Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the efficacy and safety of two concentrations (0.5 percent [%] and 1%) and two application frequencies (once a day and twice a day) of GSK2894512 cream for the topical treatment in subjects with plaque psoriasis. Results from this study will be considered when selecting the most appropriate concentration of GSK2894512 cream and dosing frequency in future clinical safety and efficacy studies. This is a multicenter (United States, Canada, and Japan), randomized, double-blind (sponsor-unblind), vehicle-controlled, 6-arm, parallel-group, dose-finding study. Two concentrations of GSK2894512 cream (0.5% and 1%) and a vehicle control cream will be equally randomized and evaluated following application to all psoriasis lesions (except on the scalp) once daily (evening) or twice daily (morning and evening) for 12 weeks. This study will consist of 3 periods: up to 4 weeks screening, 12 weeks double-blind treatment, and 4 weeks post-treatment follow-up. The total duration of subject participation will be approximately 16 to 20 weeks. Approximately 270 adult males and females subjects with plaque psoriasis will be screened in order to have at least 228 randomized subjects (38 subjects for each of the 6 treatment groups) and approximately 204 evaluable subjects overall. Approximately 30 subjects will be randomized in Japan to achieve at least 24 evaluable Japanese subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK2894512 1% cream twice daily | Experimental | Subjects will apply a thin layer of GSK2894512 1% (10 milligram per gram [mg/g]) topical cream twice daily (morning and evening) for 12 weeks, to all psoriasis lesions (except on the scalp). |
|
| GSK2894512 1% cream once daily | Experimental | Subjects will apply a thin layer of GSK2894512 1% (10 mg/g) topical cream once daily (evening) for 12 weeks, to all psoriasis lesions (except on the scalp). |
|
| GSK2894512 0.5% cream twice daily | Experimental | Subjects will apply a thin layer of GSK2894512 0.5% (5 mg/g) topical cream twice daily (morning and evening) for 12 weeks, to all psoriasis lesions (except on the scalp). |
|
| GSK2894512 0.5% cream once daily | Experimental | Subjects will apply a thin layer of GSK2894512 0.5% (5 mg/g) topical cream once daily (evening) for 12 weeks, to all psoriasis lesions (except on the scalp). |
|
| Vehicle cream twice daily | Placebo Comparator | Subjects will apply a thin layer of vehicle topical cream twice daily (morning and evening) for 12 weeks, to all psoriasis lesions (except on the scalp). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK2894512 1% Cream | Drug | 1.0% (10 mg/g) GSK2894512 will be supplied as white to off-white cream to be applied topically |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Have a Physician Global Assessment (PGA) Score of 0 or 1 at Week 12 and a Minimum 2-grade Improvement in PGA Score From Baseline to Week 12 | The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of responders that is, participants who achieved a PGA score of 0 or 1 and a minimum 2-grade improvement from Baseline were summarized. Baseline was defined as the latest assessment prior to the first dose. The analysis was performed on modified intent-to-treat (mITT) Population which comprised of all randomized participants except those enrolled at center ID 220008. | Baseline and up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | The PASI is a standard clinical tool for assessing the severity of psoriasis based on severity of erythema, thickness and scale, as well as the extent of body surface area (BSA) affected with psoriasis. The 3 clinical signs were graded on a 5 point scale (0 to 4) and the % BSA affected was scored on a 7-point scale (0 to 6) for each of the 4 specified body regions (head, upper extremities, trunk and lower extremities). The individual scores were multiplied by a weighted factor for each body region. The sum of these scores gave the overall PASI score. Higher scores indicated more severe disease. The percentage of participants with >=75% improvement in PASI from Baseline were summarized. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
NOTES: The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF), with machine over-read. The QTc should be based on a single ECG obtained over a brief recording period. If QTc is outside of the threshold value, triplicate ECGs may be performed with the QTc values averaged.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | San Diego | California | 92123 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37076998 | Derived | Grossmann MC, Pixley JN, Feldman SR. A Review of Topical Tapinarof for the Treatment of Plaque Psoriasis. Ann Pharmacother. 2024 Jan;58(1):76-85. doi: 10.1177/10600280231164775. Epub 2023 Apr 19. |
Not provided
Not provided
A total of 290 participants were screened of which 63 failed screening and 227 participants were randomized into the study. Participants in the treatment phase were randomized to receive GSK2894512 cream (0.5 or 1 percent) or vehicle control once daily (QD) or twice daily (BID).
This was a randomized, double-blind, dose-finding study of GSK2894512 in adult participants with psoriasis. The study consisted of 3 periods: 4 weeks screening, 12 weeks double-blind treatment, and 4 weeks post-treatment follow-up. The total duration of study for a participant was 16-20 weeks.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | GSK2894512 1% BID | The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Vehicle cream once daily | Placebo Comparator | Subjects will apply a thin layer of vehicle topical cream once daily (evening) for 12 weeks, to all psoriasis lesions (except on the scalp). |
|
| GSK2894512 0.5% Cream | Drug | 0.5% (5 mg/g) GSK2894512 will be supplied as white to off-white cream to be applied topically |
|
| Vehicle cream | Drug | White to off-white vehicle cream base to be applied topically |
|
| Baseline and up to Week 16 |
| Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of participants who achieved a minimum 2-grade improvement from Baseline for each study visit were summarized. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Baseline and up to Week 16 |
| Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of participants who achieved a PGA score of 0 or 1 from Baseline at each study visit was summarized. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Up to Week 16 |
| Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | The extent of BSA affected by psoriasis is a general indicator of disease severity and was measured throughout the study. The extent of BSA to which study treatment was applied was also recorded. For the purpose of approximate clinical estimation, the total palmar surface of the palm plus 5 digits was assumed to be approximately equivalent to 1 percent BSA. Assessment of BSA affected with psoriasis was performed separately for four body surface regions: the head, the upper extremities, the trunk and the lower extremities, corresponding to 10, 20, 30 and 40 percent of the total body area, respectively. The mean change in percent BSA affected from Baseline was summarized for each study visit. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Baseline and up to Week 16 |
| Mean Change in PASI Score From Baseline to Each Study Visit | The PASI is a standard clinical tool for assessing the severity of psoriasis based on severity of erythema, thickness and scale, as well as the extent of BSA affected with psoriasis. The 3 clinical signs were graded on a 5 point scale (0=None to 4=Severe) and the percent of BSA affected is scored on a 7-point scale (0=0% involvement to 6=90-100%) for each of 4 specified body regions (head, upper extremities, trunk and lower extremities). The individual scores were multiplied by a weighted factor for each body region. The sum of these scores gave the overall PASI score. PASI score ranged from 0=no psoriasis to 72=worse psoriasis. The mean change in PASI score from Baseline was summarized for each study visit. Baseline was the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Baseline and up to Week 16 |
| PGA Scores at Each Study Visit | The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The mean of PGA scores at each study visit was summarized. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Up to Week 16 |
| Mean Change in PGA Score From Baseline to Each Study Visit | The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The mean change in PGA scores from Baseline was summarized for each study visit. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Baseline and up to Week 16 |
| Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | A single target lesion of at least 3 centimeter (cm) x 3 cm was selected at Baseline. For the selected lesion, the severity of erythema, scaling and plaque thickness (induration) was assessed by the investigator on a 5-point scale ranging from 0=none to 4=severe. The mean change in individual grading scores from Baseline was summarized for each study visit. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Baseline and up to Week 16 |
| Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | The participant reported itch severity was obtained from the response of the participants to the itch NRS item in the psoriasis symptom diary (PSD). PSD was developed to assess daily self-reports of psoriasis symptoms and the functional impact related to the underlying pathophysiology of the disease. The participants answered questions related to the severity and impact of the signs and symptoms daily using a 11 point NRS with scores ranging from 0 (absent) to 10 (worst imaginable). Mean change in itch/pruritis NRS from Baseline to each study visit was presented. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the post dose weekly average value minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Baseline and up to Week 16 |
| Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of responders that is, participants who achieved a PGA score of 0 or 1 and a minimum 2-grade improvement from baseline were summarized. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Baseline and up to Week 16 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | An AE is defined as any untoward medical occurrence in a participant under clinical investigation, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. A TEAE is defined as an AE which occurred on or after study treatment start date and on or before the last visit. Number of participants with AEs and SAEs were presented. The analysis was performed on safety Population which comprised of all participants who received at least one dose of study treatment. | Up to Week 16 |
| Number of Participants With Reported Local Tolerability Scores | The assessment of the presence and degree of burning/stinging and itching at the application site following application of the study treatment was done at each specified study visit using a 5 point tolerability scale. The scores ranged from 0 to 4 where 0=None and 4=Strong/Severe. The score represented an average across all application sites. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Up to Week 14 |
| Change From Baseline in Albumin and Protein Level | Blood samples were collected for the evaluation of change in albumin and protein levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Baseline and up to Week 14 |
| Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Blood samples were collected for the evaluation of change in levels of alk phos, ALT, AST and GGT from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Baseline and up to Week 14 |
| Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Blood samples were collected for the evaluation of change in levels of direct bil, bil, creatinine and urate from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Baseline and up to Week 14 |
| Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Blood samples were collected for the evaluation of change in levels of calcium, chloride, CO2, glucose, potassium, sodium, and urea from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Baseline and up to Week 14 |
| Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Blood samples were collected for the evaluation of change in levels of basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocyte count from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Baseline and up to Week 14 |
| Change From Baseline in Hematocrit Levels | Blood samples were collected for the evaluation of change in hematocrit levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Baseline and up to Week 14 |
| Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Blood samples were collected for the evaluation of change in Hgb levels and MCHC from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Baseline and up to Week 14 |
| Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Blood samples were collected for the evaluation of change in erythrocyte mean corpuscular hemoglobin level from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Baseline and up to Week 14 |
| Change From Baseline in Erythrocyte Mean Corpuscular Volume | Blood samples were collected for the evaluation of change in erythrocyte mean corpuscular volume from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Baseline and up to Week 14 |
| Change From Baseline in Erythrocyte Count | Blood samples were collected for the evaluation of change in erythrocyte count from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Baseline and up to Week 14 |
| Number of Participants With Chemistry Data of Potential Clinical Importance | Blood samples were collected for the evaluation of clinical chemistry parameters including alk phos, ALT, AST, bil, calcium, CO2, creatinine, glucose and potassium. The number of participants with chemistry data of potential clinical importance for the mentioned parameters was presented. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Up to Week 14 |
| Number of Participants With Hematology Data of Clinical Importance | Blood samples were collected for the evaluation of hematology parameters including hematocrit, Hgb, lymphocytes, neutrophils and platelets. The number of participants with clinically significant abnormal values of the mentioned hematology parameters was presented. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Up to Week 14 |
| Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | Blood samples were collected for the evaluation of change in IgA, IgG and IgM levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Baseline and up to Week 12 |
| Number of Participants With Ig Data Outside the Reference Range | Blood samples were collected for the evaluation of change in Ig levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Up to Week 12 |
| Number of Participants With Immunophenotyping Data Outside the Reference Range | Blood samples were collected for the evaluation of change in levels of cluster of differentiation (CD)19, CD3, CD3 Treg flow cytometry (CD3TFLC), CD3+CD8+, CD3+CD8+ TFLC, CD3+CD4+, CD3+CD4+ TFLC, CD16+CD56+, CD3+CD4+CD25+CD127 flow cytometry (CD3+CD4+CD25+CD127), CD3+CD4+foxP3+CD25+CD127 flow cytometry (CD3+CD4+fP3+CD25+CD127) and T Cell B Cell Natural Killer Lymphocytes flow cytometry (T-B cell NKL). Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Up to Week 12 |
| Change From Baseline in Immunophenotype Data | Blood samples were collected for the evaluation of change from Baseline in immunophenotype levels including CD19, CD3, CD3TFLC, CD3+CD8+, CD3+CD8+ TFLC, CD3+CD4+, CD3+CD4+ TFLC, CD16+CD56+, CD3+CD4+CD25+CD127 flow cytometry (CD3+CD4+CD25+CD127), CD3+CD4+foxP3+CD25+CD127 flow cytometry (CD3+CD4+fP3+CD25+CD127) and T-B cell NKL. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Baseline and up to Week 12 |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP and DBP were measured in semi-supine position after at least 5 minutes of rest. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Baseline and up to Week 14 |
| Change From Baseline in Pulse Rate | Pulse rate was measured in semi-supine position after at least 5 minutes of rest. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Baseline and up to Week 14 |
| Change From Baseline in Temperature | Temperature was measured in semi-supine position after at least 5 minutes of rest. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Baseline and up to Week 14 |
| Number of Participants With Vital Signs of Clinical Importance | The vital signs including SBP, DBP and pulse rate were measured from Baseline throughout the study. The number of participants with clinically significant abnormal vital signs were presented. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Up to Week 14 |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Single 12-lead ECGs were obtained over a brief recording period at each specified time point during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. For multiple ECGs at one visit, or "Any time post-screen", a participant is categorized as "Abnormal" if >=1 assessment is abnormal. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Up to Week 14 |
| North Logan |
| Connecticut |
| 06032 |
| United States |
| GSK Investigational Site | Miami | Florida | 33142 | United States |
| GSK Investigational Site | Chicago | Illinois | 60612 | United States |
| GSK Investigational Site | Plainfield | Indiana | 46168 | United States |
| GSK Investigational Site | Overland Park | Kansas | 66215 | United States |
| GSK Investigational Site | Louisville | Kentucky | 40217 | United States |
| GSK Investigational Site | Fort Gratiot Township | Michigan | 48059 | United States |
| GSK Investigational Site | High Point | North Carolina | 27262 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19103 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15213 | United States |
| GSK Investigational Site | Johnston | Rhode Island | 02919 | United States |
| GSK Investigational Site | Goodlettsville | Tennessee | 37072 | United States |
| GSK Investigational Site | Austin | Texas | 78705 | United States |
| GSK Investigational Site | Houston | Texas | 77004 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Webster | Texas | 77598 | United States |
| GSK Investigational Site | Seattle | Washington | 98101 | United States |
| GSK Investigational Site | Surrey | British Columbia | V3R 6A7 | Canada |
| GSK Investigational Site | Hamilton | Ontario | L8N 1V6 | Canada |
| GSK Investigational Site | Markham | Ontario | L3P1X2 | Canada |
| GSK Investigational Site | North Bay | Ontario | P1B 3Z7 | Canada |
| GSK Investigational Site | Oakville | Ontario | L6J 7W5 | Canada |
| GSK Investigational Site | Ottawa | Ontario | K2G 6E2 | Canada |
| GSK Investigational Site | Peterborough | Ontario | K9J5K2 | Canada |
| GSK Investigational Site | Richmond Hill | Ontario | L4B 1A5 | Canada |
| GSK Investigational Site | Waterloo | Ontario | N2J 1C4 | Canada |
| GSK Investigational Site | Windsor | Ontario | N8W 1E6 | Canada |
| GSK Investigational Site | Windsor | Ontario | N8W 5L7 | Canada |
| GSK Investigational Site | Montreal | Quebec | H2K 4L5 | Canada |
| GSK Investigational Site | Québec | Quebec | G1V4X7 | Canada |
| GSK Investigational Site | Fukuoka | 813-0044 | Japan |
| GSK Investigational Site | Fukuoka | 819-0373 | Japan |
| GSK Investigational Site | Hokkaido | 006-0022 | Japan |
| GSK Investigational Site | Hokkaido | 066-0021 | Japan |
| GSK Investigational Site | Hokkaido | 066-0064 | Japan |
| GSK Investigational Site | Kanagawa | 221-0825 | Japan |
| GSK Investigational Site | Kumamoto | 861-3101 | Japan |
| GSK Investigational Site | Osaka | 572-0838 | Japan |
| GSK Investigational Site | Osaka | 593-8324 | Japan |
| GSK Investigational Site | Tokyo | 133-0057 | Japan |
| GSK Investigational Site | Tokyo | 136-0074 | Japan |
| GSK Investigational Site | Tokyo | 190-0023 | Japan |
| GSK Investigational Site | Tokyo | 194-0013 | Japan |
| GSK Investigational Site | Tokyo | 195-0053 | Japan |
| GSK Investigational Site | Tokyo | 203-0003 | Japan |
| GSK2894512 1% QD |
The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| FG002 | GSK2894512 0.5% BID | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| FG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| FG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| FG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GSK2894512 1% BID | The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| BG001 | GSK2894512 1% QD | The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| BG002 | GSK2894512 0.5% BID | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| BG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| BG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| BG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Have a Physician Global Assessment (PGA) Score of 0 or 1 at Week 12 and a Minimum 2-grade Improvement in PGA Score From Baseline to Week 12 | The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of responders that is, participants who achieved a PGA score of 0 or 1 and a minimum 2-grade improvement from Baseline were summarized. Baseline was defined as the latest assessment prior to the first dose. The analysis was performed on modified intent-to-treat (mITT) Population which comprised of all randomized participants except those enrolled at center ID 220008. | mITT Population | Posted | Number | Percentage of participants | Baseline and up to Week 12 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | The PASI is a standard clinical tool for assessing the severity of psoriasis based on severity of erythema, thickness and scale, as well as the extent of body surface area (BSA) affected with psoriasis. The 3 clinical signs were graded on a 5 point scale (0 to 4) and the % BSA affected was scored on a 7-point scale (0 to 6) for each of the 4 specified body regions (head, upper extremities, trunk and lower extremities). The individual scores were multiplied by a weighted factor for each body region. The sum of these scores gave the overall PASI score. Higher scores indicated more severe disease. The percentage of participants with >=75% improvement in PASI from Baseline were summarized. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | mITT Population | Posted | Number | Percentage of participants | Baseline and up to Week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of participants who achieved a minimum 2-grade improvement from Baseline for each study visit were summarized. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | mITT Population | Posted | Number | Percentage of participants | Baseline and up to Week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of participants who achieved a PGA score of 0 or 1 from Baseline at each study visit was summarized. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | mITT Population | Posted | Number | Percentage of participants | Up to Week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | The extent of BSA affected by psoriasis is a general indicator of disease severity and was measured throughout the study. The extent of BSA to which study treatment was applied was also recorded. For the purpose of approximate clinical estimation, the total palmar surface of the palm plus 5 digits was assumed to be approximately equivalent to 1 percent BSA. Assessment of BSA affected with psoriasis was performed separately for four body surface regions: the head, the upper extremities, the trunk and the lower extremities, corresponding to 10, 20, 30 and 40 percent of the total body area, respectively. The mean change in percent BSA affected from Baseline was summarized for each study visit. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | mITT Population | Posted | Mean | Standard Deviation | Percentage of BSA | Baseline and up to Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in PASI Score From Baseline to Each Study Visit | The PASI is a standard clinical tool for assessing the severity of psoriasis based on severity of erythema, thickness and scale, as well as the extent of BSA affected with psoriasis. The 3 clinical signs were graded on a 5 point scale (0=None to 4=Severe) and the percent of BSA affected is scored on a 7-point scale (0=0% involvement to 6=90-100%) for each of 4 specified body regions (head, upper extremities, trunk and lower extremities). The individual scores were multiplied by a weighted factor for each body region. The sum of these scores gave the overall PASI score. PASI score ranged from 0=no psoriasis to 72=worse psoriasis. The mean change in PASI score from Baseline was summarized for each study visit. Baseline was the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | mITT Population | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and up to Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PGA Scores at Each Study Visit | The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The mean of PGA scores at each study visit was summarized. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | mITT Population | Posted | Mean | Standard Deviation | Scores on a scale | Up to Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in PGA Score From Baseline to Each Study Visit | The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The mean change in PGA scores from Baseline was summarized for each study visit. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | mITT Population | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and up to Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | A single target lesion of at least 3 centimeter (cm) x 3 cm was selected at Baseline. For the selected lesion, the severity of erythema, scaling and plaque thickness (induration) was assessed by the investigator on a 5-point scale ranging from 0=none to 4=severe. The mean change in individual grading scores from Baseline was summarized for each study visit. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | mITT Population | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and up to Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | The participant reported itch severity was obtained from the response of the participants to the itch NRS item in the psoriasis symptom diary (PSD). PSD was developed to assess daily self-reports of psoriasis symptoms and the functional impact related to the underlying pathophysiology of the disease. The participants answered questions related to the severity and impact of the signs and symptoms daily using a 11 point NRS with scores ranging from 0 (absent) to 10 (worst imaginable). Mean change in itch/pruritis NRS from Baseline to each study visit was presented. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the post dose weekly average value minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | mITT Population | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and up to Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of responders that is, participants who achieved a PGA score of 0 or 1 and a minimum 2-grade improvement from baseline were summarized. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | mITT Population | Posted | Number | Percentage of participants | Baseline and up to Week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | An AE is defined as any untoward medical occurrence in a participant under clinical investigation, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. A TEAE is defined as an AE which occurred on or after study treatment start date and on or before the last visit. Number of participants with AEs and SAEs were presented. The analysis was performed on safety Population which comprised of all participants who received at least one dose of study treatment. | Safety Population | Posted | Number | Participants | Up to Week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Reported Local Tolerability Scores | The assessment of the presence and degree of burning/stinging and itching at the application site following application of the study treatment was done at each specified study visit using a 5 point tolerability scale. The scores ranged from 0 to 4 where 0=None and 4=Strong/Severe. The score represented an average across all application sites. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Safety Population | Posted | Number | Participants | Up to Week 14 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Albumin and Protein Level | Blood samples were collected for the evaluation of change in albumin and protein levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Safety Population | Posted | Mean | Standard Deviation | grams/liter (g/L) | Baseline and up to Week 14 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Blood samples were collected for the evaluation of change in levels of alk phos, ALT, AST and GGT from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Safety Population | Posted | Mean | Standard Deviation | International Units (IU)/L | Baseline and up to Week 14 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Blood samples were collected for the evaluation of change in levels of direct bil, bil, creatinine and urate from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Safety Population | Posted | Mean | Standard Deviation | micromoles (µmol)/L | Baseline and up to Week 14 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Blood samples were collected for the evaluation of change in levels of calcium, chloride, CO2, glucose, potassium, sodium, and urea from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Safety Population | Posted | Mean | Standard Deviation | millimoles (mmol)/L | Baseline and up to Week 14 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Blood samples were collected for the evaluation of change in levels of basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocyte count from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Safety Population | Posted | Mean | Standard Deviation | Giga unit/liter (GI/L) | Baseline and up to Week 14 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Hematocrit Levels | Blood samples were collected for the evaluation of change in hematocrit levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Safety Population | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Baseline and up to Week 14 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Blood samples were collected for the evaluation of change in Hgb levels and MCHC from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Safety Population | Posted | Mean | Standard Deviation | G/L | Baseline and up to Week 14 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Blood samples were collected for the evaluation of change in erythrocyte mean corpuscular hemoglobin level from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Safety Population | Posted | Mean | Standard Deviation | Picogram (pg) | Baseline and up to Week 14 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Blood samples were collected for the evaluation of change in erythrocyte mean corpuscular volume from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Safety Population | Posted | Mean | Standard Deviation | Femtoliter (fL) | Baseline and up to Week 14 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Erythrocyte Count | Blood samples were collected for the evaluation of change in erythrocyte count from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Safety Population | Posted | Mean | Standard Deviation | Tetra unit/L (TI/L) | Baseline and up to Week 14 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Chemistry Data of Potential Clinical Importance | Blood samples were collected for the evaluation of clinical chemistry parameters including alk phos, ALT, AST, bil, calcium, CO2, creatinine, glucose and potassium. The number of participants with chemistry data of potential clinical importance for the mentioned parameters was presented. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Safety Population | Posted | Number | Participants | Up to Week 14 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Hematology Data of Clinical Importance | Blood samples were collected for the evaluation of hematology parameters including hematocrit, Hgb, lymphocytes, neutrophils and platelets. The number of participants with clinically significant abnormal values of the mentioned hematology parameters was presented. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Safety Population | Posted | Number | Participants | Up to Week 14 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | Blood samples were collected for the evaluation of change in IgA, IgG and IgM levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Safety Population | Posted | Mean | Standard Deviation | g/L | Baseline and up to Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Ig Data Outside the Reference Range | Blood samples were collected for the evaluation of change in Ig levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Safety Population | Posted | Number | Participants | Up to Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Immunophenotyping Data Outside the Reference Range | Blood samples were collected for the evaluation of change in levels of cluster of differentiation (CD)19, CD3, CD3 Treg flow cytometry (CD3TFLC), CD3+CD8+, CD3+CD8+ TFLC, CD3+CD4+, CD3+CD4+ TFLC, CD16+CD56+, CD3+CD4+CD25+CD127 flow cytometry (CD3+CD4+CD25+CD127), CD3+CD4+foxP3+CD25+CD127 flow cytometry (CD3+CD4+fP3+CD25+CD127) and T Cell B Cell Natural Killer Lymphocytes flow cytometry (T-B cell NKL). Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Safety Population | Posted | Number | Participants | Up to Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Immunophenotype Data | Blood samples were collected for the evaluation of change from Baseline in immunophenotype levels including CD19, CD3, CD3TFLC, CD3+CD8+, CD3+CD8+ TFLC, CD3+CD4+, CD3+CD4+ TFLC, CD16+CD56+, CD3+CD4+CD25+CD127 flow cytometry (CD3+CD4+CD25+CD127), CD3+CD4+foxP3+CD25+CD127 flow cytometry (CD3+CD4+fP3+CD25+CD127) and T-B cell NKL. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Safety Population | Posted | Mean | Standard Deviation | GI/L | Baseline and up to Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP and DBP were measured in semi-supine position after at least 5 minutes of rest. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Safety Population | Posted | Mean | Standard Deviation | Millimeter of mercury (mmHg) | Baseline and up to Week 14 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pulse Rate | Pulse rate was measured in semi-supine position after at least 5 minutes of rest. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Safety Population | Posted | Mean | Standard Deviation | beats per minute | Baseline and up to Week 14 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Temperature | Temperature was measured in semi-supine position after at least 5 minutes of rest. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Safety Population | Posted | Mean | Standard Deviation | degree Celsius | Baseline and up to Week 14 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Vital Signs of Clinical Importance | The vital signs including SBP, DBP and pulse rate were measured from Baseline throughout the study. The number of participants with clinically significant abnormal vital signs were presented. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Safety Population | Posted | Number | Participants | Up to Week 14 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Single 12-lead ECGs were obtained over a brief recording period at each specified time point during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. For multiple ECGs at one visit, or "Any time post-screen", a participant is categorized as "Abnormal" if >=1 assessment is abnormal. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). | Safety Population | Posted | Number | Participants | Up to Week 14 |
|
On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up Visit 2 at Week 16.
Safety Population which comprised of all participants who received at least one dose of study treatment
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GSK2894512 1% BID | The participants were topically administered GSK2894512 1% (10 milligrams per gram [mg/g]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. | 0 | 38 | 1 | 38 | 17 | 38 |
| EG001 | GSK2894512 1% QD | The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. | 0 | 38 | 3 | 38 | 12 | 38 |
| EG002 | GSK2894512 0.5% BID | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. | 0 | 38 | 3 | 38 | 11 | 38 |
| EG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. | 0 | 38 | 0 | 38 | 11 | 38 |
| EG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. | 0 | 37 | 0 | 37 | 3 | 37 |
| EG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. | 0 | 38 | 0 | 38 | 3 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Alcoholic pancreatitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Enlarged uvula | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hemolytic uremic syndrome | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Application site dermatitis | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C571829 | tapinarof |
Not provided
Not provided
Not provided
| Male |
|
| Asian/South East Asian Descent/Japanese Descent |
|
| Black/African American (Afr Amer) |
|
| White/Caucasian |
|
| Amer Ind/Ala Nat & Black/Afr Amer &White/Caucasian |
|
| Black/Afr Amer & White/Caucasian |
|
| Proportion difference |
| 51.0 |
| 2-Sided |
| 95 |
| 22.2 |
| 73.2 |
Difference between GSK2894512 1% QD and Vehicle QD has been presented |
| Other |
| Proportion difference | 35.6 | 2-Sided | 95 | 6.3 | 60.5 | Difference between GSK2894512 0.5% BID and Vehicle BID has been presented | Other |
| Proportion difference | 30.7 | 2-Sided | 95 | 1.6 | 55.9 | Difference between GSK2894512 0.5% QD and Vehicle QD has been presented | Other |
The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
| OG002 | GSK2894512 0.5% BID | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
|
| OG002 | GSK2894512 0.5% BID | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
| OG002 | GSK2894512 0.5% BID | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
| OG002 | GSK2894512 0.5% BID | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
| OG002 | GSK2894512 0.5% BID | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
| OG002 |
| GSK2894512 0.5% BID |
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
| OG002 | GSK2894512 0.5% BID | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
| OG002 | GSK2894512 0.5% BID | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
| OG002 | GSK2894512 0.5% BID | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG002 | GSK2894512 0.5% BID | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
|
| OG002 | GSK2894512 0.5% BID | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp.
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
| GSK2894512 0.5% BID |
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
| GSK2894512 0.5% BID |
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG003 | GSK2894512 0.5% QD | The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG004 | Vehicle BID | The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
| OG005 | Vehicle QD | The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|