of participants
|
33 Percentage of participants
|
37 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit
Week 12, n=23, 25, 26, 28, 19, 20
|
36 Percentage of participants
|
11 Percentage of participants
|
5 Percentage of participants
|
65 Percentage of participants
|
46 Percentage of participants
|
56 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit
Week 14, n=23, 26, 24, 27, 19, 19
|
37 Percentage of participants
|
5 Percentage of participants
|
0 Percentage of participants
|
57 Percentage of participants
|
29 Percentage of participants
|
62 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit
Week 16, n=24, 26, 26, 28, 19, 19
|
36 Percentage of participants
|
5 Percentage of participants
|
0 Percentage of participants
|
58 Percentage of participants
|
35 Percentage of participants
|
54 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit
EW, n=10, 7, 4, 2, 10, 9
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
10 Percentage of participants
|
25 Percentage of participants
|
43 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 16Population: Safety Population
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.
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=38 Participants
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.
|
Vehicle BID
n=37 Participants
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.
|
Vehicle QD
n=38 Participants
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.
|
GSK2894512 1% BID
n=38 Participants
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.
|
GSK2894512 0.5% BID
n=38 Participants
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.
|
GSK2894512 1% QD
n=38 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
TEAEs
|
17 Participants
|
9 Participants
|
10 Participants
|
26 Participants
|
22 Participants
|
20 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
serious TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to Week 14Population: Safety Population
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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=38 Participants
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.
|
Vehicle BID
n=37 Participants
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.
|
Vehicle QD
n=38 Participants
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.
|
GSK2894512 1% BID
n=38 Participants
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.
|
GSK2894512 0.5% BID
n=38 Participants
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.
|
GSK2894512 1% QD
n=38 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Reported Local Tolerability Scores
Week 1, none, n=36, 38, 37,38, 35, 37
|
26 Participants
|
19 Participants
|
26 Participants
|
19 Participants
|
18 Participants
|
17 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
Week 1, slight, n=36, 38, 37,38, 35, 37
|
1 Participants
|
6 Participants
|
8 Participants
|
4 Participants
|
7 Participants
|
8 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
Week 1, mild, n=36, 38, 37,38, 35, 37
|
8 Participants
|
6 Participants
|
2 Participants
|
8 Participants
|
5 Participants
|
9 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
Week 1, moderate, n=36, 38, 37,38, 35, 37
|
3 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
Week 1, strong/severe, n=36, 38, 37,38, 35, 37
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
Week 2, none, n=36, 36, 36,38, 31, 35
|
31 Participants
|
23 Participants
|
26 Participants
|
24 Participants
|
20 Participants
|
28 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
Week 2, slight, n=36, 36, 36,38, 31, 35
|
4 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
4 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
Week 2, mild, n=36, 36, 36,38, 31, 35
|
2 Participants
|
1 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
Week 2, moderate, n=36, 36, 36,38, 31, 35
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
Week 2, strong/severe, n=36, 36, 36,38, 31, 35
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
Week 4, none, n=32, 34, 35,38, 29, 31
|
32 Participants
|
21 Participants
|
26 Participants
|
19 Participants
|
23 Participants
|
24 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
Week 4, slight, n=32, 34, 35,38, 29, 31
|
2 Participants
|
3 Participants
|
3 Participants
|
7 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
Week 4, mild, n=32, 34, 35,38, 29, 31
|
3 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
Week 4, moderate, n=32, 34, 35,38, 29, 31
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
Week 4, strong/severe, n=32, 34, 35,38, 29, 31
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
Week 8, none, n=30, 31, 33,38, 27, 26
|
33 Participants
|
24 Participants
|
22 Participants
|
24 Participants
|
24 Participants
|
24 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
Week 8, slight, n=30, 31, 33,38, 27, 26
|
3 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
Week 8, mild, n=30, 31, 33,38, 27, 26
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
Week 8, moderate, n=30, 31, 33,38, 27, 26
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
Week 8, strong/severe, n=30, 31, 33,38, 27, 26
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
Week 12, none, n=27, 29, 32,35, 26, 25
|
31 Participants
|
24 Participants
|
23 Participants
|
20 Participants
|
25 Participants
|
24 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
Week 12, slight, n=27, 29, 32,35, 26, 25
|
3 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
Week 12, mild, n=27, 29, 32,35, 26, 25
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
Week 12, moderate, n=27, 29, 32,35, 26, 25
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
Week 12, strong/severe, n=27, 29, 32,35, 26, 25
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
Week 14, none, n=27, 30, 33, 33, 27, 24
|
31 Participants
|
25 Participants
|
23 Participants
|
24 Participants
|
25 Participants
|
25 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
Week 14, slight, n=27, 30, 33, 33, 27, 24
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
Week 14, mild, n=27, 30, 33, 33, 27, 24
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
Week 14, moderate, n=27, 30, 33, 33, 27, 24
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
Week 14, strong/severe, n=27, 30, 33, 33, 27, 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
EW, none, n=9, 7, 4, 2, 10, 9
|
2 Participants
|
4 Participants
|
8 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
EW, slight, n=9, 7, 4, 2, 10, 9
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
EW, mild, n=9, 7, 4, 2, 10, 9
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
EW, moderate, n=9, 7, 4, 2, 10, 9
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Reported Local Tolerability Scores
EW, strong/severe, n=9,7,4, 2, 10, 9
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and up to Week 14Population: Safety Population
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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=38 Participants
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.
|
Vehicle BID
n=37 Participants
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.
|
Vehicle QD
n=38 Participants
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.
|
GSK2894512 1% BID
n=38 Participants
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.
|
GSK2894512 0.5% BID
n=38 Participants
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.
|
GSK2894512 1% QD
n=38 Participants
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.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Albumin and Protein Level
Albumin, Week 14, n=29, 31, 33, 34, 27, 24
|
-1.1 grams/liter (g/L)
Standard Deviation 2.81
|
-1.6 grams/liter (g/L)
Standard Deviation 4.24
|
-2.0 grams/liter (g/L)
Standard Deviation 2.40
|
-1.3 grams/liter (g/L)
Standard Deviation 2.74
|
-1.5 grams/liter (g/L)
Standard Deviation 2.71
|
-1.1 grams/liter (g/L)
Standard Deviation 2.72
|
|
Change From Baseline in Albumin and Protein Level
Albumin, Week 12, n=27, 30, 32, 36, 26, 24
|
-1.2 grams/liter (g/L)
Standard Deviation 1.67
|
-0.6 grams/liter (g/L)
Standard Deviation 3.14
|
-1.1 grams/liter (g/L)
Standard Deviation 2.85
|
-0.8 grams/liter (g/L)
Standard Deviation 2.19
|
-1.3 grams/liter (g/L)
Standard Deviation 3.39
|
-0.5 grams/liter (g/L)
Standard Deviation 3.31
|
|
Change From Baseline in Albumin and Protein Level
Albumin, Week 2, n=35, 36, 35, 37, 29, 34
|
-1.1 grams/liter (g/L)
Standard Deviation 2.33
|
-0.9 grams/liter (g/L)
Standard Deviation 3.37
|
-0.6 grams/liter (g/L)
Standard Deviation 2.76
|
-0.9 grams/liter (g/L)
Standard Deviation 2.11
|
-0.9 grams/liter (g/L)
Standard Deviation 2.83
|
-1.1 grams/liter (g/L)
Standard Deviation 2.70
|
|
Change From Baseline in Albumin and Protein Level
Albumin, Week 4, n=32, 34, 33, 37, 29, 30
|
-0.4 grams/liter (g/L)
Standard Deviation 1.99
|
-0.8 grams/liter (g/L)
Standard Deviation 3.53
|
-0.2 grams/liter (g/L)
Standard Deviation 3.23
|
-1.3 grams/liter (g/L)
Standard Deviation 2.10
|
-1.0 grams/liter (g/L)
Standard Deviation 3.57
|
-1.2 grams/liter (g/L)
Standard Deviation 2.52
|
|
Change From Baseline in Albumin and Protein Level
Albumin, Week 8, n=30, 31, 32, 37, 27, 26
|
-1.0 grams/liter (g/L)
Standard Deviation 2.49
|
-0.6 grams/liter (g/L)
Standard Deviation 3.19
|
-1.0 grams/liter (g/L)
Standard Deviation 2.36
|
-1.0 grams/liter (g/L)
Standard Deviation 1.65
|
-1.0 grams/liter (g/L)
Standard Deviation 3.33
|
-0.6 grams/liter (g/L)
Standard Deviation 2.33
|
|
Change From Baseline in Albumin and Protein Level
Albumin, EW, n=10, 6, 3, 2, 10, 9
|
-3.5 grams/liter (g/L)
Standard Deviation 3.54
|
-0.8 grams/liter (g/L)
Standard Deviation 1.99
|
-0.2 grams/liter (g/L)
Standard Deviation 2.54
|
-0.3 grams/liter (g/L)
Standard Deviation 2.06
|
0.0 grams/liter (g/L)
Standard Deviation 3.46
|
-1.7 grams/liter (g/L)
Standard Deviation 2.50
|
|
Change From Baseline in Albumin and Protein Level
Protein, Week 2, n=35, 36, 35, 37, 29, 34
|
-1.5 grams/liter (g/L)
Standard Deviation 3.07
|
-1.8 grams/liter (g/L)
Standard Deviation 4.21
|
-1.0 grams/liter (g/L)
Standard Deviation 4.25
|
-1.1 grams/liter (g/L)
Standard Deviation 3.84
|
-1.3 grams/liter (g/L)
Standard Deviation 4.25
|
-2.5 grams/liter (g/L)
Standard Deviation 3.95
|
|
Change From Baseline in Albumin and Protein Level
Protein, Week 4, n=32, 34, 33, 37, 29, 30
|
-0.7 grams/liter (g/L)
Standard Deviation 3.37
|
-1.9 grams/liter (g/L)
Standard Deviation 4.99
|
-0.3 grams/liter (g/L)
Standard Deviation 4.70
|
-2.3 grams/liter (g/L)
Standard Deviation 3.23
|
-0.9 grams/liter (g/L)
Standard Deviation 4.94
|
-2.9 grams/liter (g/L)
Standard Deviation 3.41
|
|
Change From Baseline in Albumin and Protein Level
Protein, Week 8, n=30, 31, 32, 37, 27, 26
|
-1.3 grams/liter (g/L)
Standard Deviation 3.89
|
-1.5 grams/liter (g/L)
Standard Deviation 4.42
|
-1.4 grams/liter (g/L)
Standard Deviation 3.30
|
-2.1 grams/liter (g/L)
Standard Deviation 3.28
|
-1.9 grams/liter (g/L)
Standard Deviation 4.88
|
-1.7 grams/liter (g/L)
Standard Deviation 3.74
|
|
Change From Baseline in Albumin and Protein Level
Protein, Week 12, n=27, 30, 32, 36, 26, 24
|
-1.7 grams/liter (g/L)
Standard Deviation 3.27
|
-1.8 grams/liter (g/L)
Standard Deviation 4.05
|
-1.5 grams/liter (g/L)
Standard Deviation 3.84
|
-1.3 grams/liter (g/L)
Standard Deviation 2.73
|
-2.4 grams/liter (g/L)
Standard Deviation 4.23
|
-2.5 grams/liter (g/L)
Standard Deviation 3.72
|
|
Change From Baseline in Albumin and Protein Level
Protein, Week 14, n=29, 31, 33, 34, 27, 24
|
-1.9 grams/liter (g/L)
Standard Deviation 4.01
|
-3.0 grams/liter (g/L)
Standard Deviation 4.32
|
-2.6 grams/liter (g/L)
Standard Deviation 2.81
|
-2.1 grams/liter (g/L)
Standard Deviation 3.06
|
-2.4 grams/liter (g/L)
Standard Deviation 4.34
|
-2.9 grams/liter (g/L)
Standard Deviation 3.61
|
|
Change From Baseline in Albumin and Protein Level
Protein, EW, n=10, 6, 3, 2, 10, 9
|
-3.5 grams/liter (g/L)
Standard Deviation 2.12
|
-1.2 grams/liter (g/L)
Standard Deviation 3.52
|
-0.2 grams/liter (g/L)
Standard Deviation 3.42
|
-0.8 grams/liter (g/L)
Standard Deviation 2.66
|
-3.0 grams/liter (g/L)
Standard Deviation 5.00
|
-3.5 grams/liter (g/L)
Standard Deviation 3.83
|
SECONDARY outcome
Timeframe: Baseline and up to Week 14Population: Safety Population
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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=38 Participants
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.
|
Vehicle BID
n=37 Participants
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.
|
Vehicle QD
n=38 Participants
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.
|
GSK2894512 1% BID
n=38 Participants
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.
|
GSK2894512 0.5% BID
n=38 Participants
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.
|
GSK2894512 1% QD
n=38 Participants
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.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels.
ALT, Week 8, n=30, 31, 32, 37, 27, 26
|
-4.4 International Units (IU)/L
Standard Deviation 10.88
|
0.3 International Units (IU)/L
Standard Deviation 14.28
|
-0.4 International Units (IU)/L
Standard Deviation 10.21
|
-1.5 International Units (IU)/L
Standard Deviation 10.37
|
0.1 International Units (IU)/L
Standard Deviation 11.68
|
-3.9 International Units (IU)/L
Standard Deviation 12.47
|
|
Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels.
Alk. Phos, Week 2, n=35, 36, 35, 37, 29, 34
|
-2.9 International Units (IU)/L
Standard Deviation 10.93
|
0.7 International Units (IU)/L
Standard Deviation 18.06
|
-2.1 International Units (IU)/L
Standard Deviation 7.02
|
-0.6 International Units (IU)/L
Standard Deviation 10.83
|
-0.7 International Units (IU)/L
Standard Deviation 13.47
|
-0.9 International Units (IU)/L
Standard Deviation 8.44
|
|
Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels.
Alk. Phos, Week 4, n=32, 34, 33, 37, 29, 30
|
0.4 International Units (IU)/L
Standard Deviation 11.33
|
-0.0 International Units (IU)/L
Standard Deviation 14.42
|
-2.9 International Units (IU)/L
Standard Deviation 8.69
|
-0.2 International Units (IU)/L
Standard Deviation 20.50
|
0.1 International Units (IU)/L
Standard Deviation 13.51
|
-0.6 International Units (IU)/L
Standard Deviation 7.03
|
|
Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels.
Alk. Phos, Week 8, n=30, 31, 32, 37, 27, 26
|
-3.9 International Units (IU)/L
Standard Deviation 9.54
|
0.0 International Units (IU)/L
Standard Deviation 12.56
|
2.3 International Units (IU)/L
Standard Deviation 11.25
|
-4.1 International Units (IU)/L
Standard Deviation 17.59
|
-0.1 International Units (IU)/L
Standard Deviation 9.53
|
-1.2 International Units (IU)/L
Standard Deviation 11.06
|
|
Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels.
Alk. Phos, Week 12, n=27, 30, 32, 36, 26, 24
|
-2.3 International Units (IU)/L
Standard Deviation 8.30
|
-1.7 International Units (IU)/L
Standard Deviation 15.72
|
1.2 International Units (IU)/L
Standard Deviation 13.29
|
-5.7 International Units (IU)/L
Standard Deviation 18.74
|
-1.7 International Units (IU)/L
Standard Deviation 9.29
|
-3.1 International Units (IU)/L
Standard Deviation 10.45
|
|
Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels.
Alk. Phos, Week 14, n=29, 31, 33, 34, 27, 24
|
-4.9 International Units (IU)/L
Standard Deviation 13.20
|
-2.4 International Units (IU)/L
Standard Deviation 16.98
|
-2.8 International Units (IU)/L
Standard Deviation 13.62
|
-2.3 International Units (IU)/L
Standard Deviation 15.62
|
-3.1 International Units (IU)/L
Standard Deviation 12.34
|
-4.1 International Units (IU)/L
Standard Deviation 10.56
|
|
Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels.
Alk. Phos, EW, n=10, 6, 3, 2, 10, 9
|
-13.5 International Units (IU)/L
Standard Deviation 6.36
|
-3.4 International Units (IU)/L
Standard Deviation 10.51
|
-1.8 International Units (IU)/L
Standard Deviation 9.13
|
-3.7 International Units (IU)/L
Standard Deviation 7.27
|
7.7 International Units (IU)/L
Standard Deviation 16.80
|
2.7 International Units (IU)/L
Standard Deviation 10.95
|
|
Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels.
ALT, Week 2, n=35, 36, 35, 37, 29, 34
|
-2.9 International Units (IU)/L
Standard Deviation 9.75
|
-2.7 International Units (IU)/L
Standard Deviation 13.45
|
-1.3 International Units (IU)/L
Standard Deviation 4.54
|
-2.1 International Units (IU)/L
Standard Deviation 7.98
|
-2.3 International Units (IU)/L
Standard Deviation 6.18
|
-2.6 International Units (IU)/L
Standard Deviation 7.95
|
|
Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels.
ALT, Week 4, n=32, 34, 33, 37, 29, 30
|
-2.9 International Units (IU)/L
Standard Deviation 9.91
|
-2.4 International Units (IU)/L
Standard Deviation 11.83
|
2.3 International Units (IU)/L
Standard Deviation 9.10
|
0.3 International Units (IU)/L
Standard Deviation 22.68
|
-3.7 International Units (IU)/L
Standard Deviation 13.21
|
-2.7 International Units (IU)/L
Standard Deviation 5.99
|
|
Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels.
ALT, Week 12, n=27, 30, 32, 36, 26, 24
|
-5.4 International Units (IU)/L
Standard Deviation 9.54
|
-2.6 International Units (IU)/L
Standard Deviation 14.93
|
1.5 International Units (IU)/L
Standard Deviation 20.39
|
-1.8 International Units (IU)/L
Standard Deviation 15.35
|
-0.1 International Units (IU)/L
Standard Deviation 13.72
|
-2.2 International Units (IU)/L
Standard Deviation 8.25
|
|
Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels.
ALT, Week 14, n=29, 31, 33, 34, 27, 24
|
-6.5 International Units (IU)/L
Standard Deviation 10.33
|
-1.4 International Units (IU)/L
Standard Deviation 19.63
|
-1.7 International Units (IU)/L
Standard Deviation 9.27
|
-3.8 International Units (IU)/L
Standard Deviation 17.42
|
-1.8 International Units (IU)/L
Standard Deviation 12.99
|
-3.5 International Units (IU)/L
Standard Deviation 10.37
|
|
Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels.
ALT, EW, n=10, 6, 3, 2, 10, 9
|
-5.0 International Units (IU)/L
Standard Deviation 7.07
|
-8.2 International Units (IU)/L
Standard Deviation 12.16
|
-1.3 International Units (IU)/L
Standard Deviation 5.52
|
-1.1 International Units (IU)/L
Standard Deviation 5.02
|
5.0 International Units (IU)/L
Standard Deviation 16.64
|
-2.2 International Units (IU)/L
Standard Deviation 7.31
|
|
Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels.
AST, Week 2, n=35, 36, 35, 37, 29, 34
|
-1.8 International Units (IU)/L
Standard Deviation 11.91
|
-2.3 International Units (IU)/L
Standard Deviation 10.76
|
-1.0 International Units (IU)/L
Standard Deviation 5.70
|
-0.6 International Units (IU)/L
Standard Deviation 4.91
|
0.5 International Units (IU)/L
Standard Deviation 3.71
|
-1.2 International Units (IU)/L
Standard Deviation 5.09
|
|
Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels.
AST, Week 4, n=32, 34, 33, 37, 29, 30
|
-3.1 International Units (IU)/L
Standard Deviation 11.61
|
-1.9 International Units (IU)/L
Standard Deviation 9.05
|
0.5 International Units (IU)/L
Standard Deviation 6.66
|
0.2 International Units (IU)/L
Standard Deviation 9.76
|
-1.0 International Units (IU)/L
Standard Deviation 5.22
|
-1.9 International Units (IU)/L
Standard Deviation 3.21
|
|
Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels.
AST, Week 8, n=30, 31, 32, 37, 27, 26
|
-4.2 International Units (IU)/L
Standard Deviation 11.50
|
-0.3 International Units (IU)/L
Standard Deviation 10.52
|
-1.7 International Units (IU)/L
Standard Deviation 8.47
|
-1.0 International Units (IU)/L
Standard Deviation 4.22
|
2.6 International Units (IU)/L
Standard Deviation 11.60
|
-2.2 International Units (IU)/L
Standard Deviation 6.32
|
|
Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels.
AST, Week 12, n=27, 30, 32, 36, 26, 24
|
-4.1 International Units (IU)/L
Standard Deviation 9.90
|
-1.6 International Units (IU)/L
Standard Deviation 12.75
|
-0.3 International Units (IU)/L
Standard Deviation 8.45
|
0.6 International Units (IU)/L
Standard Deviation 9.09
|
1.9 International Units (IU)/L
Standard Deviation 8.89
|
-2.2 International Units (IU)/L
Standard Deviation 7.49
|
|
Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels.
AST, Week 14, n=29, 31, 33, 34, 27, 24
|
-5.1 International Units (IU)/L
Standard Deviation 11.36
|
-1.3 International Units (IU)/L
Standard Deviation 13.40
|
-1.0 International Units (IU)/L
Standard Deviation 6.92
|
-0.4 International Units (IU)/L
Standard Deviation 7.55
|
0.7 International Units (IU)/L
Standard Deviation 8.39
|
-2.7 International Units (IU)/L
Standard Deviation 8.76
|
|
Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels.
AST, EW, n=10, 6, 3, 2, 10, 9
|
-1.0 International Units (IU)/L
Standard Deviation 4.24
|
-3.7 International Units (IU)/L
Standard Deviation 7.73
|
-0.3 International Units (IU)/L
Standard Deviation 7.48
|
-1.0 International Units (IU)/L
Standard Deviation 4.24
|
1.7 International Units (IU)/L
Standard Deviation 9.07
|
5.2 International Units (IU)/L
Standard Deviation 15.84
|
|
Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels.
GGT, Week 2, n=35, 36, 35, 37, 29, 34
|
-1.6 International Units (IU)/L
Standard Deviation 14.39
|
-3.1 International Units (IU)/L
Standard Deviation 15.17
|
-4.5 International Units (IU)/L
Standard Deviation 9.92
|
-1.0 International Units (IU)/L
Standard Deviation 6.63
|
-0.4 International Units (IU)/L
Standard Deviation 17.64
|
-2.1 International Units (IU)/L
Standard Deviation 8.38
|
|
Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels.
GGT, Week 4, n=32, 34, 33, 37, 29, 30
|
0.3 International Units (IU)/L
Standard Deviation 15.40
|
-2.5 International Units (IU)/L
Standard Deviation 18.08
|
-2.1 International Units (IU)/L
Standard Deviation 11.77
|
8.5 International Units (IU)/L
Standard Deviation 56.71
|
-4.6 International Units (IU)/L
Standard Deviation 22.06
|
-3.5 International Units (IU)/L
Standard Deviation 17.84
|
|
Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels.
GGT, Week 8, n=30, 31, 32, 37, 27, 26
|
-3.2 International Units (IU)/L
Standard Deviation 20.11
|
-3.1 International Units (IU)/L
Standard Deviation 23.93
|
-0.4 International Units (IU)/L
Standard Deviation 13.61
|
1.9 International Units (IU)/L
Standard Deviation 20.56
|
-1.2 International Units (IU)/L
Standard Deviation 21.11
|
-7.6 International Units (IU)/L
Standard Deviation 32.91
|
|
Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels.
GGT, Week 12, n=27, 30, 32, 36, 26, 24
|
-5.9 International Units (IU)/L
Standard Deviation 12.56
|
-3.7 International Units (IU)/L
Standard Deviation 30.64
|
3.3 International Units (IU)/L
Standard Deviation 23.10
|
-0.1 International Units (IU)/L
Standard Deviation 24.48
|
2.1 International Units (IU)/L
Standard Deviation 20.03
|
-2.4 International Units (IU)/L
Standard Deviation 12.78
|
|
Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels.
GGT, Week 14, n=29, 31, 33, 34, 27, 24
|
-5.9 International Units (IU)/L
Standard Deviation 17.67
|
-0.5 International Units (IU)/L
Standard Deviation 38.93
|
-1.3 International Units (IU)/L
Standard Deviation 11.15
|
-1.9 International Units (IU)/L
Standard Deviation 16.31
|
-0.1 International Units (IU)/L
Standard Deviation 16.58
|
-2.5 International Units (IU)/L
Standard Deviation 11.69
|
|
Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels.
GGT, EW, n=10, 6, 3, 2, 10, 9
|
-2.5 International Units (IU)/L
Standard Deviation 7.78
|
-2.6 International Units (IU)/L
Standard Deviation 4.65
|
-10.1 International Units (IU)/L
Standard Deviation 25.73
|
-2.0 International Units (IU)/L
Standard Deviation 6.25
|
-2.0 International Units (IU)/L
Standard Deviation 6.56
|
-5.3 International Units (IU)/L
Standard Deviation 7.42
|
SECONDARY outcome
Timeframe: Baseline and up to Week 14Population: Safety Population
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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=38 Participants
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.
|
Vehicle BID
n=37 Participants
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.
|
Vehicle QD
n=38 Participants
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.
|
GSK2894512 1% BID
n=38 Participants
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.
|
GSK2894512 0.5% BID
n=38 Participants
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.
|
GSK2894512 1% QD
n=38 Participants
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.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate.
Direct bil, Week 8, n=30, 31, 32, 37, 27, 26
|
-0.2 micromoles (µmol)/L
Standard Deviation 1.03
|
-0.1 micromoles (µmol)/L
Standard Deviation 1.35
|
-0.5 micromoles (µmol)/L
Standard Deviation 1.33
|
-0.4 micromoles (µmol)/L
Standard Deviation 0.97
|
-0.2 micromoles (µmol)/L
Standard Deviation 0.93
|
-0.3 micromoles (µmol)/L
Standard Deviation 1.24
|
|
Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate.
Urate, EW, n=10, 6, 3, 2, 10, 9
|
-10.0 micromoles (µmol)/L
Standard Deviation 14.14
|
-13.0 micromoles (µmol)/L
Standard Deviation 33.68
|
-13.3 micromoles (µmol)/L
Standard Deviation 52.92
|
-2.0 micromoles (µmol)/L
Standard Deviation 35.21
|
76.7 micromoles (µmol)/L
Standard Deviation 98.15
|
-38.3 micromoles (µmol)/L
Standard Deviation 31.89
|
|
Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate.
Creatinine, Week 14, n=29, 31, 33, 34, 27, 24
|
1.67 micromoles (µmol)/L
Standard Deviation 14.096
|
-2.33 micromoles (µmol)/L
Standard Deviation 9.715
|
3.06 micromoles (µmol)/L
Standard Deviation 8.970
|
1.74 micromoles (µmol)/L
Standard Deviation 5.748
|
3.41 micromoles (µmol)/L
Standard Deviation 7.309
|
1.67 micromoles (µmol)/L
Standard Deviation 7.316
|
|
Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate.
Creatinine, EW, n=10, 6, 3, 2, 10, 9
|
-1.80 micromoles (µmol)/L
Standard Deviation 0.000
|
-1.58 micromoles (µmol)/L
Standard Deviation 6.009
|
-2.36 micromoles (µmol)/L
Standard Deviation 5.544
|
-0.80 micromoles (µmol)/L
Standard Deviation 8.570
|
21.77 micromoles (µmol)/L
Standard Deviation 31.832
|
-5.02 micromoles (µmol)/L
Standard Deviation 9.374
|
|
Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate.
Direct bil, Week 12, n=27, 30, 32, 36, 26, 24
|
-0.4 micromoles (µmol)/L
Standard Deviation 1.15
|
0.0 micromoles (µmol)/L
Standard Deviation 1.26
|
-0.1 micromoles (µmol)/L
Standard Deviation 1.10
|
-0.2 micromoles (µmol)/L
Standard Deviation 0.64
|
-0.2 micromoles (µmol)/L
Standard Deviation 1.18
|
-0.3 micromoles (µmol)/L
Standard Deviation 1.26
|
|
Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate.
Direct bil, Week 14, n=29, 31, 33, 34, 27, 24
|
-0.1 micromoles (µmol)/L
Standard Deviation 1.04
|
0.1 micromoles (µmol)/L
Standard Deviation 1.52
|
-0.2 micromoles (µmol)/L
Standard Deviation 0.82
|
0.1 micromoles (µmol)/L
Standard Deviation 1.19
|
-0.1 micromoles (µmol)/L
Standard Deviation 1.06
|
-0.3 micromoles (µmol)/L
Standard Deviation 1.28
|
|
Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate.
Direct bil, EW, n=10, 6, 3, 2, 10, 9
|
2.0 micromoles (µmol)/L
Standard Deviation 0.00
|
-0.4 micromoles (µmol)/L
Standard Deviation 1.26
|
-0.2 micromoles (µmol)/L
Standard Deviation 1.20
|
0.2 micromoles (µmol)/L
Standard Deviation 1.14
|
0.0 micromoles (µmol)/L
Standard Deviation 0.00
|
0.0 micromoles (µmol)/L
Standard Deviation 0.00
|
|
Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate.
Bil, Week 2, n=35, 36, 35, 37, 29, 34
|
-0.3 micromoles (µmol)/L
Standard Deviation 2.56
|
-0.3 micromoles (µmol)/L
Standard Deviation 4.40
|
0.8 micromoles (µmol)/L
Standard Deviation 4.15
|
-0.7 micromoles (µmol)/L
Standard Deviation 3.03
|
-0.6 micromoles (µmol)/L
Standard Deviation 2.98
|
-1.4 micromoles (µmol)/L
Standard Deviation 3.24
|
|
Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate.
Urate, Week 2, n=35, 36, 35, 37, 29, 34
|
6.2 micromoles (µmol)/L
Standard Deviation 61.07
|
-8.3 micromoles (µmol)/L
Standard Deviation 62.91
|
-0.3 micromoles (µmol)/L
Standard Deviation 62.06
|
-6.0 micromoles (µmol)/L
Standard Deviation 55.26
|
15.4 micromoles (µmol)/L
Standard Deviation 41.96
|
-7.8 micromoles (µmol)/L
Standard Deviation 40.29
|
|
Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate.
Urate, Week 4, n=32, 34, 33, 37, 29, 30
|
5.7 micromoles (µmol)/L
Standard Deviation 49.36
|
-10.7 micromoles (µmol)/L
Standard Deviation 54.11
|
2.7 micromoles (µmol)/L
Standard Deviation 52.06
|
-12.5 micromoles (µmol)/L
Standard Deviation 34.36
|
11.2 micromoles (µmol)/L
Standard Deviation 48.01
|
-7.9 micromoles (µmol)/L
Standard Deviation 43.82
|
|
Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate.
Bil, Week 4, n=32, 34, 33, 37, 29, 30
|
-0.6 micromoles (µmol)/L
Standard Deviation 2.87
|
-0.6 micromoles (µmol)/L
Standard Deviation 4.84
|
1.7 micromoles (µmol)/L
Standard Deviation 4.29
|
-0.4 micromoles (µmol)/L
Standard Deviation 3.50
|
0.4 micromoles (µmol)/L
Standard Deviation 4.34
|
-1.2 micromoles (µmol)/L
Standard Deviation 3.42
|
|
Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate.
Bil, Week 8, n=30, 31, 32, 37, 27, 26
|
-0.3 micromoles (µmol)/L
Standard Deviation 3.06
|
-0.9 micromoles (µmol)/L
Standard Deviation 4.27
|
0.2 micromoles (µmol)/L
Standard Deviation 3.81
|
-0.3 micromoles (µmol)/L
Standard Deviation 2.86
|
-0.8 micromoles (µmol)/L
Standard Deviation 2.48
|
0.1 micromoles (µmol)/L
Standard Deviation 2.73
|
|
Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate.
Bil, Week 12, n=27, 30, 32, 36, 26, 24
|
-0.4 micromoles (µmol)/L
Standard Deviation 3.13
|
-0.4 micromoles (µmol)/L
Standard Deviation 4.93
|
0.6 micromoles (µmol)/L
Standard Deviation 4.02
|
-0.2 micromoles (µmol)/L
Standard Deviation 2.10
|
-0.9 micromoles (µmol)/L
Standard Deviation 3.13
|
-0.7 micromoles (µmol)/L
Standard Deviation 2.70
|
|
Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate.
Bil, Week 14, n=29, 31, 33, 34, 27, 24
|
-0.5 micromoles (µmol)/L
Standard Deviation 3.56
|
-0.8 micromoles (µmol)/L
Standard Deviation 4.84
|
0.5 micromoles (µmol)/L
Standard Deviation 2.96
|
0.6 micromoles (µmol)/L
Standard Deviation 3.70
|
-0.9 micromoles (µmol)/L
Standard Deviation 2.74
|
-0.7 micromoles (µmol)/L
Standard Deviation 4.34
|
|
Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate.
Bil, EW, n=10, 6, 3, 2, 10, 9
|
-1.0 micromoles (µmol)/L
Standard Deviation 1.41
|
0.4 micromoles (µmol)/L
Standard Deviation 3.10
|
-0.2 micromoles (µmol)/L
Standard Deviation 3.23
|
-0.8 micromoles (µmol)/L
Standard Deviation 2.53
|
2.7 micromoles (µmol)/L
Standard Deviation 3.06
|
0.0 micromoles (µmol)/L
Standard Deviation 2.19
|
|
Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate.
Creatinine, Week 2, n=35, 36, 35, 37, 29, 34
|
0.27 micromoles (µmol)/L
Standard Deviation 9.708
|
-1.65 micromoles (µmol)/L
Standard Deviation 5.812
|
1.22 micromoles (µmol)/L
Standard Deviation 6.632
|
-0.26 micromoles (µmol)/L
Standard Deviation 7.565
|
1.14 micromoles (µmol)/L
Standard Deviation 7.202
|
0.86 micromoles (µmol)/L
Standard Deviation 9.588
|
|
Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate.
Creatinine, Week 4, n=32, 34, 33, 37, 29, 30
|
1.81 micromoles (µmol)/L
Standard Deviation 7.510
|
-2.38 micromoles (µmol)/L
Standard Deviation 6.095
|
1.57 micromoles (µmol)/L
Standard Deviation 10.282
|
-2.27 micromoles (µmol)/L
Standard Deviation 6.493
|
0.97 micromoles (µmol)/L
Standard Deviation 7.802
|
0.12 micromoles (µmol)/L
Standard Deviation 8.469
|
|
Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate.
Creatinine, Week 8, n=30, 31, 32, 37, 27, 26
|
2.82 micromoles (µmol)/L
Standard Deviation 11.713
|
-2.89 micromoles (µmol)/L
Standard Deviation 7.566
|
1.40 micromoles (µmol)/L
Standard Deviation 8.515
|
-0.09 micromoles (µmol)/L
Standard Deviation 6.792
|
0.48 micromoles (µmol)/L
Standard Deviation 7.086
|
0.55 micromoles (µmol)/L
Standard Deviation 7.030
|
|
Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate.
Creatinine, Week 12, n=27, 30, 32, 36, 26, 24
|
0.37 micromoles (µmol)/L
Standard Deviation 11.501
|
-4.35 micromoles (µmol)/L
Standard Deviation 10.528
|
1.49 micromoles (µmol)/L
Standard Deviation 7.718
|
2.39 micromoles (µmol)/L
Standard Deviation 7.526
|
0.34 micromoles (µmol)/L
Standard Deviation 6.852
|
0.14 micromoles (µmol)/L
Standard Deviation 6.543
|
|
Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate.
Urate, Week 8, n=30, 31, 32, 37, 27, 26
|
-0.3 micromoles (µmol)/L
Standard Deviation 45.43
|
-6.3 micromoles (µmol)/L
Standard Deviation 73.54
|
-4.2 micromoles (µmol)/L
Standard Deviation 75.80
|
-5.0 micromoles (µmol)/L
Standard Deviation 37.30
|
-3.8 micromoles (µmol)/L
Standard Deviation 32.30
|
-8.7 micromoles (µmol)/L
Standard Deviation 37.13
|
|
Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate.
Urate, Week 12, n=27, 30, 32, 36, 26, 24
|
-1.7 micromoles (µmol)/L
Standard Deviation 55.01
|
0.4 micromoles (µmol)/L
Standard Deviation 88.79
|
15.4 micromoles (µmol)/L
Standard Deviation 66.27
|
-6.3 micromoles (µmol)/L
Standard Deviation 28.44
|
1.6 micromoles (µmol)/L
Standard Deviation 35.21
|
5.7 micromoles (µmol)/L
Standard Deviation 34.51
|
|
Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate.
Urate, Week 14, n=29, 31, 33, 34, 27, 24
|
-5.9 micromoles (µmol)/L
Standard Deviation 54.72
|
-14.1 micromoles (µmol)/L
Standard Deviation 59.37
|
-2.5 micromoles (µmol)/L
Standard Deviation 65.62
|
3.1 micromoles (µmol)/L
Standard Deviation 41.15
|
16.4 micromoles (µmol)/L
Standard Deviation 48.98
|
19.4 micromoles (µmol)/L
Standard Deviation 71.04
|
|
Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate.
Direct bil, Week 2, n=35, 36, 35, 37, 29, 34
|
-0.1 micromoles (µmol)/L
Standard Deviation 1.24
|
-0.1 micromoles (µmol)/L
Standard Deviation 1.51
|
0.0 micromoles (µmol)/L
Standard Deviation 0.85
|
-0.2 micromoles (µmol)/L
Standard Deviation 0.81
|
0.0 micromoles (µmol)/L
Standard Deviation 1.08
|
-0.4 micromoles (µmol)/L
Standard Deviation 1.36
|
|
Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate.
Direct bil, Week 4, n=32, 34, 33, 37, 29, 30
|
-0.2 micromoles (µmol)/L
Standard Deviation 0.99
|
-0.1 micromoles (µmol)/L
Standard Deviation 1.36
|
-0.1 micromoles (µmol)/L
Standard Deviation 1.17
|
-0.3 micromoles (µmol)/L
Standard Deviation 0.67
|
-0.1 micromoles (µmol)/L
Standard Deviation 1.17
|
-0.5 micromoles (µmol)/L
Standard Deviation 1.50
|
SECONDARY outcome
Timeframe: Baseline and up to Week 14Population: Safety Population
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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=38 Participants
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.
|
Vehicle BID
n=37 Participants
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.
|
Vehicle QD
n=38 Participants
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.
|
GSK2894512 1% BID
n=38 Participants
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.
|
GSK2894512 0.5% BID
n=38 Participants
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.
|
GSK2894512 1% QD
n=38 Participants
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.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Calcium, Week 2, n=35, 36, 35, 37, 29, 34
|
-0.036 millimoles (mmol)/L
Standard Deviation 0.0967
|
-0.048 millimoles (mmol)/L
Standard Deviation 0.1239
|
-0.006 millimoles (mmol)/L
Standard Deviation 0.0887
|
-0.036 millimoles (mmol)/L
Standard Deviation 0.1241
|
-0.041 millimoles (mmol)/L
Standard Deviation 0.1411
|
-0.036 millimoles (mmol)/L
Standard Deviation 0.0935
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Calcium, Week 4, n=32, 34, 33, 37, 29, 30
|
-0.014 millimoles (mmol)/L
Standard Deviation 0.0899
|
-0.036 millimoles (mmol)/L
Standard Deviation 0.1451
|
0.003 millimoles (mmol)/L
Standard Deviation 0.0830
|
-0.037 millimoles (mmol)/L
Standard Deviation 0.1003
|
-0.033 millimoles (mmol)/L
Standard Deviation 0.1306
|
-0.045 millimoles (mmol)/L
Standard Deviation 0.0788
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Calcium, Week 8, n=30, 31, 32, 37, 27, 26
|
-0.010 millimoles (mmol)/L
Standard Deviation 0.1000
|
-0.039 millimoles (mmol)/L
Standard Deviation 0.1131
|
-0.017 millimoles (mmol)/L
Standard Deviation 0.0948
|
-0.034 millimoles (mmol)/L
Standard Deviation 0.1205
|
-0.036 millimoles (mmol)/L
Standard Deviation 0.0951
|
-0.015 millimoles (mmol)/L
Standard Deviation 0.0853
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Calcium, Week 12, n=27, 30, 32, 36, 26, 24
|
-0.021 millimoles (mmol)/L
Standard Deviation 0.1129
|
-0.032 millimoles (mmol)/L
Standard Deviation 0.0988
|
0.011 millimoles (mmol)/L
Standard Deviation 0.1127
|
-0.019 millimoles (mmol)/L
Standard Deviation 0.0910
|
-0.034 millimoles (mmol)/L
Standard Deviation 0.0845
|
-0.013 millimoles (mmol)/L
Standard Deviation 0.0934
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Calcium, Week 14, n=29, 31, 33, 34, 27, 24
|
-0.025 millimoles (mmol)/L
Standard Deviation 0.0935
|
-0.045 millimoles (mmol)/L
Standard Deviation 0.1270
|
-0.020 millimoles (mmol)/L
Standard Deviation 0.1052
|
-0.028 millimoles (mmol)/L
Standard Deviation 0.0912
|
-0.029 millimoles (mmol)/L
Standard Deviation 0.0930
|
-0.030 millimoles (mmol)/L
Standard Deviation 0.1067
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Calcium, EW, n=10, 6, 3, 2, 10, 9
|
-0.030 millimoles (mmol)/L
Standard Deviation 0.0990
|
-0.014 millimoles (mmol)/L
Standard Deviation 0.0366
|
0.004 millimoles (mmol)/L
Standard Deviation 0.0691
|
-0.024 millimoles (mmol)/L
Standard Deviation 0.0717
|
0.007 millimoles (mmol)/L
Standard Deviation 0.1286
|
-0.020 millimoles (mmol)/L
Standard Deviation 0.0632
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Chloride, Week 2, n=35, 36, 35, 37, 29, 34
|
0.1 millimoles (mmol)/L
Standard Deviation 2.05
|
0.3 millimoles (mmol)/L
Standard Deviation 2.44
|
-0.0 millimoles (mmol)/L
Standard Deviation 2.29
|
-0.1 millimoles (mmol)/L
Standard Deviation 2.30
|
-0.3 millimoles (mmol)/L
Standard Deviation 1.98
|
0.3 millimoles (mmol)/L
Standard Deviation 2.00
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Chloride, Week 4, n=32, 34, 33, 37, 29, 30
|
-0.5 millimoles (mmol)/L
Standard Deviation 1.83
|
0.1 millimoles (mmol)/L
Standard Deviation 2.62
|
-0.7 millimoles (mmol)/L
Standard Deviation 2.74
|
-0.1 millimoles (mmol)/L
Standard Deviation 1.66
|
-0.4 millimoles (mmol)/L
Standard Deviation 2.56
|
0.5 millimoles (mmol)/L
Standard Deviation 1.97
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Chloride, Week 8, n=30, 31, 32, 37, 27, 26
|
0.3 millimoles (mmol)/L
Standard Deviation 2.03
|
-0.1 millimoles (mmol)/L
Standard Deviation 2.13
|
-0.3 millimoles (mmol)/L
Standard Deviation 3.07
|
0.3 millimoles (mmol)/L
Standard Deviation 1.73
|
-0.3 millimoles (mmol)/L
Standard Deviation 2.02
|
0.6 millimoles (mmol)/L
Standard Deviation 1.89
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Chloride, Week 12, n=27, 30, 32, 36, 26, 24
|
-0.2 millimoles (mmol)/L
Standard Deviation 2.35
|
0.7 millimoles (mmol)/L
Standard Deviation 2.37
|
-0.7 millimoles (mmol)/L
Standard Deviation 2.80
|
-0.4 millimoles (mmol)/L
Standard Deviation 2.62
|
0.1 millimoles (mmol)/L
Standard Deviation 2.29
|
0.7 millimoles (mmol)/L
Standard Deviation 2.00
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Chloride, Week 14, n=29, 31, 33, 34, 27, 24
|
0.5 millimoles (mmol)/L
Standard Deviation 2.30
|
-0.3 millimoles (mmol)/L
Standard Deviation 2.84
|
0.2 millimoles (mmol)/L
Standard Deviation 2.55
|
0.4 millimoles (mmol)/L
Standard Deviation 2.24
|
-0.3 millimoles (mmol)/L
Standard Deviation 2.31
|
0.5 millimoles (mmol)/L
Standard Deviation 2.23
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Chloride, EW, n=10, 6, 3, 2, 10, 9
|
1.0 millimoles (mmol)/L
Standard Deviation 1.41
|
0.0 millimoles (mmol)/L
Standard Deviation 2.31
|
-1.9 millimoles (mmol)/L
Standard Deviation 2.98
|
-0.8 millimoles (mmol)/L
Standard Deviation 3.19
|
-1.0 millimoles (mmol)/L
Standard Deviation 2.00
|
-1.5 millimoles (mmol)/L
Standard Deviation 0.84
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
CO2, Week 2, n=35, 36, 35, 37, 29, 34
|
-1.2 millimoles (mmol)/L
Standard Deviation 1.96
|
-0.6 millimoles (mmol)/L
Standard Deviation 2.37
|
-0.9 millimoles (mmol)/L
Standard Deviation 2.04
|
-1.6 millimoles (mmol)/L
Standard Deviation 2.13
|
-1.2 millimoles (mmol)/L
Standard Deviation 2.64
|
-1.1 millimoles (mmol)/L
Standard Deviation 2.48
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
CO2, Week 4, n=32, 34, 33, 37, 29, 30
|
-0.8 millimoles (mmol)/L
Standard Deviation 2.12
|
-0.5 millimoles (mmol)/L
Standard Deviation 1.99
|
-1.5 millimoles (mmol)/L
Standard Deviation 2.50
|
-1.0 millimoles (mmol)/L
Standard Deviation 2.21
|
-2.0 millimoles (mmol)/L
Standard Deviation 2.81
|
-1.4 millimoles (mmol)/L
Standard Deviation 2.57
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
CO2, Week 8, n=30, 31, 32, 37, 27, 26
|
-1.0 millimoles (mmol)/L
Standard Deviation 2.25
|
-1.0 millimoles (mmol)/L
Standard Deviation 1.85
|
-1.5 millimoles (mmol)/L
Standard Deviation 2.47
|
-1.6 millimoles (mmol)/L
Standard Deviation 2.19
|
-1.3 millimoles (mmol)/L
Standard Deviation 1.89
|
-1.5 millimoles (mmol)/L
Standard Deviation 2.49
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
CO2, Week 12, n=27, 30, 32, 36, 26, 24
|
-1.1 millimoles (mmol)/L
Standard Deviation 2.31
|
-0.9 millimoles (mmol)/L
Standard Deviation 2.66
|
-1.1 millimoles (mmol)/L
Standard Deviation 2.23
|
-1.0 millimoles (mmol)/L
Standard Deviation 1.58
|
-1.2 millimoles (mmol)/L
Standard Deviation 2.55
|
-1.1 millimoles (mmol)/L
Standard Deviation 1.87
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
CO2, Week 14, n=29, 31, 33, 34, 27, 24
|
-1.1 millimoles (mmol)/L
Standard Deviation 2.32
|
-0.3 millimoles (mmol)/L
Standard Deviation 2.31
|
-1.2 millimoles (mmol)/L
Standard Deviation 2.19
|
-0.7 millimoles (mmol)/L
Standard Deviation 2.02
|
-1.0 millimoles (mmol)/L
Standard Deviation 2.38
|
-0.7 millimoles (mmol)/L
Standard Deviation 2.55
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
CO2, EW, n=10, 6, 3, 2, 10, 9
|
0.0 millimoles (mmol)/L
Standard Deviation 1.41
|
-0.6 millimoles (mmol)/L
Standard Deviation 1.65
|
-0.1 millimoles (mmol)/L
Standard Deviation 1.27
|
-1.7 millimoles (mmol)/L
Standard Deviation 1.57
|
0.0 millimoles (mmol)/L
Standard Deviation 3.46
|
0.5 millimoles (mmol)/L
Standard Deviation 1.52
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Glucose, Week 2, n=35, 36, 35, 37, 29, 34
|
0.05 millimoles (mmol)/L
Standard Deviation 1.864
|
-0.01 millimoles (mmol)/L
Standard Deviation 1.168
|
0.28 millimoles (mmol)/L
Standard Deviation 1.398
|
0.35 millimoles (mmol)/L
Standard Deviation 1.147
|
-0.09 millimoles (mmol)/L
Standard Deviation 1.852
|
0.59 millimoles (mmol)/L
Standard Deviation 1.445
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Glucose, Week 4, n=32, 34, 33, 37, 29, 30
|
0.42 millimoles (mmol)/L
Standard Deviation 2.842
|
0.01 millimoles (mmol)/L
Standard Deviation 1.299
|
0.73 millimoles (mmol)/L
Standard Deviation 2.436
|
0.84 millimoles (mmol)/L
Standard Deviation 1.750
|
0.40 millimoles (mmol)/L
Standard Deviation 3.059
|
0.53 millimoles (mmol)/L
Standard Deviation 1.656
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Glucose, Week 8, n=30, 31, 32, 37, 27, 26
|
0.35 millimoles (mmol)/L
Standard Deviation 1.376
|
0.18 millimoles (mmol)/L
Standard Deviation 1.505
|
0.55 millimoles (mmol)/L
Standard Deviation 2.392
|
0.32 millimoles (mmol)/L
Standard Deviation 1.571
|
0.63 millimoles (mmol)/L
Standard Deviation 2.604
|
0.29 millimoles (mmol)/L
Standard Deviation 1.340
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Glucose, Week 12, n=27, 30, 32, 36, 26, 24
|
-0.02 millimoles (mmol)/L
Standard Deviation 1.977
|
-0.24 millimoles (mmol)/L
Standard Deviation 0.966
|
0.45 millimoles (mmol)/L
Standard Deviation 1.703
|
0.26 millimoles (mmol)/L
Standard Deviation 2.223
|
0.42 millimoles (mmol)/L
Standard Deviation 2.704
|
-0.33 millimoles (mmol)/L
Standard Deviation 1.099
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Glucose, Week 14, n=29, 31, 33, 34, 27, 24
|
0.12 millimoles (mmol)/L
Standard Deviation 2.224
|
-0.02 millimoles (mmol)/L
Standard Deviation 2.104
|
0.13 millimoles (mmol)/L
Standard Deviation 1.696
|
0.03 millimoles (mmol)/L
Standard Deviation 1.708
|
0.79 millimoles (mmol)/L
Standard Deviation 2.608
|
0.15 millimoles (mmol)/L
Standard Deviation 1.628
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Glucose, EW, n=10, 6, 3, 2, 10, 9
|
-0.25 millimoles (mmol)/L
Standard Deviation 0.212
|
0.35 millimoles (mmol)/L
Standard Deviation 0.357
|
0.37 millimoles (mmol)/L
Standard Deviation 1.665
|
0.00 millimoles (mmol)/L
Standard Deviation 1.524
|
0.43 millimoles (mmol)/L
Standard Deviation 1.361
|
0.58 millimoles (mmol)/L
Standard Deviation 2.185
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Potassium, Week 2, n=35, 36, 35, 37, 29, 34
|
0.12 millimoles (mmol)/L
Standard Deviation 0.349
|
0.20 millimoles (mmol)/L
Standard Deviation 0.408
|
-0.00 millimoles (mmol)/L
Standard Deviation 0.306
|
0.07 millimoles (mmol)/L
Standard Deviation 0.412
|
0.10 millimoles (mmol)/L
Standard Deviation 0.450
|
0.03 millimoles (mmol)/L
Standard Deviation 0.322
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Potassium, Week 4, n=32, 34, 33, 37, 29, 30
|
-0.01 millimoles (mmol)/L
Standard Deviation 0.307
|
0.13 millimoles (mmol)/L
Standard Deviation 0.480
|
0.01 millimoles (mmol)/L
Standard Deviation 0.380
|
0.07 millimoles (mmol)/L
Standard Deviation 0.382
|
0.05 millimoles (mmol)/L
Standard Deviation 0.281
|
0.09 millimoles (mmol)/L
Standard Deviation 0.370
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Potassium, Week 8, n=30, 31, 32, 37, 27, 26
|
-0.04 millimoles (mmol)/L
Standard Deviation 0.302
|
0.05 millimoles (mmol)/L
Standard Deviation 0.377
|
0.10 millimoles (mmol)/L
Standard Deviation 0.600
|
0.10 millimoles (mmol)/L
Standard Deviation 0.365
|
0.06 millimoles (mmol)/L
Standard Deviation 0.312
|
0.09 millimoles (mmol)/L
Standard Deviation 0.576
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Potassium, Week 12, n=27, 30, 32, 36, 26, 24
|
0.00 millimoles (mmol)/L
Standard Deviation 0.359
|
0.02 millimoles (mmol)/L
Standard Deviation 0.376
|
0.02 millimoles (mmol)/L
Standard Deviation 0.298
|
-0.07 millimoles (mmol)/L
Standard Deviation 0.321
|
0.13 millimoles (mmol)/L
Standard Deviation 0.395
|
0.02 millimoles (mmol)/L
Standard Deviation 0.228
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Potassium, Week 14, n=29, 31, 33, 34, 27, 24
|
-0.06 millimoles (mmol)/L
Standard Deviation 0.319
|
-0.01 millimoles (mmol)/L
Standard Deviation 0.372
|
0.01 millimoles (mmol)/L
Standard Deviation 0.372
|
-0.01 millimoles (mmol)/L
Standard Deviation 0.274
|
0.05 millimoles (mmol)/L
Standard Deviation 0.361
|
0.02 millimoles (mmol)/L
Standard Deviation 0.268
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Potassium, EW, n=10, 6, 3, 2, 10, 9
|
0.35 millimoles (mmol)/L
Standard Deviation 0.071
|
-0.15 millimoles (mmol)/L
Standard Deviation 0.357
|
-0.08 millimoles (mmol)/L
Standard Deviation 0.291
|
-0.05 millimoles (mmol)/L
Standard Deviation 0.217
|
0.23 millimoles (mmol)/L
Standard Deviation 0.493
|
-0.02 millimoles (mmol)/L
Standard Deviation 0.605
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Sodium, Week 2, n=35, 36, 35, 37, 29, 34
|
-0.6 millimoles (mmol)/L
Standard Deviation 2.09
|
-0.0 millimoles (mmol)/L
Standard Deviation 2.21
|
-0.5 millimoles (mmol)/L
Standard Deviation 1.94
|
-0.7 millimoles (mmol)/L
Standard Deviation 2.19
|
-0.2 millimoles (mmol)/L
Standard Deviation 2.13
|
-0.2 millimoles (mmol)/L
Standard Deviation 2.04
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Sodium, Week 4, n=32, 34, 33, 37, 29, 30
|
-0.8 millimoles (mmol)/L
Standard Deviation 2.07
|
0.1 millimoles (mmol)/L
Standard Deviation 2.47
|
-1.2 millimoles (mmol)/L
Standard Deviation 2.06
|
-0.6 millimoles (mmol)/L
Standard Deviation 1.52
|
-1.1 millimoles (mmol)/L
Standard Deviation 2.28
|
-0.1 millimoles (mmol)/L
Standard Deviation 1.81
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Sodium, Week 8, n=30, 31, 32, 37, 27, 26
|
-0.2 millimoles (mmol)/L
Standard Deviation 2.25
|
-1.1 millimoles (mmol)/L
Standard Deviation 2.21
|
-0.8 millimoles (mmol)/L
Standard Deviation 2.43
|
-0.3 millimoles (mmol)/L
Standard Deviation 1.86
|
-0.9 millimoles (mmol)/L
Standard Deviation 2.01
|
-0.2 millimoles (mmol)/L
Standard Deviation 1.93
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Sodium, Week 12, n=27, 30, 32, 36, 26, 24
|
-0.5 millimoles (mmol)/L
Standard Deviation 1.90
|
-0.2 millimoles (mmol)/L
Standard Deviation 2.60
|
-1.2 millimoles (mmol)/L
Standard Deviation 2.08
|
-0.6 millimoles (mmol)/L
Standard Deviation 2.75
|
-0.3 millimoles (mmol)/L
Standard Deviation 2.43
|
0.1 millimoles (mmol)/L
Standard Deviation 1.93
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Sodium, EW, n=10, 6, 3, 2, 10, 9
|
1.0 millimoles (mmol)/L
Standard Deviation 1.41
|
-0.8 millimoles (mmol)/L
Standard Deviation 2.15
|
-2.0 millimoles (mmol)/L
Standard Deviation 2.06
|
-1.4 millimoles (mmol)/L
Standard Deviation 2.17
|
-1.0 millimoles (mmol)/L
Standard Deviation 2.65
|
-0.5 millimoles (mmol)/L
Standard Deviation 1.52
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Sodium, Week 14, n=29, 31, 33, 34, 27, 24
|
-0.7 millimoles (mmol)/L
Standard Deviation 2.29
|
-0.8 millimoles (mmol)/L
Standard Deviation 2.33
|
-1.0 millimoles (mmol)/L
Standard Deviation 2.30
|
-0.3 millimoles (mmol)/L
Standard Deviation 2.17
|
-0.6 millimoles (mmol)/L
Standard Deviation 2.18
|
-0.2 millimoles (mmol)/L
Standard Deviation 1.51
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Urea, Week 2, n=35, 36, 35, 37, 29, 34
|
0.38 millimoles (mmol)/L
Standard Deviation 1.187
|
-0.09 millimoles (mmol)/L
Standard Deviation 1.044
|
0.10 millimoles (mmol)/L
Standard Deviation 1.347
|
0.17 millimoles (mmol)/L
Standard Deviation 1.317
|
0.06 millimoles (mmol)/L
Standard Deviation 1.193
|
0.44 millimoles (mmol)/L
Standard Deviation 2.242
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Urea, Week 4, n=32, 34, 33, 37, 29, 30
|
0.36 millimoles (mmol)/L
Standard Deviation 0.991
|
-0.19 millimoles (mmol)/L
Standard Deviation 1.198
|
0.28 millimoles (mmol)/L
Standard Deviation 1.501
|
-0.23 millimoles (mmol)/L
Standard Deviation 0.907
|
0.05 millimoles (mmol)/L
Standard Deviation 1.195
|
0.41 millimoles (mmol)/L
Standard Deviation 1.469
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Urea, Week 8, n=30, 31, 32, 37, 27, 26
|
0.32 millimoles (mmol)/L
Standard Deviation 0.876
|
-0.22 millimoles (mmol)/L
Standard Deviation 1.022
|
-0.13 millimoles (mmol)/L
Standard Deviation 1.179
|
-0.07 millimoles (mmol)/L
Standard Deviation 1.158
|
-0.45 millimoles (mmol)/L
Standard Deviation 1.310
|
-0.13 millimoles (mmol)/L
Standard Deviation 1.049
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Urea, Week 12, n=27, 30, 32, 36, 26, 24
|
0.43 millimoles (mmol)/L
Standard Deviation 1.220
|
-0.19 millimoles (mmol)/L
Standard Deviation 0.861
|
-0.15 millimoles (mmol)/L
Standard Deviation 1.485
|
-0.17 millimoles (mmol)/L
Standard Deviation 0.888
|
-0.27 millimoles (mmol)/L
Standard Deviation 1.344
|
0.28 millimoles (mmol)/L
Standard Deviation 1.201
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Urea, Week 14, n=29, 31, 33, 34, 27, 24
|
0.07 millimoles (mmol)/L
Standard Deviation 1.303
|
0.35 millimoles (mmol)/L
Standard Deviation 1.199
|
-0.15 millimoles (mmol)/L
Standard Deviation 1.272
|
-0.10 millimoles (mmol)/L
Standard Deviation 1.105
|
-0.08 millimoles (mmol)/L
Standard Deviation 1.442
|
0.55 millimoles (mmol)/L
Standard Deviation 1.485
|
|
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Urea, EW, n=10, 6, 3, 2, 10, 9
|
0.00 millimoles (mmol)/L
Standard Deviation 1.414
|
-0.05 millimoles (mmol)/L
Standard Deviation 1.012
|
0.28 millimoles (mmol)/L
Standard Deviation 1.460
|
0.25 millimoles (mmol)/L
Standard Deviation 1.007
|
1.83 millimoles (mmol)/L
Standard Deviation 3.884
|
-0.83 millimoles (mmol)/L
Standard Deviation 0.983
|
SECONDARY outcome
Timeframe: Baseline and up to Week 14Population: Safety Population
Blood samples were collected for the evaluation of change in levels of basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocyte count 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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=38 Participants
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.
|
Vehicle BID
n=37 Participants
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.
|
Vehicle QD
n=38 Participants
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.
|
GSK2894512 1% BID
n=38 Participants
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.
|
GSK2894512 0.5% BID
n=38 Participants
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.
|
GSK2894512 1% QD
n=38 Participants
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.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Neutrophils, Week 12, n=27, 30, 31, 36, 26, 25
|
-0.008 Giga unit/liter (GI/L)
Standard Deviation 1.4329
|
0.043 Giga unit/liter (GI/L)
Standard Deviation 1.3470
|
0.008 Giga unit/liter (GI/L)
Standard Deviation 1.0432
|
0.277 Giga unit/liter (GI/L)
Standard Deviation 1.0785
|
-0.015 Giga unit/liter (GI/L)
Standard Deviation 1.4752
|
0.099 Giga unit/liter (GI/L)
Standard Deviation 1.3124
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Neutrophils, Week 14, n=29, 30, 33, 34, 27, 23
|
-0.225 Giga unit/liter (GI/L)
Standard Deviation 1.5059
|
0.267 Giga unit/liter (GI/L)
Standard Deviation 2.2299
|
-0.052 Giga unit/liter (GI/L)
Standard Deviation 0.8640
|
0.158 Giga unit/liter (GI/L)
Standard Deviation 1.0726
|
-0.053 Giga unit/liter (GI/L)
Standard Deviation 1.0828
|
0.519 Giga unit/liter (GI/L)
Standard Deviation 1.4793
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Basophils, Week 2, n=35, 35, 36, 37, 29, 35
|
0.006 Giga unit/liter (GI/L)
Standard Deviation 0.0243
|
0.003 Giga unit/liter (GI/L)
Standard Deviation 0.0248
|
0.003 Giga unit/liter (GI/L)
Standard Deviation 0.0172
|
0.004 Giga unit/liter (GI/L)
Standard Deviation 0.0213
|
-0.005 Giga unit/liter (GI/L)
Standard Deviation 0.0178
|
-0.005 Giga unit/liter (GI/L)
Standard Deviation 0.0167
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Basophils, Week 4, n=31, 34, 35, 37, 29, 31
|
-0.003 Giga unit/liter (GI/L)
Standard Deviation 0.0184
|
0.002 Giga unit/liter (GI/L)
Standard Deviation 0.0175
|
-0.000 Giga unit/liter (GI/L)
Standard Deviation 0.0143
|
0.003 Giga unit/liter (GI/L)
Standard Deviation 0.0176
|
-0.002 Giga unit/liter (GI/L)
Standard Deviation 0.0166
|
-0.002 Giga unit/liter (GI/L)
Standard Deviation 0.0285
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Basophils, Week 8, n=30, 30, 32, 37, 27, 26
|
-0.002 Giga unit/liter (GI/L)
Standard Deviation 0.0195
|
0.002 Giga unit/liter (GI/L)
Standard Deviation 0.0233
|
-0.008 Giga unit/liter (GI/L)
Standard Deviation 0.0145
|
-0.001 Giga unit/liter (GI/L)
Standard Deviation 0.0167
|
-0.004 Giga unit/liter (GI/L)
Standard Deviation 0.0150
|
-0.001 Giga unit/liter (GI/L)
Standard Deviation 0.0181
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Basophils, Week 12, n=27, 30, 31, 36, 26, 25
|
0.000 Giga unit/liter (GI/L)
Standard Deviation 0.0161
|
0.006 Giga unit/liter (GI/L)
Standard Deviation 0.0250
|
-0.003 Giga unit/liter (GI/L)
Standard Deviation 0.0151
|
-0.003 Giga unit/liter (GI/L)
Standard Deviation 0.0151
|
-0.007 Giga unit/liter (GI/L)
Standard Deviation 0.0170
|
0.004 Giga unit/liter (GI/L)
Standard Deviation 0.0233
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Basophils, Week 14, n=29, 30, 33, 34, 27, 23
|
0.002 Giga unit/liter (GI/L)
Standard Deviation 0.0250
|
-0.001 Giga unit/liter (GI/L)
Standard Deviation 0.0188
|
-0.001 Giga unit/liter (GI/L)
Standard Deviation 0.0216
|
-0.003 Giga unit/liter (GI/L)
Standard Deviation 0.0176
|
-0.003 Giga unit/liter (GI/L)
Standard Deviation 0.0188
|
-0.003 Giga unit/liter (GI/L)
Standard Deviation 0.0184
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Basophils, EW, n=10, 6, 3, 2, 10, 9
|
0.000 Giga unit/liter (GI/L)
Standard Deviation 0.000
|
-0.005 Giga unit/liter (GI/L)
Standard Deviation 0.0151
|
0.012 Giga unit/liter (GI/L)
Standard Deviation 0.0217
|
-0.001 Giga unit/liter (GI/L)
Standard Deviation 0.0179
|
-0.010 Giga unit/liter (GI/L)
Standard Deviation 0.0100
|
-0.017 Giga unit/liter (GI/L)
Standard Deviation 0.0294
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Eosinophils, Week 2, n=35, 35, 36, 37, 29, 35
|
0.011 Giga unit/liter (GI/L)
Standard Deviation 0.0972
|
-0.021 Giga unit/liter (GI/L)
Standard Deviation 0.1363
|
-0.015 Giga unit/liter (GI/L)
Standard Deviation 0.1295
|
0.021 Giga unit/liter (GI/L)
Standard Deviation 0.1157
|
-0.017 Giga unit/liter (GI/L)
Standard Deviation 0.1857
|
0.043 Giga unit/liter (GI/L)
Standard Deviation 0.1356
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Eosinophils, Week 4, n=31, 34, 35, 37, 29, 31
|
0.005 Giga unit/liter (GI/L)
Standard Deviation 0.0954
|
-0.019 Giga unit/liter (GI/L)
Standard Deviation 0.1205
|
-0.005 Giga unit/liter (GI/L)
Standard Deviation 0.1522
|
0.019 Giga unit/liter (GI/L)
Standard Deviation 0.1380
|
-0.005 Giga unit/liter (GI/L)
Standard Deviation 0.1554
|
0.034 Giga unit/liter (GI/L)
Standard Deviation 0.1371
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Eosinophils, Week 8, n=30, 30, 32, 37, 27, 26
|
0.037 Giga unit/liter (GI/L)
Standard Deviation 0.1001
|
-0.008 Giga unit/liter (GI/L)
Standard Deviation 0.1142
|
-0.048 Giga unit/liter (GI/L)
Standard Deviation 0.1258
|
0.012 Giga unit/liter (GI/L)
Standard Deviation 0.1134
|
-0.008 Giga unit/liter (GI/L)
Standard Deviation 0.1495
|
0.024 Giga unit/liter (GI/L)
Standard Deviation 0.1015
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Eosinophils, Week 12, n=27, 30, 31, 36, 26, 25
|
0.026 Giga unit/liter (GI/L)
Standard Deviation 0.0934
|
0.001 Giga unit/liter (GI/L)
Standard Deviation 0.1375
|
-0.027 Giga unit/liter (GI/L)
Standard Deviation 0.1322
|
0.047 Giga unit/liter (GI/L)
Standard Deviation 0.2302
|
-0.032 Giga unit/liter (GI/L)
Standard Deviation 0.1714
|
0.000 Giga unit/liter (GI/L)
Standard Deviation 0.1002
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Eosinophils, Week 14, n=29, 30, 33, 34, 27, 23
|
0.002 Giga unit/liter (GI/L)
Standard Deviation 0.1053
|
0.004 Giga unit/liter (GI/L)
Standard Deviation 0.1469
|
-0.053 Giga unit/liter (GI/L)
Standard Deviation 0.1867
|
0.033 Giga unit/liter (GI/L)
Standard Deviation 0.1084
|
-0.011 Giga unit/liter (GI/L)
Standard Deviation 0.2186
|
0.004 Giga unit/liter (GI/L)
Standard Deviation 0.0979
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Eosinophils, EW, n=10, 6, 3, 2, 10, 9
|
0.095 Giga unit/liter (GI/L)
Standard Deviation 0.0071
|
0.053 Giga unit/liter (GI/L)
Standard Deviation 0.2675
|
-0.047 Giga unit/liter (GI/L)
Standard Deviation 0.1775
|
0.029 Giga unit/liter (GI/L)
Standard Deviation 0.0841
|
-0.233 Giga unit/liter (GI/L)
Standard Deviation 0.3955
|
0.090 Giga unit/liter (GI/L)
Standard Deviation 0.1563
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Lymphocytes, Week 2, n=35, 35, 36, 37, 29, 35
|
0.145 Giga unit/liter (GI/L)
Standard Deviation 0.3966
|
-0.138 Giga unit/liter (GI/L)
Standard Deviation 0.4764
|
-0.018 Giga unit/liter (GI/L)
Standard Deviation 0.4774
|
0.100 Giga unit/liter (GI/L)
Standard Deviation 0.4690
|
0.097 Giga unit/liter (GI/L)
Standard Deviation 0.3995
|
-0.002 Giga unit/liter (GI/L)
Standard Deviation 0.3827
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Lymphocytes, Week 4, n=31, 34, 35, 37, 29, 31
|
0.228 Giga unit/liter (GI/L)
Standard Deviation 0.5664
|
-0.142 Giga unit/liter (GI/L)
Standard Deviation 0.4421
|
-0.077 Giga unit/liter (GI/L)
Standard Deviation 0.4524
|
-0.083 Giga unit/liter (GI/L)
Standard Deviation 0.6201
|
0.041 Giga unit/liter (GI/L)
Standard Deviation 0.3875
|
-0.044 Giga unit/liter (GI/L)
Standard Deviation 0.4101
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Lymphocytes, Week 8, n=30, 30, 32, 37, 27, 26
|
0.075 Giga unit/liter (GI/L)
Standard Deviation 0.5255
|
-0.110 Giga unit/liter (GI/L)
Standard Deviation 0.6406
|
0.032 Giga unit/liter (GI/L)
Standard Deviation 0.4913
|
0.048 Giga unit/liter (GI/L)
Standard Deviation 0.5656
|
-0.048 Giga unit/liter (GI/L)
Standard Deviation 0.4379
|
-0.009 Giga unit/liter (GI/L)
Standard Deviation 0.3778
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Lymphocytes, Week 12, n=27, 30, 31, 36, 26, 25
|
0.148 Giga unit/liter (GI/L)
Standard Deviation 0.4774
|
-0.110 Giga unit/liter (GI/L)
Standard Deviation 0.6003
|
-0.145 Giga unit/liter (GI/L)
Standard Deviation 0.4177
|
0.050 Giga unit/liter (GI/L)
Standard Deviation 0.6354
|
0.120 Giga unit/liter (GI/L)
Standard Deviation 0.5800
|
0.052 Giga unit/liter (GI/L)
Standard Deviation 0.4589
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Lymphocytes, Week 14, n=29, 30, 33, 34, 27, 23
|
0.174 Giga unit/liter (GI/L)
Standard Deviation 0.7327
|
-0.031 Giga unit/liter (GI/L)
Standard Deviation 0.6712
|
0.109 Giga unit/liter (GI/L)
Standard Deviation 0.4985
|
0.261 Giga unit/liter (GI/L)
Standard Deviation 0.9065
|
0.075 Giga unit/liter (GI/L)
Standard Deviation 0.5712
|
0.021 Giga unit/liter (GI/L)
Standard Deviation 0.6397
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Lymphocytes, EW, n=10, 6, 3, 2, 10, 9
|
-0.185 Giga unit/liter (GI/L)
Standard Deviation 0.1061
|
0.032 Giga unit/liter (GI/L)
Standard Deviation 0.2862
|
0.246 Giga unit/liter (GI/L)
Standard Deviation 0.4375
|
-0.164 Giga unit/liter (GI/L)
Standard Deviation 0.6069
|
-0.113 Giga unit/liter (GI/L)
Standard Deviation 0.3502
|
-0.078 Giga unit/liter (GI/L)
Standard Deviation 0.3542
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Monocytes, Week 2, n=35, 35, 36, 37, 29, 35
|
-0.035 Giga unit/liter (GI/L)
Standard Deviation 0.1117
|
-0.007 Giga unit/liter (GI/L)
Standard Deviation 0.1583
|
-0.013 Giga unit/liter (GI/L)
Standard Deviation 0.1083
|
0.029 Giga unit/liter (GI/L)
Standard Deviation 0.1833
|
0.012 Giga unit/liter (GI/L)
Standard Deviation 0.1314
|
-0.061 Giga unit/liter (GI/L)
Standard Deviation 0.1055
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Monocytes, Week 4, n=31, 34, 35, 37, 29, 31
|
-0.049 Giga unit/liter (GI/L)
Standard Deviation 0.1119
|
-0.032 Giga unit/liter (GI/L)
Standard Deviation 0.1972
|
-0.011 Giga unit/liter (GI/L)
Standard Deviation 0.1464
|
-0.017 Giga unit/liter (GI/L)
Standard Deviation 0.1241
|
-0.014 Giga unit/liter (GI/L)
Standard Deviation 0.1226
|
-0.014 Giga unit/liter (GI/L)
Standard Deviation 0.1706
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Monocytes, Week 8, n=30, 30, 32, 37, 27, 26
|
-0.043 Giga unit/liter (GI/L)
Standard Deviation 0.1579
|
-0.048 Giga unit/liter (GI/L)
Standard Deviation 0.1692
|
-0.025 Giga unit/liter (GI/L)
Standard Deviation 0.1770
|
0.034 Giga unit/liter (GI/L)
Standard Deviation 0.1468
|
-0.036 Giga unit/liter (GI/L)
Standard Deviation 0.1252
|
-0.071 Giga unit/liter (GI/L)
Standard Deviation 0.1258
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Monocytes, Week 12, n=27, 30, 31, 36, 26, 25
|
-0.043 Giga unit/liter (GI/L)
Standard Deviation 0.1578
|
-0.015 Giga unit/liter (GI/L)
Standard Deviation 0.1964
|
-0.026 Giga unit/liter (GI/L)
Standard Deviation 0.1323
|
-0.002 Giga unit/liter (GI/L)
Standard Deviation 0.1173
|
-0.055 Giga unit/liter (GI/L)
Standard Deviation 0.1399
|
-0.050 Giga unit/liter (GI/L)
Standard Deviation 0.1036
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Monocytes, Week 14, n=29, 30, 33, 34, 27, 23
|
-0.054 Giga unit/liter (GI/L)
Standard Deviation 0.1609
|
-0.025 Giga unit/liter (GI/L)
Standard Deviation 0.2130
|
-0.017 Giga unit/liter (GI/L)
Standard Deviation 0.1202
|
0.031 Giga unit/liter (GI/L)
Standard Deviation 0.1418
|
-0.057 Giga unit/liter (GI/L)
Standard Deviation 0.1378
|
-0.009 Giga unit/liter (GI/L)
Standard Deviation 0.1341
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Monocytes, EW, n=10, 6, 3, 2, 10, 9
|
-0.045 Giga unit/liter (GI/L)
Standard Deviation 0.1061
|
0.006 Giga unit/liter (GI/L)
Standard Deviation 0.1179
|
-0.084 Giga unit/liter (GI/L)
Standard Deviation 0.2625
|
0.046 Giga unit/liter (GI/L)
Standard Deviation 0.1959
|
-0.243 Giga unit/liter (GI/L)
Standard Deviation 0.2593
|
-0.015 Giga unit/liter (GI/L)
Standard Deviation 0.1299
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Neutrophils, Week 2, n=35, 35, 36, 37, 29, 35
|
0.009 Giga unit/liter (GI/L)
Standard Deviation 1.3107
|
-0.058 Giga unit/liter (GI/L)
Standard Deviation 1.8094
|
0.107 Giga unit/liter (GI/L)
Standard Deviation 1.1007
|
0.355 Giga unit/liter (GI/L)
Standard Deviation 1.7248
|
0.341 Giga unit/liter (GI/L)
Standard Deviation 1.3914
|
0.310 Giga unit/liter (GI/L)
Standard Deviation 1.3852
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Neutrophils, Week 4, n=31, 34, 35, 37, 29, 31
|
0.267 Giga unit/liter (GI/L)
Standard Deviation 1.3310
|
0.049 Giga unit/liter (GI/L)
Standard Deviation 1.7831
|
0.059 Giga unit/liter (GI/L)
Standard Deviation 1.0011
|
0.215 Giga unit/liter (GI/L)
Standard Deviation 1.5812
|
0.291 Giga unit/liter (GI/L)
Standard Deviation 1.2083
|
0.139 Giga unit/liter (GI/L)
Standard Deviation 1.6995
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Neutrophils, Week 8, n=30, 30, 32, 37, 27, 26
|
-0.075 Giga unit/liter (GI/L)
Standard Deviation 1.4243
|
-0.181 Giga unit/liter (GI/L)
Standard Deviation 1.4359
|
0.285 Giga unit/liter (GI/L)
Standard Deviation 1.3332
|
0.402 Giga unit/liter (GI/L)
Standard Deviation 1.1117
|
-0.049 Giga unit/liter (GI/L)
Standard Deviation 1.4021
|
0.140 Giga unit/liter (GI/L)
Standard Deviation 1.1014
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Neutrophils, EW, n=10, 6, 3, 2, 10, 9
|
-0.735 Giga unit/liter (GI/L)
Standard Deviation 0.2899
|
-0.285 Giga unit/liter (GI/L)
Standard Deviation 1.2029
|
-0.019 Giga unit/liter (GI/L)
Standard Deviation 0.9601
|
0.307 Giga unit/liter (GI/L)
Standard Deviation 1.1539
|
2.727 Giga unit/liter (GI/L)
Standard Deviation 3.3561
|
-0.305 Giga unit/liter (GI/L)
Standard Deviation 1.3530
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Platelets, Week 2, n=35, 35, 36, 37, 29, 35
|
-5.6 Giga unit/liter (GI/L)
Standard Deviation 47.57
|
0.5 Giga unit/liter (GI/L)
Standard Deviation 29.07
|
-6.1 Giga unit/liter (GI/L)
Standard Deviation 23.70
|
-0.3 Giga unit/liter (GI/L)
Standard Deviation 36.30
|
2.3 Giga unit/liter (GI/L)
Standard Deviation 26.06
|
5.4 Giga unit/liter (GI/L)
Standard Deviation 40.50
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Platelets, Week 4, n=32, 34, 35, 37, 29, 31
|
-1.0 Giga unit/liter (GI/L)
Standard Deviation 38.16
|
2.6 Giga unit/liter (GI/L)
Standard Deviation 26.00
|
-0.7 Giga unit/liter (GI/L)
Standard Deviation 28.81
|
-12.3 Giga unit/liter (GI/L)
Standard Deviation 39.49
|
1.9 Giga unit/liter (GI/L)
Standard Deviation 26.97
|
-4.1 Giga unit/liter (GI/L)
Standard Deviation 26.64
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Platelets, Week 8, n=30, 31, 32, 38, 27, 26
|
-11.5 Giga unit/liter (GI/L)
Standard Deviation 50.01
|
0.2 Giga unit/liter (GI/L)
Standard Deviation 28.94
|
-1.5 Giga unit/liter (GI/L)
Standard Deviation 23.61
|
-6.8 Giga unit/liter (GI/L)
Standard Deviation 34.57
|
-1.8 Giga unit/liter (GI/L)
Standard Deviation 25.81
|
-1.0 Giga unit/liter (GI/L)
Standard Deviation 23.87
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Platelets, Week 12, n=27, 30, 31, 36, 26, 25
|
-15.7 Giga unit/liter (GI/L)
Standard Deviation 38.39
|
-5.5 Giga unit/liter (GI/L)
Standard Deviation 38.31
|
-8.9 Giga unit/liter (GI/L)
Standard Deviation 26.72
|
-10.3 Giga unit/liter (GI/L)
Standard Deviation 35.25
|
-4.9 Giga unit/liter (GI/L)
Standard Deviation 26.54
|
-7.9 Giga unit/liter (GI/L)
Standard Deviation 24.25
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Platelets, Week 14, n=29, 30, 33, 34, 27, 23
|
-18.5 Giga unit/liter (GI/L)
Standard Deviation 41.03
|
-1.7 Giga unit/liter (GI/L)
Standard Deviation 37.21
|
1.2 Giga unit/liter (GI/L)
Standard Deviation 18.69
|
-2.9 Giga unit/liter (GI/L)
Standard Deviation 18.68
|
-2.9 Giga unit/liter (GI/L)
Standard Deviation 20.21
|
-9.6 Giga unit/liter (GI/L)
Standard Deviation 29.12
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Platelets, EW, n=10, 5, 3, 2, 9, 9
|
-30.5 Giga unit/liter (GI/L)
Standard Deviation 48.79
|
1.6 Giga unit/liter (GI/L)
Standard Deviation 22.36
|
23.1 Giga unit/liter (GI/L)
Standard Deviation 25.21
|
-2.1 Giga unit/liter (GI/L)
Standard Deviation 27.63
|
37.0 Giga unit/liter (GI/L)
Standard Deviation 37.80
|
-7.6 Giga unit/liter (GI/L)
Standard Deviation 13.89
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Leukocytes, Week 2, n=35, 35, 36, 37, 29, 35
|
0.12 Giga unit/liter (GI/L)
Standard Deviation 1.391
|
-0.21 Giga unit/liter (GI/L)
Standard Deviation 1.892
|
0.08 Giga unit/liter (GI/L)
Standard Deviation 1.166
|
0.50 Giga unit/liter (GI/L)
Standard Deviation 1.834
|
0.42 Giga unit/liter (GI/L)
Standard Deviation 1.686
|
0.28 Giga unit/liter (GI/L)
Standard Deviation 1.381
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Leukocytes, Week 4, n=31, 34, 35, 37, 29, 31
|
0.44 Giga unit/liter (GI/L)
Standard Deviation 1.398
|
-0.14 Giga unit/liter (GI/L)
Standard Deviation 1.798
|
-0.03 Giga unit/liter (GI/L)
Standard Deviation 1.059
|
0.13 Giga unit/liter (GI/L)
Standard Deviation 1.972
|
0.31 Giga unit/liter (GI/L)
Standard Deviation 1.374
|
0.12 Giga unit/liter (GI/L)
Standard Deviation 1.748
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Leukocytes, Week 8, n=30, 30, 32, 37, 27, 26
|
-0.02 Giga unit/liter (GI/L)
Standard Deviation 1.604
|
-0.35 Giga unit/liter (GI/L)
Standard Deviation 1.392
|
0.23 Giga unit/liter (GI/L)
Standard Deviation 1.527
|
0.49 Giga unit/liter (GI/L)
Standard Deviation 1.272
|
-0.14 Giga unit/liter (GI/L)
Standard Deviation 1.516
|
0.08 Giga unit/liter (GI/L)
Standard Deviation 1.167
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Leukocytes, Week 12, n=27, 30, 31, 36, 26, 25
|
0.10 Giga unit/liter (GI/L)
Standard Deviation 1.538
|
-0.07 Giga unit/liter (GI/L)
Standard Deviation 1.301
|
-0.19 Giga unit/liter (GI/L)
Standard Deviation 1.221
|
0.36 Giga unit/liter (GI/L)
Standard Deviation 1.439
|
0.02 Giga unit/liter (GI/L)
Standard Deviation 1.460
|
0.12 Giga unit/liter (GI/L)
Standard Deviation 1.359
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Leukocytes, Week 14, n=29, 30, 33, 34, 27, 23
|
-0.11 Giga unit/liter (GI/L)
Standard Deviation 1.380
|
0.22 Giga unit/liter (GI/L)
Standard Deviation 2.172
|
-0.00 Giga unit/liter (GI/L)
Standard Deviation 1.207
|
0.47 Giga unit/liter (GI/L)
Standard Deviation 1.472
|
-0.05 Giga unit/liter (GI/L)
Standard Deviation 1.256
|
0.54 Giga unit/liter (GI/L)
Standard Deviation 1.757
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Leukocytes, EW, n=10, 6, 3, 2, 10, 9
|
-0.85 Giga unit/liter (GI/L)
Standard Deviation 0.354
|
-0.21 Giga unit/liter (GI/L)
Standard Deviation 1.260
|
0.10 Giga unit/liter (GI/L)
Standard Deviation 0.505
|
0.21 Giga unit/liter (GI/L)
Standard Deviation 1.066
|
2.13 Giga unit/liter (GI/L)
Standard Deviation 2.940
|
-0.35 Giga unit/liter (GI/L)
Standard Deviation 1.395
|
SECONDARY outcome
Timeframe: Baseline and up to Week 14Population: Safety Population
Blood samples were collected for the evaluation of change in hematocrit 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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=38 Participants
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.
|
Vehicle BID
n=37 Participants
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.
|
Vehicle QD
n=38 Participants
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.
|
GSK2894512 1% BID
n=38 Participants
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.
|
GSK2894512 0.5% BID
n=38 Participants
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.
|
GSK2894512 1% QD
n=38 Participants
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.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hematocrit Levels
Week 2, n=35, 35, 36, 37, 29, 35
|
-0.0038 Proportion of red blood cells in blood
Standard Deviation 0.0193
|
-0.0063 Proportion of red blood cells in blood
Standard Deviation 0.0243
|
0.0011 Proportion of red blood cells in blood
Standard Deviation 0.0217
|
0.0029 Proportion of red blood cells in blood
Standard Deviation 0.0198
|
-0.0002 Proportion of red blood cells in blood
Standard Deviation 0.0251
|
-0.0036 Proportion of red blood cells in blood
Standard Deviation 0.0243
|
|
Change From Baseline in Hematocrit Levels
Week 4, n=32, 34, 35, 37, 29, 31
|
-0.0008 Proportion of red blood cells in blood
Standard Deviation 0.0269
|
0.0028 Proportion of red blood cells in blood
Standard Deviation 0.0291
|
0.0054 Proportion of red blood cells in blood
Standard Deviation 0.0239
|
0.0007 Proportion of red blood cells in blood
Standard Deviation 0.0227
|
0.0058 Proportion of red blood cells in blood
Standard Deviation 0.0283
|
-0.0049 Proportion of red blood cells in blood
Standard Deviation 0.0238
|
|
Change From Baseline in Hematocrit Levels
Week 8, n=30, 31, 32, 38, 27, 26
|
-0.0036 Proportion of red blood cells in blood
Standard Deviation 0.0342
|
0.0084 Proportion of red blood cells in blood
Standard Deviation 0.0284
|
0.0092 Proportion of red blood cells in blood
Standard Deviation 0.0319
|
0.0020 Proportion of red blood cells in blood
Standard Deviation 0.0273
|
-0.0004 Proportion of red blood cells in blood
Standard Deviation 0.0288
|
0.0047 Proportion of red blood cells in blood
Standard Deviation 0.0274
|
|
Change From Baseline in Hematocrit Levels
Week 12, n=27, 30, 31, 36, 26, 25
|
-0.0013 Proportion of red blood cells in blood
Standard Deviation 0.0202
|
0.0045 Proportion of red blood cells in blood
Standard Deviation 0.0225
|
0.0084 Proportion of red blood cells in blood
Standard Deviation 0.0286
|
0.0045 Proportion of red blood cells in blood
Standard Deviation 0.0238
|
0.0059 Proportion of red blood cells in blood
Standard Deviation 0.0235
|
0.0059 Proportion of red blood cells in blood
Standard Deviation 0.0275
|
|
Change From Baseline in Hematocrit Levels
Week 14, n=29, 30, 33, 34, 27, 23
|
-0.0120 Proportion of red blood cells in blood
Standard Deviation 0.0348
|
-0.0021 Proportion of red blood cells in blood
Standard Deviation 0.0336
|
0.0035 Proportion of red blood cells in blood
Standard Deviation 0.0186
|
0.0017 Proportion of red blood cells in blood
Standard Deviation 0.0259
|
0.0021 Proportion of red blood cells in blood
Standard Deviation 0.0288
|
-0.0010 Proportion of red blood cells in blood
Standard Deviation 0.0274
|
|
Change From Baseline in Hematocrit Levels
EW, n=10, 6, 3, 2, 10, 9
|
-0.0050 Proportion of red blood cells in blood
Standard Deviation 0.0014
|
-0.0017 Proportion of red blood cells in blood
Standard Deviation 0.0161
|
0.0014 Proportion of red blood cells in blood
Standard Deviation 0.0268
|
0.0014 Proportion of red blood cells in blood
Standard Deviation 0.0185
|
-0.0093 Proportion of red blood cells in blood
Standard Deviation 0.0134
|
-0.0273 Proportion of red blood cells in blood
Standard Deviation 0.0221
|
SECONDARY outcome
Timeframe: Baseline and up to Week 14Population: Safety Population
Blood samples were collected for the evaluation of change in Hgb levels and MCHC 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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=38 Participants
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.
|
Vehicle BID
n=37 Participants
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.
|
Vehicle QD
n=38 Participants
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.
|
GSK2894512 1% BID
n=38 Participants
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.
|
GSK2894512 0.5% BID
n=38 Participants
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.
|
GSK2894512 1% QD
n=38 Participants
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.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC)
Hgb, Week 4, n=32, 34, 35, 37, 29, 31
|
-0.1 G/L
Standard Deviation 8.82
|
-0.7 G/L
Standard Deviation 8.77
|
1.0 G/L
Standard Deviation 5.68
|
-1.0 G/L
Standard Deviation 6.02
|
0.3 G/L
Standard Deviation 8.74
|
-2.5 G/L
Standard Deviation 5.86
|
|
Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC)
MCHC, Week 12, n=27, 30, 31, 36, 26, 25
|
-4.8 G/L
Standard Deviation 10.39
|
-5.9 G/L
Standard Deviation 10.14
|
-5.0 G/L
Standard Deviation 10.74
|
-6.1 G/L
Standard Deviation 12.65
|
-8.6 G/L
Standard Deviation 11.49
|
-6.1 G/L
Standard Deviation 11.25
|
|
Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC)
Hgb, Week 8, n=30, 31, 32, 38, 27, 26
|
-2.1 G/L
Standard Deviation 9.17
|
1.0 G/L
Standard Deviation 8.82
|
1.2 G/L
Standard Deviation 7.73
|
-1.8 G/L
Standard Deviation 6.18
|
-2.8 G/L
Standard Deviation 9.06
|
0.1 G/L
Standard Deviation 6.78
|
|
Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC)
Hgb, Week 12, n=27, 30, 31, 36, 26, 25
|
-2.4 G/L
Standard Deviation 5.94
|
-1.0 G/L
Standard Deviation 7.65
|
0.2 G/L
Standard Deviation 6.27
|
-1.3 G/L
Standard Deviation 5.74
|
-1.9 G/L
Standard Deviation 8.76
|
-0.8 G/L
Standard Deviation 6.86
|
|
Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC)
Hgb, Week 14, n=29, 30, 33, 34, 27, 23
|
-5.0 G/L
Standard Deviation 10.24
|
-2.8 G/L
Standard Deviation 8.82
|
-1.6 G/L
Standard Deviation 5.94
|
-1.9 G/L
Standard Deviation 7.85
|
-2.6 G/L
Standard Deviation 8.64
|
-2.7 G/L
Standard Deviation 7.54
|
|
Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC)
Hgb, EW, n=10, 6, 3, 2, 10, 9
|
-1.5 G/L
Standard Deviation 0.71
|
-2.3 G/L
Standard Deviation 4.99
|
-0.1 G/L
Standard Deviation 6.13
|
0.0 G/L
Standard Deviation 7.26
|
-5.7 G/L
Standard Deviation 3.79
|
-7.8 G/L
Standard Deviation 8.73
|
|
Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC)
MCHC, Week 2, n=35, 35, 36, 37, 29, 35
|
1.0 G/L
Standard Deviation 7.15
|
0.9 G/L
Standard Deviation 7.99
|
-0.5 G/L
Standard Deviation 7.10
|
-1.5 G/L
Standard Deviation 8.77
|
-3.0 G/L
Standard Deviation 10.32
|
-1.3 G/L
Standard Deviation 9.44
|
|
Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC)
MCHC, Week 4, n=32, 34, 35, 37, 29, 31
|
0.4 G/L
Standard Deviation 8.36
|
-3.8 G/L
Standard Deviation 9.19
|
-1.6 G/L
Standard Deviation 10.02
|
-3.1 G/L
Standard Deviation 11.45
|
-3.6 G/L
Standard Deviation 10.60
|
-2.1 G/L
Standard Deviation 9.88
|
|
Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC)
MCHC, Week 8, n=30, 31, 32, 38, 27, 26
|
-2.3 G/L
Standard Deviation 11.29
|
-4.4 G/L
Standard Deviation 10.65
|
-3.8 G/L
Standard Deviation 11.40
|
-5.4 G/L
Standard Deviation 11.25
|
-5.9 G/L
Standard Deviation 13.41
|
-3.2 G/L
Standard Deviation 12.76
|
|
Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC)
MCHC, Week 14, n=29, 30, 33, 34, 27, 23
|
-2.7 G/L
Standard Deviation 9.40
|
-5.3 G/L
Standard Deviation 9.27
|
-5.9 G/L
Standard Deviation 9.79
|
-5.4 G/L
Standard Deviation 8.55
|
-7.4 G/L
Standard Deviation 10.74
|
-5.5 G/L
Standard Deviation 9.15
|
|
Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC)
MCHC, EW, n=10, 6, 3, 2, 10, 9
|
0.0 G/L
Standard Deviation 0.00
|
-4.1 G/L
Standard Deviation 4.12
|
-1.3 G/L
Standard Deviation 9.10
|
-1.1 G/L
Standard Deviation 11.57
|
-6.3 G/L
Standard Deviation 9.07
|
1.5 G/L
Standard Deviation 8.50
|
|
Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC)
Hgb, Week 2, n=35, 35, 36, 37, 29, 35
|
-0.6 G/L
Standard Deviation 6.29
|
-1.3 G/L
Standard Deviation 7.79
|
0.1 G/L
Standard Deviation 6.18
|
0.3 G/L
Standard Deviation 5.84
|
-1.4 G/L
Standard Deviation 7.51
|
-1.6 G/L
Standard Deviation 6.98
|
SECONDARY outcome
Timeframe: Baseline and up to Week 14Population: Safety Population
Blood samples were collected for the evaluation of change in erythrocyte mean corpuscular hemoglobin level 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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=38 Participants
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.
|
Vehicle BID
n=37 Participants
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.
|
Vehicle QD
n=38 Participants
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.
|
GSK2894512 1% BID
n=38 Participants
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.
|
GSK2894512 0.5% BID
n=38 Participants
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.
|
GSK2894512 1% QD
n=38 Participants
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.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level
Week 2, n=35, 35, 36, 37, 29, 35
|
0.11 Picogram (pg)
Standard Deviation 0.733
|
-0.10 Picogram (pg)
Standard Deviation 1.519
|
-0.01 Picogram (pg)
Standard Deviation 0.605
|
0.10 Picogram (pg)
Standard Deviation 0.493
|
-0.08 Picogram (pg)
Standard Deviation 0.590
|
0.05 Picogram (pg)
Standard Deviation 0.408
|
|
Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level
Week 4, n=32, 34, 35, 37, 29, 31
|
0.08 Picogram (pg)
Standard Deviation 0.774
|
-0.15 Picogram (pg)
Standard Deviation 1.257
|
-0.15 Picogram (pg)
Standard Deviation 0.863
|
0.01 Picogram (pg)
Standard Deviation 0.562
|
-0.19 Picogram (pg)
Standard Deviation 0.750
|
-0.06 Picogram (pg)
Standard Deviation 0.517
|
|
Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level
Week 8, n=30, 31, 32, 38, 27, 26
|
-0.04 Picogram (pg)
Standard Deviation 0.803
|
-0.13 Picogram (pg)
Standard Deviation 1.286
|
-0.09 Picogram (pg)
Standard Deviation 0.753
|
0.13 Picogram (pg)
Standard Deviation 0.608
|
-0.20 Picogram (pg)
Standard Deviation 0.805
|
0.31 Picogram (pg)
Standard Deviation 2.220
|
|
Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level
Week 12, n=27, 30, 31, 36, 26, 25
|
-0.00 Picogram (pg)
Standard Deviation 0.837
|
-0.30 Picogram (pg)
Standard Deviation 1.265
|
-0.21 Picogram (pg)
Standard Deviation 0.764
|
0.20 Picogram (pg)
Standard Deviation 0.804
|
-0.15 Picogram (pg)
Standard Deviation 0.532
|
-0.07 Picogram (pg)
Standard Deviation 0.672
|
|
Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level
Week 14, n=29, 30, 33, 34, 27, 23
|
0.07 Picogram (pg)
Standard Deviation 0.785
|
-0.23 Picogram (pg)
Standard Deviation 1.396
|
0.01 Picogram (pg)
Standard Deviation 0.557
|
0.39 Picogram (pg)
Standard Deviation 0.671
|
-0.19 Picogram (pg)
Standard Deviation 0.685
|
0.02 Picogram (pg)
Standard Deviation 0.406
|
|
Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level
EW, n=10, 6, 3, 2, 10, 9
|
0.05 Picogram (pg)
Standard Deviation 0.071
|
-0.02 Picogram (pg)
Standard Deviation 0.181
|
-0.12 Picogram (pg)
Standard Deviation 0.533
|
0.10 Picogram (pg)
Standard Deviation 0.371
|
-0.50 Picogram (pg)
Standard Deviation 0.520
|
0.15 Picogram (pg)
Standard Deviation 0.734
|
SECONDARY outcome
Timeframe: Baseline and up to Week 14Population: Safety Population
Blood samples were collected for the evaluation of change in erythrocyte mean corpuscular volume 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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=38 Participants
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.
|
Vehicle BID
n=37 Participants
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.
|
Vehicle QD
n=38 Participants
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.
|
GSK2894512 1% BID
n=38 Participants
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.
|
GSK2894512 0.5% BID
n=38 Participants
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.
|
GSK2894512 1% QD
n=38 Participants
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.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Erythrocyte Mean Corpuscular Volume
Week 2, n=35, 35, 36, 37, 29, 35
|
0.1 Femtoliter (fL)
Standard Deviation 2.11
|
-0.5 Femtoliter (fL)
Standard Deviation 4.05
|
0.2 Femtoliter (fL)
Standard Deviation 1.96
|
0.7 Femtoliter (fL)
Standard Deviation 2.38
|
0.6 Femtoliter (fL)
Standard Deviation 2.39
|
0.6 Femtoliter (fL)
Standard Deviation 2.07
|
|
Change From Baseline in Erythrocyte Mean Corpuscular Volume
Week 4, n=32, 34, 35, 37, 29, 31
|
0.2 Femtoliter (fL)
Standard Deviation 2.39
|
0.7 Femtoliter (fL)
Standard Deviation 3.73
|
0.0 Femtoliter (fL)
Standard Deviation 3.10
|
0.8 Femtoliter (fL)
Standard Deviation 2.21
|
0.4 Femtoliter (fL)
Standard Deviation 2.65
|
0.4 Femtoliter (fL)
Standard Deviation 1.94
|
|
Change From Baseline in Erythrocyte Mean Corpuscular Volume
Week 8, n=30, 31, 32, 38, 27, 26
|
0.6 Femtoliter (fL)
Standard Deviation 3.41
|
0.9 Femtoliter (fL)
Standard Deviation 3.80
|
0.9 Femtoliter (fL)
Standard Deviation 3.10
|
2.0 Femtoliter (fL)
Standard Deviation 2.39
|
1.1 Femtoliter (fL)
Standard Deviation 3.57
|
2.0 Femtoliter (fL)
Standard Deviation 5.05
|
|
Change From Baseline in Erythrocyte Mean Corpuscular Volume
Week 12, n=27, 30, 31, 36, 26, 25
|
1.4 Femtoliter (fL)
Standard Deviation 3.72
|
0.8 Femtoliter (fL)
Standard Deviation 3.98
|
0.9 Femtoliter (fL)
Standard Deviation 2.93
|
2.4 Femtoliter (fL)
Standard Deviation 2.27
|
1.9 Femtoliter (fL)
Standard Deviation 3.41
|
1.6 Femtoliter (fL)
Standard Deviation 1.94
|
|
Change From Baseline in Erythrocyte Mean Corpuscular Volume
Week 14, n=29, 30, 33, 34, 27, 23
|
0.9 Femtoliter (fL)
Standard Deviation 3.27
|
0.9 Femtoliter (fL)
Standard Deviation 3.95
|
1.9 Femtoliter (fL)
Standard Deviation 2.36
|
2.7 Femtoliter (fL)
Standard Deviation 2.87
|
1.5 Femtoliter (fL)
Standard Deviation 3.04
|
1.6 Femtoliter (fL)
Standard Deviation 2.08
|
|
Change From Baseline in Erythrocyte Mean Corpuscular Volume
EW, n=10, 6, 3, 2, 10, 9
|
-0.5 Femtoliter (fL)
Standard Deviation 0.71
|
1.1 Femtoliter (fL)
Standard Deviation 1.60
|
0.1 Femtoliter (fL)
Standard Deviation 2.42
|
0.6 Femtoliter (fL)
Standard Deviation 3.41
|
-0.3 Femtoliter (fL)
Standard Deviation 0.58
|
0.0 Femtoliter (fL)
Standard Deviation 2.19
|
SECONDARY outcome
Timeframe: Baseline and up to Week 14Population: Safety Population
Blood samples were collected for the evaluation of change in erythrocyte count 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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=38 Participants
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.
|
Vehicle BID
n=37 Participants
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.
|
Vehicle QD
n=38 Participants
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.
|
GSK2894512 1% BID
n=38 Participants
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.
|
GSK2894512 0.5% BID
n=38 Participants
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.
|
GSK2894512 1% QD
n=38 Participants
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.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Erythrocyte Count
Week 8, n=30, 31, 32, 38, 27, 26
|
-0.07 Tetra unit/L (TI/L)
Standard Deviation 0.257
|
0.06 Tetra unit/L (TI/L)
Standard Deviation 0.356
|
0.03 Tetra unit/L (TI/L)
Standard Deviation 0.317
|
-0.09 Tetra unit/L (TI/L)
Standard Deviation 0.273
|
-0.07 Tetra unit/L (TI/L)
Standard Deviation 0.306
|
-0.05 Tetra unit/L (TI/L)
Standard Deviation 0.468
|
|
Change From Baseline in Erythrocyte Count
EW, n=10, 6, 3, 2, 10, 9
|
-0.10 Tetra unit/L (TI/L)
Standard Deviation 0.000
|
-0.07 Tetra unit/L (TI/L)
Standard Deviation 0.200
|
0.00 Tetra unit/L (TI/L)
Standard Deviation 0.212
|
-0.03 Tetra unit/L (TI/L)
Standard Deviation 0.250
|
-0.13 Tetra unit/L (TI/L)
Standard Deviation 0.153
|
-0.30 Tetra unit/L (TI/L)
Standard Deviation 0.268
|
|
Change From Baseline in Erythrocyte Count
Week 2, n=35, 35, 36, 37, 29, 35
|
-0.05 Tetra unit/L (TI/L)
Standard Deviation 0.210
|
-0.03 Tetra unit/L (TI/L)
Standard Deviation 0.363
|
0.01 Tetra unit/L (TI/L)
Standard Deviation 0.269
|
-0.01 Tetra unit/L (TI/L)
Standard Deviation 0.180
|
-0.04 Tetra unit/L (TI/L)
Standard Deviation 0.315
|
-0.06 Tetra unit/L (TI/L)
Standard Deviation 0.243
|
|
Change From Baseline in Erythrocyte Count
Week 4, n=32, 34, 35, 37, 29, 31
|
-0.01 Tetra unit/L (TI/L)
Standard Deviation 0.269
|
0.01 Tetra unit/L (TI/L)
Standard Deviation 0.421
|
0.05 Tetra unit/L (TI/L)
Standard Deviation 0.294
|
-0.03 Tetra unit/L (TI/L)
Standard Deviation 0.213
|
0.02 Tetra unit/L (TI/L)
Standard Deviation 0.358
|
-0.06 Tetra unit/L (TI/L)
Standard Deviation 0.220
|
|
Change From Baseline in Erythrocyte Count
Week 12, n=27, 30, 31, 36, 26, 25
|
-0.08 Tetra unit/L (TI/L)
Standard Deviation 0.228
|
0.00 Tetra unit/L (TI/L)
Standard Deviation 0.328
|
0.04 Tetra unit/L (TI/L)
Standard Deviation 0.229
|
-0.07 Tetra unit/L (TI/L)
Standard Deviation 0.237
|
-0.05 Tetra unit/L (TI/L)
Standard Deviation 0.356
|
0.00 Tetra unit/L (TI/L)
Standard Deviation 0.257
|
|
Change From Baseline in Erythrocyte Count
Week 14, n=29, 30, 33, 34, 27, 23
|
-0.18 Tetra unit/L (TI/L)
Standard Deviation 0.343
|
-0.06 Tetra unit/L (TI/L)
Standard Deviation 0.370
|
-0.07 Tetra unit/L (TI/L)
Standard Deviation 0.194
|
-0.13 Tetra unit/L (TI/L)
Standard Deviation 0.334
|
-0.07 Tetra unit/L (TI/L)
Standard Deviation 0.374
|
-0.09 Tetra unit/L (TI/L)
Standard Deviation 0.252
|
SECONDARY outcome
Timeframe: Up to Week 14Population: Safety Population
Blood samples were collected for the evaluation of clinical chemistry parameters including alk phos, ALT, AST, bil, calcium, CO2, creatinine, glucose and potassium. The number of participants with chemistry data of potential clinical importance for the mentioned parameters was presented. Baseline was defined as the latest assessment (including unscheduled visits) 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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=38 Participants
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.
|
Vehicle BID
n=37 Participants
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.
|
Vehicle QD
n=38 Participants
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.
|
GSK2894512 1% BID
n=38 Participants
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.
|
GSK2894512 0.5% BID
n=38 Participants
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.
|
GSK2894512 1% QD
n=38 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Alk. Phos, Baseline, n=38, 38, 38, 38, 37, 38
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Alk. Phos, Week 2, n=35, 36, 35, 37, 29, 34
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Alk. Phos, Week 4, n=32, 34, 33, 37, 29, 30
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Alk. Phos, Week 8, n=30, 31, 32, 37, 27, 26
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Alk. Phos, Week 12, n=27, 30, 32, 36, 26, 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Alk. Phos, Week 14, n=29, 31, 33, 34, 27, 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Alk. Phos, EW, n=10, 6, 3, 2, 10, 9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Alk. Phos,post-screen(PS),n=38, 37, 37, 38, 36, 36
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
ALT, Baseline, n=38, 38, 38, 38, 37, 38
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
ALT, Week 2, n=35, 36, 35, 37, 29, 34
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
ALT, Week 4, n=32, 34, 33, 37, 29, 30
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
ALT, Week 8, n=30, 31, 32, 37, 27, 26
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
ALT, Week 12, n=27, 30, 32, 36, 26, 24
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
ALT, Week 14, n=29, 31, 33, 34, 27, 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
ALT, EW, n=10, 6, 3, 2, 10, 9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
ALT, PS, n=38, 37, 37, 38, 36, 36
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
AST, Baseline, n=38, 38, 38, 38, 37, 38
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
AST, Week 2, n=35, 36, 35, 37, 29, 34
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
AST, Week 4, n=32, 34, 33, 37, 29, 30
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
AST, Week 8, n=30, 31, 32, 37, 27, 26
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
AST, Week 12, n=27, 30, 32, 36, 26, 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
AST, Week 14, n=29, 31, 33, 34, 27, 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
AST, EW, n=10, 6, 3, 2, 10, 9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
AST, PS, n=38, 37, 37, 38, 36, 36
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Bil, Baseline, n=38, 38, 38, 38, 37, 38
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Bil, Week 2, n=35, 36, 35, 37, 29, 34
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Bil, Week 4, n=32, 34, 33, 37, 29, 30
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Bil, Week 8, n=30, 31, 32, 37, 27, 26
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Bil, Week 12, n=27, 30, 32, 36, 26, 24
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Bil, Week 14, n=29, 31, 33, 34, 27, 24
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Bil, EW, n=10, 6, 3, 2, 10, 9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Calcium, Week 4, n=32, 34, 33, 37, 29, 30
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Calcium, Week 12, n=27, 30, 32, 36, 26, 24
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Calcium, Week 14, n=29, 31, 33, 34, 27, 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Calcium, EW, n=10, 6, 3, 2, 10, 9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Calcium, PS, n=38, 37, 37, 38, 36, 36
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
CO2, Baseline, n=38, 38, 38, 38, 37, 38
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
CO2, Week 2, n=35, 36, 35, 37, 29, 34
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
CO2, Week 4, n=32, 34, 33, 37, 29, 30
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
CO2, Week 8, n=30, 31, 32, 37, 27, 26
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
CO2, Week 14, n=29, 31, 33, 34, 27, 24
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Creatinine, Week 2, n=35, 36, 35, 37, 29, 34
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Creatinine, Week 4, n=32, 34, 33, 37, 29, 30
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Creatinine, Week 8, n=30, 31, 32, 37, 27, 26
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Glucose, Week 4, n=32, 34, 33, 37, 29, 30
|
3 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Glucose, EW, n=10, 6, 3, 2, 10, 9
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Glucose, PS, n=38, 37, 37, 38, 36, 36
|
8 Participants
|
6 Participants
|
9 Participants
|
7 Participants
|
7 Participants
|
7 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Potassium, Baseline, n=38, 38, 38, 38, 37, 38
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Potassium, Week 12, n=27, 30, 32, 36, 26, 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Potassium, PS, n=38, 37, 37, 38, 36, 36
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Creatinine, Baseline, n=38, 38, 38, 38, 37, 38
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
CO2, PS, n=38, 37, 37, 38, 36, 36
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
8 Participants
|
1 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Glucose, Week 8, n=30, 31, 32, 37, 27, 26
|
2 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
6 Participants
|
3 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Bil, PS, n=38, 37, 37, 38, 36, 36
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Calcium, Baseline, n=38, 38, 38, 38, 37, 38
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Calcium, Week 2, n=35, 36, 35, 37, 29, 34
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Calcium, Week 8, n=30, 31, 32, 37, 27, 26
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Creatinine, Week 12, n=27, 30, 32, 36, 26, 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Creatinine, Week 14, n=29, 31, 33, 34, 27, 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Creatinine, EW, n=10, 6, 3, 2, 10, 9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Creatinine, PS, n=38, 37, 37, 38, 36, 36
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Glucose, Baseline, n=38, 38, 38, 38, 37, 38
|
2 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Glucose, Week 2, n=35, 36, 35, 37, 29, 34
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Glucose, Week 12, n=27, 30, 32, 36, 26, 24
|
4 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Glucose, Week 14, n=29, 31, 33, 34, 27, 24
|
4 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
7 Participants
|
2 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Potassium, Week 2, n=35, 36, 35, 37, 29, 34
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
CO2, Week 12, n=27, 30, 32, 36, 26, 24
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
CO2, EW, n=10, 6, 3, 2, 10, 9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Potassium, Week 4, n=32, 34, 33, 37, 29, 30
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Potassium, Week 8, n=30, 31, 32, 37, 27, 26
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Potassium, Week 14, n=29, 31, 33, 34, 27, 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Data of Potential Clinical Importance
Potassium, EW, n=10, 6, 3, 2, 10, 9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 14Population: Safety Population
Blood samples were collected for the evaluation of hematology parameters including hematocrit, Hgb, lymphocytes, neutrophils and platelets. The number of participants with clinically significant abnormal values of the mentioned hematology parameters was presented. Baseline was defined as the latest assessment (including unscheduled visits) 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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=38 Participants
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.
|
Vehicle BID
n=37 Participants
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.
|
Vehicle QD
n=38 Participants
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.
|
GSK2894512 1% BID
n=38 Participants
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.
|
GSK2894512 0.5% BID
n=38 Participants
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.
|
GSK2894512 1% QD
n=38 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Hematology Data of Clinical Importance
Hematocrit,Baseline, n=38, 38, 38, 38, 37, 38
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Hgb,Baseline, n=38, 38, 38, 38, 37, 38
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Hgb, Week 2, n=35, 35, 36, 37, 29, 35
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Lymphocytes, Baseline, n=38, 38, 38, 38, 37, 38
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Hematocrit, Week 8, n=30, 31, 32, 38, 27, 26
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Neutrophils, Week 14, n=29, 30, 33, 34, 27, 23
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Neutrophils, EW, n=10, 6, 3, 2, 10, 9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Lymphocytes, Week 14, n=29, 30, 33, 34, 27, 23
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Lymphocytes, EW, n=10, 6, 3, 2, 10, 9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Lymphocytes, PS, n=38, 37, 37, 38, 36, 36
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Neutrophils,Baseline, n=38, 38, 38, 38, 37, 38
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Neutrophils, Week 2, n=35, 35, 36, 37, 29, 35
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Neutrophils, Week 4, n=31, 34, 35, 37, 29, 31
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Neutrophils, Week 8, n=30, 30, 32, 37, 27, 26
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Neutrophils, Week 12, n=27, 30, 31, 36, 26, 25
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Neutrophils, PS, n=38, 37, 37, 38, 36, 36
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Platelets,Baseline, n=38, 38, 38, 38, 37, 38
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Platelets, Week 2, n=35, 35, 36, 37, 29, 35
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Platelets, Week 4, n=32, 34, 35, 37, 29, 31
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Platelets, Week 8, n=30, 31, 32, 38, 27, 26
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Platelets, Week 12, n=27, 30, 31, 36, 26, 25
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Platelets, Week 14, n=29, 30, 33, 34, 27, 23
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Platelets, EW, n=10, 5, 3, 2, 9, 9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Platelets, PS, n=38, 37, 37, 38, 35, 36
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Hematocrit, Week 12, n=27, 30, 31, 36, 26, 25
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Hematocrit, Week 2, n=35, 35, 36, 37, 29, 35
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Hematocrit, Week 4, n=32, 34, 35, 37, 29, 31
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Hematocrit, Week 14, n=29, 30, 33, 34, 27, 23
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Hematocrit, EW, n=10, 6, 3, 2, 10, 9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Hematocrit, PS, n=38, 37, 37, 38, 36, 36
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Hgb, Week 4, n=32, 34, 35, 37, 29, 31
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Hgb, Week 8, n=30, 31, 32, 38, 27, 26
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Hgb, Week 12, n=27, 30, 31, 36, 26, 25
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Hgb, Week 14, n=29, 30, 33, 34, 27, 23
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Hgb, EW, n=10, 6, 3, 2, 10, 9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Hgb, PS, n=38, 37, 37, 38, 36, 36
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Lymphocytes, Week 2, n=35, 35, 36, 37, 29, 35
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Lymphocytes, Week 4, n=31, 34, 35, 37, 29, 31
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Lymphocytes, Week 8, n=30, 30, 32, 37, 27, 26
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Data of Clinical Importance
Lymphocytes, Week 12, n=27, 30, 31, 36, 26, 25
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and up to Week 12Population: Safety Population
Blood samples were collected for the evaluation of change in IgA, IgG and IgM 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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=38 Participants
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.
|
Vehicle BID
n=37 Participants
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.
|
Vehicle QD
n=38 Participants
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.
|
GSK2894512 1% BID
n=38 Participants
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.
|
GSK2894512 0.5% BID
n=38 Participants
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.
|
GSK2894512 1% QD
n=38 Participants
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.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels
IgA, Week 4, n=32, 34, 35, 38, 29, 31
|
-0.024 g/L
Standard Deviation 0.6150
|
0.125 g/L
Standard Deviation 0.5462
|
0.006 g/L
Standard Deviation 0.2350
|
-0.035 g/L
Standard Deviation 0.2151
|
-0.153 g/L
Standard Deviation 0.5744
|
-0.138 g/L
Standard Deviation 0.3147
|
|
Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels
IgA, Week 8, n=30, 31, 33, 38, 27, 26
|
-0.064 g/L
Standard Deviation 0.6353
|
0.086 g/L
Standard Deviation 0.6911
|
-0.050 g/L
Standard Deviation 0.4347
|
0.021 g/L
Standard Deviation 0.3615
|
-0.239 g/L
Standard Deviation 0.6447
|
-0.151 g/L
Standard Deviation 0.3497
|
|
Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels
IgA, Week 12, n=27, 30, 32, 36, 26, 24
|
-0.037 g/L
Standard Deviation 1.0705
|
-0.023 g/L
Standard Deviation 0.8912
|
-0.018 g/L
Standard Deviation 0.2355
|
-0.028 g/L
Standard Deviation 0.2806
|
-0.271 g/L
Standard Deviation 0.6764
|
-0.138 g/L
Standard Deviation 0.2461
|
|
Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels
IgG, Week 4, n=32, 34, 35, 38, 29, 31
|
0.028 g/L
Standard Deviation 1.7157
|
0.441 g/L
Standard Deviation 1.6655
|
0.218 g/L
Standard Deviation 1.1025
|
0.130 g/L
Standard Deviation 0.8150
|
0.117 g/L
Standard Deviation 1.4003
|
-0.223 g/L
Standard Deviation 1.0422
|
|
Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels
IgG, Week 8, n=30, 31, 33, 38, 27, 26
|
0.195 g/L
Standard Deviation 1.4330
|
0.634 g/L
Standard Deviation 1.4913
|
0.299 g/L
Standard Deviation 1.3855
|
-0.098 g/L
Standard Deviation 1.1559
|
-0.016 g/L
Standard Deviation 1.4066
|
-0.055 g/L
Standard Deviation 1.1243
|
|
Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels
IgG, Week 12, n=27, 30, 32, 36, 26, 24
|
0.251 g/L
Standard Deviation 1.4115
|
0.377 g/L
Standard Deviation 2.0539
|
0.283 g/L
Standard Deviation 1.0979
|
0.248 g/L
Standard Deviation 0.8937
|
-0.360 g/L
Standard Deviation 1.3683
|
0.029 g/L
Standard Deviation 1.1145
|
|
Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels
IgM, Week 4, n=32, 34, 35, 38, 29, 31
|
-0.017 g/L
Standard Deviation 0.1434
|
-0.004 g/L
Standard Deviation 0.1951
|
-0.016 g/L
Standard Deviation 0.1371
|
-0.077 g/L
Standard Deviation 0.1215
|
-0.023 g/L
Standard Deviation 0.3524
|
-0.050 g/L
Standard Deviation 0.0797
|
|
Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels
IgM, Week 8, n=30, 31, 33, 38, 27, 26
|
-0.012 g/L
Standard Deviation 0.1213
|
-0.011 g/L
Standard Deviation 0.1951
|
-0.006 g/L
Standard Deviation 0.1802
|
-0.103 g/L
Standard Deviation 0.1649
|
-0.005 g/L
Standard Deviation 0.4892
|
-0.030 g/L
Standard Deviation 0.1737
|
|
Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels
IgM, Week 12, n=27, 30, 32, 36, 26, 24
|
-0.017 g/L
Standard Deviation 0.1495
|
-0.023 g/L
Standard Deviation 0.2431
|
-0.033 g/L
Standard Deviation 0.1900
|
-0.072 g/L
Standard Deviation 0.0992
|
-0.047 g/L
Standard Deviation 0.5307
|
-0.082 g/L
Standard Deviation 0.1264
|
SECONDARY outcome
Timeframe: Up to Week 12Population: Safety Population
Blood samples were collected for the evaluation of change in Ig levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) 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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=38 Participants
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.
|
Vehicle BID
n=37 Participants
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.
|
Vehicle QD
n=38 Participants
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.
|
GSK2894512 1% BID
n=38 Participants
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.
|
GSK2894512 0.5% BID
n=38 Participants
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.
|
GSK2894512 1% QD
n=38 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Ig Data Outside the Reference Range
IgA, Baseline, n=38, 38, 38, 38, 37, 38
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Ig Data Outside the Reference Range
IgA, Week 4, n=32, 34, 35, 38, 29, 31
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Ig Data Outside the Reference Range
IgA, Week 8, n=30, 31, 33, 38, 27, 26
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Ig Data Outside the Reference Range
IgA, Week 12, n=27, 30, 32, 36, 26, 24
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Ig Data Outside the Reference Range
IgA, PS, n=33, 34, 36, 38, 29, 31
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Ig Data Outside the Reference Range
IgG, Baseline, n=38, 38, 38, 38, 37, 38
|
2 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Ig Data Outside the Reference Range
IgG, Week 4, n=32, 34, 35, 38, 29, 31
|
3 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Ig Data Outside the Reference Range
IgG, Week 8, n=30, 31, 33, 38, 27, 26
|
2 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Ig Data Outside the Reference Range
IgG, Week 12, n=27, 30, 32, 36, 26, 24
|
4 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Ig Data Outside the Reference Range
IgG, PS, n=33, 34, 36, 38, 29, 31
|
4 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants With Ig Data Outside the Reference Range
IgM, Baseline, n=38, 38, 38, 38, 37, 38
|
3 Participants
|
2 Participants
|
5 Participants
|
11 Participants
|
9 Participants
|
5 Participants
|
|
Number of Participants With Ig Data Outside the Reference Range
IgM, Week 4, n=32, 34, 35, 38, 29, 31
|
4 Participants
|
2 Participants
|
3 Participants
|
9 Participants
|
9 Participants
|
5 Participants
|
|
Number of Participants With Ig Data Outside the Reference Range
IgM, Week 8, n=30, 31, 33, 38, 27, 26
|
4 Participants
|
2 Participants
|
4 Participants
|
9 Participants
|
8 Participants
|
6 Participants
|
|
Number of Participants With Ig Data Outside the Reference Range
IgM, Week 12, n=27, 30, 32, 36, 26, 24
|
3 Participants
|
2 Participants
|
2 Participants
|
8 Participants
|
8 Participants
|
5 Participants
|
|
Number of Participants With Ig Data Outside the Reference Range
IgM, PS, n=33, 34, 36, 38, 29, 31
|
5 Participants
|
3 Participants
|
4 Participants
|
11 Participants
|
10 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to Week 12Population: Safety Population
Blood samples were collected for the evaluation of change in levels of cluster of differentiation (CD)19, CD3, CD3 Treg flow cytometry (CD3TFLC), CD3+CD8+, CD3+CD8+ TFLC, CD3+CD4+, CD3+CD4+ TFLC, CD16+CD56+, CD3+CD4+CD25+CD127 flow cytometry (CD3+CD4+CD25+CD127), CD3+CD4+foxP3+CD25+CD127 flow cytometry (CD3+CD4+fP3+CD25+CD127) and T Cell B Cell Natural Killer Lymphocytes flow cytometry (T-B cell NKL). Baseline was defined as the latest assessment (including unscheduled visits) 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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=38 Participants
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.
|
Vehicle BID
n=37 Participants
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.
|
Vehicle QD
n=38 Participants
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.
|
GSK2894512 1% BID
n=38 Participants
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.
|
GSK2894512 0.5% BID
n=38 Participants
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.
|
GSK2894512 1% QD
n=38 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD19, Week 8, n=30, 31, 33, 38, 27, 26
|
6 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD19, Week 12, n=27, 29, 32, 36, 26, 24
|
4 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD19, Baseline, n=38, 38, 38, 38, 37, 38
|
7 Participants
|
11 Participants
|
1 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD19, Week 4, n=30, 32, 35, 38, 29, 30
|
6 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD19, PS, n=33, 34, 36, 38, 29, 31
|
7 Participants
|
9 Participants
|
4 Participants
|
5 Participants
|
8 Participants
|
7 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3, Baseline, n=38, 38, 38, 38, 37, 38
|
3 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3, Week 4, n=30, 32, 35, 38, 29, 30
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3, Week 8, n=30, 31, 33, 38, 27, 26
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3, Week 12, n=27, 29, 32, 36, 26, 24
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3, PS, n=33, 34, 36, 38, 29, 31
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
8 Participants
|
4 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3 TFLC, Baseline, n=37,36,38, 38, 36, 38
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3 TFLC, Week 4, n=28, 30, 32, 36, 28, 26
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3 TFLC, Week 8, n=30, 29, 31, 34, 25, 22
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3 TFLC, Week 12, n=26,26,30, 34, 24, 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3 TFLC, PS, n=33, 33, 36, 38, 29, 31
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD8+, Baseline, n=38, 38, 38, 38, 37, 38
|
3 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD8+, Week 4, n=30, 32, 35, 38, 29, 30
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD8+, Week 8, n=30, 31, 33, 38, 27, 26
|
1 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD8+, Week 12, n=27, 29, 32, 36, 26, 24
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD8+, PS, n=33, 34, 36, 38, 29, 31
|
3 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD8+ TFLC, Baseline, n=37, 36, 38, 38, 36, 38
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD8+ TFLC, Week 4, n=28, 30, 32, 36, 28, 36
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD8+ TFLC, Week 8, n=30, 29, 31, 34, 25, 22
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD8+ TFLC, Week 12, n=26, 26, 30, 34, 24, 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD8+TFLC, PS, n=33, 33,36, 38, 29, 31
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD4+, Baseline, n=38, 38, 38, 38, 37, 38
|
2 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD4+, Week 4, n=30, 32, 35, 38, 29, 30
|
3 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD4+, Week 8, n=30, 31, 33, 38, 27, 26
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD4+, Week 12, n=27, 29, 32, 36, 26, 24
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD4+, PS, n=33, 34, 36, 38, 29, 31
|
5 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
8 Participants
|
6 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD4+ TFLC, Baseline, n=37, 36, 38, 38, 36, 38
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD4+ TFLC, Week 4, n=28, 30, 32, 36, 28, 36
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD4+ TFLC, Week 8, n=30, 29, 31, 34, 25, 22
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD4+ TFLC, Week 12, n=26, 26, 30, 34, 24, 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD4+ TF, PS, n=33, 33, 36, 38, 29, 31
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD16+CD56+, Baseline, n=38, 38, 38, 38, 37, 38
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD16+CD56+, Week 4, n=30, 32, 35, 38, 29, 30
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD16+CD56+, Week 8, n=30, 31, 33, 38, 27, 26
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD16+CD56+, Week 12, n=27, 29, 32, 36, 26, 24
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD16+CD56+, PS, n=33, 34, 36, 38, 29, 31
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD4+CD25+CD127, Baseline, n=37,36,38,38,36,38
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD4+CD25+CD127, Week 4, n=28,30,32,36,28,36
|
3 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD4+CD25+CD127, Week 8, n=30,29,31,34,25,22
|
2 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD4+CD25+CD127, Week 12, n=26,26,30,34,24,24
|
7 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD4+CD25+CD127, PS, n=33,33,36,38,29,31
|
9 Participants
|
7 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD4+fP3+CD25+CD127Baseline,n=37,36,38,38,36,38
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD4+fP3+CD25+CD127, Week 4,n=28,30,32,36,28,36
|
5 Participants
|
7 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
8 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD4+fP3+CD25+CD127, Week 8,n=30,29,31,34,25,22
|
6 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD4+fP3+CD25+CD127 Week 12,n=26,26,30,34,24,24
|
8 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
CD3+CD4+fP3+CD25+CD127, PS,n=33,33,36,38,29,31
|
15 Participants
|
11 Participants
|
7 Participants
|
11 Participants
|
12 Participants
|
14 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
T-B cell NKL, Baseline, n=38,38,38,38,37,38
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
T-B cell NKL, Week 4, n=30,32,35,38,29,30
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
T-B cell NKL, Week 8, n=30,31,33,38,27,26
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
T-B cell NKL, Week 12, n=27,29,32,36,26,24
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Immunophenotyping Data Outside the Reference Range
T-B cell NKL, PS, n=33,34,36,38,29,31
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and up to Week 12Population: Safety Population
Blood samples were collected for the evaluation of change from Baseline in immunophenotype levels including CD19, CD3, CD3TFLC, CD3+CD8+, CD3+CD8+ TFLC, CD3+CD4+, CD3+CD4+ TFLC, CD16+CD56+, CD3+CD4+CD25+CD127 flow cytometry (CD3+CD4+CD25+CD127), CD3+CD4+foxP3+CD25+CD127 flow cytometry (CD3+CD4+fP3+CD25+CD127) and T-B cell NKL. 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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=38 Participants
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.
|
Vehicle BID
n=37 Participants
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.
|
Vehicle QD
n=38 Participants
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.
|
GSK2894512 1% BID
n=38 Participants
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.
|
GSK2894512 0.5% BID
n=38 Participants
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.
|
GSK2894512 1% QD
n=38 Participants
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.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Immunophenotype Data
CD3+CD4+, Week 12, n=27, 29, 32, 36, 26, 24
|
-0.0249 GI/L
Standard Deviation 0.2005
|
-0.0798 GI/L
Standard Deviation 0.1817
|
-0.0458 GI/L
Standard Deviation 0.1960
|
-0.0228 GI/L
Standard Deviation 0.2928
|
-0.0225 GI/L
Standard Deviation 0.2149
|
0.0936 GI/L
Standard Deviation 0.2664
|
|
Change From Baseline in Immunophenotype Data
CD19, Week 4, n=30, 32, 35, 38, 29, 30
|
-0.0184 GI/L
Standard Deviation 0.2460
|
-0.0241 GI/L
Standard Deviation 0.3210
|
-0.0109 GI/L
Standard Deviation 0.0659
|
-0.0182 GI/L
Standard Deviation 0.1060
|
-0.0261 GI/L
Standard Deviation 0.1177
|
0.0318 GI/L
Standard Deviation 0.1046
|
|
Change From Baseline in Immunophenotype Data
CD19, Week 8, n=30, 31, 33, 38, 27, 26
|
-0.0464 GI/L
Standard Deviation 0.2220
|
-0.0533 GI/L
Standard Deviation 0.2878
|
0.0150 GI/L
Standard Deviation 0.1099
|
0.0367 GI/L
Standard Deviation 0.1284
|
-0.0288 GI/L
Standard Deviation 0.0953
|
0.0491 GI/L
Standard Deviation 0.0984
|
|
Change From Baseline in Immunophenotype Data
CD19, Week 12, n=27, 29, 32, 36, 26, 24
|
-0.0305 GI/L
Standard Deviation 0.2591
|
-0.0443 GI/L
Standard Deviation 0.2863
|
-0.0097 GI/L
Standard Deviation 0.0774
|
0.0059 GI/L
Standard Deviation 0.1178
|
-0.0334 GI/L
Standard Deviation 0.0968
|
0.0362 GI/L
Standard Deviation 0.0968
|
|
Change From Baseline in Immunophenotype Data
CD3, Week 4, n=30, 32, 35, 38, 29, 30
|
0.0186 GI/L
Standard Deviation 0.3417
|
-0.0842 GI/L
Standard Deviation 0.2888
|
-0.0584 GI/L
Standard Deviation 0.3175
|
-0.1067 GI/L
Standard Deviation 0.3964
|
-0.0360 GI/L
Standard Deviation 0.3419
|
0.1044 GI/L
Standard Deviation 0.3945
|
|
Change From Baseline in Immunophenotype Data
CD3, Week 8, n=30, 31, 33, 38, 27, 26
|
-0.0053 GI/L
Standard Deviation 0.3463
|
-0.1063 GI/L
Standard Deviation 0.4996
|
-0.0213 GI/L
Standard Deviation 0.2936
|
0.0227 GI/L
Standard Deviation 0.4318
|
-0.0101 GI/L
Standard Deviation 0.3231
|
0.1426 GI/L
Standard Deviation 0.3650
|
|
Change From Baseline in Immunophenotype Data
CD3, Week 12, n=27, 29, 32, 36, 26, 24
|
-0.0315 GI/L
Standard Deviation 0.3259
|
-0.0822 GI/L
Standard Deviation 0.3222
|
-0.0142 GI/L
Standard Deviation 0.3345
|
-0.0511 GI/L
Standard Deviation 0.4225
|
-0.0248 GI/L
Standard Deviation 0.3140
|
0.1327 GI/L
Standard Deviation 0.4230
|
|
Change From Baseline in Immunophenotype Data
CD3 TFLC, Week 4, n=27, 29, 32, 36, 28, 26
|
0.0320 GI/L
Standard Deviation 0.3412
|
-0.0937 GI/L
Standard Deviation 0.3115
|
-0.1031 GI/L
Standard Deviation 0.3504
|
-0.0829 GI/L
Standard Deviation 0.4002
|
0.0196 GI/L
Standard Deviation 0.3104
|
0.1270 GI/L
Standard Deviation 0.4233
|
|
Change From Baseline in Immunophenotype Data
CD3 TFLC, Week 8, n=29, 27, 31, 34, 25, 22
|
0.0053 GI/L
Standard Deviation 0.2782
|
-0.1393 GI/L
Standard Deviation 0.5368
|
-0.0383 GI/L
Standard Deviation 0.3471
|
0.0187 GI/L
Standard Deviation 0.4749
|
-0.0158 GI/L
Standard Deviation 0.3503
|
0.1296 GI/L
Standard Deviation 0.3352
|
|
Change From Baseline in Immunophenotype Data
CD3 TFLC, Week 12, n=25,24,30, 34, 24, 24
|
-0.0342 GI/L
Standard Deviation 0.3157
|
-0.1220 GI/L
Standard Deviation 0.3010
|
-0.0280 GI/L
Standard Deviation 0.3630
|
-0.0916 GI/L
Standard Deviation 0.4466
|
-0.0266 GI/L
Standard Deviation 0.3227
|
0.1494 GI/L
Standard Deviation 0.4745
|
|
Change From Baseline in Immunophenotype Data
CD3+CD8+, Week 4, n=30, 32, 35, 38, 29, 30
|
0.0095 GI/L
Standard Deviation 0.1217
|
-0.0009 GI/L
Standard Deviation 0.1871
|
0.0179 GI/L
Standard Deviation 0.1504
|
-0.0297 GI/L
Standard Deviation 0.1394
|
0.0094 GI/L
Standard Deviation 0.1279
|
0.0524 GI/L
Standard Deviation 0.1516
|
|
Change From Baseline in Immunophenotype Data
CD3+CD8+, Week 8, n=30, 31, 33, 38, 27, 26
|
0.0219 GI/L
Standard Deviation 0.1550
|
-0.0189 GI/L
Standard Deviation 0.2073
|
0.0566 GI/L
Standard Deviation 0.1508
|
0.0001 GI/L
Standard Deviation 0.1582
|
0.0100 GI/L
Standard Deviation 0.1006
|
0.0683 GI/L
Standard Deviation 0.1697
|
|
Change From Baseline in Immunophenotype Data
CD3+CD8+, Week 12, n=27, 29, 32, 36, 26, 24
|
0.0151 GI/L
Standard Deviation 0.1594
|
0.0081 GI/L
Standard Deviation 0.1920
|
0.0326 GI/L
Standard Deviation 0.1690
|
-0.0174 GI/L
Standard Deviation 0.1417
|
0.0106 GI/L
Standard Deviation 0.1253
|
0.0477 GI/L
Standard Deviation 0.1642
|
|
Change From Baseline in Immunophenotype Data
CD3+CD8+ TFLC, Week 4, n=27, 29, 32, 36, 28, 26
|
-0.0069 GI/L
Standard Deviation 0.1480
|
-0.0107 GI/L
Standard Deviation 0.1759
|
-0.0180 GI/L
Standard Deviation 0.1055
|
-0.0203 GI/L
Standard Deviation 0.1264
|
0.0083 GI/L
Standard Deviation 0.0980
|
0.0359 GI/L
Standard Deviation 0.1719
|
|
Change From Baseline in Immunophenotype Data
CD3+CD8+ TFLC, Week 8, n=29, 27, 31, 34, 25, 22
|
0.0035 GI/L
Standard Deviation 0.1194
|
-0.0254 GI/L
Standard Deviation 0.2065
|
0.0139 GI/L
Standard Deviation 0.1195
|
-0.0066 GI/L
Standard Deviation 0.1420
|
0.0091 GI/L
Standard Deviation 0.0920
|
0.0375 GI/L
Standard Deviation 0.1628
|
|
Change From Baseline in Immunophenotype Data
CD3+CD8+ TFLC, Week 12, n=25, 24, 30, 34, 24, 24
|
0.0010 GI/L
Standard Deviation 0.1518
|
-0.0112 GI/L
Standard Deviation 0.1493
|
0.0193 GI/L
Standard Deviation 0.1535
|
-0.0306 GI/L
Standard Deviation 0.1284
|
-0.0042 GI/L
Standard Deviation 0.1113
|
0.0260 GI/L
Standard Deviation 0.1760
|
|
Change From Baseline in Immunophenotype Data
CD3+CD4+, Week 4, n=30, 32, 35, 38, 29, 30
|
0.0210 GI/L
Standard Deviation 0.2475
|
-0.0857 GI/L
Standard Deviation 0.1802
|
-0.0775 GI/L
Standard Deviation 0.2286
|
-0.0750 GI/L
Standard Deviation 0.2756
|
-0.0374 GI/L
Standard Deviation 0.2429
|
0.0525 GI/L
Standard Deviation 0.2577
|
|
Change From Baseline in Immunophenotype Data
CD3+CD4+, Week 8, n=30, 31, 33, 38, 27, 26
|
-0.0164 GI/L
Standard Deviation 0.2338
|
-0.0821 GI/L
Standard Deviation 0.3158
|
-0.0715 GI/L
Standard Deviation 0.2205
|
0.0296 GI/L
Standard Deviation 0.3006
|
-0.0042 GI/L
Standard Deviation 0.2396
|
0.0758 GI/L
Standard Deviation 0.2036
|
|
Change From Baseline in Immunophenotype Data
CD3+CD4+ TFLC, Week 4, n=27, 29, 32, 36, 28, 26
|
0.0280 GI/L
Standard Deviation 0.2521
|
-0.0729 GI/L
Standard Deviation 0.1786
|
-0.0621 GI/L
Standard Deviation 0.2216
|
-0.0512 GI/L
Standard Deviation 0.2493
|
0.0009 GI/L
Standard Deviation 0.2121
|
0.0764 GI/L
Standard Deviation 0.2613
|
|
Change From Baseline in Immunophenotype Data
CD3+CD4+ TFLC, Week 8, n=29, 27, 31, 34, 25, 22
|
0.0138 GI/L
Standard Deviation 0.2066
|
-0.0784 GI/L
Standard Deviation 0.3136
|
-0.0298 GI/L
Standard Deviation 0.2089
|
0.0268 GI/L
Standard Deviation 0.3134
|
-0.0075 GI/L
Standard Deviation 0.2525
|
0.0857 GI/L
Standard Deviation 0.1814
|
|
Change From Baseline in Immunophenotype Data
CD3+CD4+ TFLC, Week 12, n=25, 24, 30, 34, 24, 24
|
0.0044 GI/L
Standard Deviation 0.1730
|
-0.0679 GI/L
Standard Deviation 0.1740
|
-0.0386 GI/L
Standard Deviation 0.1832
|
-0.0511 GI/L
Standard Deviation 0.2835
|
-0.0159 GI/L
Standard Deviation 0.2244
|
0.1196 GI/L
Standard Deviation 0.2891
|
|
Change From Baseline in Immunophenotype Data
CD16+CD56+, Week 4, n=30, 32, 35, 38, 29, 30
|
-0.009 GI/L
Standard Deviation 0.0821
|
-0.013 GI/L
Standard Deviation 0.1134
|
0.001 GI/L
Standard Deviation 0.0876
|
-0.023 GI/L
Standard Deviation 0.0910
|
0.011 GI/L
Standard Deviation 0.0897
|
0.014 GI/L
Standard Deviation 0.1031
|
|
Change From Baseline in Immunophenotype Data
CD16+CD56+, Week 8, n=30, 31, 33, 38, 27, 26
|
-0.002 GI/L
Standard Deviation 0.0713
|
-0.000 GI/L
Standard Deviation 0.1800
|
0.013 GI/L
Standard Deviation 0.1339
|
0.002 GI/L
Standard Deviation 0.0699
|
0.009 GI/L
Standard Deviation 0.0867
|
0.011 GI/L
Standard Deviation 0.1312
|
|
Change From Baseline in Immunophenotype Data
CD16+CD56+, Week 12, n=27, 29, 32, 36, 26, 24
|
-0.022 GI/L
Standard Deviation 0.1082
|
-0.035 GI/L
Standard Deviation 0.1168
|
0.024 GI/L
Standard Deviation 0.0792
|
-0.010 GI/L
Standard Deviation 0.0861
|
-0.015 GI/L
Standard Deviation 0.0861
|
-0.001 GI/L
Standard Deviation 0.1283
|
|
Change From Baseline in Immunophenotype Data
CD3+CD4+CD25+CD127, Week 4, n=27,29,32,36,28,26
|
-0.0036 GI/L
Standard Deviation 0.0218
|
-0.0016 GI/L
Standard Deviation 0.0172
|
-0.0008 GI/L
Standard Deviation 0.0097
|
0.0016 GI/L
Standard Deviation 0.0109
|
0.0019 GI/L
Standard Deviation 0.0147
|
0.0021 GI/L
Standard Deviation 0.0195
|
|
Change From Baseline in Immunophenotype Data
CD3+CD4+CD25+CD127, Week 8, n=29,27,31,34,25,22
|
-0.0019 GI/L
Standard Deviation 0.0200
|
-0.0034 GI/L
Standard Deviation 0.0205
|
0.0020 GI/L
Standard Deviation 0.0122
|
0.0002 GI/L
Standard Deviation 0.0141
|
0.0027 GI/L
Standard Deviation 0.0133
|
0.0040 GI/L
Standard Deviation 0.0228
|
|
Change From Baseline in Immunophenotype Data
CD3+CD4+CD25+CD127, Week 12, n=25,24,30,34,24,24
|
-0.0035 GI/L
Standard Deviation 0.0229
|
-0.0037 GI/L
Standard Deviation 0.0141
|
-0.0010 GI/L
Standard Deviation 0.0106
|
0.0060 GI/L
Standard Deviation 0.0121
|
0.0029 GI/L
Standard Deviation 0.0164
|
0.0035 GI/L
Standard Deviation 0.0279
|
|
Change From Baseline in Immunophenotype Data
CD3+CD4+fP3+CD25+CD127, Week4,n=27,29,32,36,28,26
|
-0.0024 GI/L
Standard Deviation 0.0130
|
-0.0005 GI/L
Standard Deviation 0.0115
|
-0.0003 GI/L
Standard Deviation 0.0104
|
-0.0019 GI/L
Standard Deviation 0.0118
|
0.0018 GI/L
Standard Deviation 0.0107
|
0.0057 GI/L
Standard Deviation 0.0110
|
|
Change From Baseline in Immunophenotype Data
CD3+CD4+fP3+CD25+CD127, Week 8,n=29,27,31,34,25,22
|
0.0055 GI/L
Standard Deviation 0.0134
|
0.0003 GI/L
Standard Deviation 0.0107
|
-0.0000 GI/L
Standard Deviation 0.0100
|
-0.0006 GI/L
Standard Deviation 0.0170
|
0.0004 GI/L
Standard Deviation 0.0118
|
0.0055 GI/L
Standard Deviation 0.0121
|
|
Change From Baseline in Immunophenotype Data
CD3+CD4+fP3+CD25+CD127 Week12,n=25,24,30,34,24,24
|
-0.0001 GI/L
Standard Deviation 0.0125
|
0.0001 GI/L
Standard Deviation 0.0099
|
0.0001 GI/L
Standard Deviation 0.0124
|
0.0063 GI/L
Standard Deviation 0.0115
|
0.0005 GI/L
Standard Deviation 0.0127
|
0.0041 GI/L
Standard Deviation 0.0147
|
|
Change From Baseline in Immunophenotype Data
T-B cell NKL, Week 4, n=30,32,35,38,29,30
|
-0.009 GI/L
Standard Deviation 0.4837
|
-0.137 GI/L
Standard Deviation 0.4446
|
-0.083 GI/L
Standard Deviation 0.4134
|
-0.157 GI/L
Standard Deviation 0.5537
|
-0.051 GI/L
Standard Deviation 0.4505
|
0.152 GI/L
Standard Deviation 0.5655
|
|
Change From Baseline in Immunophenotype Data
T-B cell NKL, Week 8, n=30,31,33,38,27,26
|
-0.064 GI/L
Standard Deviation 0.4563
|
-0.186 GI/L
Standard Deviation 0.4999
|
0.006 GI/L
Standard Deviation 0.4809
|
0.057 GI/L
Standard Deviation 0.5699
|
-0.028 GI/L
Standard Deviation 0.4384
|
0.195 GI/L
Standard Deviation 0.5345
|
|
Change From Baseline in Immunophenotype Data
T-B cell NKL, Week 12, n=27,29,32,36,26,24
|
-0.094 GI/L
Standard Deviation 0.5229
|
-0.193 GI/L
Standard Deviation 0.4038
|
0.008 GI/L
Standard Deviation 0.4342
|
-0.063 GI/L
Standard Deviation 0.5793
|
-0.081 GI/L
Standard Deviation 0.4282
|
0.163 GI/L
Standard Deviation 0.6093
|
SECONDARY outcome
Timeframe: Baseline and up to Week 14Population: Safety Population
SBP and DBP were measured in semi-supine position after at least 5 minutes of rest. 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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=38 Participants
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.
|
Vehicle BID
n=37 Participants
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.
|
Vehicle QD
n=38 Participants
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.
|
GSK2894512 1% BID
n=38 Participants
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.
|
GSK2894512 0.5% BID
n=38 Participants
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.
|
GSK2894512 1% QD
n=38 Participants
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.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Week 14, n=29, 31, 33, 34, 27, 26
|
-1.1 Millimeter of mercury (mmHg)
Standard Deviation 9.70
|
-2.4 Millimeter of mercury (mmHg)
Standard Deviation 15.05
|
2.2 Millimeter of mercury (mmHg)
Standard Deviation 10.97
|
-0.3 Millimeter of mercury (mmHg)
Standard Deviation 13.10
|
2.6 Millimeter of mercury (mmHg)
Standard Deviation 11.66
|
-0.9 Millimeter of mercury (mmHg)
Standard Deviation 14.44
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Week 2, n=36, 36, 36, 38, 31, 35
|
0.3 Millimeter of mercury (mmHg)
Standard Deviation 7.11
|
1.2 Millimeter of mercury (mmHg)
Standard Deviation 9.51
|
0.0 Millimeter of mercury (mmHg)
Standard Deviation 7.94
|
0.5 Millimeter of mercury (mmHg)
Standard Deviation 8.13
|
2.3 Millimeter of mercury (mmHg)
Standard Deviation 6.52
|
0.3 Millimeter of mercury (mmHg)
Standard Deviation 7.55
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Week 4, n=32, 34, 35, 38, 29, 31
|
-0.2 Millimeter of mercury (mmHg)
Standard Deviation 5.77
|
-1.8 Millimeter of mercury (mmHg)
Standard Deviation 9.32
|
-0.2 Millimeter of mercury (mmHg)
Standard Deviation 7.54
|
1.0 Millimeter of mercury (mmHg)
Standard Deviation 8.04
|
1.2 Millimeter of mercury (mmHg)
Standard Deviation 6.79
|
0.7 Millimeter of mercury (mmHg)
Standard Deviation 7.53
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Week 1, n=36, 38, 37, 38, 35, 37
|
2.1 Millimeter of mercury (mmHg)
Standard Deviation 6.97
|
1.4 Millimeter of mercury (mmHg)
Standard Deviation 11.18
|
1.1 Millimeter of mercury (mmHg)
Standard Deviation 11.16
|
-1.4 Millimeter of mercury (mmHg)
Standard Deviation 10.54
|
1.6 Millimeter of mercury (mmHg)
Standard Deviation 10.08
|
-0.8 Millimeter of mercury (mmHg)
Standard Deviation 10.54
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Week 2, n=36, 36, 36, 38, 31, 35
|
-0.1 Millimeter of mercury (mmHg)
Standard Deviation 9.79
|
0.6 Millimeter of mercury (mmHg)
Standard Deviation 13.73
|
-1.1 Millimeter of mercury (mmHg)
Standard Deviation 13.15
|
-2.0 Millimeter of mercury (mmHg)
Standard Deviation 11.61
|
3.0 Millimeter of mercury (mmHg)
Standard Deviation 10.73
|
-1.0 Millimeter of mercury (mmHg)
Standard Deviation 11.45
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Week 4, n=32, 34, 35, 38, 29, 31
|
-1.4 Millimeter of mercury (mmHg)
Standard Deviation 8.35
|
-0.3 Millimeter of mercury (mmHg)
Standard Deviation 13.35
|
-0.3 Millimeter of mercury (mmHg)
Standard Deviation 13.22
|
0.4 Millimeter of mercury (mmHg)
Standard Deviation 12.40
|
2.6 Millimeter of mercury (mmHg)
Standard Deviation 11.54
|
-2.0 Millimeter of mercury (mmHg)
Standard Deviation 12.68
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Week 8, n=30, 31, 33, 38, 27, 26
|
0.3 Millimeter of mercury (mmHg)
Standard Deviation 13.42
|
0.4 Millimeter of mercury (mmHg)
Standard Deviation 13.34
|
2.4 Millimeter of mercury (mmHg)
Standard Deviation 13.81
|
4.0 Millimeter of mercury (mmHg)
Standard Deviation 12.11
|
4.0 Millimeter of mercury (mmHg)
Standard Deviation 14.69
|
-1.6 Millimeter of mercury (mmHg)
Standard Deviation 14.25
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Week 12, n=26, 30, 32, 36, 26, 25
|
-0.6 Millimeter of mercury (mmHg)
Standard Deviation 9.51
|
2.0 Millimeter of mercury (mmHg)
Standard Deviation 11.16
|
1.2 Millimeter of mercury (mmHg)
Standard Deviation 12.02
|
3.4 Millimeter of mercury (mmHg)
Standard Deviation 14.09
|
1.1 Millimeter of mercury (mmHg)
Standard Deviation 12.97
|
-1.5 Millimeter of mercury (mmHg)
Standard Deviation 14.88
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, EW, n=10, 7, 4, 2, 10, 9
|
-10.5 Millimeter of mercury (mmHg)
Standard Deviation 2.12
|
-1.3 Millimeter of mercury (mmHg)
Standard Deviation 16.15
|
-4.0 Millimeter of mercury (mmHg)
Standard Deviation 13.19
|
5.3 Millimeter of mercury (mmHg)
Standard Deviation 14.73
|
1.3 Millimeter of mercury (mmHg)
Standard Deviation 8.73
|
0.4 Millimeter of mercury (mmHg)
Standard Deviation 17.22
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Week 1, n=36, 38, 37, 38, 35, 37
|
1.5 Millimeter of mercury (mmHg)
Standard Deviation 7.48
|
1.5 Millimeter of mercury (mmHg)
Standard Deviation 10.14
|
-0.8 Millimeter of mercury (mmHg)
Standard Deviation 8.27
|
0.9 Millimeter of mercury (mmHg)
Standard Deviation 7.70
|
0.4 Millimeter of mercury (mmHg)
Standard Deviation 6.61
|
-0.2 Millimeter of mercury (mmHg)
Standard Deviation 7.64
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Week 8, n=30, 31, 33, 38, 27, 26
|
0.9 Millimeter of mercury (mmHg)
Standard Deviation 9.66
|
0.6 Millimeter of mercury (mmHg)
Standard Deviation 8.42
|
0.6 Millimeter of mercury (mmHg)
Standard Deviation 8.18
|
0.1 Millimeter of mercury (mmHg)
Standard Deviation 6.44
|
2.1 Millimeter of mercury (mmHg)
Standard Deviation 7.26
|
1.4 Millimeter of mercury (mmHg)
Standard Deviation 9.17
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Week 12, n=26, 30, 32, 36, 26, 25
|
0.3 Millimeter of mercury (mmHg)
Standard Deviation 8.02
|
0.1 Millimeter of mercury (mmHg)
Standard Deviation 8.60
|
-0.1 Millimeter of mercury (mmHg)
Standard Deviation 7.98
|
2.4 Millimeter of mercury (mmHg)
Standard Deviation 9.98
|
1.0 Millimeter of mercury (mmHg)
Standard Deviation 8.28
|
1.3 Millimeter of mercury (mmHg)
Standard Deviation 9.00
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Week 14, n=29, 31, 33, 34, 27, 26
|
-0.1 Millimeter of mercury (mmHg)
Standard Deviation 7.64
|
-1.1 Millimeter of mercury (mmHg)
Standard Deviation 9.45
|
0.2 Millimeter of mercury (mmHg)
Standard Deviation 9.85
|
0.3 Millimeter of mercury (mmHg)
Standard Deviation 8.80
|
2.2 Millimeter of mercury (mmHg)
Standard Deviation 5.56
|
2.5 Millimeter of mercury (mmHg)
Standard Deviation 8.27
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, EW, n=10, 7, 4, 2, 10, 9
|
3.5 Millimeter of mercury (mmHg)
Standard Deviation 16.26
|
1.2 Millimeter of mercury (mmHg)
Standard Deviation 11.49
|
-1.1 Millimeter of mercury (mmHg)
Standard Deviation 6.13
|
3.4 Millimeter of mercury (mmHg)
Standard Deviation 6.22
|
3.5 Millimeter of mercury (mmHg)
Standard Deviation 5.97
|
1.4 Millimeter of mercury (mmHg)
Standard Deviation 7.32
|
SECONDARY outcome
Timeframe: Baseline and up to Week 14Population: Safety Population
Pulse rate was measured in semi-supine position after at least 5 minutes of rest. 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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=38 Participants
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.
|
Vehicle BID
n=37 Participants
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.
|
Vehicle QD
n=38 Participants
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.
|
GSK2894512 1% BID
n=38 Participants
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.
|
GSK2894512 0.5% BID
n=38 Participants
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.
|
GSK2894512 1% QD
n=38 Participants
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.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Pulse Rate
Week 1, n=36, 38, 37, 38, 35, 37
|
-0.1 beats per minute
Standard Deviation 9.18
|
-0.0 beats per minute
Standard Deviation 7.65
|
-0.6 beats per minute
Standard Deviation 9.96
|
0.5 beats per minute
Standard Deviation 8.82
|
1.7 beats per minute
Standard Deviation 7.07
|
-0.4 beats per minute
Standard Deviation 9.40
|
|
Change From Baseline in Pulse Rate
Week 2, n=36, 36, 36, 38, 31, 35
|
1.7 beats per minute
Standard Deviation 9.76
|
-1.5 beats per minute
Standard Deviation 11.51
|
1.6 beats per minute
Standard Deviation 10.40
|
0.9 beats per minute
Standard Deviation 10.33
|
1.4 beats per minute
Standard Deviation 7.73
|
-3.2 beats per minute
Standard Deviation 9.77
|
|
Change From Baseline in Pulse Rate
Week 4, n=32, 34, 35, 38, 29, 31
|
1.5 beats per minute
Standard Deviation 9.78
|
2.4 beats per minute
Standard Deviation 11.14
|
-1.7 beats per minute
Standard Deviation 7.59
|
1.2 beats per minute
Standard Deviation 8.08
|
0.8 beats per minute
Standard Deviation 7.13
|
-0.9 beats per minute
Standard Deviation 8.08
|
|
Change From Baseline in Pulse Rate
Week 8, n=30, 31, 33, 38, 27, 26
|
1.3 beats per minute
Standard Deviation 9.38
|
2.8 beats per minute
Standard Deviation 10.54
|
0.2 beats per minute
Standard Deviation 10.28
|
-0.4 beats per minute
Standard Deviation 8.06
|
0.2 beats per minute
Standard Deviation 8.02
|
-0.9 beats per minute
Standard Deviation 7.59
|
|
Change From Baseline in Pulse Rate
Week 12, n=26, 30, 32, 36, 26, 25
|
0.6 beats per minute
Standard Deviation 9.80
|
1.2 beats per minute
Standard Deviation 11.75
|
2.6 beats per minute
Standard Deviation 8.04
|
0.1 beats per minute
Standard Deviation 9.16
|
1.4 beats per minute
Standard Deviation 8.18
|
-2.2 beats per minute
Standard Deviation 10.18
|
|
Change From Baseline in Pulse Rate
Week 14, n=29, 31, 33, 34, 27, 26
|
-0.1 beats per minute
Standard Deviation 8.48
|
-0.1 beats per minute
Standard Deviation 11.14
|
1.3 beats per minute
Standard Deviation 6.24
|
-0.6 beats per minute
Standard Deviation 8.52
|
0.2 beats per minute
Standard Deviation 9.20
|
-0.8 beats per minute
Standard Deviation 8.27
|
|
Change From Baseline in Pulse Rate
EW, n=10, 7, 4, 2, 10, 9
|
-4.5 beats per minute
Standard Deviation 3.54
|
2.4 beats per minute
Standard Deviation 11.99
|
-2.1 beats per minute
Standard Deviation 7.36
|
-2.2 beats per minute
Standard Deviation 4.54
|
-2.5 beats per minute
Standard Deviation 5.80
|
-2.7 beats per minute
Standard Deviation 9.25
|
SECONDARY outcome
Timeframe: Baseline and up to Week 14Population: Safety Population
Temperature was measured in semi-supine position after at least 5 minutes of rest. 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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=38 Participants
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.
|
Vehicle BID
n=37 Participants
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.
|
Vehicle QD
n=38 Participants
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.
|
GSK2894512 1% BID
n=38 Participants
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.
|
GSK2894512 0.5% BID
n=38 Participants
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.
|
GSK2894512 1% QD
n=38 Participants
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.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Temperature
Week 1, n=36, 38, 37, 38, 35, 37
|
0.07 degree Celsius
Standard Deviation 0.401
|
-0.03 degree Celsius
Standard Deviation 0.548
|
-0.03 degree Celsius
Standard Deviation 0.468
|
0.01 degree Celsius
Standard Deviation 0.356
|
-0.03 degree Celsius
Standard Deviation 0.271
|
-0.00 degree Celsius
Standard Deviation 0.336
|
|
Change From Baseline in Temperature
Week 14, n=29, 31, 33, 34, 27, 26
|
0.11 degree Celsius
Standard Deviation 0.406
|
-0.03 degree Celsius
Standard Deviation 0.522
|
0.00 degree Celsius
Standard Deviation 0.591
|
-0.04 degree Celsius
Standard Deviation 0.372
|
0.01 degree Celsius
Standard Deviation 0.456
|
0.10 degree Celsius
Standard Deviation 0.364
|
|
Change From Baseline in Temperature
Week 2, n=36, 36, 36, 38, 31, 35
|
0.19 degree Celsius
Standard Deviation 0.442
|
-0.17 degree Celsius
Standard Deviation 0.473
|
0.03 degree Celsius
Standard Deviation 0.384
|
0.03 degree Celsius
Standard Deviation 0.395
|
-0.01 degree Celsius
Standard Deviation 0.314
|
-0.01 degree Celsius
Standard Deviation 0.410
|
|
Change From Baseline in Temperature
Week 4, n=31, 34, 35, 38, 29, 31
|
0.07 degree Celsius
Standard Deviation 0.318
|
-0.04 degree Celsius
Standard Deviation 0.405
|
0.03 degree Celsius
Standard Deviation 0.439
|
0.05 degree Celsius
Standard Deviation 0.445
|
0.06 degree Celsius
Standard Deviation 0.333
|
0.11 degree Celsius
Standard Deviation 0.385
|
|
Change From Baseline in Temperature
Week 8, n=29, 31, 32, 38, 27, 26
|
0.17 degree Celsius
Standard Deviation 0.453
|
0.14 degree Celsius
Standard Deviation 0.473
|
0.11 degree Celsius
Standard Deviation 0.473
|
-0.02 degree Celsius
Standard Deviation 0.503
|
0.12 degree Celsius
Standard Deviation 0.345
|
0.17 degree Celsius
Standard Deviation 0.334
|
|
Change From Baseline in Temperature
Week 12, n=26, 30, 32, 36, 26, 25
|
0.18 degree Celsius
Standard Deviation 0.520
|
0.02 degree Celsius
Standard Deviation 0.492
|
0.12 degree Celsius
Standard Deviation 0.561
|
0.02 degree Celsius
Standard Deviation 0.343
|
0.12 degree Celsius
Standard Deviation 0.429
|
0.14 degree Celsius
Standard Deviation 0.423
|
|
Change From Baseline in Temperature
EW, n=10, 7, 4, 2, 10, 9
|
0.25 degree Celsius
Standard Deviation 0.778
|
0.30 degree Celsius
Standard Deviation 0.533
|
-0.27 degree Celsius
Standard Deviation 0.255
|
0.12 degree Celsius
Standard Deviation 0.466
|
0.22 degree Celsius
Standard Deviation 0.330
|
-0.09 degree Celsius
Standard Deviation 0.339
|
SECONDARY outcome
Timeframe: Up to Week 14Population: Safety Population
The vital signs including SBP, DBP and pulse rate were measured from Baseline throughout the study. The number of participants with clinically significant abnormal vital signs were presented. 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).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=38 Participants
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.
|
Vehicle BID
n=37 Participants
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.
|
Vehicle QD
n=38 Participants
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.
|
GSK2894512 1% BID
n=38 Participants
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.
|
GSK2894512 0.5% BID
n=38 Participants
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.
|
GSK2894512 1% QD
n=38 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs of Clinical Importance
DBP, Baseline, n=38, 38, 38, 38, 37, 38
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs of Clinical Importance
Pulse rate, Week 12, n=26, 30, 32, 36, 26, 25
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs of Clinical Importance
SBP, Baseline, n=38, 38, 38, 38, 37, 38
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Vital Signs of Clinical Importance
SBP, Week 1, n=36, 38, 37, 38, 35, 37
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs of Clinical Importance
SBP, Week 2, n=36, 36, 36, 38, 31, 35
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs of Clinical Importance
SBP, Week 4, n=32, 34, 35, 38, 29, 31
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs of Clinical Importance
SBP, Week 8, n=30, 31, 33, 38, 27, 26
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs of Clinical Importance
SBP, Week 12, n=26, 30, 32, 36, 26, 25
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs of Clinical Importance
SBP, Week 14, n=29, 31, 33, 34, 27, 26
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs of Clinical Importance
SBP, EW, n=10, 7, 4, 2, 10, 9
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs of Clinical Importance
SBP, PS, n=n=38, 38, 38, 38, 37, 38
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Vital Signs of Clinical Importance
DBP, Week 1, n=36, 38, 37, 38, 35, 37
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs of Clinical Importance
DBP, Week 2, n=36, 36, 36, 38, 31, 35
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs of Clinical Importance
DBP, Week 4, n=32, 34, 35, 38, 29, 31
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs of Clinical Importance
DBP, Week 8, n=30, 31, 33, 38, 27, 26
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs of Clinical Importance
DBP, Week 12, n=26, 30, 32, 36, 26, 25
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs of Clinical Importance
DBP, Week 14, n=29, 31, 33, 34, 27, 26
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs of Clinical Importance
DBP, EW, n=10, 7, 4, 2, 10, 9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs of Clinical Importance
DBP, PS, n=38, 38, 38, 38, 37, 38
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Vital Signs of Clinical Importance
Pulse rate, Baseline, n=38, 38, 38, 38, 37, 38
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs of Clinical Importance
Pulse rate, Week 1, n=36, 38, 37, 38, 35, 37
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs of Clinical Importance
Pulse rate, Week 2, n=36, 36, 36, 38, 31, 35
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs of Clinical Importance
Pulse rate, Week 4, n=32, 34, 35, 38, 29, 31
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs of Clinical Importance
Pulse rate, Week 8, n=30, 31, 33, 38, 27, 26
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs of Clinical Importance
Pulse rate, Week 14, n=29, 31, 33, 34, 27, 26
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs of Clinical Importance
Pulse rate, EW, n=10, 7, 4, 2, 10, 9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs of Clinical Importance
Pulse rate, PS, n=38, 38, 38, 38, 37, 38
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Week 14Population: Safety Population
Single 12-lead ECGs were obtained over a brief recording period at each specified time point during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. For multiple ECGs at one visit, or "Any time post-screen", a participant is categorized as "Abnormal" if \>=1 assessment is abnormal. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Outcome measures
| Measure |
GSK2894512 0.5% QD
n=38 Participants
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.
|
Vehicle BID
n=37 Participants
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.
|
Vehicle QD
n=38 Participants
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.
|
GSK2894512 1% BID
n=38 Participants
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.
|
GSK2894512 0.5% BID
n=38 Participants
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.
|
GSK2894512 1% QD
n=38 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Baseline, n=38, 38, 38, 38, 37, 38
|
4 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
6 Participants
|
8 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
PS, n=38, 38, 38, 38, 36, 37
|
7 Participants
|
7 Participants
|
7 Participants
|
7 Participants
|
10 Participants
|
11 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Week 1, n=36, 38, 37, 37, 34, 37
|
4 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
7 Participants
|
8 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Week 12, n=26, 30, 32, 36, 26, 25
|
4 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Week 14, n=29, 31, 33, 34, 27, 25
|
5 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
10 Participants
|
5 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
EW, n=10, 6, 4, 2, 10, 9
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
Adverse Events
GSK2894512 1% BID
GSK2894512 1% QD
GSK2894512 0.5% BID
GSK2894512 0.5% QD
Vehicle BID
Vehicle QD
Serious adverse events
| Measure |
GSK2894512 1% BID
n=38 participants at risk
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.
|
GSK2894512 1% QD
n=38 participants at risk
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.
|
GSK2894512 0.5% BID
n=38 participants at risk
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.
|
GSK2894512 0.5% QD
n=38 participants at risk
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.
|
Vehicle BID
n=37 participants at risk
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.
|
Vehicle QD
n=38 participants at risk
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.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
2.6%
1/38 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
2.6%
1/38 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
2.6%
1/38 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
2.6%
1/38 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Enlarged uvula
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
2.6%
1/38 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
|
Blood and lymphatic system disorders
Hemolytic uremic syndrome
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
2.6%
1/38 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
2.6%
1/38 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
2.6%
1/38 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
Other adverse events
| Measure |
GSK2894512 1% BID
n=38 participants at risk
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.
|
GSK2894512 1% QD
n=38 participants at risk
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.
|
GSK2894512 0.5% BID
n=38 participants at risk
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.
|
GSK2894512 0.5% QD
n=38 participants at risk
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.
|
Vehicle BID
n=37 participants at risk
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.
|
Vehicle QD
n=38 participants at risk
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.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
7.9%
3/38 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
2.7%
1/37 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
|
General disorders
Application site dermatitis
|
2.6%
1/38 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
5.3%
2/38 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
|
Infections and infestations
Folliculitis
|
21.1%
8/38 • Number of events 8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
5.3%
2/38 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
10.5%
4/38 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
13.2%
5/38 • Number of events 5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
2.7%
1/37 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
|
Infections and infestations
Nasopharyngitis
|
2.6%
1/38 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
10.5%
4/38 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
5.3%
2/38 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
5.3%
2/38 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
|
Nervous system disorders
Headache
|
10.5%
4/38 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
2.6%
1/38 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
2.6%
1/38 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
2.7%
1/37 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
2.6%
1/38 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.3%
2/38 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
2.6%
1/38 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
5.3%
2/38 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
10.5%
4/38 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
10.5%
4/38 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
2.6%
1/38 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
7.9%
3/38 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
5.3%
2/38 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
2.6%
1/38 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
5.3%
2/38 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER