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This study will evaluate efficacy and safety of GSK1070806 in moderate to severe atopic dermatitis (AtD) participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: GSK1070806 | Experimental | Participants received a single dose of 2 mg/kg GSK1070806 as intravenous infusion on Day 1. |
|
| Group 1: Placebo | Placebo Comparator | Participants received Placebo as intravenous infusion on Day 1. |
|
| Group 2: Dupilumab-IR with GSK1070806 | Experimental | Participants received a single dose of 2 mg/kg GSK1070806 as intravenous infusion on Day 1. |
|
| Group 2: Dupilumab IR with Placebo | Placebo Comparator | Participants received Placebo as intravenous infusion on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1070806 | Drug | GSK1070806 will be administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline (PCFB) in Eczema Area and Severity Index (EASI) Score at Week 12 in Group 1 | EASI scoring system is standardized clinical tool for assessment of extent (area) and severity of atopic dermatitis (AD). Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk and lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % body surface area with AD in body region: 0 (0%), 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100% The final EASI score was obtained by weight-averaging these 4 scores and scores ranged from 0 to 72, with higher scores= more severe or extensive condition. Posterior Median presented from Bayesian analysis under the hypothetical strategy. The percent change from baseline in the EASI score at week 12 in group 1 is reported here. Data reported as 'Median' refers to 'Posterior Median' and '95% Confidence Interval' refers to '95% Credible Interval'. | Baseline (Day 1) and at Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in EASI Score at Week 12 in Group 1 | EASI scoring system is standardized clinical tool for assessment of extent (area) and severity of atopic dermatitis (AD). Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk and lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % body surface area with AD in body region: 0 (0%), 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100% The final EASI score was obtained by weight-averaging these 4 scores and scores ranged from 0 to 72, with higher scores= more severe or extensive condition. Posterior Median presented from Bayesian analysis under the hypothetical strategy. The change from baseline in the EASI score at week 12 in group 1 is reported here. Data reported as 'Median' refers to 'Posterior Median' and '95% Confidence Interval' refers to '95% Credible Interval'. |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | North Little Rock | Arkansas | 72117 | United States | ||
| GSK Investigational Site |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
The study assessed the impact of GSK1070806 in two groups (Group 1 and Group 2) of participants with moderate-to-severe Atopic Dermatitis (AtD). Group 1 included participants naive to biologic treatment (and who have failed topical therapies) and Group 2 included participants who have not adequately responded (or have been intolerant) to dupilumab (Dupixent).
A total of 34 participants were enrolled at different centers in Canada and United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: GSK1070806 | Participants received a single dose of 2 milligram per kilogram (mg/kg) GSK1070806 as intravenous infusion on Day 1. |
| FG001 | Group 1: Placebo | Participants received Placebo as intravenous infusion on Day 1. |
| FG002 | Group 2: Dupilumab- Inadequate Responders (IR) With GSK1070806 | Participants received a single dose of 2 mg/kg GSK1070806 as intravenous infusion on Day 1. |
| FG003 | Group 2: Dupilumab IR With Placebo | Participants received Placebo as intravenous infusion on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The analysis population comprised of enrolled analysis set who were assigned to study intervention. Because of the small sample size, summary of baseline/demographics categorical variables are presented as de-identified to prevent risk of participant re-identification.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: GSK1070806 | Participants received a single dose of 2 mg/kg GSK1070806 as intravenous infusion on Day 1. |
| BG001 | Group 1: Placebo | Participants received Placebo as intravenous infusion on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline (PCFB) in Eczema Area and Severity Index (EASI) Score at Week 12 in Group 1 | EASI scoring system is standardized clinical tool for assessment of extent (area) and severity of atopic dermatitis (AD). Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk and lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % body surface area with AD in body region: 0 (0%), 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100% The final EASI score was obtained by weight-averaging these 4 scores and scores ranged from 0 to 72, with higher scores= more severe or extensive condition. Posterior Median presented from Bayesian analysis under the hypothetical strategy. The percent change from baseline in the EASI score at week 12 in group 1 is reported here. Data reported as 'Median' refers to 'Posterior Median' and '95% Confidence Interval' refers to '95% Credible Interval'. | The Safety Set included all randomized participants who received the study intervention. Participants were analyzed according to the intervention they actually received. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | Percent Change | Baseline (Day 1) and at Week 12 |
From Day 1 and up to Week 24
Safety Set comprised of all randomized participants who received study intervention and reported for both Group 1 and group 2 combined as pre-specified in the protocol objectives.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GSK1070806 | Group-1, Biologic naive and group-2, Dupilumab-Inadequate (Dupi-IR) Responder participants received a single dose of 2 mg/kg of GSK1070806 intravenous infusion on Day 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 6, 2022 | Dec 19, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 15, 2022 | Dec 19, 2023 | SAP_001.pdf |
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| 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 |
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| ID | Term |
|---|---|
| C000608195 | GSK1070806 |
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This is a double-blind study
| Placebo | Drug | Placebo will be administered |
|
| Baseline (Day 1) and at Week 12 |
| Number of Participants Achieving EASI-50, ≥ 50% Reduction in EASI Score at Week 12 in Group 1 | EASI scoring system is standardized clinical tool for assessment of extent (area) and severity of atopic dermatitis (AD). Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk and lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % body surface area with AD in body region: 0 (0%), 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100% The final EASI score was obtained by weight-averaging these 4 scores and scores ranged from 0 to 72, with higher scores= more severe or extensive condition. The EASI-50 responder is defined as a participant who achieves a ≥ 50% improvement from baseline in the EASI score. | At Week 12 |
| Number of Participants Achieving EASI-75, ≥ 75% Reduction in EASI Score at Week 12 in Group 1 | EASI scoring system is standardized clinical tool for assessment of extent (area) and severity of atopic dermatitis (AD). Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk and lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % body surface area with AD in body region: 0 (0%), 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100% The final EASI score was obtained by weight-averaging these 4 scores and scores ranged from 0 to 72, with higher scores= more severe or extensive condition. The EASI-75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score. | At Week 12 |
| Number of Participants Achieving EASI-90, ≥ 90% Reduction in EASI Score at Week 12 in Group 1 | EASI scoring system is standardized clinical tool for assessment of extent (area) and severity of atopic dermatitis (AD). Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk and lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % body surface area with AD in body region: 0 (0%), 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100% The final EASI score was obtained by weight-averaging these 4 scores and scores ranged from 0 to 72, with higher scores= more severe or extensive condition. The EASI-90 responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score. | At Week 12 |
| Number of Participants With Investigator Global Assessment (IGA) Score of 0 or 1 at Week 12 in Group 1 | The Investigator Global Assessment (IGA) is a clinical tool for assessing the current state/severity of a participant's atopic dermatitis. It is a static 5-point morphological assessment of overall disease severity determined by the investigator, sub-investigator, or trained healthcare professional with required qualifications on a scale of 0 to 4 where, 0-clear, 1-almost clear, 2-mild, 3-moderate, and 4- severe. Higher score indicates severity of disease. A Responder is defined as a participant who had an IGA score of 0 or 1 at each visit. | At Week 12 |
| Percent Change From Baseline in EASI Score at Week 12 in Group 2 | EASI scoring system is standardized clinical tool for assessment of extent (area) and severity of atopic dermatitis (AD). Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk and lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % body surface area with AD in body region: 0 (0%), 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100% The final EASI score was obtained by weight-averaging these 4 scores and scores ranged from 0 to 72, with higher scores= more severe or extensive condition. NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation (SD) was not derived. | Baseline (Day 1) and at Week 12 |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) - Groups 1 and 2 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any serious adverse event that, at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and other situations as per investigator's medical or scientific judgment. | Up to Week 24 |
| Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 | Vital signs included diastolic blood pressure (DBP), systolic blood pressure (SBP), pulse rate (PR) and body temperature were measured after resting for at least 5 minutes in semi-supine position. PCI ranges- SBP (millimeters of mercury[mmHg]): <85 (low) or >160 (high), DBP (mmHg): <45 (low) or >100 (high), PR (beats per minute): <40 (low) or >110 (high) and body temperature (degrees Celsius) <=35.5 (low) or >38.0 (high). Participants with worst case results relative to PCI criteria and who had values "to high" are reported here. Participants with a missing baseline value are assumed to have a within range value. | Up to Week 24 |
| Number of Participants With Worst Case 12-lead Electrocardiogram (ECG) Post-Baseline Relative to Baseline - Groups 1 and 2 | Twelve lead ECG was obtained using an ECG machine that automatically calculated the heart rate and measured QTc, PR, QRS intervals. Participants with clinically significant changes relative to baseline are reported here. Clinically significant findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | Up to Week 24 |
| Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline - Groups 1 and 2 | Urine samples were collected to assess urine glucose, bilirubin, protein, occult blood, Leukocyte Esterase and ketones using dipstick method. Participants with clinically significant changes relative to baseline are reported here. Clinically significant findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Baseline was defined as the latest pre-dose assessment. | Up to Week 24 |
| Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 | Blood samples were collected for analysis of chemistry parameters. PCI ranges were >3*Upper limit of normal (ULN) units per liter (U/L)(Alanine Aminotransferase [ALT]), >3*ULN (U/L) (Aspartate Aminotransferase ([AST]), >2*ULN (Alkaline Phosphatase [ALP]) (U/L), >2*ULN (micromoles per liter) (bilirubin), <3 or >6.5 mmol/L (potassium), <130 or >160 mmol/L (sodium), <1.5 or >3.25 mmol/L (Corrected Calcium) and >40 mmol/L (Urea). Participants with worst case results relative to PCI criteria and who had values "to high" are reported here. Participants with a missing baseline value are assumed to have a within range value. | Up to Week 24 |
| Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 | Blood samples were collected for analysis of hematology parameters. The ranges for the hematology parameters are as follows: Hematocrit [High >0.54 Proportion of red blood cells in blood, Low <0.1 Proportion of red blood cells in blood], Haemoglobin [Higher: > 185 grams/Litre (g/L) Low: less than (<) 100 g/L ], Lymphocytes [<0.8 10^9/L], Neutrophils [<1.5 10^9/L], Platelets [High: > 999 10^9/ L and Low: < 100 10^9/ L] and White blood cells [Low:<2 10^9/L]. Participants were counted in worst case category that their value changes to (low, within range or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (for example [e.g.], High to High), or whose value became within range, were recorded in "To within Range or No Change" category. Participants were counted twice if participant has values that changed 'To Low' & 'To High', so the percentages may not add to 100%. | Up to Week 25 |
| Number of Participants With Anti-drug Antibodies (ADA)- Groups 1 and 2 | Serum samples were analyzed for the presence of antibodies using a validated assay method. The treatment emergent ADA assay results up to week 24 are reported. | Up to Week 24 |
| Miami |
| Florida |
| 33155 |
| United States |
| GSK Investigational Site | Tampa | Florida | 33613 | United States |
| GSK Investigational Site | Troy | Michigan | 48084 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73118 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19103 | United States |
| GSK Investigational Site | San Antonio | Texas | 78218 | United States |
| GSK Investigational Site | Sugar Land | Texas | 77479 | United States |
| GSK Investigational Site | Edmonton | Alberta | T6G 1C3 | Canada |
| GSK Investigational Site | London | Ontario | N6A 5R9 | Canada |
| GSK Investigational Site | London | Ontario | N6H 5L5 | Canada |
| Withdrawal by Subject |
|
| BG002 | Group 2: Dupilumab-IR With GSK1070806 | Participants received a single dose of 2 mg/kg GSK1070806 as intravenous infusion on Day 1. |
| BG003 | Group 2: Dupilumab IR With Placebo | Participants received Placebo as intravenous infusion on Day 1. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
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|
|
| Secondary | Change From Baseline in EASI Score at Week 12 in Group 1 | EASI scoring system is standardized clinical tool for assessment of extent (area) and severity of atopic dermatitis (AD). Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk and lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % body surface area with AD in body region: 0 (0%), 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100% The final EASI score was obtained by weight-averaging these 4 scores and scores ranged from 0 to 72, with higher scores= more severe or extensive condition. Posterior Median presented from Bayesian analysis under the hypothetical strategy. The change from baseline in the EASI score at week 12 in group 1 is reported here. Data reported as 'Median' refers to 'Posterior Median' and '95% Confidence Interval' refers to '95% Credible Interval'. | The Safety Set included all randomized participants who received the study intervention. Participants were analyzed according to the intervention they actually received. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | Scores on a Scale | Baseline (Day 1) and at Week 12 |
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| Secondary | Number of Participants Achieving EASI-50, ≥ 50% Reduction in EASI Score at Week 12 in Group 1 | EASI scoring system is standardized clinical tool for assessment of extent (area) and severity of atopic dermatitis (AD). Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk and lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % body surface area with AD in body region: 0 (0%), 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100% The final EASI score was obtained by weight-averaging these 4 scores and scores ranged from 0 to 72, with higher scores= more severe or extensive condition. The EASI-50 responder is defined as a participant who achieves a ≥ 50% improvement from baseline in the EASI score. | The Safety Set included all randomized participants who received the study intervention. Participants were analyzed according to the intervention they actually received. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | At Week 12 |
|
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| Secondary | Number of Participants Achieving EASI-75, ≥ 75% Reduction in EASI Score at Week 12 in Group 1 | EASI scoring system is standardized clinical tool for assessment of extent (area) and severity of atopic dermatitis (AD). Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk and lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % body surface area with AD in body region: 0 (0%), 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100% The final EASI score was obtained by weight-averaging these 4 scores and scores ranged from 0 to 72, with higher scores= more severe or extensive condition. The EASI-75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score. | The Safety Set included all randomized participants who received the study intervention. Participants were analyzed according to the intervention they actually received. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | At Week 12 |
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| Secondary | Number of Participants Achieving EASI-90, ≥ 90% Reduction in EASI Score at Week 12 in Group 1 | EASI scoring system is standardized clinical tool for assessment of extent (area) and severity of atopic dermatitis (AD). Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk and lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % body surface area with AD in body region: 0 (0%), 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100% The final EASI score was obtained by weight-averaging these 4 scores and scores ranged from 0 to 72, with higher scores= more severe or extensive condition. The EASI-90 responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score. | The Safety Set included all randomized participants who received the study intervention. Participants were analyzed according to the intervention they actually received. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | At Week 12 |
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| Secondary | Number of Participants With Investigator Global Assessment (IGA) Score of 0 or 1 at Week 12 in Group 1 | The Investigator Global Assessment (IGA) is a clinical tool for assessing the current state/severity of a participant's atopic dermatitis. It is a static 5-point morphological assessment of overall disease severity determined by the investigator, sub-investigator, or trained healthcare professional with required qualifications on a scale of 0 to 4 where, 0-clear, 1-almost clear, 2-mild, 3-moderate, and 4- severe. Higher score indicates severity of disease. A Responder is defined as a participant who had an IGA score of 0 or 1 at each visit. | The analysis was performed on Safety Set that included all randomized participants who received the study intervention. Participants were analyzed according to the intervention they actually received. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | At Week 12 |
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| Secondary | Percent Change From Baseline in EASI Score at Week 12 in Group 2 | EASI scoring system is standardized clinical tool for assessment of extent (area) and severity of atopic dermatitis (AD). Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk and lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % body surface area with AD in body region: 0 (0%), 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100% The final EASI score was obtained by weight-averaging these 4 scores and scores ranged from 0 to 72, with higher scores= more severe or extensive condition. NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation (SD) was not derived. | The analysis was performed on Safety Set that included all randomized participants who received the study intervention. Participants were analyzed according to the intervention they actually received. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Percent Change | Baseline (Day 1) and at Week 12 |
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| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) - Groups 1 and 2 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any serious adverse event that, at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and other situations as per investigator's medical or scientific judgment. | The analysis was performed on the Safety Set that included all randomized participants who received the study intervention. Participants were analyzed according to the intervention they actually received. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Up to Week 24 |
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| Secondary | Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 | Vital signs included diastolic blood pressure (DBP), systolic blood pressure (SBP), pulse rate (PR) and body temperature were measured after resting for at least 5 minutes in semi-supine position. PCI ranges- SBP (millimeters of mercury[mmHg]): <85 (low) or >160 (high), DBP (mmHg): <45 (low) or >100 (high), PR (beats per minute): <40 (low) or >110 (high) and body temperature (degrees Celsius) <=35.5 (low) or >38.0 (high). Participants with worst case results relative to PCI criteria and who had values "to high" are reported here. Participants with a missing baseline value are assumed to have a within range value. | The analysis was performed on the Safety Set that included all randomized participants who received the study intervention. Participants were analyzed according to the intervention they actually received. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Up to Week 24 |
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| Secondary | Number of Participants With Worst Case 12-lead Electrocardiogram (ECG) Post-Baseline Relative to Baseline - Groups 1 and 2 | Twelve lead ECG was obtained using an ECG machine that automatically calculated the heart rate and measured QTc, PR, QRS intervals. Participants with clinically significant changes relative to baseline are reported here. Clinically significant findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | The analysis was performed on the Safety Set that included all randomized participants who received the study intervention. Participants were analyzed according to the intervention they actually received. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Up to Week 24 |
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| Secondary | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline - Groups 1 and 2 | Urine samples were collected to assess urine glucose, bilirubin, protein, occult blood, Leukocyte Esterase and ketones using dipstick method. Participants with clinically significant changes relative to baseline are reported here. Clinically significant findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Baseline was defined as the latest pre-dose assessment. | The analysis was performed on the Safety Set that included all randomized participants who received the study intervention. Participants were analyzed according to the intervention they actually received. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Up to Week 24 |
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| Secondary | Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 | Blood samples were collected for analysis of chemistry parameters. PCI ranges were >3*Upper limit of normal (ULN) units per liter (U/L)(Alanine Aminotransferase [ALT]), >3*ULN (U/L) (Aspartate Aminotransferase ([AST]), >2*ULN (Alkaline Phosphatase [ALP]) (U/L), >2*ULN (micromoles per liter) (bilirubin), <3 or >6.5 mmol/L (potassium), <130 or >160 mmol/L (sodium), <1.5 or >3.25 mmol/L (Corrected Calcium) and >40 mmol/L (Urea). Participants with worst case results relative to PCI criteria and who had values "to high" are reported here. Participants with a missing baseline value are assumed to have a within range value. | The analysis was performed on the Safety Set that included all randomized participants who received the study intervention. Participants were analyzed according to the intervention they actually received. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Up to Week 24 |
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| Secondary | Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 | Blood samples were collected for analysis of hematology parameters. The ranges for the hematology parameters are as follows: Hematocrit [High >0.54 Proportion of red blood cells in blood, Low <0.1 Proportion of red blood cells in blood], Haemoglobin [Higher: > 185 grams/Litre (g/L) Low: less than (<) 100 g/L ], Lymphocytes [<0.8 10^9/L], Neutrophils [<1.5 10^9/L], Platelets [High: > 999 10^9/ L and Low: < 100 10^9/ L] and White blood cells [Low:<2 10^9/L]. Participants were counted in worst case category that their value changes to (low, within range or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (for example [e.g.], High to High), or whose value became within range, were recorded in "To within Range or No Change" category. Participants were counted twice if participant has values that changed 'To Low' & 'To High', so the percentages may not add to 100%. | The analysis was performed on the Safety Set that included all randomized participants who received the study intervention. Participants were analyzed according to the intervention they actually received. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Up to Week 25 |
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| Secondary | Number of Participants With Anti-drug Antibodies (ADA)- Groups 1 and 2 | Serum samples were analyzed for the presence of antibodies using a validated assay method. The treatment emergent ADA assay results up to week 24 are reported. | The analysis was performed on the Safety Set that included all randomized participants who received the study intervention. Participants were analyzed according to the intervention they actually received. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Up to Week 24 |
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|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 10 |
| 23 |
| EG001 | Placebo | Participants received Placebo intravenous infusion in group 1 and 2 on Day 1. | 0 | 11 | 0 | 11 | 6 | 11 |
| COVID-19 | Infections and infestations | v26.0 | Systematic Assessment |
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| Chills | General disorders | v26.0 | Systematic Assessment |
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| Cold sweat | Skin and subcutaneous tissue disorders | v26.0 | Systematic Assessment |
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| Dermal cyst | Skin and subcutaneous tissue disorders | v26.0 | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | v26.0 | Systematic Assessment |
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| Dermatitis atopic | Skin and subcutaneous tissue disorders | v26.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | v26.0 | Systematic Assessment |
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| Face injury | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | v26.0 | Systematic Assessment |
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| Headache | Nervous system disorders | v26.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | v26.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | v26.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | v26.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | v26.0 | Systematic Assessment |
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| Neutrophil count abnormal | Investigations | v26.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
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| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | v26.0 | Systematic Assessment |
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| Sunburn | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
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| Suspected COVID-19 | Infections and infestations | v26.0 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | v26.0 | Systematic Assessment |
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| White blood cell disorder | Blood and lymphatic system disorders | v26.0 | Systematic Assessment |
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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.
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Diastolic Blood Pressure (mmHg),Worst Case Post-Baseline, To High |
|
| Pulse Rate (beats/min),Worst Case Post-Baseline,To Low |
|
| Pulse Rate (beats/min),Worst Case Post-Baseline, To w/in Range or No Change |
|
| Pulse Rate (beats/min),Worst Case Post-Baseline, To High |
|
| Systolic Blood Pressure (mmHg),Worst Case Post-Baseline,To Low |
|
| Systolic Blood Pressure (mmHg),Worst Case Post-Baseline, To w/in Range or No Change |
|
| Systolic Blood Pressure (mmHg),Worst Case Post-Baseline, To High |
|
| Temperature (C),Worst Case Post-Baseline,To Low |
|
| Temperature (C),Worst Case Post-Baseline, To w/in Range or No Change |
|
| Temperature (C), Worst Case Post-Baseline, To High |
|
| Alanine Aminotransferase (IU/L),Worst Case Post-Baseline,To High |
|
| Albumin (g/L),Worst Case Post-Baseline,To Low |
|
| Albumin (g/L),Worst Case Post-Baseline,To W/in Range or No Change |
|
| Albumin (g/L),Worst Case Post-Baseline,,To High |
|
| Alkaline Phosphatase (IU/L),Worst Case Post-Baseline,To Low |
|
| Alkaline Phosphatase (IU/L),Worst Case Post-Baseline,To W/in Range or No Change |
|
| Alkaline Phosphatase (IU/L),Worst Case Post-Baseline,,To High |
|
| Aspartate Aminotransferase (IU/L),Worst Case Post-Baseline,To Low |
|
| Aspartate Aminotransferase (IU/L),Worst Case Post-Baseline,To W/in Range or No Change |
|
| Aspartate Aminotransferase (IU/L),Worst Case Post-Baseline,,To High |
|
| Bilirubin (umol/L),Worst Case Post-Baseline,To Low |
|
| Bilirubin (umol/L),Worst Case Post-Baseline,To W/in Range or No Change |
|
| Bilirubin (umol/L),Worst Case Post-Baseline,To High |
|
| Calcium Corrected for Albumin (mmol/L),Worst Case Post-Baseline,To Low |
|
| Calcium Corrected for Albumin (mmol/L),Worst Case Post-Baseline,To W/in Range or No Change |
|
| Calcium Corrected for Albumin (mmol/L),Worst Case Post-Baseline,To High |
|
| Potassium (mmol/L),Worst Case Post-Baseline,To Low |
|
| Potassium (mmol/L),Worst Case Post-Baseline,To W/in Range or No Change |
|
| Potassium (mmol/L),Worst Case Post-Baseline,To High |
|
| Sodium (mmol/L),Worst Case Post-Baseline,To Low |
|
| Sodium (mmol/L),Worst Case Post-Baseline,To W/in Range or No Change |
|
| Sodium (mmol/L),Worst Case Post-Baseline,To High |
|
| Urea (mmol/L),Worst Case Post-Baseline,To Low |
|
| Urea (mmol/L),Worst Case Post-Baseline,To W/in Range or No Change |
|
| Urea (mmol/L),Worst Case Post-Baseline,To High |
|
| Hematocrit (fraction of 1),Worst Case Post-Baseline,To High |
|
| Hemoglobin (g/L),Worst Case Post-Baseline,To Low |
|
| Hemoglobin (g/L),Worst Case Post-Baseline,To W/in Range or No Change |
|
| Hemoglobin (g/L),Worst Case Post-Baseline,To High |
|
| Leukocytes (10^9/L),Worst Case Post-Baseline,To Low |
|
| Leukocytes (10^9/L),Worst Case Post-Baseline,To W/in Range or No Change |
|
| Leukocytes (10^9/L),Worst Case Post-Baseline,To High |
|
| Lymphocytes (10^9/L),Worst Case Post-Baseline,To Low |
|
| Lymphocytes (10^9/L),Worst Case Post-Baseline,To W/in Range or No Change |
|
| Lymphocytes (10^9/L),Worst Case Post-Baseline,To High |
|
| Neutrophils (10^9/L),Worst Case Post-Baseline,To Low |
|
| Neutrophils (10^9/L),Worst Case Post-Baseline,To W/in Range or No Change |
|
| Neutrophils (10^9/L),Worst Case Post-Baseline,To High |
|
| Platelets (10^9/L),Worst Case Post-Baseline,To Low |
|
| Platelets (10^9/L),Worst Case Post-Baseline,To W/in Range or No Change |
|
| Platelets (10^9/L),Worst Case Post-Baseline,To High |
|