Trial Outcomes & Findings for Clinical Effect, Safety and Tolerability of GSK1070806 in Atopic Dermatitis (NCT NCT04975438)

Last Updated: 2025-08-28

Results Overview

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'.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

34 participants

Primary outcome timeframe

Baseline (Day 1) and at Week 12

Results posted on

2025-08-28

Participant Flow

A total of 34 participants were enrolled at different centers in Canada and United States.

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).

Participant milestones

Participant milestones
Measure	Group 1: GSK1070806 Participants received a single dose of 2 milligram per kilogram (mg/kg) GSK1070806 as intravenous infusion on Day 1.	Group 1: Placebo Participants received Placebo as intravenous infusion on Day 1.	Group 2: Dupilumab- Inadequate Responders (IR) With GSK1070806 Participants received a single dose of 2 mg/kg GSK1070806 as intravenous infusion on Day 1.	Group 2: Dupilumab IR With Placebo Participants received Placebo as intravenous infusion on Day 1.
Overall Study STARTED	20	10	3	1
Overall Study COMPLETED	18	10	2	1
Overall Study NOT COMPLETED	2	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: GSK1070806 Participants received a single dose of 2 milligram per kilogram (mg/kg) GSK1070806 as intravenous infusion on Day 1.	Group 1: Placebo Participants received Placebo as intravenous infusion on Day 1.	Group 2: Dupilumab- Inadequate Responders (IR) With GSK1070806 Participants received a single dose of 2 mg/kg GSK1070806 as intravenous infusion on Day 1.	Group 2: Dupilumab IR With Placebo Participants received Placebo as intravenous infusion on Day 1.
Overall Study Lost to Follow-up	1	0	1	0
Overall Study Withdrawal by Subject	1	0	0	0

Baseline Characteristics

Clinical Effect, Safety and Tolerability of GSK1070806 in Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: GSK1070806 n=20 Participants Participants received a single dose of 2 mg/kg GSK1070806 as intravenous infusion on Day 1.	Group 1: Placebo n=10 Participants Participants received Placebo as intravenous infusion on Day 1.	Group 2: Dupilumab-IR With GSK1070806 n=3 Participants Participants received a single dose of 2 mg/kg GSK1070806 as intravenous infusion on Day 1.	Group 2: Dupilumab IR With Placebo n=1 Participants Participants received Placebo as intravenous infusion on Day 1.	Total n=34 Participants Total of all reporting groups
Age, Customized De-identified	20 Participants n=5 Participants	10 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	34 Participants n=21 Participants
Sex/Gender, Customized De-identified	20 Participants n=5 Participants	10 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	34 Participants n=21 Participants
Race/Ethnicity, Customized De-identified	20 Participants n=5 Participants	10 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	34 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and at Week 12

Population: 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.

Outcome measures

Outcome measures
Measure	Group 1: GSK1070806 n=19 Participants In group 1, participants received a single dose of GSK1070806 2 mg/kg intravenous infusion on Day 1.	Group 1: Placebo n=9 Participants In group 1, participants received Placebo intravenous infusion on Day 1.
Percent Change From Baseline (PCFB) in Eczema Area and Severity Index (EASI) Score at Week 12 in Group 1	-66.11 Percent Change Interval -78.65 to -53.54	-32.81 Percent Change Interval -46.59 to -20.34

SECONDARY outcome

Timeframe: 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 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'.

Outcome measures

Outcome measures
Measure	Group 1: GSK1070806 n=19 Participants In group 1, participants received a single dose of GSK1070806 2 mg/kg intravenous infusion on Day 1.	Group 1: Placebo n=9 Participants In group 1, participants received Placebo intravenous infusion on Day 1.
Change From Baseline in EASI Score at Week 12 in Group 1	-16.83 Scores on a Scale Interval -20.3 to -13.36	-7.15 Scores on a Scale Interval -12.12 to -2.2

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Outcome measures
Measure	Group 1: GSK1070806 n=19 Participants In group 1, participants received a single dose of GSK1070806 2 mg/kg intravenous infusion on Day 1.	Group 1: Placebo n=9 Participants In group 1, participants received Placebo intravenous infusion on Day 1.
Number of Participants Achieving EASI-50, ≥ 50% Reduction in EASI Score at Week 12 in Group 1 Responder	14 Participants	3 Participants
Number of Participants Achieving EASI-50, ≥ 50% Reduction in EASI Score at Week 12 in Group 1 Non-responder	5 Participants	6 Participants

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Outcome measures
Measure	Group 1: GSK1070806 n=19 Participants In group 1, participants received a single dose of GSK1070806 2 mg/kg intravenous infusion on Day 1.	Group 1: Placebo n=9 Participants In group 1, participants received Placebo intravenous infusion on Day 1.
Number of Participants Achieving EASI-75, ≥ 75% Reduction in EASI Score at Week 12 in Group 1 Responder	7 Participants	1 Participants
Number of Participants Achieving EASI-75, ≥ 75% Reduction in EASI Score at Week 12 in Group 1 Non-responder	12 Participants	8 Participants

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Outcome measures
Measure	Group 1: GSK1070806 n=19 Participants In group 1, participants received a single dose of GSK1070806 2 mg/kg intravenous infusion on Day 1.	Group 1: Placebo n=9 Participants In group 1, participants received Placebo intravenous infusion on Day 1.
Number of Participants Achieving EASI-90, ≥ 90% Reduction in EASI Score at Week 12 in Group 1 Non-responder	14 Participants	8 Participants
Number of Participants Achieving EASI-90, ≥ 90% Reduction in EASI Score at Week 12 in Group 1 Responder	5 Participants	1 Participants

SECONDARY outcome

Timeframe: At Week 12

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Group 1: GSK1070806 n=19 Participants In group 1, participants received a single dose of GSK1070806 2 mg/kg intravenous infusion on Day 1.	Group 1: Placebo n=9 Participants In group 1, participants received Placebo intravenous infusion on Day 1.
Number of Participants With Investigator Global Assessment (IGA) Score of 0 or 1 at Week 12 in Group 1 Almost Clear (1)	4 Participants	1 Participants
Number of Participants With Investigator Global Assessment (IGA) Score of 0 or 1 at Week 12 in Group 1 Clear (0)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Outcome measures
Measure	Group 1: GSK1070806 n=3 Participants In group 1, participants received a single dose of GSK1070806 2 mg/kg intravenous infusion on Day 1.	Group 1: Placebo n=1 Participants In group 1, participants received Placebo intravenous infusion on Day 1.
Percent Change From Baseline in EASI Score at Week 12 in Group 2	-94.213 Percent Change Standard Deviation 8.1841	-38.868 Percent Change Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.

SECONDARY outcome

Timeframe: Up to Week 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Group 1: GSK1070806 n=23 Participants In group 1, participants received a single dose of GSK1070806 2 mg/kg intravenous infusion on Day 1.	Group 1: Placebo n=11 Participants In group 1, participants received Placebo intravenous infusion on Day 1.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) - Groups 1 and 2 Adverse Events	10 Participants	6 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) - Groups 1 and 2 Serious Adverse Events	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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 to have a within range value.

Outcome measures

Outcome measures
Measure	Group 1: GSK1070806 n=23 Participants In group 1, participants received a single dose of GSK1070806 2 mg/kg intravenous infusion on Day 1.	Group 1: Placebo n=11 Participants In group 1, participants received Placebo intravenous infusion on Day 1.
Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Systolic Blood Pressure (mmHg),Worst Case Post-Baseline, To High	1 Participants	0 Participants
Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Temperature (C),Worst Case Post-Baseline,To Low	1 Participants	0 Participants
Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Diastolic Blood Pressure (mmHg), Worst Case Post-Baseline,To Low	0 Participants	0 Participants
Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Diastolic Blood Pressure (mmHg),Worst Case Post-Baseline, To w/in Range or No Change	22 Participants	10 Participants
Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Diastolic Blood Pressure (mmHg),Worst Case Post-Baseline, To High	1 Participants	1 Participants
Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Pulse Rate (beats/min),Worst Case Post-Baseline,To Low	0 Participants	0 Participants
Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Pulse Rate (beats/min),Worst Case Post-Baseline, To w/in Range or No Change	23 Participants	11 Participants
Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Pulse Rate (beats/min),Worst Case Post-Baseline, To High	0 Participants	0 Participants
Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Systolic Blood Pressure (mmHg),Worst Case Post-Baseline,To Low	0 Participants	0 Participants
Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Systolic Blood Pressure (mmHg),Worst Case Post-Baseline, To w/in Range or No Change	22 Participants	11 Participants
Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Temperature (C),Worst Case Post-Baseline, To w/in Range or No Change	22 Participants	11 Participants
Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Temperature (C), Worst Case Post-Baseline, To High	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group 1: GSK1070806 n=21 Participants In group 1, participants received a single dose of GSK1070806 2 mg/kg intravenous infusion on Day 1.	Group 1: Placebo n=10 Participants In group 1, participants received Placebo intravenous infusion on Day 1.
Number of Participants With Worst Case 12-lead Electrocardiogram (ECG) Post-Baseline Relative to Baseline - Groups 1 and 2	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group 1: GSK1070806 n=22 Participants In group 1, participants received a single dose of GSK1070806 2 mg/kg intravenous infusion on Day 1.	Group 1: Placebo n=11 Participants In group 1, participants received Placebo intravenous infusion on Day 1.
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline - Groups 1 and 2	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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 value are assumed to have a within range value.

Outcome measures

Outcome measures
Measure	Group 1: GSK1070806 n=23 Participants In group 1, participants received a single dose of GSK1070806 2 mg/kg intravenous infusion on Day 1.	Group 1: Placebo n=11 Participants In group 1, participants received Placebo intravenous infusion on Day 1.
Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Bilirubin (umol/L),Worst Case Post-Baseline,To High	23 Participants	11 Participants
Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Calcium Corrected for Albumin (mmol/L),Worst Case Post-Baseline,To High	0 Participants	0 Participants
Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Alanine Aminotransferase (IU/L),Worst Case Post-Baseline,To Low	0 Participants	0 Participants
Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Alanine Aminotransferase (IU/L),Worst Case Post-Baseline,To W/in Range or No Change	22 Participants	11 Participants
Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Alanine Aminotransferase (IU/L),Worst Case Post-Baseline,To High	1 Participants	0 Participants
Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Albumin (g/L),Worst Case Post-Baseline,To Low	0 Participants	0 Participants
Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Albumin (g/L),Worst Case Post-Baseline,To W/in Range or No Change	23 Participants	11 Participants
Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Albumin (g/L),Worst Case Post-Baseline,,To High	0 Participants	0 Participants
Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Alkaline Phosphatase (IU/L),Worst Case Post-Baseline,To Low	0 Participants	0 Participants
Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Alkaline Phosphatase (IU/L),Worst Case Post-Baseline,To W/in Range or No Change	23 Participants	11 Participants
Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Alkaline Phosphatase (IU/L),Worst Case Post-Baseline,,To High	0 Participants	0 Participants
Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Aspartate Aminotransferase (IU/L),Worst Case Post-Baseline,To Low	0 Participants	0 Participants
Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Aspartate Aminotransferase (IU/L),Worst Case Post-Baseline,To W/in Range or No Change	22 Participants	10 Participants
Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Aspartate Aminotransferase (IU/L),Worst Case Post-Baseline,,To High	1 Participants	1 Participants
Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Bilirubin (umol/L),Worst Case Post-Baseline,To Low	0 Participants	0 Participants
Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Bilirubin (umol/L),Worst Case Post-Baseline,To W/in Range or No Change	0 Participants	0 Participants
Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Calcium Corrected for Albumin (mmol/L),Worst Case Post-Baseline,To Low	0 Participants	0 Participants
Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Calcium Corrected for Albumin (mmol/L),Worst Case Post-Baseline,To W/in Range or No Change	23 Participants	11 Participants
Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Potassium (mmol/L),Worst Case Post-Baseline,To Low	0 Participants	0 Participants
Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Potassium (mmol/L),Worst Case Post-Baseline,To W/in Range or No Change	23 Participants	11 Participants
Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Potassium (mmol/L),Worst Case Post-Baseline,To High	0 Participants	0 Participants
Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Sodium (mmol/L),Worst Case Post-Baseline,To Low	2 Participants	0 Participants
Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Sodium (mmol/L),Worst Case Post-Baseline,To W/in Range or No Change	21 Participants	11 Participants
Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Sodium (mmol/L),Worst Case Post-Baseline,To High	0 Participants	0 Participants
Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Urea (mmol/L),Worst Case Post-Baseline,To Low	0 Participants	0 Participants
Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Urea (mmol/L),Worst Case Post-Baseline,To W/in Range or No Change	23 Participants	11 Participants
Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Urea (mmol/L),Worst Case Post-Baseline,To High	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 25

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%.

Outcome measures

Outcome measures
Measure	Group 1: GSK1070806 n=23 Participants In group 1, participants received a single dose of GSK1070806 2 mg/kg intravenous infusion on Day 1.	Group 1: Placebo n=11 Participants In group 1, participants received Placebo intravenous infusion on Day 1.
Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Hematocrit (fraction of 1),Worst Case Post-Baseline,To Low	0 Participants	0 Participants
Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Hematocrit (fraction of 1),Worst Case Post-Baseline,To W/in Range or No Change	22 Participants	11 Participants
Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Hematocrit (fraction of 1),Worst Case Post-Baseline,To High	1 Participants	0 Participants
Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Hemoglobin (g/L),Worst Case Post-Baseline,To Low	2 Participants	0 Participants
Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Hemoglobin (g/L),Worst Case Post-Baseline,To W/in Range or No Change	21 Participants	11 Participants
Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Hemoglobin (g/L),Worst Case Post-Baseline,To High	0 Participants	0 Participants
Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Leukocytes (10^9/L),Worst Case Post-Baseline,To Low	0 Participants	0 Participants
Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Leukocytes (10^9/L),Worst Case Post-Baseline,To W/in Range or No Change	23 Participants	11 Participants
Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Leukocytes (10^9/L),Worst Case Post-Baseline,To High	0 Participants	0 Participants
Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Lymphocytes (10^9/L),Worst Case Post-Baseline,To Low	2 Participants	2 Participants
Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Lymphocytes (10^9/L),Worst Case Post-Baseline,To W/in Range or No Change	21 Participants	9 Participants
Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Lymphocytes (10^9/L),Worst Case Post-Baseline,To High	0 Participants	0 Participants
Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Neutrophils (10^9/L),Worst Case Post-Baseline,To Low	2 Participants	0 Participants
Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Neutrophils (10^9/L),Worst Case Post-Baseline,To W/in Range or No Change	21 Participants	11 Participants
Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Neutrophils (10^9/L),Worst Case Post-Baseline,To High	0 Participants	0 Participants
Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Platelets (10^9/L),Worst Case Post-Baseline,To Low	0 Participants	0 Participants
Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Platelets (10^9/L),Worst Case Post-Baseline,To W/in Range or No Change	23 Participants	11 Participants
Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Platelets (10^9/L),Worst Case Post-Baseline,To High	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 24

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.

Outcome measures

Outcome measures
Measure	Group 1: GSK1070806 n=22 Participants In group 1, participants received a single dose of GSK1070806 2 mg/kg intravenous infusion on Day 1.	Group 1: Placebo n=11 Participants In group 1, participants received Placebo intravenous infusion on Day 1.
Number of Participants With Anti-drug Antibodies (ADA)- Groups 1 and 2	0 Participants	0 Participants

Adverse Events

GSK1070806

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	GSK1070806 n=23 participants at risk 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	Placebo n=11 participants at risk Participants received Placebo intravenous infusion in group 1 and 2 on Day 1.
Musculoskeletal and connective tissue disorders Back pain	4.3% 1/23 • Number of events 1 • 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.	0.00% 0/11 • 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.
Infections and infestations COVID-19	8.7% 2/23 • Number of events 2 • 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.	9.1% 1/11 • Number of events 1 • 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.
General disorders Chills	0.00% 0/23 • 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.	9.1% 1/11 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Cold sweat	0.00% 0/23 • 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.	9.1% 1/11 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Dermal cyst	4.3% 1/23 • Number of events 1 • 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.	0.00% 0/11 • 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.
Skin and subcutaneous tissue disorders Dermatitis	4.3% 1/23 • Number of events 1 • 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.	0.00% 0/11 • 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.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/23 • 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.	18.2% 2/11 • Number of events 3 • 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.
Gastrointestinal disorders Diarrhoea	4.3% 1/23 • Number of events 1 • 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.	0.00% 0/11 • 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.
Injury, poisoning and procedural complications Face injury	4.3% 1/23 • Number of events 1 • 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.	0.00% 0/11 • 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.
Infections and infestations Gastroenteritis	4.3% 1/23 • Number of events 1 • 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.	0.00% 0/11 • 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.
Nervous system disorders Headache	4.3% 1/23 • Number of events 1 • 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.	18.2% 2/11 • Number of events 3 • 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.
Skin and subcutaneous tissue disorders Hyperhidrosis	4.3% 1/23 • Number of events 1 • 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.	0.00% 0/11 • 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.
Metabolism and nutrition disorders Hyponatraemia	4.3% 1/23 • Number of events 1 • 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.	0.00% 0/11 • 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.
Psychiatric disorders Insomnia	0.00% 0/23 • 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.	9.1% 1/11 • Number of events 1 • 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.
Infections and infestations Nasopharyngitis	0.00% 0/23 • 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.	18.2% 2/11 • Number of events 2 • 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.
Investigations Neutrophil count abnormal	4.3% 1/23 • Number of events 1 • 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.	0.00% 0/11 • 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.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/23 • 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.	9.1% 1/11 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/23 • 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.	9.1% 1/11 • Number of events 1 • 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.
Injury, poisoning and procedural complications Sunburn	0.00% 0/23 • 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.	9.1% 1/11 • Number of events 1 • 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.
Infections and infestations Suspected COVID-19	4.3% 1/23 • Number of events 1 • 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.	0.00% 0/11 • 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.
Skin and subcutaneous tissue disorders Urticaria	4.3% 1/23 • Number of events 1 • 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.	9.1% 1/11 • Number of events 1 • 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.
Blood and lymphatic system disorders White blood cell disorder	4.3% 1/23 • Number of events 1 • 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.	0.00% 0/11 • 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.