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A Dose Finding Study to Investigate the Safety and Effectiveness of GSK1070806 in Adult Participants With Moderate to Severe Atopic Dermatitis

Primary Purpose

Dermatitis, Atopic

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
GSK1070806
Placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Dermatitis, Atopic, GSK1070806, 219538, Eczema, Skin Diseases, Safety, Efficacy, Immune System Diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult participants 18 years to 75 years of age Participants with: AtD defined by the AAD Consensus Criteria. Diagnosis of AtD ≥1 year. An IGA score ≥3. AtD involvement of ≥10% body surface area (BSA). EASI score ≥16 Baseline pruritus numerical rating scale average score for maximum intensity of at least 3. Participants may have had exposure to 1 biologic therapy meeting at least 1 of the following conditions: Participants who stopped treatment due to non-response, partial response, loss of efficacy. Participants who stopped treatment due to intolerance or AEs. Participants who stopped treatment due to cost or loss of access. Participant with a recent history less than or equal to (≤6) months prior to the Screening visit) of inadequate response to a stable regimen of prescription topical medication. Participants for whom prescription topical medications are not tolerated. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical study Exclusion Criteria: Chronic or acute infection requiring treatment with oral or IV antibiotics, antivirals, anti-protozoal, or antifungals within 4 weeks before the Screening visit or anytime between the Screening and Baseline visits. Superficial skin infections within 1 week before the Screening visit or active infections (including localized infections), or history of recurrent infections (excluding recurrent fungal infections of the nail bed) Known, pre-existing or suspected parasitic infection within 6 months before the Screening visit. Symptomatic herpes zoster within 3 months prior to screening Uncontrolled hypertension. Current or chronic history of liver disease or known hepatic or biliary abnormalities. Known or suspected history of immunosuppression, including history of invasive opportunistic infections despite infection resolution or unusually frequent, recurrent, or prolonged infections, per the Investigator's judgment. Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years Breast cancer within the past 10 years. History or presence of significant medical illness including but not limited to cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurological, or psychiatric disorders which in the opinion of the investigator would interfere with the study procedures and/or assessments. Previously treated with any oral Janus Kinase inhibitor (JAKi) or other kinase inhibitors, experimental or approved. Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma. Presence of Hepatitis B surface antibody (HBsAg) or Hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study intervention. Positive hepatitis C antibody test result at screening or within 3 months prior to starting study intervention. Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention. Positive HIV antibody test. Evidence of active or latent TB as documented by medical history, examination, and TB testing with a positive QuantiFERON test at initial Screening visit. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    GSK1070806 Dose 1

    GSK1070806 Dose 2

    GSK1070806 Dose 3

    GSK1070806 Dose 4

    Placebo

    Arm Description

    Participants will receive GSK1070806 dose 1.

    Participants will receive GSK1070806 dose 2.

    Participants will receive GSK1070806 dose 3.

    Participants will receive GSK1070806 dose 4.

    Participants will receive placebo.

    Outcomes

    Primary Outcome Measures

    Percent Change from Baseline (PCFB) in the Eczema Area and Severity Index (EASI) at Week 16
    EASI is an internationally used classification for AtD severity and an investigator-assessed measure that is used to assess the extent (area) and severity of AtD. The range of the scale is 0-72, with a higher score indicating greater severity.

    Secondary Outcome Measures

    Percent Change from Baseline (PCFB) EASI Score for GSK1070806 at Each Time Point
    EASI score percent changes from baseline at each time point will be reported. EASI is an internationally used classification for AtD severity and an investigator-assessed measure that is used to assess the extent (area) and severity of AtD. The range of the scale is 0-72, with a higher score indicating greater severity.
    Number of Participants Achieving EASI Reduction of Greater than or Equal to (≥) 75 Percentage (%) from Baseline at Week 16
    The occurrence of ≥75% reduction from baseline achieving EASI75 score at Week 16 will be reported. EASI is an internationally used classification for AtD severity and an investigator-assessed measure that is used to assess the extent (area) and severity of AtD. The range of the scale is 0-72, with a higher score indicating greater severity.
    Number of Participants Achieving Investigator's Global Assessment (IGA) score of 0 or 1 at Week 16
    IGA for AtD is a measure of overall disease severity at the time of assessment on a 5-point scale by the investigator. Where 0-clear, 1-almost clear, 2-mild disease, 3-moderate disease, and 4- severe disease. Higher score indicates severity of disease. A participant with an IGA score of 0 or 1 from baseline will be reported.
    Change from Baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) Score at Week 16
    PP-NRS is a patient reported measure of pruritus (itch) intensity assessing worst itch (in the past 24 hours). The values will be evaluated using an 11-point scale (from 0 to 10), with 0 being no itch and 10 being the worst imaginable itch.
    Number of Participants Achieving PP-NRS Reduction of ≥4 points from Baseline at Week. 16
    Participants achieving a reduction of ≥4 points from baseline of peak pruritus NRS score at Week 16 will be reported. The values will be evaluated using an 11-point scale (from 0 to 10), with 0 being no itch and 10 being the worst imaginable itch.
    Number of Participants Achieving EASI Reduction of ≥50% or 90% or 100% from Baseline at Week 16
    The occurrence of ≥50% or 90% or 100% reduction from baseline achieving EASI score at Week 16 will be reported. EASI is an internationally used classification for AtD severity and an investigator-assessed measure that is used to assess the extent (area) and severity of AtD. The range of the scale is 0-72, with a higher score indicating greater severity.
    Number of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Reduction of ≥ 50% or 75% from Baseline at Week 16
    Participants achieving a reduction SCORAD reduction of 50% or 75% from Baseline will be reported. SCORAD is a clinical tool to assess the extent and severity of AtD with 3 components. The total score for SCORAD index formula is computed as formula A is defined as the extent (0-100), B is defined as the intensity (0-18) and C is defined as the subjective symptoms (0-20). The total SCORAD score ranges from 0 (no disease) to 103 (severe disease).
    Change from Baseline in the Body surface area (BSA) of GSK1070806 at Week 16
    The BSA assessment estimates the extent of disease or skin involvement with respect to AtD and is expressed as a percentage of total body surface. BSA will be determined by the Investigator or designee using the patient palm = 1% rule
    Change from Baseline in the SCORAD of GSK1070806 at Week 16
    SCORAD is a clinical tool to assess the extent and severity of AtD with 3 components. The total score for SCORAD index formula is computed as formula A is defined as the extent (0-100), B is defined as the intensity (0-18) and C is defined as the subjective symptoms (0-20). The total SCORAD score ranges from 0 (no disease) to 103 (severe disease).
    Change from Baseline in Patient Reported Outcomes (PRO) Measure of Skin Pain Numerical Rating Scale (SP-NRS) at Week 16
    SP-NRS is a patient reported measure assessing worst level of skin pain (in the past 24 hours). The values will be evaluated using an 11-point scale from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable.
    Change from Baseline in PRO Measure of Patient Reported Outcomes Measurement Information System (PROMIS) -Sleep Disturbance 8b at Week 16
    The PROMIS Short Form Sleep disturbance 8b is a PRO instrument designed to assess self-reported sleep disturbance for which the recall period is the past 7 days. The items are rated on a 5-point verbal rating scale. Items are summed giving a range in raw score from 8 to 40, with higher scores indicating greater severity of sleep disturbance.
    Change from Baseline in PRO Measure of Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue at Week 16
    The FACIT-Fatigue scale is a short, 13-item measure that assesses self-reported fatigue and its associated impact for daily activities over the past week. The items are rated on a 5-point Likert-type scale (i.e., 4 = not at all to 0 = very much). The scale range is 0 to 52, with 0 being the worst possible score and 52 indicating no fatigue.
    Change from Baseline in PRO Measure of Brief Fatigue Inventory (BFI) - Item 3 at Week 16
    The BFI is a self-administered questionnaire developed to assess fatigue severity. The BFI has 9 items. BFI item 3 assesses the worst level of fatigue related concepts (i.e., tiredness, weariness) during the past 24 hours. Participants report their worst level of fatigue daily, for the previous 24 hours, using a numerical rating scale ranging from 0 (no fatigue) to 10 (as bad as you can imagine).
    Change from Baseline in PRO Measure of Patient Oriented Eczema Measure (POEM) at Week 16
    POEM is a 7-item questionnaire that assesses symptoms of dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping over the last week. The scoring symptom ranges from 0 (absent disease) to 28 (severe disease). Higher score indicates poor QoL.
    Change from Baseline in PRO Measure of Dermatology Life Quality Index (DLQI) at Week 16
    The DLQI is a 10-item questionnaire that asks participants to evaluate the degree that their skin disease has affected their QoL. It is calculated by summing the scores of the 10 questions, ranging from 0 to 30 with higher scores indicating more impaired QoL. A score of 0 or 1 means that the disease has no effect at all.
    Change from Baseline in PRO Measure of Hospital Anxiety and Depression Scale (HADS) at Week 16
    The HADS is a self-reported questionnaire which measures depression and generalized anxiety, in the past week. Each item on the questionnaire ranges from 0 (no, not at all) to 3 (yes, definitely). The scale ranges from 0 to 21, with lower score indicating better QoL.
    Change from Baseline in PRO Measure of Work Productivity and Activity Impairment Questionnaire-Atopic Dermatitis (WPAI- AD) at Week 16
    The WPAI-AD is a validated, patient-reported, quantitative assessment of absenteeism (work time missed), presentism (reduced on-the-job effectiveness), work productivity loss and activity impairment due to a specific health problem.
    Occurrences of Adverse Events (AEs), Serious AE (SAEs), and AEs of Special Interest (AESI)
    AEs, SAEs, and AESIs will be reported. An AE is any untoward medical occurrence in participant, temporally associated with use of study intervention, whether or not considered related to medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, medically important were categorized as SAE. AESIs of the study drug includes serious and opportunistic infections, serious hypersensitivity reactions and Injection site reactions.
    Change from Baseline in Haematology Parameter: Haemoglobin (Hb) (Grams per Litre)
    Change from Baseline in Haematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, White Blood Cell (WBC), and Platelet Count (Giga Cells per Litre)
    Change from Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Gamma-Glutamyl Transferase (GGT), and Alkaline Phosphatase (AP) (Units per Litre)
    Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST) (International Units per Litre)
    Change from Baseline in Clinical Chemistry Parameter: Total Bilirubin (Micromoles per Litre)
    Number of Participants with Greater than or Equal to (≥) Grade 3 Hematological/Clinical Chemistry Abnormalities According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE)
    Hematological/clinical chemistry abnormalities summarized according to NCI CTCAE grade.

    Full Information

    First Posted
    August 11, 2023
    Last Updated
    August 22, 2023
    Sponsor
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05999799
    Brief Title
    A Dose Finding Study to Investigate the Safety and Effectiveness of GSK1070806 in Adult Participants With Moderate to Severe Atopic Dermatitis
    Official Title
    A Phase 2b, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Dose Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GSK1070806 SC Injection in Adult Participants With Moderate to Severe Atopic Dermatitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 25, 2023 (Anticipated)
    Primary Completion Date
    May 9, 2025 (Anticipated)
    Study Completion Date
    September 26, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GlaxoSmithKline

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study is parallel group, placebo-controlled dose-ranging study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of GSK1070806 in adult participants with moderate to severe Atopic Dermatitis (AtD), who have previously been treated with medicated topical treatments or a biologic therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dermatitis, Atopic
    Keywords
    Dermatitis, Atopic, GSK1070806, 219538, Eczema, Skin Diseases, Safety, Efficacy, Immune System Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    This is a dose finding, placebo-controlled study where participants will be randomized to receive either GSK1070806 or placebo.
    Masking
    ParticipantInvestigator
    Masking Description
    Participants and investigator are blinded to study intervention.
    Allocation
    Randomized
    Enrollment
    175 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    GSK1070806 Dose 1
    Arm Type
    Experimental
    Arm Description
    Participants will receive GSK1070806 dose 1.
    Arm Title
    GSK1070806 Dose 2
    Arm Type
    Experimental
    Arm Description
    Participants will receive GSK1070806 dose 2.
    Arm Title
    GSK1070806 Dose 3
    Arm Type
    Experimental
    Arm Description
    Participants will receive GSK1070806 dose 3.
    Arm Title
    GSK1070806 Dose 4
    Arm Type
    Experimental
    Arm Description
    Participants will receive GSK1070806 dose 4.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will receive placebo.
    Intervention Type
    Drug
    Intervention Name(s)
    GSK1070806
    Intervention Description
    GSK1070806 will be administered.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo will be administered.
    Primary Outcome Measure Information:
    Title
    Percent Change from Baseline (PCFB) in the Eczema Area and Severity Index (EASI) at Week 16
    Description
    EASI is an internationally used classification for AtD severity and an investigator-assessed measure that is used to assess the extent (area) and severity of AtD. The range of the scale is 0-72, with a higher score indicating greater severity.
    Time Frame
    Baseline and Week 16
    Secondary Outcome Measure Information:
    Title
    Percent Change from Baseline (PCFB) EASI Score for GSK1070806 at Each Time Point
    Description
    EASI score percent changes from baseline at each time point will be reported. EASI is an internationally used classification for AtD severity and an investigator-assessed measure that is used to assess the extent (area) and severity of AtD. The range of the scale is 0-72, with a higher score indicating greater severity.
    Time Frame
    Baseline and up to Week 28
    Title
    Number of Participants Achieving EASI Reduction of Greater than or Equal to (≥) 75 Percentage (%) from Baseline at Week 16
    Description
    The occurrence of ≥75% reduction from baseline achieving EASI75 score at Week 16 will be reported. EASI is an internationally used classification for AtD severity and an investigator-assessed measure that is used to assess the extent (area) and severity of AtD. The range of the scale is 0-72, with a higher score indicating greater severity.
    Time Frame
    Baseline and Week 16
    Title
    Number of Participants Achieving Investigator's Global Assessment (IGA) score of 0 or 1 at Week 16
    Description
    IGA for AtD is a measure of overall disease severity at the time of assessment on a 5-point scale by the investigator. Where 0-clear, 1-almost clear, 2-mild disease, 3-moderate disease, and 4- severe disease. Higher score indicates severity of disease. A participant with an IGA score of 0 or 1 from baseline will be reported.
    Time Frame
    Up to Week 16
    Title
    Change from Baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) Score at Week 16
    Description
    PP-NRS is a patient reported measure of pruritus (itch) intensity assessing worst itch (in the past 24 hours). The values will be evaluated using an 11-point scale (from 0 to 10), with 0 being no itch and 10 being the worst imaginable itch.
    Time Frame
    Baseline and Week 16
    Title
    Number of Participants Achieving PP-NRS Reduction of ≥4 points from Baseline at Week. 16
    Description
    Participants achieving a reduction of ≥4 points from baseline of peak pruritus NRS score at Week 16 will be reported. The values will be evaluated using an 11-point scale (from 0 to 10), with 0 being no itch and 10 being the worst imaginable itch.
    Time Frame
    Baseline and Week 16
    Title
    Number of Participants Achieving EASI Reduction of ≥50% or 90% or 100% from Baseline at Week 16
    Description
    The occurrence of ≥50% or 90% or 100% reduction from baseline achieving EASI score at Week 16 will be reported. EASI is an internationally used classification for AtD severity and an investigator-assessed measure that is used to assess the extent (area) and severity of AtD. The range of the scale is 0-72, with a higher score indicating greater severity.
    Time Frame
    Baseline and Week 16
    Title
    Number of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Reduction of ≥ 50% or 75% from Baseline at Week 16
    Description
    Participants achieving a reduction SCORAD reduction of 50% or 75% from Baseline will be reported. SCORAD is a clinical tool to assess the extent and severity of AtD with 3 components. The total score for SCORAD index formula is computed as formula A is defined as the extent (0-100), B is defined as the intensity (0-18) and C is defined as the subjective symptoms (0-20). The total SCORAD score ranges from 0 (no disease) to 103 (severe disease).
    Time Frame
    Baseline and Week 16
    Title
    Change from Baseline in the Body surface area (BSA) of GSK1070806 at Week 16
    Description
    The BSA assessment estimates the extent of disease or skin involvement with respect to AtD and is expressed as a percentage of total body surface. BSA will be determined by the Investigator or designee using the patient palm = 1% rule
    Time Frame
    Baseline and Week 16
    Title
    Change from Baseline in the SCORAD of GSK1070806 at Week 16
    Description
    SCORAD is a clinical tool to assess the extent and severity of AtD with 3 components. The total score for SCORAD index formula is computed as formula A is defined as the extent (0-100), B is defined as the intensity (0-18) and C is defined as the subjective symptoms (0-20). The total SCORAD score ranges from 0 (no disease) to 103 (severe disease).
    Time Frame
    Baseline and Week 16
    Title
    Change from Baseline in Patient Reported Outcomes (PRO) Measure of Skin Pain Numerical Rating Scale (SP-NRS) at Week 16
    Description
    SP-NRS is a patient reported measure assessing worst level of skin pain (in the past 24 hours). The values will be evaluated using an 11-point scale from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable.
    Time Frame
    Baseline and Week 16
    Title
    Change from Baseline in PRO Measure of Patient Reported Outcomes Measurement Information System (PROMIS) -Sleep Disturbance 8b at Week 16
    Description
    The PROMIS Short Form Sleep disturbance 8b is a PRO instrument designed to assess self-reported sleep disturbance for which the recall period is the past 7 days. The items are rated on a 5-point verbal rating scale. Items are summed giving a range in raw score from 8 to 40, with higher scores indicating greater severity of sleep disturbance.
    Time Frame
    Baseline and Week 16
    Title
    Change from Baseline in PRO Measure of Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue at Week 16
    Description
    The FACIT-Fatigue scale is a short, 13-item measure that assesses self-reported fatigue and its associated impact for daily activities over the past week. The items are rated on a 5-point Likert-type scale (i.e., 4 = not at all to 0 = very much). The scale range is 0 to 52, with 0 being the worst possible score and 52 indicating no fatigue.
    Time Frame
    Baseline and Week 16
    Title
    Change from Baseline in PRO Measure of Brief Fatigue Inventory (BFI) - Item 3 at Week 16
    Description
    The BFI is a self-administered questionnaire developed to assess fatigue severity. The BFI has 9 items. BFI item 3 assesses the worst level of fatigue related concepts (i.e., tiredness, weariness) during the past 24 hours. Participants report their worst level of fatigue daily, for the previous 24 hours, using a numerical rating scale ranging from 0 (no fatigue) to 10 (as bad as you can imagine).
    Time Frame
    Baseline and Week 16
    Title
    Change from Baseline in PRO Measure of Patient Oriented Eczema Measure (POEM) at Week 16
    Description
    POEM is a 7-item questionnaire that assesses symptoms of dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping over the last week. The scoring symptom ranges from 0 (absent disease) to 28 (severe disease). Higher score indicates poor QoL.
    Time Frame
    Baseline and Week 16
    Title
    Change from Baseline in PRO Measure of Dermatology Life Quality Index (DLQI) at Week 16
    Description
    The DLQI is a 10-item questionnaire that asks participants to evaluate the degree that their skin disease has affected their QoL. It is calculated by summing the scores of the 10 questions, ranging from 0 to 30 with higher scores indicating more impaired QoL. A score of 0 or 1 means that the disease has no effect at all.
    Time Frame
    Baseline and Week 16
    Title
    Change from Baseline in PRO Measure of Hospital Anxiety and Depression Scale (HADS) at Week 16
    Description
    The HADS is a self-reported questionnaire which measures depression and generalized anxiety, in the past week. Each item on the questionnaire ranges from 0 (no, not at all) to 3 (yes, definitely). The scale ranges from 0 to 21, with lower score indicating better QoL.
    Time Frame
    Baseline and Week 16
    Title
    Change from Baseline in PRO Measure of Work Productivity and Activity Impairment Questionnaire-Atopic Dermatitis (WPAI- AD) at Week 16
    Description
    The WPAI-AD is a validated, patient-reported, quantitative assessment of absenteeism (work time missed), presentism (reduced on-the-job effectiveness), work productivity loss and activity impairment due to a specific health problem.
    Time Frame
    Baseline and Week 16
    Title
    Occurrences of Adverse Events (AEs), Serious AE (SAEs), and AEs of Special Interest (AESI)
    Description
    AEs, SAEs, and AESIs will be reported. An AE is any untoward medical occurrence in participant, temporally associated with use of study intervention, whether or not considered related to medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, medically important were categorized as SAE. AESIs of the study drug includes serious and opportunistic infections, serious hypersensitivity reactions and Injection site reactions.
    Time Frame
    Up to Week 28
    Title
    Change from Baseline in Haematology Parameter: Haemoglobin (Hb) (Grams per Litre)
    Time Frame
    Baseline and Up to Week 28
    Title
    Change from Baseline in Haematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, White Blood Cell (WBC), and Platelet Count (Giga Cells per Litre)
    Time Frame
    Baseline and Up to Week 28
    Title
    Change from Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Gamma-Glutamyl Transferase (GGT), and Alkaline Phosphatase (AP) (Units per Litre)
    Time Frame
    Baseline and Up to Week 28
    Title
    Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST) (International Units per Litre)
    Time Frame
    Baseline and Up to Week 28
    Title
    Change from Baseline in Clinical Chemistry Parameter: Total Bilirubin (Micromoles per Litre)
    Time Frame
    Baseline and Up to Week 28
    Title
    Number of Participants with Greater than or Equal to (≥) Grade 3 Hematological/Clinical Chemistry Abnormalities According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE)
    Description
    Hematological/clinical chemistry abnormalities summarized according to NCI CTCAE grade.
    Time Frame
    Up to Week 28

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult participants 18 years to 75 years of age Participants with: AtD defined by the AAD Consensus Criteria. Diagnosis of AtD ≥1 year. An IGA score ≥3. AtD involvement of ≥10% body surface area (BSA). EASI score ≥16 Baseline pruritus numerical rating scale average score for maximum intensity of at least 3. Participants may have had exposure to 1 biologic therapy meeting at least 1 of the following conditions: Participants who stopped treatment due to non-response, partial response, loss of efficacy. Participants who stopped treatment due to intolerance or AEs. Participants who stopped treatment due to cost or loss of access. Participant with a recent history less than or equal to (≤6) months prior to the Screening visit) of inadequate response to a stable regimen of prescription topical medication. Participants for whom prescription topical medications are not tolerated. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical study Exclusion Criteria: Chronic or acute infection requiring treatment with oral or IV antibiotics, antivirals, anti-protozoal, or antifungals within 4 weeks before the Screening visit or anytime between the Screening and Baseline visits. Superficial skin infections within 1 week before the Screening visit or active infections (including localized infections), or history of recurrent infections (excluding recurrent fungal infections of the nail bed) Known, pre-existing or suspected parasitic infection within 6 months before the Screening visit. Symptomatic herpes zoster within 3 months prior to screening Uncontrolled hypertension. Current or chronic history of liver disease or known hepatic or biliary abnormalities. Known or suspected history of immunosuppression, including history of invasive opportunistic infections despite infection resolution or unusually frequent, recurrent, or prolonged infections, per the Investigator's judgment. Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years Breast cancer within the past 10 years. History or presence of significant medical illness including but not limited to cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurological, or psychiatric disorders which in the opinion of the investigator would interfere with the study procedures and/or assessments. Previously treated with any oral Janus Kinase inhibitor (JAKi) or other kinase inhibitors, experimental or approved. Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma. Presence of Hepatitis B surface antibody (HBsAg) or Hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study intervention. Positive hepatitis C antibody test result at screening or within 3 months prior to starting study intervention. Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention. Positive HIV antibody test. Evidence of active or latent TB as documented by medical history, examination, and TB testing with a positive QuantiFERON test at initial Screening visit. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    US GSK Clinical Trials Call Center
    Phone
    877-379-3718
    Email
    GSKClinicalSupportHD@gsk.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    EU GSK Clinical Trials Call Center
    Phone
    +44 (0) 20 89904466
    Email
    GSKClinicalSupportHD@gsk.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    GSK Clinical Trials
    Organizational Affiliation
    GlaxoSmithKline
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
    IPD Sharing Time Frame
    Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
    IPD Sharing Access Criteria
    Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
    IPD Sharing URL
    https://www.gsk.com/en-gb/innovation/trials/data-transparency/

    Learn more about this trial

    A Dose Finding Study to Investigate the Safety and Effectiveness of GSK1070806 in Adult Participants With Moderate to Severe Atopic Dermatitis

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