Adults 18 to 75, any sex, with Dermatitis, Atopic. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percent Change From Baseline (PCFB) in Eczema Area and Severity Index (EASI) Score at Week 12 in Group 1Primary· Baseline (Day 1) and at Week 12
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
Group
Value
95% CI
Group 1: GSK1070806
-66.11
-78.65 – -53.54
Group 1: Placebo
-32.81
-46.59 – -20.34
Change From Baseline in EASI Score at Week 12 in Group 1Secondary· Baseline (Day 1) and at Week 12
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
Group
Value
95% CI
Group 1: GSK1070806
-16.83
-20.30 – -13.36
Group 1: Placebo
-7.15
-12.12 – -2.20
Number of Participants Achieving EASI-50, ≥ 50% Reduction in EASI Score at Week 12 in Group 1Secondary· At Week 12
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
Responder
Group
Value
95% CI
Group 1: GSK1070806
14
Group 1: Placebo
3
Non-responder
Group
Value
95% CI
Group 1: GSK1070806
5
Group 1: Placebo
6
Number of Participants Achieving EASI-75, ≥ 75% Reduction in EASI Score at Week 12 in Group 1Secondary· At Week 12
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
Responder
Group
Value
95% CI
Group 1: GSK1070806
7
Group 1: Placebo
1
Non-responder
Group
Value
95% CI
Group 1: GSK1070806
12
Group 1: Placebo
8
Number of Participants Achieving EASI-90, ≥ 90% Reduction in EASI Score at Week 12 in Group 1Secondary· At Week 12
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
Responder
Group
Value
95% CI
Group 1: GSK1070806
5
Group 1: Placebo
1
Non-responder
Group
Value
95% CI
Group 1: GSK1070806
14
Group 1: Placebo
8
Number of Participants With Investigator Global Assessment (IGA) Score of 0 or 1 at Week 12 in Group 1Secondary· At Week 12
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.
Almost Clear (1)
Group
Value
95% CI
Group 1: GSK1070806
4
Group 1: Placebo
1
Clear (0)
Group
Value
95% CI
Group 1: GSK1070806
1
Group 1: Placebo
0
Percent Change From Baseline in EASI Score at Week 12 in Group 2Secondary· Baseline (Day 1) and at Week 12
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
Group
Value
95% CI
Group 2: Dupilumab-Inadequate Responders (IR) With GSK1070806
-94.213
± 8.1841
Group 2: Dupilumab IR With Placebo
-38.868
± NA
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) - Groups 1 and 2Secondary· Up to Week 24
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.
Adverse Events
Group
Value
95% CI
Group 1 and 2: GSK1070806
10
Group 1 and 2: Placebo
6
Serious Adverse Events
Group
Value
95% CI
Group 1 and 2: GSK1070806
0
Group 1 and 2: Placebo
0
Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2Secondary· Up to Week 24
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
Diastolic Blood Pressure (mmHg), Worst Case Post-Baseline,To Low
Group
Value
95% CI
Group 1 and 2: GSK1070806
0
Group 1 and 2: Placebo
0
Diastolic Blood Pressure (mmHg),Worst Case Post-Baseline, To w/in Range or No Change
Group
Value
95% CI
Group 1 and 2: GSK1070806
22
Group 1 and 2: Placebo
10
Diastolic Blood Pressure (mmHg),Worst Case Post-Baseline, To High
Group
Value
95% CI
Group 1 and 2: GSK1070806
1
Group 1 and 2: Placebo
1
Pulse Rate (beats/min),Worst Case Post-Baseline,To Low
Group
Value
95% CI
Group 1 and 2: GSK1070806
0
Group 1 and 2: Placebo
0
Pulse Rate (beats/min),Worst Case Post-Baseline, To w/in Range or No Change
Group
Value
95% CI
Group 1 and 2: GSK1070806
23
Group 1 and 2: Placebo
11
Pulse Rate (beats/min),Worst Case Post-Baseline, To High
Group
Value
95% CI
Group 1 and 2: GSK1070806
0
Group 1 and 2: Placebo
0
Systolic Blood Pressure (mmHg),Worst Case Post-Baseline,To Low
Group
Value
95% CI
Group 1 and 2: GSK1070806
0
Group 1 and 2: Placebo
0
Systolic Blood Pressure (mmHg),Worst Case Post-Baseline, To w/in Range or No Change
Group
Value
95% CI
Group 1 and 2: GSK1070806
22
Group 1 and 2: Placebo
11
Number of Participants With Worst Case 12-lead Electrocardiogram (ECG) Post-Baseline Relative to Baseline - Groups 1 and 2Secondary· Up to Week 24
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.
Group
Value
95% CI
Group 1 and 2: GSK1070806
0
Group 1 and 2: Placebo
0
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline - Groups 1 and 2Secondary· Up to Week 24
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.
Group
Value
95% CI
Group 1 and 2: GSK1070806
0
Group 1 and 2: Placebo
0
Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2Secondary· Up to Week 24
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 va
Alanine Aminotransferase (IU/L),Worst Case Post-Baseline,To Low
Group
Value
95% CI
Group 1 and 2: GSK1070806
0
Group 1 and 2: Placebo
0
Alanine Aminotransferase (IU/L),Worst Case Post-Baseline,To W/in Range or No Change
Group
Value
95% CI
Group 1 and 2: GSK1070806
22
Group 1 and 2: Placebo
11
Alanine Aminotransferase (IU/L),Worst Case Post-Baseline,To High
Group
Value
95% CI
Group 1 and 2: GSK1070806
1
Group 1 and 2: Placebo
0
Albumin (g/L),Worst Case Post-Baseline,To Low
Group
Value
95% CI
Group 1 and 2: GSK1070806
0
Group 1 and 2: Placebo
0
Albumin (g/L),Worst Case Post-Baseline,To W/in Range or No Change
Group
Value
95% CI
Group 1 and 2: GSK1070806
23
Group 1 and 2: Placebo
11
Albumin (g/L),Worst Case Post-Baseline,,To High
Group
Value
95% CI
Group 1 and 2: GSK1070806
0
Group 1 and 2: Placebo
0
Alkaline Phosphatase (IU/L),Worst Case Post-Baseline,To Low
Group
Value
95% CI
Group 1 and 2: GSK1070806
0
Group 1 and 2: Placebo
0
Alkaline Phosphatase (IU/L),Worst Case Post-Baseline,To W/in Range or No Change
Group
Value
95% CI
Group 1 and 2: GSK1070806
23
Group 1 and 2: Placebo
11
Adverse events — posted to ClinicalTrials.gov
Time frame: From Day 1 and up to Week 24.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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· terminated
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 28 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04975438.