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Study on the Effects of GSK1070806 Injection in Adults with Moderate to Severe Atopic Dermatitis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Atopic Dermatitis, a condition that causes the skin to become red, itchy, and inflamed. The study will evaluate a new treatment called GSK1070806, which is a type of medication known as a humanised IgG1 kappa monoclonal antibody against interleukin 18. This treatment is given as an injection under the skin. The trial will also use a comparison treatment called Locally Sourced 0.9% Sodium Chloride, which is a common solution used in medical settings.

The purpose of the study is to assess how effective and safe the GSK1070806 injection is for adults with moderate to severe Atopic Dermatitis. Participants in the study will be randomly assigned to receive either the new treatment or a placebo. The study will last for a period of 16 weeks, during which participants will receive regular injections and attend scheduled visits to monitor their condition and any changes in their symptoms.

Throughout the study, researchers will collect information on how the treatment affects the severity and extent of the eczema, as well as any side effects experienced by participants. This information will help determine the potential benefits and risks of using GSK1070806 for treating Atopic Dermatitis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant must have signed and dated an informed consent form.

    The participant should be an adult aged between 18 and 75 years, with specific age requirements for participants from South Korea and Thailand.

    The participant's body mass index (BMI) should be between 18 and 39.9 kg/m².

  2. Step 2

    Baseline assessment

    The participant must have a diagnosis of atopic dermatitis (AtD) for at least one year.

    The participant should have an Investigator's Global Assessment (IGA) score of 3 or higher at both the screening and baseline visits.

    The participant should have atopic dermatitis affecting at least 10% of their body surface area at both the screening and baseline visits.

    The participant should have an Eczema Area and Severity Index (EASI) score of 16 or higher at both the screening and baseline visits.

    The participant should have a baseline pruritus numerical rating scale average score for maximum itch intensity of at least 3, based on the average of daily scores reported during the 7 days prior to randomization.

  3. Step 3

    Medication regimen

    Participants who have previously used biologic therapies for atopic dermatitis, such as dupilumab, tralokinumab, or lebrikizumab, must meet specific conditions related to their response or tolerance to these treatments.

    Biologic naive participants must have a recent history of inadequate response to a stable regimen of prescription topical medication or intolerance to such medications.

    Participants should apply a stable dose of non-medicated topical moisturizer at least twice daily for at least 7 days prior to the baseline visit.

  4. Step 4

    Treatment administration

    The study involves the administration of GSK1070806, a humanised IgG1 kappa monoclonal antibody against interleukin 18, via subcutaneous injection.

    The treatment is compared to a placebo, which is a locally sourced 0.9% sodium chloride injection.

  5. Step 5

    Primary endpoint evaluation

    The primary endpoint of the study is the percent change from baseline in the Eczema Area and Severity Index (EASI) at week 16.

Who can join the trial?

12 criteria

  • The participant or their legally authorized representative must sign and date a form that shows they agree to take part in the study.
  • Participants must be adults aged between 18 and 75 years. In South Korea, participants must be at least 19 years old, and in Thailand, they must be at least 20 years old.
  • The participant's Body Mass Index (BMI) must be between 18 and 39.9. BMI is a measure of body fat based on height and weight.
  • The participant must have been diagnosed with **Atopic Dermatitis (AtD)** for at least one year. Atopic Dermatitis is a skin condition that causes itchy and inflamed skin.
  • The participant must have an **Investigator's Global Assessment (IGA)** score of 3 or higher at both the screening and baseline visits. The IGA score is a way to measure the severity of the skin condition.
  • The participant must have Atopic Dermatitis affecting at least 10% of their body at both the screening and baseline visits.
  • The participant must have an **Eczema Area and Severity Index (EASI)** score of 16 or higher at both the screening and baseline visits. The EASI score measures the extent and severity of eczema.
  • The participant must have an average itch intensity score of at least 3, based on daily itch scores reported during the 7 days before starting the study.
  • Participants who have used biologic therapy for Atopic Dermatitis must meet certain conditions, such as stopping treatment due to lack of response or side effects. Biologic therapy refers to advanced treatments that target specific parts of the immune system.
  • Participants who have not used biologic therapy must have had an inadequate response to other treatments like moisturizers or prescription topical medications.
  • Participants must apply a non-medicated moisturizer at least twice daily for at least 7 days before the baseline visit.
  • Participants must complete electronic diary entries for itch intensity for at least 4 out of the 7 days before starting the study.

Who cannot join the trial?

4 criteria

  • Individuals who do not have a diagnosis of Atopic Dermatitis (a type of skin condition that causes itchy and inflamed skin) cannot participate.
  • Participants must be adults, meaning they should be within the age range specified for adults in the study.
  • Both males and females are eligible, but if someone does not identify as either, they may not be able to participate.
  • People who are considered part of a vulnerable population (groups that may need special protection or care) are not included in this study.
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Investigated drugs

GSK1070806 is an investigational medication being studied for its potential to help adults with moderate to severe atopic dermatitis. This medication is given as an injection under the skin. The study aims to find out how well it works, how safe it is, and how it behaves in the body.

What is already known about the treatment

GSK1070806 – This medication is administered as a subcutaneous injection and is currently being studied in clinical trials for its effectiveness in treating moderate to severe atopic dermatitis. It is in the investigational stage, meaning it is not yet approved for general medical use, but it is being evaluated for its potential benefits and safety. The main therapeutic indication for GSK1070806 is atopic dermatitis, a condition characterized by inflamed, itchy skin. The medication works by targeting specific pathways in the immune system to reduce inflammation and alleviate symptoms. It is classified pharmacologically as an immunomodulator, which means it helps regulate or normalize the immune system's response.

Investigated diseases

Atopic Dermatitis – Atopic dermatitis is a chronic skin condition characterized by dry, itchy, and inflamed skin. It often begins in childhood but can occur at any age. The skin may become red, swollen, and cracked, and in some cases, blisters may form. The condition tends to flare periodically and then subside. It is commonly associated with other allergic conditions like asthma and hay fever. The exact cause is unknown, but it involves a combination of genetic and environmental factors.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505414-15-00Protocol code219538Estimated enrolment175 patientsSponsorGlaxosmithkline Research & Development Limited

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