A Phase 1 interventional study of GSK1070806 and Placebo in Dermatitis, Atopic, sponsored by GlaxoSmithKline. Completed at 11 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-28.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
This study will evaluate efficacy and safety of GSK1070806 in moderate to severe atopic dermatitis (AtD) participants.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 34 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received a single dose of 2 mg/kg GSK1070806 as intravenous infusion on Day 1.
Drug: GSK1070806
Participants received Placebo as intravenous infusion on Day 1.
Drug: Placebo
Participants received a single dose of 2 mg/kg GSK1070806 as intravenous infusion on Day 1.
Drug: GSK1070806
Participants received Placebo as intravenous infusion on Day 1.
Drug: Placebo
GSK1070806 will be administered
Placebo will be administered
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'.
Time frame: Baseline (Day 1) and at Week 12
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'.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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%.
Time frame: 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.
Time frame: Up to Week 24
A total of 34 participants were enrolled at different centers in Canada and United States.
| Milestone | Group 1: GSK1070806 | Group 1: Placebo | Group 2: Dupilumab- Inadequate Responders (IR) With GSK1070806 | Group 2: Dupilumab IR With Placebo |
|---|---|---|---|---|
| Started | 20 | 10 | 3 | 1 |
| Completed | 18 | 10 | 2 | 1 |
| Not completed | 2 | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 0 |
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'.
| Percent Change | Group 1: GSK1070806 | Group 1: Placebo |
|---|---|---|
| Percent Change From Baseline (PCFB) in Eczema Area and Severity Index (EASI) Score at Week 12 in Group 1 | -66.11 (-78.65 to -53.54) | -32.81 (-46.59 to -20.34) |
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'.
| Scores on a Scale | Group 1: GSK1070806 | Group 1: Placebo |
|---|---|---|
| Change From Baseline in EASI Score at Week 12 in Group 1 | -16.83 (-20.30 to -13.36) | -7.15 (-12.12 to -2.20) |
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.
| Participants | Group 1: GSK1070806 | Group 1: Placebo |
|---|---|---|
| Responder | 14 | 3 |
| Non-responder | 5 | 6 |
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.
| Participants | Group 1: GSK1070806 | Group 1: Placebo |
|---|---|---|
| Responder | 7 | 1 |
| Non-responder | 12 | 8 |
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.
| Participants | Group 1: GSK1070806 | Group 1: Placebo |
|---|---|---|
| Responder | 5 | 1 |
| Non-responder | 14 | 8 |
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.
| Participants | Group 1: GSK1070806 | Group 1: Placebo |
|---|---|---|
| Almost Clear (1) | 4 | 1 |
| Clear (0) | 1 | 0 |
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.
| Percent Change | Group 2: Dupilumab-Inadequate Responders (IR) With GSK1070806 | Group 2: Dupilumab IR With Placebo |
|---|---|---|
| Percent Change From Baseline in EASI Score at Week 12 in Group 2 | -94.213 ± 8.1841 | -38.868 ± NA |
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.
| Participants | Group 1 and 2: GSK1070806 | Group 1 and 2: Placebo |
|---|---|---|
| Adverse Events | 10 | 6 |
| Serious Adverse Events | 0 | 0 |
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.
| Participants | Group 1 and 2: GSK1070806 | Group 1 and 2: Placebo |
|---|---|---|
| Diastolic Blood Pressure (mmHg), Worst Case Post-Baseline,To Low | 0 | 0 |
| Diastolic Blood Pressure (mmHg),Worst Case Post-Baseline, To w/in Range or No Change | 22 | 10 |
| Diastolic Blood Pressure (mmHg),Worst Case Post-Baseline, To High | 1 | 1 |
| Pulse Rate (beats/min),Worst Case Post-Baseline,To Low | 0 | 0 |
| Pulse Rate (beats/min),Worst Case Post-Baseline, To w/in Range or No Change | 23 | 11 |
| Pulse Rate (beats/min),Worst Case Post-Baseline, To High | 0 | 0 |
| Systolic Blood Pressure (mmHg),Worst Case Post-Baseline,To Low | 0 | 0 |
| Systolic Blood Pressure (mmHg),Worst Case Post-Baseline, To w/in Range or No Change | 22 | 11 |
| Systolic Blood Pressure (mmHg),Worst Case Post-Baseline, To High | 1 | 0 |
| Temperature (C),Worst Case Post-Baseline,To Low | 1 | 0 |
| Temperature (C),Worst Case Post-Baseline, To w/in Range or No Change | 22 | 11 |
| Temperature (C), Worst Case Post-Baseline, To High | 0 | 0 |
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.
| Participants | Group 1 and 2: GSK1070806 | Group 1 and 2: Placebo |
|---|---|---|
| Number of Participants With Worst Case 12-lead Electrocardiogram (ECG) Post-Baseline Relative to Baseline - Groups 1 and 2 | 0 | 0 |
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.
| Participants | Group 1 and 2: GSK1070806 | Group 1 and 2: Placebo |
|---|---|---|
| Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline - Groups 1 and 2 | 0 | 0 |
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.
| Participants | Group 1 and 2: GSK1070806 | Group 1 and 2: Placebo |
|---|---|---|
| Alanine Aminotransferase (IU/L),Worst Case Post-Baseline,To Low | 0 | 0 |
| Alanine Aminotransferase (IU/L),Worst Case Post-Baseline,To W/in Range or No Change | 22 | 11 |
| Alanine Aminotransferase (IU/L),Worst Case Post-Baseline,To High | 1 | 0 |
| Albumin (g/L),Worst Case Post-Baseline,To Low | 0 | 0 |
| Albumin (g/L),Worst Case Post-Baseline,To W/in Range or No Change | 23 | 11 |
| Albumin (g/L),Worst Case Post-Baseline,,To High | 0 | 0 |
| Alkaline Phosphatase (IU/L),Worst Case Post-Baseline,To Low | 0 | 0 |
| Alkaline Phosphatase (IU/L),Worst Case Post-Baseline,To W/in Range or No Change | 23 | 11 |
| Alkaline Phosphatase (IU/L),Worst Case Post-Baseline,,To High | 0 | 0 |
| Aspartate Aminotransferase (IU/L),Worst Case Post-Baseline,To Low | 0 | 0 |
| Aspartate Aminotransferase (IU/L),Worst Case Post-Baseline,To W/in Range or No Change | 22 | 10 |
| Aspartate Aminotransferase (IU/L),Worst Case Post-Baseline,,To High | 1 | 1 |
| Bilirubin (umol/L),Worst Case Post-Baseline,To Low | 0 | 0 |
| Bilirubin (umol/L),Worst Case Post-Baseline,To W/in Range or No Change | 0 | 0 |
| Bilirubin (umol/L),Worst Case Post-Baseline,To High | 23 | 11 |
| Calcium Corrected for Albumin (mmol/L),Worst Case Post-Baseline,To Low | 0 | 0 |
| Calcium Corrected for Albumin (mmol/L),Worst Case Post-Baseline,To W/in Range or No Change | 23 | 11 |
| Calcium Corrected for Albumin (mmol/L),Worst Case Post-Baseline,To High | 0 | 0 |
| Potassium (mmol/L),Worst Case Post-Baseline,To Low | 0 | 0 |
| Potassium (mmol/L),Worst Case Post-Baseline,To W/in Range or No Change | 23 | 11 |
| Potassium (mmol/L),Worst Case Post-Baseline,To High | 0 | 0 |
| Sodium (mmol/L),Worst Case Post-Baseline,To Low | 2 | 0 |
| Sodium (mmol/L),Worst Case Post-Baseline,To W/in Range or No Change | 21 | 11 |
| Sodium (mmol/L),Worst Case Post-Baseline,To High | 0 | 0 |
| Urea (mmol/L),Worst Case Post-Baseline,To Low | 0 | 0 |
| Urea (mmol/L),Worst Case Post-Baseline,To W/in Range or No Change | 23 | 11 |
| Urea (mmol/L),Worst Case Post-Baseline,To High | 0 | 0 |
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%.
| Participants | Group 1 and 2: GSK1070806 | Group 1 and 2: Placebo |
|---|---|---|
| Hematocrit (fraction of 1),Worst Case Post-Baseline,To Low | 0 | 0 |
| Hematocrit (fraction of 1),Worst Case Post-Baseline,To W/in Range or No Change | 22 | 11 |
| Hematocrit (fraction of 1),Worst Case Post-Baseline,To High | 1 | 0 |
| Hemoglobin (g/L),Worst Case Post-Baseline,To Low | 2 | 0 |
| Hemoglobin (g/L),Worst Case Post-Baseline,To W/in Range or No Change | 21 | 11 |
| Hemoglobin (g/L),Worst Case Post-Baseline,To High | 0 | 0 |
| Leukocytes (10^9/L),Worst Case Post-Baseline,To Low | 0 | 0 |
| Leukocytes (10^9/L),Worst Case Post-Baseline,To W/in Range or No Change | 23 | 11 |
| Leukocytes (10^9/L),Worst Case Post-Baseline,To High | 0 | 0 |
| Lymphocytes (10^9/L),Worst Case Post-Baseline,To Low | 2 | 2 |
| Lymphocytes (10^9/L),Worst Case Post-Baseline,To W/in Range or No Change | 21 | 9 |
| Lymphocytes (10^9/L),Worst Case Post-Baseline,To High | 0 | 0 |
| Neutrophils (10^9/L),Worst Case Post-Baseline,To Low | 2 | 0 |
| Neutrophils (10^9/L),Worst Case Post-Baseline,To W/in Range or No Change | 21 | 11 |
| Neutrophils (10^9/L),Worst Case Post-Baseline,To High | 0 | 0 |
| Platelets (10^9/L),Worst Case Post-Baseline,To Low | 0 | 0 |
| Platelets (10^9/L),Worst Case Post-Baseline,To W/in Range or No Change | 23 | 11 |
| Platelets (10^9/L),Worst Case Post-Baseline,To High | 0 | 0 |
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.
| Participants | Group 1 and 2: GSK1070806 | Group 1 and 2: Placebo |
|---|---|---|
| Number of Participants With Anti-drug Antibodies (ADA)- Groups 1 and 2 | 0 | 0 |
Collected over From Day 1 and up to Week 24. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GSK1070806 | 0/23 (0%) | 0/23 (0%) | 10/23 (43.5%) |
| Placebo | 0/11 (0%) | 0/11 (0%) | 6/11 (54.5%) |
| Event | GSK1070806 | Placebo |
|---|---|---|
| Dermatitis atopicSkin and subcutaneous tissue disorders | 0/23 | 2/11 |
| HeadacheNervous system disorders | 1/23 | 2/11 |
| NasopharyngitisInfections and infestations | 0/23 | 2/11 |
| COVID-19Infections and infestations | 2/23 | 1/11 |
| ChillsGeneral disorders | 0/23 | 1/11 |
| Cold sweatSkin and subcutaneous tissue disorders | 0/23 | 1/11 |
| InsomniaPsychiatric disorders | 0/23 | 1/11 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 0/23 | 1/11 |
| Seborrhoeic dermatitisSkin and subcutaneous tissue disorders | 0/23 | 1/11 |
| SunburnInjury, poisoning and procedural complications | 0/23 | 1/11 |
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.
| Age, Customized(Participants) | Group 1: GSK1070806 | Group 1: Placebo | Group 2: Dupilumab-IR With GSK1070806 | Group 2: Dupilumab IR With Placebo | Total |
|---|---|---|---|---|---|
| De-identified | 20 | 10 | 3 | 1 | 34 |
| Sex/Gender, Customized(Participants) | Group 1: GSK1070806 | Group 1: Placebo | Group 2: Dupilumab-IR With GSK1070806 | Group 2: Dupilumab IR With Placebo | Total |
|---|---|---|---|---|---|
| De-identified | 20 | 10 | 3 | 1 | 34 |
| Race/Ethnicity, Customized(Participants) | Group 1: GSK1070806 | Group 1: Placebo | Group 2: Dupilumab-IR With GSK1070806 | Group 2: Dupilumab IR With Placebo | Total |
|---|---|---|---|---|---|
| De-identified | 20 | 10 | 3 | 1 | 34 |
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Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Sap, Icf, Csr
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