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NCT04975438

Clinical Effect, Safety and Tolerability of GSK1070806 in Atopic Dermatitis

Completed Phase 1 Results posted Last updated 28 August 2025
What this trial tests

Phase 1 trial testing GSK1070806 in Dermatitis, Atopic in 34 participants. Completed in 13 March 2023.

Timeline
18 November 2021
Primary endpoint
19 December 2022
13 March 2023

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment34
Start date18 November 2021
Primary completion19 December 2022
Estimated completion13 March 2023
Sites11 locations across Canada, United States

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

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 1 Primary · 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

GroupValue95% 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 1 Secondary · 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

GroupValue95% 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 1 Secondary · 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
GroupValue95% CI
Group 1: GSK107080614
Group 1: Placebo3
Non-responder
GroupValue95% CI
Group 1: GSK10708065
Group 1: Placebo6
Number of Participants Achieving EASI-75, ≥ 75% Reduction in EASI Score at Week 12 in Group 1 Secondary · 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
GroupValue95% CI
Group 1: GSK10708067
Group 1: Placebo1
Non-responder
GroupValue95% CI
Group 1: GSK107080612
Group 1: Placebo8
Number of Participants Achieving EASI-90, ≥ 90% Reduction in EASI Score at Week 12 in Group 1 Secondary · 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
GroupValue95% CI
Group 1: GSK10708065
Group 1: Placebo1
Non-responder
GroupValue95% CI
Group 1: GSK107080614
Group 1: Placebo8
Number of Participants With Investigator Global Assessment (IGA) Score of 0 or 1 at Week 12 in Group 1 Secondary · 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)
GroupValue95% CI
Group 1: GSK10708064
Group 1: Placebo1
Clear (0)
GroupValue95% CI
Group 1: GSK10708061
Group 1: Placebo0
Percent Change From Baseline in EASI Score at Week 12 in Group 2 Secondary · 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

GroupValue95% 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 2 Secondary · 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
GroupValue95% CI
Group 1 and 2: GSK107080610
Group 1 and 2: Placebo6
Serious Adverse Events
GroupValue95% CI
Group 1 and 2: GSK10708060
Group 1 and 2: Placebo0
Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Secondary · 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
GroupValue95% CI
Group 1 and 2: GSK10708060
Group 1 and 2: Placebo0
Diastolic Blood Pressure (mmHg),Worst Case Post-Baseline, To w/in Range or No Change
GroupValue95% CI
Group 1 and 2: GSK107080622
Group 1 and 2: Placebo10
Diastolic Blood Pressure (mmHg),Worst Case Post-Baseline, To High
GroupValue95% CI
Group 1 and 2: GSK10708061
Group 1 and 2: Placebo1
Pulse Rate (beats/min),Worst Case Post-Baseline,To Low
GroupValue95% CI
Group 1 and 2: GSK10708060
Group 1 and 2: Placebo0
Pulse Rate (beats/min),Worst Case Post-Baseline, To w/in Range or No Change
GroupValue95% CI
Group 1 and 2: GSK107080623
Group 1 and 2: Placebo11
Pulse Rate (beats/min),Worst Case Post-Baseline, To High
GroupValue95% CI
Group 1 and 2: GSK10708060
Group 1 and 2: Placebo0
Systolic Blood Pressure (mmHg),Worst Case Post-Baseline,To Low
GroupValue95% CI
Group 1 and 2: GSK10708060
Group 1 and 2: Placebo0
Systolic Blood Pressure (mmHg),Worst Case Post-Baseline, To w/in Range or No Change
GroupValue95% CI
Group 1 and 2: GSK107080622
Group 1 and 2: Placebo11
Number of Participants With Worst Case 12-lead Electrocardiogram (ECG) Post-Baseline Relative to Baseline - Groups 1 and 2 Secondary · 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.

GroupValue95% CI
Group 1 and 2: GSK10708060
Group 1 and 2: Placebo0
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline - Groups 1 and 2 Secondary · 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.

GroupValue95% CI
Group 1 and 2: GSK10708060
Group 1 and 2: Placebo0
Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2 Secondary · 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
GroupValue95% CI
Group 1 and 2: GSK10708060
Group 1 and 2: Placebo0
Alanine Aminotransferase (IU/L),Worst Case Post-Baseline,To W/in Range or No Change
GroupValue95% CI
Group 1 and 2: GSK107080622
Group 1 and 2: Placebo11
Alanine Aminotransferase (IU/L),Worst Case Post-Baseline,To High
GroupValue95% CI
Group 1 and 2: GSK10708061
Group 1 and 2: Placebo0
Albumin (g/L),Worst Case Post-Baseline,To Low
GroupValue95% CI
Group 1 and 2: GSK10708060
Group 1 and 2: Placebo0
Albumin (g/L),Worst Case Post-Baseline,To W/in Range or No Change
GroupValue95% CI
Group 1 and 2: GSK107080623
Group 1 and 2: Placebo11
Albumin (g/L),Worst Case Post-Baseline,,To High
GroupValue95% CI
Group 1 and 2: GSK10708060
Group 1 and 2: Placebo0
Alkaline Phosphatase (IU/L),Worst Case Post-Baseline,To Low
GroupValue95% CI
Group 1 and 2: GSK10708060
Group 1 and 2: Placebo0
Alkaline Phosphatase (IU/L),Worst Case Post-Baseline,To W/in Range or No Change
GroupValue95% CI
Group 1 and 2: GSK107080623
Group 1 and 2: Placebo11

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.

GSK1070806
Serious: 0/23 (0%)
Deaths: 0/23
Placebo
Serious: 0/11 (0%)
Deaths: 0/11
Other adverse events (22 terms — click to expand)

ReactionSystemGSK1070806Placebo
COVID-19Infections and infestations
Dermatitis atopicSkin and subcutaneous tissue disorders
HeadacheNervous system disorders
NasopharyngitisInfections and infestations
Back painMusculoskeletal and connective tissue disorders
ChillsGeneral disorders
Cold sweatSkin and subcutaneous tissue disorders
Dermal cystSkin and subcutaneous tissue disorders
DermatitisSkin and subcutaneous tissue disorders
DiarrhoeaGastrointestinal disorders
Face injuryInjury, poisoning and procedural complications
GastroenteritisInfections and infestations
HyperhidrosisSkin and subcutaneous tissue disorders
HyponatraemiaMetabolism and nutrition disorders
InsomniaPsychiatric disorders
Neutrophil count abnormalInvestigations
Oropharyngeal painRespiratory, thoracic and mediastinal disorders
Seborrhoeic dermatitisSkin and subcutaneous tissue disorders
SunburnInjury, poisoning and procedural complications
Suspected COVID-19Infections and infestations
UrticariaSkin and subcutaneous tissue disorders
White blood cell disorderBlood and lymphatic system disorders

Data from ClinicalTrials.gov NCT04975438 adverse events section.

Sponsor's own description

This study will evaluate efficacy and safety of GSK1070806 in moderate to severe atopic dermatitis (AtD) participants.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The role of NLRP3 inflammasome in inflammation-related skeletal muscle atrophy.
    Liu Y, Wang D, Li T, Yang F, et al · · 2022 · cited 32× · PMID 36405697 · DOI 10.3389/fimmu.2022.1035709
  2. Interleukin-18 Binding Protein in Immune Regulation and Autoimmune Diseases.
    Park SY, Hisham Y, Shin HM, Yeom SC, et al · · 2022 · cited 19× · PMID 35885055 · DOI 10.3390/biomedicines10071750
  3. Walking down Skeletal Muscle Lane: From Inflammasome to Disease.
    Dubuisson N, Versele R, Davis-López de Carrizosa MA, Selvais CM, et al · · 2021 · cited 19× · PMID 34831246 · DOI 10.3390/cells10113023
  4. Interleukin-18 Binding Protein (IL-18BP): A Long Journey From Discovery to Clinical Application.
    Kim S, Yu H, Azam T, Dinarello CA. · · 2024 · cited 4× · PMID 38455460 · DOI 10.4110/in.2024.24.e1
  5. Targeting the NLRP3 inflammasome and associated cytokines in scleroderma associated interstitial lung disease.
    Woo S, Gandhi S, Ghincea A, Saber T, et al · · 2023 · cited 3× · PMID 37849737 · DOI 10.3389/fcell.2023.1254904
  6. Very Early-Onset IBD-Associated IL-18opathy Treated with an Anti-IL-18 Antibody.
    Guha A, Diaz-Pino R, Fagbemi A, Hughes SM, et al · · 2024 · cited 2× · PMID 39458007 · DOI 10.3390/jcm13206058
  7. Clinical and Molecular Effect of the Anti-IL-18 Antibody Aletekitug in Adults With Atopic Dermatitis.
    Ellis J, Fortunato L, Wajdner H, Del Duca E, et al · · 2026 · PMID 41410194 · DOI 10.1111/all.70172
  8. Multi-omic triangulation identifies molecular candidates of atopic dermatitis severity
    Watts K, Hübenthal M, Szymczak S, Cherry H, et al · · 2025 · DOI 10.1101/2025.08.04.25332125

Verify or expand the search:

Other trials of GSK1070806

Trials testing the same drug.

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Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing