Trial Outcomes & Findings for A Study of GSK2981278 Ointment in Subjects With Plaque Psoriasis (NCT NCT03004846)
NCT ID: NCT03004846
Last Updated: 2019-04-18
Results Overview
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.
COMPLETED
PHASE1/PHASE2
8 participants
Up to Day 57
2019-04-18
Participant Flow
Participants with chronic stable plaque psoriasis were recruited in this 2 part study to evaluate safety, tolerability and clinical effect of GSK2981278.
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.
Participant milestones
| Measure |
GSK2981278 4%: Part A
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
|
GSK2981278 4%: Part B
Randomized participants were planned to receive 4% ointment of GSK2981278 twice daily for 8 weeks.
|
Vehicle Ointment: Part B
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
|
|---|---|---|---|
|
Part A (Up to 14 Weeks)
STARTED
|
8
|
0
|
0
|
|
Part A (Up to 14 Weeks)
COMPLETED
|
8
|
0
|
0
|
|
Part A (Up to 14 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
|
Part B (Up to 14 Weeks)
STARTED
|
0
|
0
|
0
|
|
Part B (Up to 14 Weeks)
COMPLETED
|
0
|
0
|
0
|
|
Part B (Up to 14 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of GSK2981278 Ointment in Subjects With Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
GSK2981278 4%: Part A
n=8 Participants
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
|
GSK2981278 4%: Part B
Randomized participants were planned to receive 4% ointment of GSK2981278 twice daily for 8 weeks.
|
Vehicle Ointment: Part B
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.9 Years
STANDARD_DEVIATION 9.43 • n=93 Participants
|
—
|
—
|
54.9 Years
STANDARD_DEVIATION 9.43 • n=483 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
—
|
—
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
—
|
—
|
8 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European heritage
|
8 Participants
n=93 Participants
|
—
|
—
|
8 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Up to Day 57Population: Safety analysis Population
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.
Outcome measures
| Measure |
GSK2981278 4%: Part A
n=8 Participants
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
|
Vehicle Ointment: Part B
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
|
|---|---|---|
|
Number of Participants With On-treatment Serious Adverse Events (SAEs) and Non-SAEs: Part A
non-SAEs
|
1 Participants
|
—
|
|
Number of Participants With On-treatment Serious Adverse Events (SAEs) and Non-SAEs: Part A
SAEs
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 1, Day 15, Day 29, Day 57Population: Safety analysis Population
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.
Outcome measures
| Measure |
GSK2981278 4%: Part A
n=8 Participants
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
|
Vehicle Ointment: Part B
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
|
|---|---|---|
|
Number of Participants With Application Site Tolerability Assessment Score During Treatment Period: Part A
Day 1; Grade 0
|
8 Participants
|
—
|
|
Number of Participants With Application Site Tolerability Assessment Score During Treatment Period: Part A
Day 1; Grade 1
|
0 Participants
|
—
|
|
Number of Participants With Application Site Tolerability Assessment Score During Treatment Period: Part A
Day 1; Grade 2
|
0 Participants
|
—
|
|
Number of Participants With Application Site Tolerability Assessment Score During Treatment Period: Part A
Day 1; Grade 3
|
0 Participants
|
—
|
|
Number of Participants With Application Site Tolerability Assessment Score During Treatment Period: Part A
Day 1; Grade 4
|
0 Participants
|
—
|
|
Number of Participants With Application Site Tolerability Assessment Score During Treatment Period: Part A
Day 15; Grade 0
|
8 Participants
|
—
|
|
Number of Participants With Application Site Tolerability Assessment Score During Treatment Period: Part A
Day 15; Grade 1
|
0 Participants
|
—
|
|
Number of Participants With Application Site Tolerability Assessment Score During Treatment Period: Part A
Day 15; Grade 2
|
0 Participants
|
—
|
|
Number of Participants With Application Site Tolerability Assessment Score During Treatment Period: Part A
Day 15; Grade 3
|
0 Participants
|
—
|
|
Number of Participants With Application Site Tolerability Assessment Score During Treatment Period: Part A
Day 15; Grade 4
|
0 Participants
|
—
|
|
Number of Participants With Application Site Tolerability Assessment Score During Treatment Period: Part A
Day 29; Grade 0
|
8 Participants
|
—
|
|
Number of Participants With Application Site Tolerability Assessment Score During Treatment Period: Part A
Day 29; Grade 1
|
0 Participants
|
—
|
|
Number of Participants With Application Site Tolerability Assessment Score During Treatment Period: Part A
Day 29; Grade 2
|
0 Participants
|
—
|
|
Number of Participants With Application Site Tolerability Assessment Score During Treatment Period: Part A
Day 29; Grade 3
|
0 Participants
|
—
|
|
Number of Participants With Application Site Tolerability Assessment Score During Treatment Period: Part A
Day 29; Grade 4
|
0 Participants
|
—
|
|
Number of Participants With Application Site Tolerability Assessment Score During Treatment Period: Part A
Day 57; Grade 0
|
8 Participants
|
—
|
|
Number of Participants With Application Site Tolerability Assessment Score During Treatment Period: Part A
Day 57; Grade 1
|
0 Participants
|
—
|
|
Number of Participants With Application Site Tolerability Assessment Score During Treatment Period: Part A
Day 57; Grade 2
|
0 Participants
|
—
|
|
Number of Participants With Application Site Tolerability Assessment Score During Treatment Period: Part A
Day 57; Grade 3
|
0 Participants
|
—
|
|
Number of Participants With Application Site Tolerability Assessment Score During Treatment Period: Part A
Day 57; Grade 4
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to Day 57Population: Safety analysis Population
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.
Outcome measures
| Measure |
GSK2981278 4%: Part A
n=8 Participants
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
|
Vehicle Ointment: Part B
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
|
|---|---|---|
|
Number of Participants With Negative Urinalysis Results: Part A
Glucose; Baseline
|
8 Participants
|
—
|
|
Number of Participants With Negative Urinalysis Results: Part A
Glucose; Day 15
|
8 Participants
|
—
|
|
Number of Participants With Negative Urinalysis Results: Part A
Glucose; Day 29
|
8 Participants
|
—
|
|
Number of Participants With Negative Urinalysis Results: Part A
Glucose; Day 57
|
8 Participants
|
—
|
|
Number of Participants With Negative Urinalysis Results: Part A
Protein; Baseline
|
8 Participants
|
—
|
|
Number of Participants With Negative Urinalysis Results: Part A
Protein; Day 15
|
8 Participants
|
—
|
|
Number of Participants With Negative Urinalysis Results: Part A
Protein; Day 29
|
8 Participants
|
—
|
|
Number of Participants With Negative Urinalysis Results: Part A
Protein; Day 57
|
8 Participants
|
—
|
|
Number of Participants With Negative Urinalysis Results: Part A
Erythrocytes; Baseline
|
8 Participants
|
—
|
|
Number of Participants With Negative Urinalysis Results: Part A
Erythrocytes; Day 15
|
8 Participants
|
—
|
|
Number of Participants With Negative Urinalysis Results: Part A
Erythrocytes; Day 29
|
8 Participants
|
—
|
|
Number of Participants With Negative Urinalysis Results: Part A
Erythrocytes; Day 57
|
8 Participants
|
—
|
|
Number of Participants With Negative Urinalysis Results: Part A
Ketones; Baseline
|
8 Participants
|
—
|
|
Number of Participants With Negative Urinalysis Results: Part A
Ketones; Day 15
|
8 Participants
|
—
|
|
Number of Participants With Negative Urinalysis Results: Part A
Ketones; Day 29
|
8 Participants
|
—
|
|
Number of Participants With Negative Urinalysis Results: Part A
Ketones; Day 57
|
8 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to Day 57Population: Safety analysis Population
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.
Outcome measures
| Measure |
GSK2981278 4%: Part A
n=8 Participants
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
|
Vehicle Ointment: Part B
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
|
|---|---|---|
|
Change From Baseline in Potential of Hydrogen (pH) of Urine: Part A
Day 15
|
0.1 Scores on a scale
Standard Deviation 0.83
|
—
|
|
Change From Baseline in Potential of Hydrogen (pH) of Urine: Part A
Day 29
|
-0.1 Scores on a scale
Standard Deviation 0.35
|
—
|
|
Change From Baseline in Potential of Hydrogen (pH) of Urine: Part A
Day 57
|
-0.1 Scores on a scale
Standard Deviation 0.35
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to Day 57Population: Safety analysis Population
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.
Outcome measures
| Measure |
GSK2981278 4%: Part A
n=8 Participants
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
|
Vehicle Ointment: Part B
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
|
|---|---|---|
|
Change From Baseline in Specific Gravity of Urine: Part A
Day 15
|
0.0019 Ratio
Standard Deviation 0.00799
|
—
|
|
Change From Baseline in Specific Gravity of Urine: Part A
Day 29
|
0.0019 Ratio
Standard Deviation 0.00530
|
—
|
|
Change From Baseline in Specific Gravity of Urine: Part A
Day 57
|
0.0025 Ratio
Standard Deviation 0.00707
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to Day 57Population: Safety analysis Population
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.
Outcome measures
| Measure |
GSK2981278 4%: Part A
n=8 Participants
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
|
Vehicle Ointment: Part B
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
|
|---|---|---|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Potassium, Sodium and Calcium Levels: Part A
BUN; Day 15
|
-0.2678 Millimoles per liter (Mmol/L)
Standard Deviation 1.23300
|
—
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Potassium, Sodium and Calcium Levels: Part A
BUN; Day 29
|
-0.3570 Millimoles per liter (Mmol/L)
Standard Deviation 0.42670
|
—
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Potassium, Sodium and Calcium Levels: Part A
BUN; Day 57
|
0.4909 Millimoles per liter (Mmol/L)
Standard Deviation 1.40146
|
—
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Potassium, Sodium and Calcium Levels: Part A
Glucose; Day 15
|
0.041632 Millimoles per liter (Mmol/L)
Standard Deviation 0.7296677
|
—
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Potassium, Sodium and Calcium Levels: Part A
Glucose; Day 29
|
0.104081 Millimoles per liter (Mmol/L)
Standard Deviation 0.7258495
|
—
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Potassium, Sodium and Calcium Levels: Part A
Glucose; Day 57
|
0.298366 Millimoles per liter (Mmol/L)
Standard Deviation 0.4163911
|
—
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Potassium, Sodium and Calcium Levels: Part A
Potassium; Day 15
|
-0.14 Millimoles per liter (Mmol/L)
Standard Deviation 0.272
|
—
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Potassium, Sodium and Calcium Levels: Part A
Potassium; Day 29
|
0.00 Millimoles per liter (Mmol/L)
Standard Deviation 0.312
|
—
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Potassium, Sodium and Calcium Levels: Part A
Potassium; Day 57
|
0.13 Millimoles per liter (Mmol/L)
Standard Deviation 0.328
|
—
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Potassium, Sodium and Calcium Levels: Part A
Sodium; Day 15
|
-1.1 Millimoles per liter (Mmol/L)
Standard Deviation 2.17
|
—
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Potassium, Sodium and Calcium Levels: Part A
Sodium; Day 29
|
0.8 Millimoles per liter (Mmol/L)
Standard Deviation 2.25
|
—
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Potassium, Sodium and Calcium Levels: Part A
Sodium; Day 57
|
-0.4 Millimoles per liter (Mmol/L)
Standard Deviation 1.06
|
—
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Potassium, Sodium and Calcium Levels: Part A
Calcium; Day 15
|
0.021 Millimoles per liter (Mmol/L)
Standard Deviation 0.0624
|
—
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Potassium, Sodium and Calcium Levels: Part A
Calcium; Day 29
|
0.038 Millimoles per liter (Mmol/L)
Standard Deviation 0.0765
|
—
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Potassium, Sodium and Calcium Levels: Part A
Calcium; Day 57
|
-0.013 Millimoles per liter (Mmol/L)
Standard Deviation 0.0886
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to Day 57Population: Safety analysis Population
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.
Outcome measures
| Measure |
GSK2981278 4%: Part A
n=8 Participants
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
|
Vehicle Ointment: Part B
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
|
|---|---|---|
|
Change From Baseline in Creatinine, Total and Direct Bilirubin Levels: Part A
Creatinine; Day 15
|
-5.8565 Micromoles per liter (µmol/L)
Standard Deviation 2.16212
|
—
|
|
Change From Baseline in Creatinine, Total and Direct Bilirubin Levels: Part A
Creatinine; Day 29
|
-3.8675 Micromoles per liter (µmol/L)
Standard Deviation 6.32075
|
—
|
|
Change From Baseline in Creatinine, Total and Direct Bilirubin Levels: Part A
Creatinine; Day 57
|
-3.7570 Micromoles per liter (µmol/L)
Standard Deviation 6.92444
|
—
|
|
Change From Baseline in Creatinine, Total and Direct Bilirubin Levels: Part A
Total bilirubin; Day 15
|
1.425 Micromoles per liter (µmol/L)
Standard Deviation 2.7396
|
—
|
|
Change From Baseline in Creatinine, Total and Direct Bilirubin Levels: Part A
Total bilirubin; Day 29
|
1.995 Micromoles per liter (µmol/L)
Standard Deviation 2.5171
|
—
|
|
Change From Baseline in Creatinine, Total and Direct Bilirubin Levels: Part A
Total bilirubin; Day 57
|
-0.342 Micromoles per liter (µmol/L)
Standard Deviation 1.4307
|
—
|
|
Change From Baseline in Creatinine, Total and Direct Bilirubin Levels: Part A
Direct bilirubin; Day 15
|
0.3705 Micromoles per liter (µmol/L)
Standard Deviation 0.66154
|
—
|
|
Change From Baseline in Creatinine, Total and Direct Bilirubin Levels: Part A
Direct bilirubin; Day 29
|
0.3990 Micromoles per liter (µmol/L)
Standard Deviation 0.79963
|
—
|
|
Change From Baseline in Creatinine, Total and Direct Bilirubin Levels: Part A
Direct bilirubin; Day 57
|
0.0000 Micromoles per liter (µmol/L)
Standard Deviation 0.52706
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to Day 57Population: Safety analysis Population
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.
Outcome measures
| Measure |
GSK2981278 4%: Part A
n=8 Participants
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
|
Vehicle Ointment: Part B
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
|
|---|---|---|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase Levels: Part A
AST; Day 15
|
1.3 International unit per liter (IU/L)
Standard Deviation 4.43
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase Levels: Part A
AST; Day 29
|
-0.3 International unit per liter (IU/L)
Standard Deviation 2.92
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase Levels: Part A
AST; Day 57
|
-0.3 International unit per liter (IU/L)
Standard Deviation 6.23
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase Levels: Part A
ALT; Day 15
|
2.8 International unit per liter (IU/L)
Standard Deviation 8.75
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase Levels: Part A
ALT; Day 29
|
0.6 International unit per liter (IU/L)
Standard Deviation 5.26
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase Levels: Part A
ALT; Day 57
|
2.0 International unit per liter (IU/L)
Standard Deviation 8.59
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase Levels: Part A
Alkaline phosphatase; Day 15
|
2.1 International unit per liter (IU/L)
Standard Deviation 5.87
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase Levels: Part A
Alkaline phosphatase; Day 29
|
2.9 International unit per liter (IU/L)
Standard Deviation 12.89
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase Levels: Part A
Alkaline phosphatase; Day 57
|
-0.8 International unit per liter (IU/L)
Standard Deviation 11.80
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to Day 57Population: Safety analysis Population
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.
Outcome measures
| Measure |
GSK2981278 4%: Part A
n=8 Participants
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
|
Vehicle Ointment: Part B
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
|
|---|---|---|
|
Change From Baseline in Protein and Albumin Levels: Part A
Protein; Day 15
|
1.9 Grams per liter (g/L)
Standard Deviation 2.90
|
—
|
|
Change From Baseline in Protein and Albumin Levels: Part A
Protein; Day 29
|
-1.4 Grams per liter (g/L)
Standard Deviation 2.83
|
—
|
|
Change From Baseline in Protein and Albumin Levels: Part A
Protein; Day 57
|
1.8 Grams per liter (g/L)
Standard Deviation 3.65
|
—
|
|
Change From Baseline in Protein and Albumin Levels: Part A
Albumin; Day 15
|
1.4 Grams per liter (g/L)
Standard Deviation 1.92
|
—
|
|
Change From Baseline in Protein and Albumin Levels: Part A
Albumin; Day 29
|
1.3 Grams per liter (g/L)
Standard Deviation 1.67
|
—
|
|
Change From Baseline in Protein and Albumin Levels: Part A
Albumin; Day 57
|
1.0 Grams per liter (g/L)
Standard Deviation 2.56
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to Day 57Population: Safety analysis Population
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.
Outcome measures
| Measure |
GSK2981278 4%: Part A
n=8 Participants
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
|
Vehicle Ointment: Part B
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
|
|---|---|---|
|
Change From Baseline in Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Levels: Part A
Platelet; Day 15
|
-3.6 10^9 cells/L
Standard Deviation 50.90
|
—
|
|
Change From Baseline in Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Levels: Part A
Platelet; Day 29
|
-1.0 10^9 cells/L
Standard Deviation 28.98
|
—
|
|
Change From Baseline in Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Levels: Part A
Platelet; Day 57
|
0.1 10^9 cells/L
Standard Deviation 25.31
|
—
|
|
Change From Baseline in Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Levels: Part A
Leukocytes; Day 15
|
0.76 10^9 cells/L
Standard Deviation 2.745
|
—
|
|
Change From Baseline in Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Levels: Part A
Leukocytes; Day 29
|
0.42 10^9 cells/L
Standard Deviation 0.910
|
—
|
|
Change From Baseline in Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Levels: Part A
Leukocytes; Day 57
|
0.35 10^9 cells/L
Standard Deviation 0.780
|
—
|
|
Change From Baseline in Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Levels: Part A
Neutrophils; Day 15
|
0.695 10^9 cells/L
Standard Deviation 2.7477
|
—
|
|
Change From Baseline in Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Levels: Part A
Neutrophils; Day 29
|
0.144 10^9 cells/L
Standard Deviation 1.1659
|
—
|
|
Change From Baseline in Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Levels: Part A
Neutrophils; Day 57
|
0.217 10^9 cells/L
Standard Deviation 0.4432
|
—
|
|
Change From Baseline in Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Levels: Part A
Lymphocytes; Day 15
|
-0.019 10^9 cells/L
Standard Deviation 0.6335
|
—
|
|
Change From Baseline in Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Levels: Part A
Lymphocytes; Day 29
|
0.243 10^9 cells/L
Standard Deviation 0.4457
|
—
|
|
Change From Baseline in Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Levels: Part A
Lymphocytes; Day 57
|
0.151 10^9 cells/L
Standard Deviation 0.3756
|
—
|
|
Change From Baseline in Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Levels: Part A
Monocytes; Day 15
|
0.090 10^9 cells/L
Standard Deviation 0.2778
|
—
|
|
Change From Baseline in Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Levels: Part A
Monocytes; Day 29
|
-0.040 10^9 cells/L
Standard Deviation 0.2099
|
—
|
|
Change From Baseline in Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Levels: Part A
Monocytes; Day 57
|
-0.063 10^9 cells/L
Standard Deviation 0.2344
|
—
|
|
Change From Baseline in Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Levels: Part A
Eosinophils; Day 15
|
0.019 10^9 cells/L
Standard Deviation 0.1579
|
—
|
|
Change From Baseline in Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Levels: Part A
Eosinophils; Day 29
|
0.085 10^9 cells/L
Standard Deviation 0.1321
|
—
|
|
Change From Baseline in Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Levels: Part A
Eosinophils; Day 57
|
0.029 10^9 cells/L
Standard Deviation 0.0825
|
—
|
|
Change From Baseline in Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Levels: Part A
Basophils; Day 15
|
-0.008 10^9 cells/L
Standard Deviation 0.0287
|
—
|
|
Change From Baseline in Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Levels: Part A
Basophils; Day 29
|
0.001 10^9 cells/L
Standard Deviation 0.0264
|
—
|
|
Change From Baseline in Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Levels: Part A
Basophils; Day 57
|
0.004 10^9 cells/L
Standard Deviation 0.0151
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to Day 57Population: Safety analysis Population
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.
Outcome measures
| Measure |
GSK2981278 4%: Part A
n=8 Participants
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
|
Vehicle Ointment: Part B
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
|
|---|---|---|
|
Change From Baseline in Erythrocyte Levels: Part A
Day 15
|
0.013 10^12 cells/L
Standard Deviation 0.2042
|
—
|
|
Change From Baseline in Erythrocyte Levels: Part A
Day 29
|
0.055 10^12 cells/L
Standard Deviation 0.2555
|
—
|
|
Change From Baseline in Erythrocyte Levels: Part A
Day 57
|
0.061 10^12 cells/L
Standard Deviation 0.2785
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to Day 57Population: Safety analysis Population
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.
Outcome measures
| Measure |
GSK2981278 4%: Part A
n=8 Participants
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
|
Vehicle Ointment: Part B
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
|
|---|---|---|
|
Change From Baseline in Hemoglobin Levels: Part A
Day 15
|
1.3 g/L
Standard Deviation 6.18
|
—
|
|
Change From Baseline in Hemoglobin Levels: Part A
Day 29
|
2.6 g/L
Standard Deviation 7.63
|
—
|
|
Change From Baseline in Hemoglobin Levels: Part A
Day 57
|
1.5 g/L
Standard Deviation 9.18
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to Day 57Population: Safety analysis Population
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.
Outcome measures
| Measure |
GSK2981278 4%: Part A
n=8 Participants
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
|
Vehicle Ointment: Part B
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
|
|---|---|---|
|
Change From Baseline in Hematocrit Levels: Part A
Day 15
|
0.0040 Proportion of Red blood cells in blood
Standard Deviation 0.01752
|
—
|
|
Change From Baseline in Hematocrit Levels: Part A
Day 29
|
0.0090 Proportion of Red blood cells in blood
Standard Deviation 0.02203
|
—
|
|
Change From Baseline in Hematocrit Levels: Part A
Day 57
|
0.0076 Proportion of Red blood cells in blood
Standard Deviation 0.02628
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to Day 57Population: Safety analysis Population
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.
Outcome measures
| Measure |
GSK2981278 4%: Part A
n=8 Participants
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
|
Vehicle Ointment: Part B
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
|
|---|---|---|
|
Change From Baseline in Mean Corpuscular Volume (MCV) Levels: Part A
Day 15
|
0.46 Femtoliter (fL)
Standard Deviation 1.235
|
—
|
|
Change From Baseline in Mean Corpuscular Volume (MCV) Levels: Part A
Day 29
|
0.86 Femtoliter (fL)
Standard Deviation 1.112
|
—
|
|
Change From Baseline in Mean Corpuscular Volume (MCV) Levels: Part A
Day 57
|
0.34 Femtoliter (fL)
Standard Deviation 1.172
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to Day 57Population: Safety analysis Population
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.
Outcome measures
| Measure |
GSK2981278 4%: Part A
n=8 Participants
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
|
Vehicle Ointment: Part B
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
|
|---|---|---|
|
Change From Baseline in Mean Corpuscular Hemoglobin (MCH) Levels: Part A
Day 15
|
0.16 Picograms (Pg)
Standard Deviation 0.325
|
—
|
|
Change From Baseline in Mean Corpuscular Hemoglobin (MCH) Levels: Part A
Day 29
|
0.21 Picograms (Pg)
Standard Deviation 0.253
|
—
|
|
Change From Baseline in Mean Corpuscular Hemoglobin (MCH) Levels: Part A
Day 57
|
-0.06 Picograms (Pg)
Standard Deviation 0.421
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to Day 57Population: Safety analysis Population
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.
Outcome measures
| Measure |
GSK2981278 4%: Part A
n=8 Participants
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
|
Vehicle Ointment: Part B
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels: Part A
SBP; Day 15
|
-1.9 Millimeters of mercury (mmHg)
Standard Deviation 4.58
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels: Part A
SBP; Day 29
|
-2.5 Millimeters of mercury (mmHg)
Standard Deviation 4.63
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels: Part A
SBP; Day 57
|
-2.5 Millimeters of mercury (mmHg)
Standard Deviation 2.67
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels: Part A
DBP; Day 15
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation 2.67
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels: Part A
DBP; Day 29
|
1.3 Millimeters of mercury (mmHg)
Standard Deviation 4.43
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels: Part A
DBP: Day 57
|
0.6 Millimeters of mercury (mmHg)
Standard Deviation 4.17
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to Day 57Population: Safety analysis Population
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.
Outcome measures
| Measure |
GSK2981278 4%: Part A
n=8 Participants
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
|
Vehicle Ointment: Part B
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
|
|---|---|---|
|
Change From Baseline in Pulse Rate Levels: Part A
Day 15
|
3.3 Beats per minute
Standard Deviation 9.19
|
—
|
|
Change From Baseline in Pulse Rate Levels: Part A
Day 29
|
0.3 Beats per minute
Standard Deviation 12.21
|
—
|
|
Change From Baseline in Pulse Rate Levels: Part A
Day 57
|
1.3 Beats per minute
Standard Deviation 11.36
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to Day 57Population: Safety analysis Population
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
Outcome measures
| Measure |
GSK2981278 4%: Part A
n=8 Participants
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
|
Vehicle Ointment: Part B
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
|
|---|---|---|
|
Change From Baseline in Electrocardiogram (ECG) Parameters Including Single RR Heart Rate: Part A
Day 29
|
-2.5 Beats per minute
Standard Deviation 16.81
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters Including Single RR Heart Rate: Part A
Day 57
|
-3.5 Beats per minute
Standard Deviation 12.42
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to Day 57Population: Safety analysis Population
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
Outcome measures
| Measure |
GSK2981278 4%: Part A
n=8 Participants
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
|
Vehicle Ointment: Part B
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
|
|---|---|---|
|
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
PR interval; Day 29
|
-0.5 Milliseconds (msec)
Standard Deviation 9.78
|
—
|
|
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
PR interval; Day 57
|
7.3 Milliseconds (msec)
Standard Deviation 12.78
|
—
|
|
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
QRS duration; Day 29
|
-0.5 Milliseconds (msec)
Standard Deviation 4.24
|
—
|
|
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
QRS duration; Day 57
|
-0.3 Milliseconds (msec)
Standard Deviation 2.92
|
—
|
|
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
QT interval; Day 29
|
12.8 Milliseconds (msec)
Standard Deviation 28.88
|
—
|
|
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
QT interval; Day 57
|
9.0 Milliseconds (msec)
Standard Deviation 28.57
|
—
|
|
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
QTcB interval; Day 29
|
10.0 Milliseconds (msec)
Standard Deviation 15.62
|
—
|
|
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
QTcB interval; Day 57
|
3.5 Milliseconds (msec)
Standard Deviation 15.96
|
—
|
|
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
RR interval; Day 29
|
9.5 Milliseconds (msec)
Standard Deviation 170.62
|
—
|
|
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
RR interval; Day 57
|
13.0 Milliseconds (msec)
Standard Deviation 124.12
|
—
|
PRIMARY outcome
Timeframe: 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 15Population: PK analysis Population
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).
Outcome measures
| Measure |
GSK2981278 4%: Part A
n=8 Participants
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
|
Vehicle Ointment: Part B
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
|
|---|---|---|
|
Plasma Concentration of GSK2981278 at Nominal Time: Part A
1 hour post-dose; Day 57; n= 8
|
1273.75 Picograms per milliliter (Pg/mL)
Standard Deviation 784.902
|
—
|
|
Plasma Concentration of GSK2981278 at Nominal Time: Part A
2 hours post-dose; Day 15; n= 8
|
893.00 Picograms per milliliter (Pg/mL)
Standard Deviation 737.610
|
—
|
|
Plasma Concentration of GSK2981278 at Nominal Time: Part A
Pre-dose; Day 29; n= 8
|
1122.00 Picograms per milliliter (Pg/mL)
Standard Deviation 587.760
|
—
|
|
Plasma Concentration of GSK2981278 at Nominal Time: Part A
Pre-dose; Day 1; n= 8
|
0.00 Picograms per milliliter (Pg/mL)
Standard Deviation 0.000
|
—
|
|
Plasma Concentration of GSK2981278 at Nominal Time: Part A
1 hour post-dose; Day 1; n= 8
|
151.89 Picograms per milliliter (Pg/mL)
Standard Deviation 210.535
|
—
|
|
Plasma Concentration of GSK2981278 at Nominal Time: Part A
2 hours post-dose; Day 1; n= 8
|
281.54 Picograms per milliliter (Pg/mL)
Standard Deviation 589.927
|
—
|
|
Plasma Concentration of GSK2981278 at Nominal Time: Part A
4 hours post-dose; Day 1; n= 8
|
171.38 Picograms per milliliter (Pg/mL)
Standard Deviation 160.357
|
—
|
|
Plasma Concentration of GSK2981278 at Nominal Time: Part A
6 hours post-dose; Day 1; n= 8
|
610.73 Picograms per milliliter (Pg/mL)
Standard Deviation 1141.415
|
—
|
|
Plasma Concentration of GSK2981278 at Nominal Time: Part A
8 hours post-dose; Day 1; n= 8
|
192.06 Picograms per milliliter (Pg/mL)
Standard Deviation 168.443
|
—
|
|
Plasma Concentration of GSK2981278 at Nominal Time: Part A
10 hours post-dose; Day 1; n= 8
|
554.94 Picograms per milliliter (Pg/mL)
Standard Deviation 828.825
|
—
|
|
Plasma Concentration of GSK2981278 at Nominal Time: Part A
Pre-dose; Day 15; n= 7
|
1203.71 Picograms per milliliter (Pg/mL)
Standard Deviation 1203.796
|
—
|
|
Plasma Concentration of GSK2981278 at Nominal Time: Part A
1 hour post-dose; Day 29; n= 8
|
1299.63 Picograms per milliliter (Pg/mL)
Standard Deviation 910.793
|
—
|
|
Plasma Concentration of GSK2981278 at Nominal Time: Part A
2 hours post-dose; Day 29; n= 8
|
1062.38 Picograms per milliliter (Pg/mL)
Standard Deviation 662.050
|
—
|
|
Plasma Concentration of GSK2981278 at Nominal Time: Part A
4 hours post-dose; Day 29; n= 8
|
769.38 Picograms per milliliter (Pg/mL)
Standard Deviation 369.861
|
—
|
|
Plasma Concentration of GSK2981278 at Nominal Time: Part A
6 hours post-dose; Day 29; n= 8
|
1022.63 Picograms per milliliter (Pg/mL)
Standard Deviation 720.269
|
—
|
|
Plasma Concentration of GSK2981278 at Nominal Time: Part A
8 hours post-dose; Day 29; n= 7
|
897.71 Picograms per milliliter (Pg/mL)
Standard Deviation 325.169
|
—
|
|
Plasma Concentration of GSK2981278 at Nominal Time: Part A
10 hours post-dose; Day 29; n= 8
|
875.38 Picograms per milliliter (Pg/mL)
Standard Deviation 584.879
|
—
|
|
Plasma Concentration of GSK2981278 at Nominal Time: Part A
Pre-dose; Day 57; n= 8
|
875.75 Picograms per milliliter (Pg/mL)
Standard Deviation 707.446
|
—
|
|
Plasma Concentration of GSK2981278 at Nominal Time: Part A
2 hours post-dose; Day 57; n= 8
|
1077.00 Picograms per milliliter (Pg/mL)
Standard Deviation 1128.070
|
—
|
|
Plasma Concentration of GSK2981278 at Nominal Time: Part A
4 hours post-dose; Day 57; n= 8
|
758.13 Picograms per milliliter (Pg/mL)
Standard Deviation 494.661
|
—
|
|
Plasma Concentration of GSK2981278 at Nominal Time: Part A
6 hours post-dose; Day 57; n= 8
|
760.38 Picograms per milliliter (Pg/mL)
Standard Deviation 550.695
|
—
|
|
Plasma Concentration of GSK2981278 at Nominal Time: Part A
8 hours post-dose; Day 57; n= 8
|
809.13 Picograms per milliliter (Pg/mL)
Standard Deviation 373.947
|
—
|
|
Plasma Concentration of GSK2981278 at Nominal Time: Part A
10 hours post-dose; Day 57; n= 8
|
841.25 Picograms per milliliter (Pg/mL)
Standard Deviation 579.772
|
—
|
PRIMARY outcome
Timeframe: Up to Day 57Population: Safety analysis population. . Data was not collected for Part B as no Participants were enrolled into this part of the study.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 57Population: Safety analysis Population. Data was not collected for Part B as no Participants were enrolled into this part of the study.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and up to Week 57Population: Safety analysis Population. Data was not collected for Part B as no Participants were enrolled into this part of the study.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and up to Day 57Population: Safety analysis Population. Data was not collected for Part B as no Participants were enrolled into this part of the study.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 57Population: Safety analysis Population. Data was not collected for Part B as no Participants were enrolled into this part of the study.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 57Population: Safety analysis Population. Data was not collected for Part B as no Participants were enrolled into this part of the study.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and up to Week 8Population: PP analysis Population. Data was not collected for Part B as no Participants were enrolled into this part of the study.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and up to Week 8Population: PP analysis Population. Data was not collected for Part B as no Participants were enrolled into this part of the study.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and up to Week 8Population: PP analysis Population. Data was not collected for Part B as no Participants were enrolled into this part of the study.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to Week 8Population: PP analysis Population
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.
Outcome measures
| Measure |
GSK2981278 4%: Part A
n=8 Participants
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
|
Vehicle Ointment: Part B
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
|
|---|---|---|
|
Mean Percent Change From Baseline in Target Plaque Severity Score (TPSS): Part A
Day 15
|
-6.5 Percent change
Standard Deviation 7.24
|
—
|
|
Mean Percent Change From Baseline in Target Plaque Severity Score (TPSS): Part A
Day 29
|
-3.0 Percent change
Standard Deviation 5.74
|
—
|
|
Mean Percent Change From Baseline in Target Plaque Severity Score (TPSS): Part A
Day 57
|
-4.3 Percent change
Standard Deviation 10.61
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to Week 8Population: PP analysis 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. 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.
Outcome measures
| Measure |
GSK2981278 4%: Part A
n=8 Participants
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
|
Vehicle Ointment: Part B
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
|
|---|---|---|
|
Mean Percent Change From Baseline in Physician's Global Assessment (PGA) Score: Part A
Day 15
|
-3.1 Percent change
Standard Deviation 8.84
|
—
|
|
Mean Percent Change From Baseline in Physician's Global Assessment (PGA) Score: Part A
Day 29
|
-3.1 Percent change
Standard Deviation 8.84
|
—
|
|
Mean Percent Change From Baseline in Physician's Global Assessment (PGA) Score: Part A
Day 57
|
0.0 Percent change
Standard Deviation 0.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to Week 8Population: PP analysis Population
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.
Outcome measures
| Measure |
GSK2981278 4%: Part A
n=8 Participants
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
|
Vehicle Ointment: Part B
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
|
|---|---|---|
|
Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score: Part A
Day 15
|
-3.98 Percent change
Standard Deviation 10.459
|
—
|
|
Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score: Part A
Day 29
|
-0.27 Percent change
Standard Deviation 4.058
|
—
|
|
Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score: Part A
Day 57
|
4.26 Percent change
Standard Deviation 7.119
|
—
|
Adverse Events
GSK2981278 4%: Part A
GSK2981278 4%: Part B
Vehicle Ointment: Part B
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GSK2981278 4%: Part A
n=8 participants at risk
Participants received 4% ointment of GSK2981278 twice daily for 8 weeks.
|
GSK2981278 4%: Part B
Randomized participants were planned to receive 4% ointment of GSK2981278 twice daily for 8 weeks.
|
Vehicle Ointment: Part B
Randomized participants were planned to receive vehicle ointment twice daily for 8 weeks.
|
|---|---|---|---|
|
Infections and infestations
COMMON COLD
|
12.5%
1/8 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Day 57.
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.
|
—
0/0 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Day 57.
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.
|
—
0/0 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Day 57.
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.
|
Additional Information
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