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A Study of GSK2981278 Ointment in Subjects With Plaque Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03004846
Recruitment Status : Completed
First Posted : December 29, 2016
Results First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Drug: GSK2981278 ointment
Drug: Vehicle ointment
Enrollment 8
Recruitment Details Participants with chronic stable plaque psoriasis were recruited in this 2 part study to evaluate safety, tolerability and clinical effect of GSK2981278.
Pre-assignment Details A total of 10 participants were screened; of which two were screen failures and eight were included in the treatment phase of Part A and received GSK2981278 4% ointment for 8 weeks. Part B of this study was not conducted as pre-defined efficacy criteria for continuing to Part B were not met. Hence no participants were enrolled in Part B.
Arm/Group Title GSK2981278 4%: Part A GSK2981278 4%: Part B Vehicle Ointment: Part B
Hide Arm/Group Description Participants received 4% ointment of GSK2981278 twice daily for 8 weeks. Randomized participants were planned to receive 4% ointment of GSK2981278 twice daily for 8 weeks. Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
Period Title: Part A (Up to 14 Weeks)
Started 8 0 0
Completed 8 0 0
Not Completed 0 0 0
Period Title: Part B (Up to 14 Weeks)
Started 0 0 0
Completed 0 0 0
Not Completed 0 0 0
Arm/Group Title GSK2981278 4%: Part A GSK2981278 4%: Part B Vehicle Ointment: Part B Total
Hide Arm/Group Description Participants received 4% ointment of GSK2981278 twice daily for 8 weeks. Randomized participants were planned to receive 4% ointment of GSK2981278 twice daily for 8 weeks. Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks. Total of all reporting groups
Overall Number of Baseline Participants 8 0 0 8
Hide Baseline Analysis Population Description
Part B of this study was not conducted as pre-defined efficacy criteria for continuing to Part B were not met. Hence no participants were enrolled in Part B.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 0 participants 0 participants 8 participants
54.9  (9.43) 54.9  (9.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 0 participants 0 participants 8 participants
Female
0
   0.0%
0
   0.0%
Male
8
 100.0%
8
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White - White/Caucasian/European heritage Number Analyzed 8 participants 0 participants 0 participants 8 participants
8
 100.0%
8
 100.0%
1.Primary Outcome
Title Number of Participants With On-treatment Serious Adverse Events (SAEs) and Non-SAEs: Part A
Hide Description An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function. The analysis was performed on Safety analysis Population which comprised of all participants exposed to at least 1 application of study medication.
Time Frame Up to Day 57
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Hide Analysis Population Description
Safety analysis Population
Arm/Group Title GSK2981278 4%: Part A
Hide Arm/Group Description:
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: Participants
non-SAEs 1
SAEs 0
2.Primary Outcome
Title Number of Participants With Application Site Tolerability Assessment Score During Treatment Period: Part A
Hide Description The investigator assessed application site tolerability focusing on the treated non-lesional skin surrounding the plaques at each visit using the 5-point tolerability assessment scale ranging from 0 (no intolerance) to 4 (very severe intolerance). Number of participants in the corresponding score at Day 1, 15, 29 and 57 has been presented.
Time Frame Day 1, Day 15, Day 29, Day 57
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Safety analysis Population
Arm/Group Title GSK2981278 4%: Part A
Hide Arm/Group Description:
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: Participants
Day 1; Grade 0 8
Day 1; Grade 1 0
Day 1; Grade 2 0
Day 1; Grade 3 0
Day 1; Grade 4 0
Day 15; Grade 0 8
Day 15; Grade 1 0
Day 15; Grade 2 0
Day 15; Grade 3 0
Day 15; Grade 4 0
Day 29; Grade 0 8
Day 29; Grade 1 0
Day 29; Grade 2 0
Day 29; Grade 3 0
Day 29; Grade 4 0
Day 57; Grade 0 8
Day 57; Grade 1 0
Day 57; Grade 2 0
Day 57; Grade 3 0
Day 57; Grade 4 0
3.Primary Outcome
Title Number of Participants With Negative Urinalysis Results: Part A
Hide Description Urine samples were collected from participants to evaluate urinalysis parameters including glucose, protein, erythrocytes and ketones. Number of participants with negative or normal urinalysis results at Day 15, Day 29 and Day 57 are presented. Last observation values collected prior to the first application of study treatment were considered as Baseline values.
Time Frame Up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis Population
Arm/Group Title GSK2981278 4%: Part A
Hide Arm/Group Description:
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: Participants
Glucose; Baseline 8
Glucose; Day 15 8
Glucose; Day 29 8
Glucose; Day 57 8
Protein; Baseline 8
Protein; Day 15 8
Protein; Day 29 8
Protein; Day 57 8
Erythrocytes; Baseline 8
Erythrocytes; Day 15 8
Erythrocytes; Day 29 8
Erythrocytes; Day 57 8
Ketones; Baseline 8
Ketones; Day 15 8
Ketones; Day 29 8
Ketones; Day 57 8
4.Primary Outcome
Title Change From Baseline in Potential of Hydrogen (pH) of Urine: Part A
Hide Description The pH scale measures how acidic or basic a substance is. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic. Urine samples were collected from participants and urine pH levels were assessed at Baseline, Day 15, Day 29 and Day 57. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
Time Frame Baseline and up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis Population
Arm/Group Title GSK2981278 4%: Part A
Hide Arm/Group Description:
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Day 15 0.1  (0.83)
Day 29 -0.1  (0.35)
Day 57 -0.1  (0.35)
5.Primary Outcome
Title Change From Baseline in Specific Gravity of Urine: Part A
Hide Description Urine samples were collected from participants and specific gravity levels were assessed at Baseline, Day 15, Day 29 and Day 57. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
Time Frame Baseline and up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis Population
Arm/Group Title GSK2981278 4%: Part A
Hide Arm/Group Description:
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Ratio
Day 15 0.0019  (0.00799)
Day 29 0.0019  (0.00530)
Day 57 0.0025  (0.00707)
6.Primary Outcome
Title Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Potassium, Sodium and Calcium Levels: Part A
Hide Description Blood samples were collected from participants to evaluate clinical chemistry parameters including BUN, glucose, potassium, sodium and calcium. Change from Baseline in clinical chemistry parameters at Day 15, Day 29 and Day 57 are presented. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
Time Frame Baseline and up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis Population
Arm/Group Title GSK2981278 4%: Part A
Hide Arm/Group Description:
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter (Mmol/L)
BUN; Day 15 -0.2678  (1.23300)
BUN; Day 29 -0.3570  (0.42670)
BUN; Day 57 0.4909  (1.40146)
Glucose; Day 15 0.041632  (0.7296677)
Glucose; Day 29 0.104081  (0.7258495)
Glucose; Day 57 0.298366  (0.4163911)
Potassium; Day 15 -0.14  (0.272)
Potassium; Day 29 0.00  (0.312)
Potassium; Day 57 0.13  (0.328)
Sodium; Day 15 -1.1  (2.17)
Sodium; Day 29 0.8  (2.25)
Sodium; Day 57 -0.4  (1.06)
Calcium; Day 15 0.021  (0.0624)
Calcium; Day 29 0.038  (0.0765)
Calcium; Day 57 -0.013  (0.0886)
7.Primary Outcome
Title Change From Baseline in Creatinine, Total and Direct Bilirubin Levels: Part A
Hide Description Blood samples were collected from participants to evaluate clinical chemistry parameters including creatinine, total and direct bilirubin. Change from Baseline in clinical chemistry parameters at Day 15, Day 29 and Day 57 are presented. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
Time Frame Baseline and up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis Population
Arm/Group Title GSK2981278 4%: Part A
Hide Arm/Group Description:
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Micromoles per liter (µmol/L)
Creatinine; Day 15 -5.8565  (2.16212)
Creatinine; Day 29 -3.8675  (6.32075)
Creatinine; Day 57 -3.7570  (6.92444)
Total bilirubin; Day 15 1.425  (2.7396)
Total bilirubin; Day 29 1.995  (2.5171)
Total bilirubin; Day 57 -0.342  (1.4307)
Direct bilirubin; Day 15 0.3705  (0.66154)
Direct bilirubin; Day 29 0.3990  (0.79963)
Direct bilirubin; Day 57 0.0000  (0.52706)
8.Primary Outcome
Title Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase Levels: Part A
Hide Description Blood samples were collected from participants to evaluate clinical chemistry parameters including AST, ALT and alkaline phosphatase. Change from Baseline in clinical chemistry parameters at Day 15, Day 29 and Day 57 are presented. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
Time Frame Baseline and up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis Population
Arm/Group Title GSK2981278 4%: Part A
Hide Arm/Group Description:
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: International unit per liter (IU/L)
AST; Day 15 1.3  (4.43)
AST; Day 29 -0.3  (2.92)
AST; Day 57 -0.3  (6.23)
ALT; Day 15 2.8  (8.75)
ALT; Day 29 0.6  (5.26)
ALT; Day 57 2.0  (8.59)
Alkaline phosphatase; Day 15 2.1  (5.87)
Alkaline phosphatase; Day 29 2.9  (12.89)
Alkaline phosphatase; Day 57 -0.8  (11.80)
9.Primary Outcome
Title Change From Baseline in Protein and Albumin Levels: Part A
Hide Description Blood samples were collected from participants to evaluate clinical chemistry parameters including protein and albumin. Change from Baseline in clinical chemistry parameters at Day 15, Day 29 and Day 57 are presented. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
Time Frame Baseline and up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis Population
Arm/Group Title GSK2981278 4%: Part A
Hide Arm/Group Description:
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Grams per liter (g/L)
Protein; Day 15 1.9  (2.90)
Protein; Day 29 -1.4  (2.83)
Protein; Day 57 1.8  (3.65)
Albumin; Day 15 1.4  (1.92)
Albumin; Day 29 1.3  (1.67)
Albumin; Day 57 1.0  (2.56)
10.Primary Outcome
Title Change From Baseline in Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Levels: Part A
Hide Description Blood samples were collected from participants to evaluate clinical hematology parameters including platelets, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Change from Baseline in clinical hematology parameters at Day 15, Day 29 and Day 57 are presented. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
Time Frame Baseline and up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis Population
Arm/Group Title GSK2981278 4%:Part A
Hide Arm/Group Description:
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/L
Platelet; Day 15 -3.6  (50.90)
Platelet; Day 29 -1.0  (28.98)
Platelet; Day 57 0.1  (25.31)
Leukocytes; Day 15 0.76  (2.745)
Leukocytes; Day 29 0.42  (0.910)
Leukocytes; Day 57 0.35  (0.780)
Neutrophils; Day 15 0.695  (2.7477)
Neutrophils; Day 29 0.144  (1.1659)
Neutrophils; Day 57 0.217  (0.4432)
Lymphocytes; Day 15 -0.019  (0.6335)
Lymphocytes; Day 29 0.243  (0.4457)
Lymphocytes; Day 57 0.151  (0.3756)
Monocytes; Day 15 0.090  (0.2778)
Monocytes; Day 29 -0.040  (0.2099)
Monocytes; Day 57 -0.063  (0.2344)
Eosinophils; Day 15 0.019  (0.1579)
Eosinophils; Day 29 0.085  (0.1321)
Eosinophils; Day 57 0.029  (0.0825)
Basophils; Day 15 -0.008  (0.0287)
Basophils; Day 29 0.001  (0.0264)
Basophils; Day 57 0.004  (0.0151)
11.Primary Outcome
Title Change From Baseline in Erythrocyte Levels: Part A
Hide Description Blood samples were collected from participants to evaluate clinical hematology parameters including erythrocytes. Change from Baseline in clinical hematology parameters at Day 15, Day 29 and Day 57 are presented. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
Time Frame Baseline and up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis Population
Arm/Group Title GSK2981278 4%: Part A
Hide Arm/Group Description:
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: 10^12 cells/L
Day 15 0.013  (0.2042)
Day 29 0.055  (0.2555)
Day 57 0.061  (0.2785)
12.Primary Outcome
Title Change From Baseline in Hemoglobin Levels: Part A
Hide Description Blood samples were collected from participants to evaluate clinical hematology parameters including hemoglobin. Change from Baseline in clinical hematology parameters at Day 15, Day 29 and Day 57 are presented. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
Time Frame Baseline and up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis Population
Arm/Group Title GSK2981278 4%: Part A
Hide Arm/Group Description:
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: g/L
Day 15 1.3  (6.18)
Day 29 2.6  (7.63)
Day 57 1.5  (9.18)
13.Primary Outcome
Title Change From Baseline in Hematocrit Levels: Part A
Hide Description Blood samples were collected from participants to evaluate clinical hematology parameters including hematocrit. Change from Baseline in clinical hematology parameters at Day 15, Day 29 and Day 57 are presented. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
Time Frame Baseline and up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis Population
Arm/Group Title GSK2981278 4%: Part A
Hide Arm/Group Description:
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Proportion of Red blood cells in blood
Day 15 0.0040  (0.01752)
Day 29 0.0090  (0.02203)
Day 57 0.0076  (0.02628)
14.Primary Outcome
Title Change From Baseline in Mean Corpuscular Volume (MCV) Levels: Part A
Hide Description Blood samples were collected from participants to evaluate clinical hematology parameters including MCV. Change from Baseline in clinical hematology parameters at Day 15, Day 29 and Day 57 are presented. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
Time Frame Baseline and up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis Population
Arm/Group Title GSK2981278 4%: Part A
Hide Arm/Group Description:
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Femtoliter (fL)
Day 15 0.46  (1.235)
Day 29 0.86  (1.112)
Day 57 0.34  (1.172)
15.Primary Outcome
Title Change From Baseline in Mean Corpuscular Hemoglobin (MCH) Levels: Part A
Hide Description Blood samples were collected from participants to evaluate clinical hematology parameters including MCH. Change from Baseline in clinical hematology parameters at Day 15, Day 29 and Day 57 are presented. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
Time Frame Baseline and up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis Population
Arm/Group Title GSK2981278 4%: Part A
Hide Arm/Group Description:
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Picograms (Pg)
Day 15 0.16  (0.325)
Day 29 0.21  (0.253)
Day 57 -0.06  (0.421)
16.Primary Outcome
Title Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels: Part A
Hide Description Vital sign measurements including SBP and DBP were taken in a seated or supine position after 5-minutes of rest. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
Time Frame Baseline and up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis Population
Arm/Group Title GSK2981278 4%: Part A
Hide Arm/Group Description:
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury (mmHg)
SBP; Day 15 -1.9  (4.58)
SBP; Day 29 -2.5  (4.63)
SBP; Day 57 -2.5  (2.67)
DBP; Day 15 0.0  (2.67)
DBP; Day 29 1.3  (4.43)
DBP: Day 57 0.6  (4.17)
17.Primary Outcome
Title Change From Baseline in Pulse Rate Levels: Part A
Hide Description Vital sign measurements including pulse rate were taken in a seated or supine position after 5-minutes of rest. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
Time Frame Baseline and up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis Population
Arm/Group Title GSK2981278 4%: Part A
Hide Arm/Group Description:
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Beats per minute
Day 15 3.3  (9.19)
Day 29 0.3  (12.21)
Day 57 1.3  (11.36)
18.Primary Outcome
Title Change From Baseline in Electrocardiogram (ECG) Parameters Including Single RR Heart Rate: Part A
Hide Description Single measurements of 12-lead ECG were obtained using an ECG machine to measure RR heart rate. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value
Time Frame Baseline and up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis Population
Arm/Group Title GSK2981278 4%: Part A
Hide Arm/Group Description:
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Beats per minute
Day 29 -2.5  (16.81)
Day 57 -3.5  (12.42)
19.Primary Outcome
Title Change From Baseline in ECG Parameters Including PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett’s Formula (QTcB) and RR Interval: Part A
Hide Description Single measurements of 12-lead ECG were obtained using an ECG machine to measure PR interval, QRS duration, QT interval, QTcB and RR interval. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value
Time Frame Baseline and up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis Population
Arm/Group Title GSK2981278 4%: Part A
Hide Arm/Group Description:
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Milliseconds (msec)
PR interval; Day 29 -0.5  (9.78)
PR interval; Day 57 7.3  (12.78)
QRS duration; Day 29 -0.5  (4.24)
QRS duration; Day 57 -0.3  (2.92)
QT interval; Day 29 12.8  (28.88)
QT interval; Day 57 9.0  (28.57)
QTcB interval; Day 29 10.0  (15.62)
QTcB interval; Day 57 3.5  (15.96)
RR interval; Day 29 9.5  (170.62)
RR interval; Day 57 13.0  (124.12)
20.Primary Outcome
Title Plasma Concentration of GSK2981278 at Nominal Time: Part A
Hide Description Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK2981278. Non-quantifiable values in a profile occurring before the first measurable concentration were assigned a value of zero concentration. Single non-quantifiable values occurring between measurable concentrations in a profile were omitted. The analysis was performed on PK analysis Population which comprised of participants with at least one sample collected and analyzed for plasma drug concentration. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Pre-dose, 1, 2, 4, 6, 8, 10 hours post-dose on Day 1, Day 29 and Day 57; Pre-dose, 2 hours post-dose on Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis Population
Arm/Group Title GSK2981278 4%: Part A
Hide Arm/Group Description:
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Picograms per milliliter (Pg/mL)
Pre-dose; Day 1; n= 8 Number Analyzed 8 participants
0.00  (0.000)
1 hour post-dose; Day 1; n= 8 Number Analyzed 8 participants
151.89  (210.535)
2 hours post-dose; Day 1; n= 8 Number Analyzed 8 participants
281.54  (589.927)
4 hours post-dose; Day 1; n= 8 Number Analyzed 8 participants
171.38  (160.357)
6 hours post-dose; Day 1; n= 8 Number Analyzed 8 participants
610.73  (1141.415)
8 hours post-dose; Day 1; n= 8 Number Analyzed 8 participants
192.06  (168.443)
10 hours post-dose; Day 1; n= 8 Number Analyzed 8 participants
554.94  (828.825)
Pre-dose; Day 15; n= 7 Number Analyzed 7 participants
1203.71  (1203.796)
2 hours post-dose; Day 15; n= 8 Number Analyzed 8 participants
893.00  (737.610)
Pre-dose; Day 29; n= 8 Number Analyzed 8 participants
1122.00  (587.760)
1 hour post-dose; Day 29; n= 8 Number Analyzed 8 participants
1299.63  (910.793)
2 hours post-dose; Day 29; n= 8 Number Analyzed 8 participants
1062.38  (662.050)
4 hours post-dose; Day 29; n= 8 Number Analyzed 8 participants
769.38  (369.861)
6 hours post-dose; Day 29; n= 8 Number Analyzed 8 participants
1022.63  (720.269)
8 hours post-dose; Day 29; n= 7 Number Analyzed 7 participants
897.71  (325.169)
10 hours post-dose; Day 29; n= 8 Number Analyzed 8 participants
875.38  (584.879)
Pre-dose; Day 57; n= 8 Number Analyzed 8 participants
875.75  (707.446)
1 hour post-dose; Day 57; n= 8 Number Analyzed 8 participants
1273.75  (784.902)
2 hours post-dose; Day 57; n= 8 Number Analyzed 8 participants
1077.00  (1128.070)
4 hours post-dose; Day 57; n= 8 Number Analyzed 8 participants
758.13  (494.661)
6 hours post-dose; Day 57; n= 8 Number Analyzed 8 participants
760.38  (550.695)
8 hours post-dose; Day 57; n= 8 Number Analyzed 8 participants
809.13  (373.947)
10 hours post-dose; Day 57; n= 8 Number Analyzed 8 participants
841.25  (579.772)
21.Primary Outcome
Title Number of Participants With SAEs and Non-SAEs: Part B
Hide Description An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function. The analysis was performed on Safety analysis set Population which comprised of all participants exposed to at least 1 application of study medication. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Time Frame Up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population. . Data was not collected for Part B as no Participants were enrolled into this part of the study.
Arm/Group Title GSK2981278 4%: Part B Vehicle Ointment: Part B
Hide Arm/Group Description:
Randomized participants were planned to receive 4% ointment of GSK2981278 twice daily for 8 weeks.
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
22.Primary Outcome
Title Number of Participants With Application Site Tolerability Assessment Score During Treatment Period: Part B
Hide Description The investigator planned to assess application site tolerability focusing on the treated non-lesional skin surrounding the plaques at each visit using the 5-point tolerability assessment scale ranging from 0 (no intolerance) to 4 (very severe intolerance). Number of participants with Application site tolerability assessment score were planned to be analyzed. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Time Frame Up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis Population. Data was not collected for Part B as no Participants were enrolled into this part of the study.
Arm/Group Title GSK2981278 4%: Part B Vehicle Ointment: Part B
Hide Arm/Group Description:
Randomized participants were planned to receive 4% ointment of GSK2981278 twice daily for 8 weeks.
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
23.Primary Outcome
Title Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline: Part B
Hide Description Blood samples were planned to be collected for evaluation of clinical chemistry parameters. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as by subtracting post-Baseline visit values minus Baseline value. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Time Frame Baseline and up to Week 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis Population. Data was not collected for Part B as no Participants were enrolled into this part of the study.
Arm/Group Title GSK2981278 4%: Part B Vehicle Ointment: Part B
Hide Arm/Group Description:
Randomized participants were planned to receive 4% ointment of GSK2981278 twice daily for 8 weeks.
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
24.Primary Outcome
Title Number of Participants With Change in Hematology Toxicity Grade From Baseline: Part B
Hide Description Blood samples were planned to be collected for the analysis of hematology parameters. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Time Frame Baseline and up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis Population. Data was not collected for Part B as no Participants were enrolled into this part of the study.
Arm/Group Title GSK2981278 4%: Part B Vehicle Ointment: Part B
Hide Arm/Group Description:
Randomized participants were planned to receive 4% ointment of GSK2981278 twice daily for 8 weeks.
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
25.Primary Outcome
Title Number of Participants With Critical Changes in Values of Vital Signs in Response to Drug: Part B
Hide Description Vital sign measurement includes SBP, DBP, temperature, pulse rate. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Time Frame Up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis Population. Data was not collected for Part B as no Participants were enrolled into this part of the study.
Arm/Group Title GSK2981278 4%: Part B Vehicle Ointment: Part B
Hide Arm/Group Description:
Randomized participants were planned to receive 4% ointment of GSK2981278 twice daily for 8 weeks.
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
26.Primary Outcome
Title Number of Participants With Abnormal Findings for ECG Parameters: Part B
Hide Description Single measurements of 12-lead ECGs were planned to be obtained using an ECG machine. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Time Frame Up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis Population. Data was not collected for Part B as no Participants were enrolled into this part of the study.
Arm/Group Title GSK2981278 4%: Part B Vehicle Ointment: Part B
Hide Arm/Group Description:
Randomized participants were planned to receive 4% ointment of GSK2981278 twice daily for 8 weeks.
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
27.Primary Outcome
Title Mean Percent Change in TPSS From Baseline to Week 8: Part B
Hide Description The TPSS is the measure of clinical effect of GSK2981278. TPSS Total score was calculated by adding the individual scores of erythema, scaling, and induration (plaque thickness), assessed by the investigator on a 5-point scale ranging from 0=none to 4=very marked. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Time Frame Baseline and up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PP analysis Population. Data was not collected for Part B as no Participants were enrolled into this part of the study.
Arm/Group Title GSK2981278 4%: Part B Vehicle Ointment: Part B
Hide Arm/Group Description:
Randomized participants were planned to receive 4% ointment of GSK2981278 twice daily for 8 weeks.
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
28.Primary Outcome
Title Mean Percent Change in PGA Score From Baseline to Week 8: Part B
Hide Description The PGA is a clinical tool for assessing the current state/severity of a participant’s psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. The 5-point scale ranges from 0=clear to 4=severe. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as by subtracting post-Baseline visit values minus Baseline value. Percent change from Baseline was calculated by dividing change from baseline value by Baseline value and multiplying it by 100. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Time Frame Baseline and up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PP analysis Population. Data was not collected for Part B as no Participants were enrolled into this part of the study.
Arm/Group Title GSK2981278 4%: Part B Vehicle Ointment: Part B
Hide Arm/Group Description:
Randomized participants were planned to receive 4% ointment of GSK2981278 twice daily for 8 weeks.
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
29.Primary Outcome
Title Mean Percent Change in PASI From Baseline to Week 8: Part B
Hide Description The PASI is a standard tool for assessing the severity of psoriasis that considers the overall severity of erythema, thickness, and scale, and the extent of body surface area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0=none to 4=severe) and the percent BSA affected is scored on a 7-point scale (0= 0% skin with psoriasis to 6=>=90% skin with psoriasis). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. Higher scores indicate more severe disease. Last observation values collected were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Percent change from Baseline was calculated by dividing change from baseline value by Baseline value and multiplying it by 100. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Time Frame Baseline and up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PP analysis Population. Data was not collected for Part B as no Participants were enrolled into this part of the study.
Arm/Group Title GSK2981278 4%: Part B Vehicle Ointment: Part B
Hide Arm/Group Description:
Randomized participants were planned to receive 4% ointment of GSK2981278 twice daily for 8 weeks.
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
30.Secondary Outcome
Title Mean Percent Change From Baseline in Target Plaque Severity Score (TPSS): Part A
Hide Description The TPSS is the measure of clinical effect of GSK2981278. A target lesion of at least 9 centimeter square (cm^2) with a TPSS >=5 and an induration sub score >=2 was selected at Baseline. TPSS Total score was calculated by adding the individual scores of erythema, scaling, and induration (plaque thickness), assessed by the investigator on a 5-point scale ranging from 0=none to 4=very marked. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100. The analysis was performed on per protocol (PP) analysis Population which comprised of all participants eligible for treatment phase and who comply closely with the protocol.
Time Frame Baseline and up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PP analysis Population
Arm/Group Title GSK2981278 4%: Part A
Hide Arm/Group Description:
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Percent change
Day 15 -6.5  (7.24)
Day 29 -3.0  (5.74)
Day 57 -4.3  (10.61)
31.Secondary Outcome
Title Mean Percent Change From Baseline in Physician’s Global Assessment (PGA) Score: Part A
Hide Description The PGA is a clinical tool for assessing the current state/severity of a participant’s psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. The 5-point scale ranges from 0=clear to 4=severe. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Percent change from Baseline was calculated by dividing change from baseline value by Baseline value and multiplying it by 100.
Time Frame Baseline and up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PP analysis Population
Arm/Group Title GSK2981278 4%: Part A
Hide Arm/Group Description:
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Percent change
Day 15 -3.1  (8.84)
Day 29 -3.1  (8.84)
Day 57 0.0  (0.0)
32.Secondary Outcome
Title Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score: Part A
Hide Description The PASI is a standard tool for assessing the severity of psoriasis that considers the overall severity of erythema, thickness, and scale, as well as the extent of body surface area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0=none to 4=severe) and the percent BSA affected is scored on a 7-point scale (0= 0% skin with psoriasis to 6=>=90% skin with psoriasis) for each of the 4 specified body regions. The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. Higher scores indicate more severe disease. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Time Frame Baseline and up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PP analysis Population
Arm/Group Title GSK2981278 4%: Part A
Hide Arm/Group Description:
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Percent change
Day 15 -3.98  (10.459)
Day 29 -0.27  (4.058)
Day 57 4.26  (7.119)
Time Frame On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Day 57.
Adverse Event Reporting Description On-therapy SAEs and non-serious AEs are reported for members of the Safety analysis Population. Data was not collected for Part B because no Participants were enrolled into this part of the study.
 
Arm/Group Title GSK2981278 4%: Part A GSK2981278 4%: Part B Vehicle Ointment: Part B
Hide Arm/Group Description Participants received 4% ointment of GSK2981278 twice daily for 8 weeks. Randomized participants were planned to receive 4% ointment of GSK2981278 twice daily for 8 weeks. Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
All-Cause Mortality
GSK2981278 4%: Part A GSK2981278 4%: Part B Vehicle Ointment: Part B
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/0   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
GSK2981278 4%: Part A GSK2981278 4%: Part B Vehicle Ointment: Part B
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
GSK2981278 4%: Part A GSK2981278 4%: Part B Vehicle Ointment: Part B
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/8 (12.50%)   0/0   0/0 
Infections and infestations       
COMMON COLD  1  1/8 (12.50%)  0/0  0/0 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03004846     History of Changes
Other Study ID Numbers: 203820
2016-002671-10 ( EudraCT Number )
First Submitted: December 2, 2016
First Posted: December 29, 2016
Results First Submitted: April 3, 2018
Results First Posted: April 18, 2019
Last Update Posted: April 18, 2019