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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 adolescent and adult subjects with atopic dermatitis. Results from this study will be considered when selecting the most appropriate concentration of GSK2894512 cream and application frequency in future clinical studies. This is a multicenter (United States, Canada, and Japan), randomized, double-blind (sponsor-unblind), vehicle-controlled, 6-arm, parallel-group, dose-finding study in adolescent and adult subjects with atopic dermatitis. Two concentrations of GSK2894512 cream (0.5% and 1%) and a vehicle control cream will be equally randomized and evaluated following application to all atopic dermatitis 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 adolescent and adult males and females subjects with atopic dermatitis 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.
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| 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 atopic dermatitis lesions (except on the scalp). |
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| 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 atopic dermatitis lesions (except on the scalp). |
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| 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 atopic dermatitis lesions (except on the scalp). |
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| 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 atopic dermatitis lesions (except on the scalp). |
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| 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 atopic dermatitis 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Have an Investigator Global Assessment (IGA) Score of Clear or Almost Clear (0 or 1) at Week 12 and a Minimum 2 Grade Improvement in IGA Score From Baseline to Week 12 for Intent to Treat (ITT) Population | The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. The percentage of participants who have an IGA score of clear or almost clear at Week 12 and a minimum 2 grade improvement from Baseline to Week 12 in IGA score was presented. . The analysis was performed on ITT Population which comprised of all randomized participants. | Baseline and up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Weekly Average of Daily Itch/Pruritus (Numeric Rating Scale [NRS]) Score | NRS is a 11-point tool ranging from 0 (absent) to 10 (worst imaginable) to assess the severity of 11 disease-related signs and symptoms including itching, discoloration, bleeding, oozing, cracking, scaling, flaking, dry/rough, painful, burning, and stinging. Participants were asked to complete the self-administered sign and symptom severity diary containing NRS using a recall period of the past 24 hours. Question 1 of the diary was used to assess itch. Mean change from Baseline to Week 12 in weekly average of daily itch/pruritus based on the NRS was presented using mean and standard deviation (SD). Baseline was defined as the latest assessment prior to first dose and Change from Baseline was defined as post-dose weekly average value minus Baseline value. |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Fort Smith | Arkansas | 72916 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38777187 | Derived | Silverberg JI, Eichenfield LF, Hebert AA, Simpson EL, Stein Gold L, Bissonnette R, Papp KA, Browning J, Kwong P, Korman NJ, Brown PM, Rubenstein DS, Piscitelli SC, Somerville MC, Tallman AM, Kircik L. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024 Sep;91(3):457-465. doi: 10.1016/j.jaad.2024.05.023. Epub 2024 May 20. |
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A total of 363 adolescent and adult participants with atopic dermatitis (AD) were screened, of which 116 were screen failures and 247 entered the treatment phase. Participants in the treatment phase were randomized to receive GSK2894512 cream (0.5 or 1%) or vehicle control once daily (QD) or twice daily (BID).
Eligible participants entered a 4 weeks screening phase and participants who met the eligibility criteria entered into the 12 weeks double-blind treatment phase and 4 weeks post-treatment follow-up phase. The total duration of participation in the study was 16 to 20 weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK2894512 1% BID | Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks. |
| FG001 | GSK2894512 1% QD | Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Vehicle cream once daily | Placebo Comparator | Subjects will apply a thin layer of vehicle topical cream once daily (evening) for 12 weeks, to all atopic dermatitis 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 12 |
| Mean Percent Change From Baseline in Weekly Average of Daily Itch/Pruritus NRS Score | NRS is a 11-point tool ranging from 0 (absent) to 10 (worst imaginable) to assess the severity of 11 disease-related signs and symptoms including itching, discoloration, bleeding, oozing, cracking, scaling, flaking, dry/rough, painful, burning, and stinging. Participants were asked to complete the self-administered sign and symptom severity diary containing NRS using a recall period of the past 24 hours. Question 1 of the diary was used to assess itch. Mean percent change in weekly average of daily itch/pruritus based on the NRS was presented using mean and SD from Baseline to Week 12. Baseline was defined as the latest assessment prior to first dose and Change from Baseline was defined as post-dose weekly average value minus Baseline value. | Baseline and up to Week 12 |
| Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | NRS is a 11-point tool ranging from 0 (absent) to 10 (worst imaginable) to assess the severity of 11 disease-related signs and symptoms including itching, discoloration, bleeding, oozing, cracking, scaling, flaking, dry/rough, painful, burning, and stinging. Participants were asked to complete the self-administered sign and symptom severity diary containing NRS using a recall period of the past 24 hours. Question 1 of the diary was used to assess itch. Percentage of participants who achieved a minimum 3-point improvement in itch/pruritus (NRS) from Baseline to each study visit were measured. Baseline was defined as the latest assessment prior to first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Week 1, 2, 4, 8, 12, 14, 16, early withdrawal (EW) (up to Week 16) |
| Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | The EASI scoring system is a standard clinical tool for assessing the severity of AD that takes into account the overall severity of erythema, infiltration/papulation, excoriation, and lichenification, as well as the extent of BSA affected with AD. These 4 clinical signs were graded on a 4-point scale (0 [absent] to 3 [severe]) for each of the 4 specified body regions (head and neck, upper extremities, lower extremities, and trunk). Body area involvement ranged from 0 (0%) to 6 (90-100%). Total EASI score was calculated as a sum of scores of all 4 specified body region. Range for EASI total score is 0 (absent) to 72 (severe). Baseline was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean change from Baseline was presented in the form of mean and SD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Week 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) |
| Mean Percent Change From Baseline in EASI Score | The EASI scoring system is a standard clinical tool for assessing the severity of AD that takes into account the overall severity of erythema, infiltration/papulation, excoriation, and lichenification, as well as the extent of BSA affected with AD. These 4 clinical signs were graded on a 4-point scale (0 [absent] to 3 [severe]) for each of the 4 specified body regions (head and neck, upper extremities, lower extremities, and trunk). Body area involvement ranged from 0 (0%) to 6 (90-100%). Total EASI score was calculated as a sum of scores of all 4 specified body region. Range for EASI total score is 0 (absent) to 72 (severe). Baseline was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean percent change from Baseline was presented in the form of mean and SD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) |
| Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. IGA is made without reference to previous scores. The percentage of participants with a minimum 2-grade improvement in IGA score from Baseline at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and early withdrawal (EW) visit was presented in the form of mean and SD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) |
| Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. IGA is made without reference to previous scores. The percentage of participants with an IGA score of 0 or 1 at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit was presented in the form of mean and SD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) |
| Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | The EASI scoring system is a standard clinical tool for assessing the severity of AD that takes into account the overall severity of erythema, infiltration/papulation, excoriation, and lichenification, as well as the extent of BSA affected with AD. These 4 clinical signs were graded on a 4-point scale for each of the 4 specified body regions (head and neck, upper extremities, lower extremities, and trunk). Percentage of participants with >=50 percent improvement in EASI score from Baseline to Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW were presented and statistical analysis was performed using a repeated measures factorial logistic regression model. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) |
| Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | The EASI scoring system is a standard clinical tool for assessing the severity of AD that takes into account the overall severity of erythema, infiltration/papulation, excoriation, and lichenification, as well as the extent of BSA affected with AD. These 4 clinical signs were graded on a 4-point scale for each of the 4 specified body regions (head and neck, upper extremities, lower extremities, and trunk). Percentage of participants with >=75 percent improvement in EASI score from Baseline to Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW were presented and statistical analysis was performed using a repeated measures factorial logistic regression model. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) |
| Mean Change From Baseline in Total Severity Score (TSS) | A target lesion of at least 3 centimeter square (cm^2) was selected at Baseline. The severity of the following signs: erythema, induration/papulation, lichenification, oozing/crusting, and scaling was assessed on a 4-point scale ranging from 0 (absent) to 3 (severe), with higher values indicating greater severity of symptoms. TSS (maximum score 15) was calculated based on these signs. Mean change from Baseline in TSS at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit was presented using mean and SD. Baseline value was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) |
| Mean Percent Change From Baseline in TSS | A target lesion of at least 3 cm^2 was selected at Baseline. The severity of the following signs: erythema, induration/papulation, lichenification, oozing/crusting, and scaling was assessed on a 4-point scale ranging from 0 (absent) to 3 (severe) , with higher values indicating greater severity of symptoms. TSS (maximum score 15) was calculated based on these signs. Mean percent change from Baseline in TSS at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit was presented using mean and SD. Baseline value was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Week 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) |
| Mean Change From Baseline in Individual Signs of TSS | The severity of the following signs: erythema, induration/papulation, lichenification, oozing/crusting, and scaling was assessed on a 4-point scale ranging from 0 (absent) to 3 (severe) and TSS (maximum score 15) was calculated based on these signs. Mean change from Baseline in individual signs of TSS was presented using mean and SD. Baseline value was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. If the participant had more than 3 missing days during the week, then the weekly average was not calculated and treated as missing data and excluded from the analysis. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) |
| Mean Percent Change From Baseline in Individual Signs of TSS | The severity of the following signs: erythema, induration/papulation, lichenification, oozing/crusting, and scaling was assessed on a 4-point scale ranging from 0 (absent) to 3 (severe) and TSS (maximum score 15) was calculated based on these signs. Mean percent change from Baseline in individual signs of TSS was presented using mean and SD. Baseline value was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. NA indicates that data were not available. If the participant had more than 3 missing days during the week, then the weekly average was not calculated and treated as missing data and excluded from the analysis. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Week 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) |
| Mean Change From Baseline in Body Surface Area (Percent BSA) | The extent of BSA affected by AD is a general indicator of disease severity and the assessment of BSA with AD was performed separately for four body surface regions: the head (h), the upper extremities (u), the trunk (t) and the lower extremities (l), corresponding to 10, 20, 30, and 40 percent of the total body area, respectively. Mean change from Baseline in percent BSA was presented using mean and SD at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit. Baseline was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) |
| Mean Change From Baseline in IGA Score | The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. IGA is made without reference to previous scores. Score ranges from 0 (clear) to 4 (severe). Higher values represent a severe disease. Mean change from Baseline in IGA score was presented using mean and SD at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit. Baseline was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) |
| Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. IGA is made without reference to previous scores. The percentage of participants who have an IGA score of clear or almost clear and a minimum 2 grade improvement from Baseline to each study visit in IGA score was presented. The statistical analysis was performed using a repeated measures factorial logistic regression model with covariates for dose, frequency of administration, and study day as well as a dose by frequency interaction term. The analysis was performed on ITT Population which comprised of all randomized participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category title). | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to week 16) |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function. Treatment emergent AEs (TEAE) is defined as AE occurred on or after study treatment start date and on or before last visit. Number of participants with AEs and serious TEAEs were presented. The analysis was performed on Safety population which comprised of all participants who receive at least one dose of study treatment. | Weeks 1, 2, 4, 8, 12, 14, EW (up to week 14) |
| Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Participants were asked to use a 5-point tolerability scale from 0 (none) to 4 (severe) to assess the presence and degree of burning/stinging and itching at the application sites that has generally been experienced following application of the study treatment. The score represented an 'average' across all application sites. A score of 3 or 4 was reported as an AE. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Week 1, 2, 4, 8, 12, 14, EW (up to Week 14) |
| Change From Baseline in Albumin and Total Protein | Blood samples were collected to evaluate change from Baseline in albumin and total protein values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. | Week 1, 2, 4, 8, 12, 14, EW (up to week 14) |
| Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Blood samples were collected to evaluate change from Baseline in Alk.phosph., ALT, AST and GGT values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. | Week 2, 4, 8, 12, 14, EW (up to week 14) |
| Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Blood samples were collected to evaluate change from Baseline in direct and total bilirubin, creatinine and urate values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. | Week 2, 4, 8, 12, 14, EW (up to week 14) |
| Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Blood samples were collected to evaluate change from Baseline in calcium, chloride, CO2, glucose, potassium, sodium and BUN values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. | Week 2, 4, 8, 12, 14, EW (up to week 14) |
| Number of Participants With Chemistry Data of Potential Clinical Importance | Blood samples were collected from participants for evaluation of clinical chemistry parameters by Potential Clinical Importance Criteria from Baseline to Week 14, EW and any visit post-screen. The vital signs included alk.phosph., ALT, AST, bilirubin, calcium, CO2, creatinine, glucose and potassium. 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 the category titles). | Week 2, 4, 8, 12, 14, EW (up to week 14) |
| Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Blood samples were collected to evaluate change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet and leukocytes and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. | Week 2, 4, 8, 12, 14, EW (up to week 14) |
| Change From Baseline in Hematocrit Levels | Blood samples were collected to evaluate change from Baseline in hematocrit and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. | Week 2, 4, 8, 12, 14, EW (up to week 14) |
| Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Blood samples were collected to evaluate change from Baseline in hemoglobin and MCHC and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. | Week 2, 4, 8, 12, 14, EW (up to week 14) |
| Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Blood samples were collected to evaluate change from Baseline in MCH and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. | Week 2, 4, 8, 12, 14, EW (up to week 14) |
| Change From Baseline in Mean Corpuscle Volume (MCV) | Blood samples were collected to evaluate change from Baseline in MCV and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. | Week 2, 4, 8, 12, 14, EW (up to week 14) |
| Change From Baseline in Erythrocyte Count | Blood samples were collected to evaluate change from Baseline in erythrocytes and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. | Weeks 2, 4, 8, 12, 14, EW (week up to 14) |
| Number of Participants With Hematology Data of Potential Clinical Importance | Blood samples were collected from participants for evaluation of hematology parameters by Potential Clinical Importance Criteria from Baseline to Week 14, EW and any visit post-screen. The vital signs included hematocrit, hemoglobin, lymphocytes, neutrophils, platelet and leukocytes. 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 the category titles). | Baseline, Week 2, 4, 8, 12, 14, early withdrawal, and post screen (up to Week 16) |
| Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | Blood samples were collected to evaluate change from Baseline in total T lympho, B lympho, T and B NK cells and (Foxp3) values at Baseline throughout the 12 weeks of study treatment. The immunophenotyping parameters included cluster of differentiation (CD)19, CD3, CD3+CD8+, CD3+CD4+, CD16+CD56+, CD3+CD4+CD25+CD127, CD3+CD4+foxP3+CD25+CD127 and T and NK lympho. CD3, CD3+CD8+ and CD3+CD4+ were also evaluated by using treg flow cytometry (cyto). 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 the category titles). Mean and SD were measured. | Week, 4, 8 and 12 |
| Number of Participants With Immunopheotyping Data Outside the Reference Range | Blood samples were collected from participants for evaluation of immunophenotyping parameters by Potential Clinical Importance Criteria at Baseline, Week 4, Week 8, Week 12 nd any visit post-screen. The immunophenotyping parameters included CD 19, CD3, CD3+CD8+, CD3+CD4+, CD16+CD56+, CD3+CD4+CD25+CD127, CD3+CD4+foxP3+CD25+CD127 and T and NK lympho. CD3, CD3+CD8+ and CD3+CD4+ were also evaluated by using treg flow cyto. 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 the category titles). | Baseline, Week, 4, 8, 12 and post-screen (up to Week 16) |
| Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | Blood samples were collected to evaluate change from Baseline in IgA, IgG, IM values at Baseline throughout the 12 weeks of study treatment. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. | Week, 4, 8 and 12 |
| Number of Participants With Immunoglobulin Data Outside the Reference Range | Blood samples were collected from participants for evaluation of immunoglobulin data outside the reference range at Baseline, Week 4, Week 8, Week 12 and any visit post-screen. The immunoglobulin parameters included IgA, IgG and Ig M. 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 the category titles). | Baseline, Week, 4, 8, 12, post-screen (up to Week 16) |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP and DBP were measured from Baseline up to follow up Visit 1 at Week 14 in semi-supine position after at least 5 minutes of rest. The Baseline value was taken at Day 1 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. | Week 1, 2, 4, 8, 12, 14, EW (up to week 14) |
| Change From Baseline in Pulse Rate | Pulse rate were measured from Baseline up to follow up Visit 1 at Week 14 in semi-supine position after at least 5 minutes of rest. The Baseline value was taken at Day 1 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. | Week 1, 2, 4, 8, 12, 14, EW (up to week 14) |
| Change From Baseline in Temperature | Temperature were measured from Baseline up to follow up Visit 1 at Week 14 in semi-supine position after at least 5 minutes of rest. The Baseline value was taken at Day 1 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. | Week 1, 2, 4, 8, 12, 14, EW (up to week 14) |
| Number of Participants With Vital Signs of Potential Clinical Importance | Blood samples were collected from participants for evaluation of vital signs by Potential Clinical Importance Criteria from Baseline to Week 14, EW and any visit post-screen. The vital signs included SBP, DBP and pulse rate. 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 the category titles). | Baseline, Week 2, 4, 8, 12, 14, EW (up to week 14) |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Single measurements of 12-lead ECGs were obtained at Baseline , Week 1, Week 12, Week 14 (follow up 1), EW and at any time post-screen using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc). Baseline was defined as the latest assessment prior to the first dose. For multiple ECGs at one visit, or "Any visit post-screen", a participant was categorized as "Abnormal" if >=1 assessment was abnormal. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Baseline, Week 1, 12, 14, EW ( up to Week 14), post-screen |
| Fresno |
| California |
| 93720-2933 |
| United States |
| GSK Investigational Site | Irvine | California | 92697 | United States |
| GSK Investigational Site | Los Angeles | California | 90045 | United States |
| GSK Investigational Site | Oceanside | California | 92056 | United States |
| GSK Investigational Site | Santa Ana | California | 92701 | United States |
| GSK Investigational Site | Denver | Colorado | 80220 | United States |
| GSK Investigational Site | North Logan | Connecticut | 06032 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30342 | United States |
| GSK Investigational Site | Chicago | Illinois | 60611 | United States |
| GSK Investigational Site | West Dundee | Illinois | 60118 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46256 | United States |
| GSK Investigational Site | New Albany | Indiana | 47150 | United States |
| GSK Investigational Site | Overland Park | Kansas | 66215 | United States |
| GSK Investigational Site | New Orleans | Louisiana | 70115 | United States |
| GSK Investigational Site | Andover | Massachusetts | 01810 | United States |
| GSK Investigational Site | Bay City | Michigan | 48706 | United States |
| GSK Investigational Site | West Bloomfield | Michigan | 48322 | United States |
| GSK Investigational Site | Fridley | Minnesota | 55432 | United States |
| GSK Investigational Site | Saint Joseph | Missouri | 64506 | United States |
| GSK Investigational Site | New York | New York | 10022 | United States |
| GSK Investigational Site | High Point | North Carolina | 27262 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45255 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19103 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15213 | United States |
| GSK Investigational Site | Cranston | Rhode Island | 2910 | United States |
| GSK Investigational Site | Greer | South Carolina | 29650 | United States |
| GSK Investigational Site | Dallas | Texas | 75230 | United States |
| GSK Investigational Site | Dallas | Texas | 75231 | United States |
| GSK Investigational Site | Houston | Texas | 77004 | United States |
| GSK Investigational Site | Houston | Texas | 77056 | United States |
| GSK Investigational Site | San Antonio | Texas | 78218 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Webster | Texas | 77598 | United States |
| GSK Investigational Site | Norfolk | Virginia | 23507 | United States |
| GSK Investigational Site | Seattle | Washington | 98101 | United States |
| GSK Investigational Site | Surrey | British Columbia | V3R 6A7 | Canada |
| GSK Investigational Site | Markham | Ontario | L3P1X2 | 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 5L7 | Canada |
| GSK Investigational Site | Drummondville | Quebec | J2B 5L4 | 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 | 003-0026 | Japan |
| GSK Investigational Site | Hokkaido | 006-0022 | Japan |
| GSK Investigational Site | Kanagawa | 211-0063 | Japan |
| GSK Investigational Site | Kanagawa | 220-0004 | 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 | 169-0075 | Japan |
| GSK Investigational Site | Tokyo | 194-0013 | Japan |
| GSK Investigational Site | Tokyo | 203-0003 | Japan |
| FG002 | GSK2894512 0.5% BID | Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks. |
| FG003 | GSK2894512 0.5% QD | Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| FG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks. |
| FG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GSK2894512 1% BID | Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks. |
| BG001 | GSK2894512 1% QD | Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| BG002 | GSK2894512 0.5% BID | Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks. |
| BG003 | GSK2894512 0.5% QD | Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| BG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| BG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
| 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants Who Have an Investigator Global Assessment (IGA) Score of Clear or Almost Clear (0 or 1) at Week 12 and a Minimum 2 Grade Improvement in IGA Score From Baseline to Week 12 for Intent to Treat (ITT) Population | The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. The percentage of participants who have an IGA score of clear or almost clear at Week 12 and a minimum 2 grade improvement from Baseline to Week 12 in IGA score was presented. . The analysis was performed on ITT Population which comprised of all randomized participants. | ITT Population. Only those participants with data available at specified data points were analyzed. | Posted | Number | Percentage of participant | Baseline and up to Week 12 |
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| Secondary | Mean Change From Baseline in Weekly Average of Daily Itch/Pruritus (Numeric Rating Scale [NRS]) Score | NRS is a 11-point tool ranging from 0 (absent) to 10 (worst imaginable) to assess the severity of 11 disease-related signs and symptoms including itching, discoloration, bleeding, oozing, cracking, scaling, flaking, dry/rough, painful, burning, and stinging. Participants were asked to complete the self-administered sign and symptom severity diary containing NRS using a recall period of the past 24 hours. Question 1 of the diary was used to assess itch. Mean change from Baseline to Week 12 in weekly average of daily itch/pruritus based on the NRS was presented using mean and standard deviation (SD). Baseline was defined as the latest assessment prior to first dose and Change from Baseline was defined as post-dose weekly average value minus Baseline value. | ITT Population | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and up to Week 12 |
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| Secondary | Mean Percent Change From Baseline in Weekly Average of Daily Itch/Pruritus NRS Score | NRS is a 11-point tool ranging from 0 (absent) to 10 (worst imaginable) to assess the severity of 11 disease-related signs and symptoms including itching, discoloration, bleeding, oozing, cracking, scaling, flaking, dry/rough, painful, burning, and stinging. Participants were asked to complete the self-administered sign and symptom severity diary containing NRS using a recall period of the past 24 hours. Question 1 of the diary was used to assess itch. Mean percent change in weekly average of daily itch/pruritus based on the NRS was presented using mean and SD from Baseline to Week 12. Baseline was defined as the latest assessment prior to first dose and Change from Baseline was defined as post-dose weekly average value minus Baseline value. | ITT Population | Posted | Mean | Standard Deviation | Percentage Change | Baseline and up to Week 12 |
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| Secondary | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | NRS is a 11-point tool ranging from 0 (absent) to 10 (worst imaginable) to assess the severity of 11 disease-related signs and symptoms including itching, discoloration, bleeding, oozing, cracking, scaling, flaking, dry/rough, painful, burning, and stinging. Participants were asked to complete the self-administered sign and symptom severity diary containing NRS using a recall period of the past 24 hours. Question 1 of the diary was used to assess itch. Percentage of participants who achieved a minimum 3-point improvement in itch/pruritus (NRS) from Baseline to each study visit were measured. Baseline was defined as the latest assessment prior to first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | ITT Population | Posted | Number | Percentage of Participants | Week 1, 2, 4, 8, 12, 14, 16, early withdrawal (EW) (up to Week 16) |
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| Secondary | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | The EASI scoring system is a standard clinical tool for assessing the severity of AD that takes into account the overall severity of erythema, infiltration/papulation, excoriation, and lichenification, as well as the extent of BSA affected with AD. These 4 clinical signs were graded on a 4-point scale (0 [absent] to 3 [severe]) for each of the 4 specified body regions (head and neck, upper extremities, lower extremities, and trunk). Body area involvement ranged from 0 (0%) to 6 (90-100%). Total EASI score was calculated as a sum of scores of all 4 specified body region. Range for EASI total score is 0 (absent) to 72 (severe). Baseline was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean change from Baseline was presented in the form of mean and SD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | ITT Population | Posted | Mean | Standard Deviation | Scores on a scale | Week 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) |
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| Secondary | Mean Percent Change From Baseline in EASI Score | The EASI scoring system is a standard clinical tool for assessing the severity of AD that takes into account the overall severity of erythema, infiltration/papulation, excoriation, and lichenification, as well as the extent of BSA affected with AD. These 4 clinical signs were graded on a 4-point scale (0 [absent] to 3 [severe]) for each of the 4 specified body regions (head and neck, upper extremities, lower extremities, and trunk). Body area involvement ranged from 0 (0%) to 6 (90-100%). Total EASI score was calculated as a sum of scores of all 4 specified body region. Range for EASI total score is 0 (absent) to 72 (severe). Baseline was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean percent change from Baseline was presented in the form of mean and SD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | ITT Population | Posted | Mean | Standard Deviation | Percentage Change | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) |
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| Secondary | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. IGA is made without reference to previous scores. The percentage of participants with a minimum 2-grade improvement in IGA score from Baseline at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and early withdrawal (EW) visit was presented in the form of mean and SD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | ITT Population | Posted | Number | Percentage of participants | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) |
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| Secondary | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. IGA is made without reference to previous scores. The percentage of participants with an IGA score of 0 or 1 at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit was presented in the form of mean and SD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | ITT Population | Posted | Number | Percentage of participants | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) |
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| Secondary | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | The EASI scoring system is a standard clinical tool for assessing the severity of AD that takes into account the overall severity of erythema, infiltration/papulation, excoriation, and lichenification, as well as the extent of BSA affected with AD. These 4 clinical signs were graded on a 4-point scale for each of the 4 specified body regions (head and neck, upper extremities, lower extremities, and trunk). Percentage of participants with >=50 percent improvement in EASI score from Baseline to Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW were presented and statistical analysis was performed using a repeated measures factorial logistic regression model. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | ITT Population | Posted | Number | Percentage of participants | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) |
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| Secondary | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | The EASI scoring system is a standard clinical tool for assessing the severity of AD that takes into account the overall severity of erythema, infiltration/papulation, excoriation, and lichenification, as well as the extent of BSA affected with AD. These 4 clinical signs were graded on a 4-point scale for each of the 4 specified body regions (head and neck, upper extremities, lower extremities, and trunk). Percentage of participants with >=75 percent improvement in EASI score from Baseline to Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW were presented and statistical analysis was performed using a repeated measures factorial logistic regression model. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | ITT Population | Posted | Number | Percentage of participants | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) |
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| Secondary | Mean Change From Baseline in Total Severity Score (TSS) | A target lesion of at least 3 centimeter square (cm^2) was selected at Baseline. The severity of the following signs: erythema, induration/papulation, lichenification, oozing/crusting, and scaling was assessed on a 4-point scale ranging from 0 (absent) to 3 (severe), with higher values indicating greater severity of symptoms. TSS (maximum score 15) was calculated based on these signs. Mean change from Baseline in TSS at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit was presented using mean and SD. Baseline value was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | ITT Population | Posted | Mean | Standard Deviation | Scores on a scale | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) |
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| Secondary | Mean Percent Change From Baseline in TSS | A target lesion of at least 3 cm^2 was selected at Baseline. The severity of the following signs: erythema, induration/papulation, lichenification, oozing/crusting, and scaling was assessed on a 4-point scale ranging from 0 (absent) to 3 (severe) , with higher values indicating greater severity of symptoms. TSS (maximum score 15) was calculated based on these signs. Mean percent change from Baseline in TSS at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit was presented using mean and SD. Baseline value was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | ITT Population | Posted | Mean | Standard Deviation | Percentage Change | Week 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) |
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| Secondary | Mean Change From Baseline in Individual Signs of TSS | The severity of the following signs: erythema, induration/papulation, lichenification, oozing/crusting, and scaling was assessed on a 4-point scale ranging from 0 (absent) to 3 (severe) and TSS (maximum score 15) was calculated based on these signs. Mean change from Baseline in individual signs of TSS was presented using mean and SD. Baseline value was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. If the participant had more than 3 missing days during the week, then the weekly average was not calculated and treated as missing data and excluded from the analysis. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | ITT Population | Posted | Mean | Standard Deviation | Scores on a scale | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) |
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| Secondary | Mean Percent Change From Baseline in Individual Signs of TSS | The severity of the following signs: erythema, induration/papulation, lichenification, oozing/crusting, and scaling was assessed on a 4-point scale ranging from 0 (absent) to 3 (severe) and TSS (maximum score 15) was calculated based on these signs. Mean percent change from Baseline in individual signs of TSS was presented using mean and SD. Baseline value was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. NA indicates that data were not available. If the participant had more than 3 missing days during the week, then the weekly average was not calculated and treated as missing data and excluded from the analysis. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | ITT Population | Posted | Mean | Standard Deviation | Percentage Change | Week 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) |
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| Secondary | Mean Change From Baseline in Body Surface Area (Percent BSA) | The extent of BSA affected by AD is a general indicator of disease severity and the assessment of BSA with AD was performed separately for four body surface regions: the head (h), the upper extremities (u), the trunk (t) and the lower extremities (l), corresponding to 10, 20, 30, and 40 percent of the total body area, respectively. Mean change from Baseline in percent BSA was presented using mean and SD at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit. Baseline was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | ITT Population | Posted | Mean | Standard Deviation | Percentage of surface area | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) |
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| Secondary | Mean Change From Baseline in IGA Score | The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. IGA is made without reference to previous scores. Score ranges from 0 (clear) to 4 (severe). Higher values represent a severe disease. Mean change from Baseline in IGA score was presented using mean and SD at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit. Baseline was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | ITT Population | Posted | Mean | Standard Deviation | Scores on a scale | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) |
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| Secondary | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. IGA is made without reference to previous scores. The percentage of participants who have an IGA score of clear or almost clear and a minimum 2 grade improvement from Baseline to each study visit in IGA score was presented. The statistical analysis was performed using a repeated measures factorial logistic regression model with covariates for dose, frequency of administration, and study day as well as a dose by frequency interaction term. The analysis was performed on ITT Population which comprised of all randomized participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category title). | ITT Population | Posted | Number | Percentage of participants | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to week 16) |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function. Treatment emergent AEs (TEAE) is defined as AE occurred on or after study treatment start date and on or before last visit. Number of participants with AEs and serious TEAEs were presented. The analysis was performed on Safety population which comprised of all participants who receive at least one dose of study treatment. | Safety Population | Posted | Number | Participants | Weeks 1, 2, 4, 8, 12, 14, EW (up to week 14) |
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| Secondary | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Participants were asked to use a 5-point tolerability scale from 0 (none) to 4 (severe) to assess the presence and degree of burning/stinging and itching at the application sites that has generally been experienced following application of the study treatment. The score represented an 'average' across all application sites. A score of 3 or 4 was reported as an AE. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Safety Population | Posted | Number | Participants | Week 1, 2, 4, 8, 12, 14, EW (up to Week 14) |
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| Secondary | Change From Baseline in Albumin and Total Protein | Blood samples were collected to evaluate change from Baseline in albumin and total protein values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. | Safety Population | Posted | Mean | Standard Deviation | Gram per Liter (G/L) | Week 1, 2, 4, 8, 12, 14, EW (up to week 14) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Blood samples were collected to evaluate change from Baseline in Alk.phosph., ALT, AST and GGT values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. | Safety Population | Posted | Mean | Standard Deviation | International unit per liter (IU/L) | Week 2, 4, 8, 12, 14, EW (up to week 14) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Blood samples were collected to evaluate change from Baseline in direct and total bilirubin, creatinine and urate values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. | Safety Population | Posted | Mean | Standard Deviation | Micromoles per liter (µmol/L) | Week 2, 4, 8, 12, 14, EW (up to week 14) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Blood samples were collected to evaluate change from Baseline in calcium, chloride, CO2, glucose, potassium, sodium and BUN values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. | Safety Population | Posted | Mean | Standard Deviation | Millimoles per liter (mmol/L) | Week 2, 4, 8, 12, 14, EW (up to week 14) |
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| Secondary | Number of Participants With Chemistry Data of Potential Clinical Importance | Blood samples were collected from participants for evaluation of clinical chemistry parameters by Potential Clinical Importance Criteria from Baseline to Week 14, EW and any visit post-screen. The vital signs included alk.phosph., ALT, AST, bilirubin, calcium, CO2, creatinine, glucose and potassium. 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 the category titles). | Safety Population | Posted | Number | Participants | Week 2, 4, 8, 12, 14, EW (up to week 14) |
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| Secondary | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Blood samples were collected to evaluate change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet and leukocytes and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. | Safety Population | Posted | Mean | Standard Deviation | Giga cells per liter (GI/L) | Week 2, 4, 8, 12, 14, EW (up to week 14) |
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| Secondary | Change From Baseline in Hematocrit Levels | Blood samples were collected to evaluate change from Baseline in hematocrit and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. | Safety Population | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Week 2, 4, 8, 12, 14, EW (up to week 14) |
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| Secondary | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Blood samples were collected to evaluate change from Baseline in hemoglobin and MCHC and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. | Safety Population | Posted | Mean | Standard Deviation | G/L | Week 2, 4, 8, 12, 14, EW (up to week 14) |
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| Secondary | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Blood samples were collected to evaluate change from Baseline in MCH and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. | Safety Population | Posted | Mean | Standard Deviation | Picogram (Pg) | Week 2, 4, 8, 12, 14, EW (up to week 14) |
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| Secondary | Change From Baseline in Mean Corpuscle Volume (MCV) | Blood samples were collected to evaluate change from Baseline in MCV and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. | Safety Population | Posted | Mean | Standard Deviation | Femtoliter (fL) | Week 2, 4, 8, 12, 14, EW (up to week 14) |
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| Secondary | Change From Baseline in Erythrocyte Count | Blood samples were collected to evaluate change from Baseline in erythrocytes and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. | Safety Population | Posted | Mean | Standard Deviation | Tetra cells per liter (TI/L) | Weeks 2, 4, 8, 12, 14, EW (week up to 14) |
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| Secondary | Number of Participants With Hematology Data of Potential Clinical Importance | Blood samples were collected from participants for evaluation of hematology parameters by Potential Clinical Importance Criteria from Baseline to Week 14, EW and any visit post-screen. The vital signs included hematocrit, hemoglobin, lymphocytes, neutrophils, platelet and leukocytes. 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 the category titles). | Safety Population | Posted | Number | Participants | Baseline, Week 2, 4, 8, 12, 14, early withdrawal, and post screen (up to Week 16) |
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| Secondary | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | Blood samples were collected to evaluate change from Baseline in total T lympho, B lympho, T and B NK cells and (Foxp3) values at Baseline throughout the 12 weeks of study treatment. The immunophenotyping parameters included cluster of differentiation (CD)19, CD3, CD3+CD8+, CD3+CD4+, CD16+CD56+, CD3+CD4+CD25+CD127, CD3+CD4+foxP3+CD25+CD127 and T and NK lympho. CD3, CD3+CD8+ and CD3+CD4+ were also evaluated by using treg flow cytometry (cyto). 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 the category titles). Mean and SD were measured. | Safety population | Posted | Mean | Standard Deviation | GI/L | Week, 4, 8 and 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Immunopheotyping Data Outside the Reference Range | Blood samples were collected from participants for evaluation of immunophenotyping parameters by Potential Clinical Importance Criteria at Baseline, Week 4, Week 8, Week 12 nd any visit post-screen. The immunophenotyping parameters included CD 19, CD3, CD3+CD8+, CD3+CD4+, CD16+CD56+, CD3+CD4+CD25+CD127, CD3+CD4+foxP3+CD25+CD127 and T and NK lympho. CD3, CD3+CD8+ and CD3+CD4+ were also evaluated by using treg flow cyto. 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 the category titles). | Safety population | Posted | Number | Participants | Baseline, Week, 4, 8, 12 and post-screen (up to Week 16) |
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| Secondary | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | Blood samples were collected to evaluate change from Baseline in IgA, IgG, IM values at Baseline throughout the 12 weeks of study treatment. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. | Safety population | Posted | Mean | Standard Deviation | G/L | Week, 4, 8 and 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Immunoglobulin Data Outside the Reference Range | Blood samples were collected from participants for evaluation of immunoglobulin data outside the reference range at Baseline, Week 4, Week 8, Week 12 and any visit post-screen. The immunoglobulin parameters included IgA, IgG and Ig M. 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 the category titles). | Safety population | Posted | Number | Participants | Baseline, Week, 4, 8, 12, post-screen (up to Week 16) |
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| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP and DBP were measured from Baseline up to follow up Visit 1 at Week 14 in semi-supine position after at least 5 minutes of rest. The Baseline value was taken at Day 1 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. | Safety Population | Posted | Mean | Standard Deviation | Millimeter of mercury (mmHg) | Week 1, 2, 4, 8, 12, 14, EW (up to week 14) |
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| Secondary | Change From Baseline in Pulse Rate | Pulse rate were measured from Baseline up to follow up Visit 1 at Week 14 in semi-supine position after at least 5 minutes of rest. The Baseline value was taken at Day 1 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. | Safety Population | Posted | Mean | Standard Deviation | Beats per minute (bpm) | Week 1, 2, 4, 8, 12, 14, EW (up to week 14) |
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| Secondary | Change From Baseline in Temperature | Temperature were measured from Baseline up to follow up Visit 1 at Week 14 in semi-supine position after at least 5 minutes of rest. The Baseline value was taken at Day 1 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. | Safety Population | Posted | Mean | Standard Deviation | Degree Celsius | Week 1, 2, 4, 8, 12, 14, EW (up to week 14) |
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| Secondary | Number of Participants With Vital Signs of Potential Clinical Importance | Blood samples were collected from participants for evaluation of vital signs by Potential Clinical Importance Criteria from Baseline to Week 14, EW and any visit post-screen. The vital signs included SBP, DBP and pulse rate. 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 the category titles). | Safety Population | Posted | Number | Participants | Baseline, Week 2, 4, 8, 12, 14, EW (up to week 14) |
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| Secondary | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Single measurements of 12-lead ECGs were obtained at Baseline , Week 1, Week 12, Week 14 (follow up 1), EW and at any time post-screen using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc). Baseline was defined as the latest assessment prior to the first dose. For multiple ECGs at one visit, or "Any visit post-screen", a participant was categorized as "Abnormal" if >=1 assessment was abnormal. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Safety population | Posted | Number | Participants | Baseline, Week 1, 12, 14, EW ( up to Week 14), post-screen |
|
On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Folow up Visit 2 at Week 16.
AEs and SAEs were collected in 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% Cream Twice Daily | 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 atopic dermatitis lesions (except on the scalp). | 0 | 40 | 1 | 40 | 28 | 40 |
| EG001 | GSK2894512 1% Cream Once Daily | Subjects will apply a thin layer of GSK2894512 1% (10 mg/g) topical cream once daily (evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp). | 0 | 41 | 0 | 41 | 22 | 41 |
| EG002 | GSK2894512 0.5% Cream Twice Daily | 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 atopic dermatitis lesions (except on the scalp). | 0 | 43 | 0 | 43 | 20 | 43 |
| EG003 | GSK2894512 0.5% Cream Once Daily | Subjects will apply a thin layer of GSK2894512 0.5% (5 mg/g) topical cream once daily (evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp). | 0 | 41 | 0 | 41 | 23 | 41 |
| EG004 | Vehicle Cream Twice Daily | Subjects will apply a thin layer of vehicle topical cream twice daily (morning and evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp). | 0 | 42 | 0 | 42 | 19 | 42 |
| EG005 | Vehicle Cream Once Daily | Subjects will apply a thin layer of vehicle topical cream once daily (evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp). | 0 | 40 | 0 | 40 | 15 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Attention deficit /hyperactivity disorder | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Upper respiratory | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Eczema impetiginous | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| External ear cellulitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Staphylococcal impetigo | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Staphylococcal skin infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Superinfection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Sycosis barbae | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hyperkeratosis follicularis et parafollicularis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Milia | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Application site pain | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Application site reaction | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cyst | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Application site erythema | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Application site oedema | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Local reaction | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Lip oedema | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Blood creatinine decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Laboratory test abnormal | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Monocyte count decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Coccydynia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Eye ulcer | Eye disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Benign neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Attention deficit/hyperactivity disorder | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.1 | 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 |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C571829 | tapinarof |
Not provided
Not provided
Not provided
| Male |
|
| Black/African American |
|
| American Indian/Alaska Native |
|
| Asian/S.E. Asian Descent/Japanese |
|
| American Indian/Alaska Native and African American |
|
| Asian/S.E. Asian/Japanese and African American |
|
| Asian/S.E. Asian/Japanese and Black and White |
|
| Asian/S.E. Asian/Japanese and White/Caucasian |
|
| Black/African American and White/Caucasian |
|
| Difference in percentages |
| 7.4 |
| 2-Sided |
| 95 |
| -18.3 |
| 32.0 |
Difference between GSK2894512 1 percent QD and Vehicle QD has been presented. |
| Other |
| Difference in percentages | 14.3 | 2-Sided | 95 | -11.2 | 38.7 | Difference between GSK2894512 0.5 percent BID and Vehicle BID has been presented. | Other |
| Difference in percentages | -4.0 | 2-Sided | 95 | -29.3 | 21.6 | Difference between GSK2894512 0.5 percent QD and Vehicle QD has been presented. | Other |
Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks. |
| OG003 | GSK2894512 0.5% QD | Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks.
| OG003 | GSK2894512 0.5% QD | Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
| GSK2894512 0.5% BID |
Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks. |
| OG003 | GSK2894512 0.5% QD | Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
| OG002 | GSK2894512 0.5% BID | Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks. |
| OG003 | GSK2894512 0.5% QD | Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
| OG002 | GSK2894512 0.5% BID | Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks. |
| OG003 | GSK2894512 0.5% QD | Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks. |
| OG003 | GSK2894512 0.5% QD | Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
| OG003 | GSK2894512 0.5% QD | Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
| GSK2894512 0.5% BID |
Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks. |
| OG003 | GSK2894512 0.5% QD | Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
|
| GSK2894512 0.5% BID |
Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks. |
| OG003 | GSK2894512 0.5% QD | Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
|
| GSK2894512 0.5% BID |
Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks. |
| OG003 | GSK2894512 0.5% QD | Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks. |
| OG003 | GSK2894512 0.5% QD | Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks. |
| OG003 | GSK2894512 0.5% QD | Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
| GSK2894512 0.5% BID |
Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks. |
| OG003 | GSK2894512 0.5% QD | Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks. |
| OG003 | GSK2894512 0.5% QD | Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
| GSK2894512 0.5% BID |
Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks. |
| OG003 | GSK2894512 0.5% QD | Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
| OG002 | GSK2894512 0.5% BID | Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks. |
| OG003 | GSK2894512 0.5% QD | Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
|
| GSK2894512 0.5% BID |
Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks. |
| OG003 | GSK2894512 0.5% QD | Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
| GSK2894512 0.5% QD |
Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
| GSK2894512 0.5% QD |
Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
| OG003 | GSK2894512 0.5% QD | Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
| OG003 |
| GSK2894512 0.5% QD |
Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
| OG003 | GSK2894512 0.5% QD | Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
| GSK2894512 0.5% QD |
Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
| OG003 | GSK2894512 0.5% QD | Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
| GSK2894512 0.5% QD |
Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
| GSK2894512 0.5% QD |
Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
| GSK2894512 0.5% QD |
Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
| OG003 |
| GSK2894512 0.5% QD |
Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
| OG003 | GSK2894512 0.5% QD | Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
| OG003 | GSK2894512 0.5% QD | Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
| GSK2894512 0.5% QD |
Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
| GSK2894512 0.5% QD |
Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
|
|
| OG003 | GSK2894512 0.5% QD | Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. |
| OG004 | Vehicle BID | Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks |
| OG005 | Vehicle QD | Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks |
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