Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on Long-Term Safety of GSK1070806 for Patients with Moderate to Severe Atopic Dermatitis

Verified siteInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 treatment called GSK1070806, which is a type of medication known as a humanised IgG1 kappa monoclonal antibody against interleukin 18. This medication is given as an injection under the skin and is being tested to see how safe and effective it is for people with moderate to severe atopic dermatitis.

The purpose of the study is to understand the long-term safety of different doses and schedules of GSK1070806 in participants who have already completed earlier related studies. Participants will receive either the study medication or a placebo, which is a substance with no active drug. The study will monitor participants over a period of time to observe any side effects and to see how well the treatment works in reducing the symptoms of atopic dermatitis.

Throughout the study, participants will have regular check-ups to assess their skin condition and overall health. The study aims to gather information on any adverse events, which are unwanted effects that may occur during treatment, and to track improvements in skin condition using specific measures. 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, participants must have completed the qualifying Phase 2 parent GSK Atopic Dermatitis (AtD) studies. Participants must be 18 years or older and provide informed consent. Women must adhere to local contraceptive regulations.

  2. Step 2

    Treatment administration

    Participants will receive an injection of GSK1070806, a humanised igg1 kappa monoclonal antibody against interleukin 18, administered subcutaneously. The specific dosage and frequency will be determined by the study protocol.

  3. Step 3

    Monitoring and assessments

    Participants will be monitored for adverse events (AEs) and serious adverse events (SAEs). Regular assessments will be conducted to evaluate the safety and efficacy of the treatment.

    The primary goal is to observe the incidence of AEs and any discontinuation from the study due to these events.

  4. Step 4

    Response evaluation

    The study will evaluate the response to treatment at Weeks 16, 32, 48, and every 48 weeks thereafter. Key measures include achieving an Investigator's Global Assessment (IGA) score of 0 or 1, and a reduction of at least 75% in the Eczema Area and Severity Index (EASI) from baseline.

  5. Step 5

    Long-term follow-up

    Participants will be followed up for long-term safety and efficacy until the estimated end date of the study in November 2029. Regular check-ins will ensure ongoing assessment of the treatment's impact.

Who can join the trial?

6 criteria

  • Participants must have a diagnosis of **moderate to severe Atopic Dermatitis (AtD)**. Atopic Dermatitis is a skin condition that causes itchy and inflamed skin.
  • Participants must have completed the qualifying Phase 2 parent GSK AtD studies. This means they have already taken part in earlier related studies.
  • The study investigator must believe that the participant may benefit from treatment with the study medication, GSK1070806.
  • Participants must be **18 years of age or older** at the time of signing the informed consent. This means they must be adults.
  • Participants must sign and date an **informed consent**. This is a document that explains the study and confirms that the participant agrees to take part.
  • Women participating in the study must use **contraception** in a way that follows local regulations. Contraception refers to methods used to prevent pregnancy.

Who cannot join the trial?

8 criteria

  • Participants who have any other skin condition that might interfere with the study.
  • Participants who have a history of severe allergic reactions to any medication.
  • Participants who are currently taking medications that might affect the study results.
  • Participants who have any serious health conditions that could make it unsafe for them to participate.
  • Participants who are pregnant or breastfeeding.
  • Participants who have participated in another clinical trial recently.
  • Participants who have a history of drug or alcohol abuse.
  • Participants who are unable to follow the study procedures or instructions.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

GSK1070806 is a medication being studied for its safety and effectiveness in treating moderate to severe atopic dermatitis, a skin condition that causes itchy and inflamed skin. This trial aims to understand how safe it is to use this medication over a long period and how well it works in managing the symptoms of the condition.

What is already known about the treatment

GSK1070806 – This medication is administered through injection and is currently being studied in clinical trials for its safety and effectiveness in treating moderate to severe atopic dermatitis. It is not yet widely available in medical practice, as it is still under investigation. The main therapeutic use of GSK1070806 is to alleviate symptoms associated with atopic dermatitis, a chronic skin condition. At the molecular level, it works by targeting specific pathways involved in the inflammatory process, helping to reduce inflammation and improve skin condition. It is classified pharmacologically as an immunomodulator, which means it helps to regulate 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 and can persist into adulthood, with periods of flare-ups and remissions. The skin may become red, swollen, and cracked, and in severe cases, it can lead to thickened skin due to constant scratching. The exact cause is not fully understood, but it is believed to involve a combination of genetic and environmental factors. It is commonly associated with other allergic conditions such as asthma and hay fever. The condition can significantly impact the quality of life due to its persistent itchiness and visible skin changes.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508474-29-00Protocol code220723Estimated enrolment158 patientsSponsorGlaxosmithkline Research & Development Limited

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.