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Humanised Igg1 Kappa Monoclonal Antibody Against Interleukin 18

This article discusses the ongoing clinical trials of a novel drug called Humanised IgG1 Kappa Monoclonal Antibody Against Interleukin 18 (GSK1070806) for the treatment of moderate to severe atopic dermatitis. These trials aim to evaluate the efficacy, safety, and long-term effects of this innovative therapy in adult patients. The studies focus on determining optimal dosing regimens and assessing the drug’s potential to improve symptoms and quality of life for individuals suffering from this chronic skin condition.

Table of Contents

What is GSK1070806?

GSK1070806 is a new medication being developed by GlaxoSmithKline for the treatment of moderate to severe atopic dermatitis (AD), also known as eczema[1]. It is classified as a humanised IgG1 kappa monoclonal antibody that targets a specific protein in the body called interleukin 18. This medication is currently in the experimental phase and is being studied to determine its effectiveness and safety for patients with difficult-to-treat eczema.

How Does It Work?

GSK1070806 works by targeting and neutralizing interleukin 18, a protein involved in the body’s immune response. In patients with atopic dermatitis, the immune system can become overactive, leading to inflammation and skin symptoms. By blocking interleukin 18, GSK1070806 aims to reduce this inflammation and improve the symptoms of eczema[1].

Potential Benefits

Research is ongoing to determine the full extent of GSK1070806’s benefits, but early studies suggest it may help improve several aspects of atopic dermatitis, including:

  • Reducing the severity and extent of eczema symptoms
  • Improving itching (pruritus)
  • Potentially providing long-term control of the condition

One of the key measures being used to assess its effectiveness is the Eczema Area and Severity Index (EASI), which quantifies the extent and severity of eczema symptoms[1].

How is GSK1070806 Administered?

GSK1070806 is administered as a subcutaneous injection. This means it is injected just under the skin, typically in areas such as the abdomen or thigh. The medication comes in the form of a 100mg/ml solution for injection[1][2].

Ongoing Research

GSK1070806 is currently being studied in clinical trials to evaluate its safety and effectiveness. Two notable studies include:

  1. A Phase 2b study to determine the optimal dosing and assess the drug’s efficacy, safety, and how it’s processed in the body (pharmacokinetics and pharmacodynamics)[1].
  2. A long-term extension study called “AtDvance” to evaluate the safety and efficacy of GSK1070806 over an extended period[2].

Who Might Be Eligible for Treatment?

Based on the ongoing clinical trials, GSK1070806 is being studied in adults with moderate to severe atopic dermatitis. Potential candidates for the treatment may include:

  • Adults aged 18-75 years (with some country-specific variations)
  • Individuals with a diagnosis of atopic dermatitis for at least one year
  • Patients with moderate to severe symptoms, as determined by specific scoring systems
  • Those who have not responded adequately to other treatments or cannot use them due to side effects

It’s important to note that eligibility criteria may change as research progresses, and the final approved indications may differ[1].

Safety Considerations

As with any new medication, safety is a primary concern. The ongoing clinical trials are closely monitoring for any adverse events. Some potential safety considerations include:

  • Allergic reactions to the medication
  • Increased risk of infections
  • Potential interactions with other medications or treatments

Patients with certain conditions, such as uncontrolled hypertension or significant allergies to monoclonal antibodies, may not be suitable candidates for this treatment[1].

Future Prospects

While GSK1070806 shows promise, it’s important to remember that it is still in the research phase. The ongoing clinical trials will provide more information about its effectiveness, optimal dosing, and long-term safety profile. If successful, this medication could offer a new option for patients with moderate to severe atopic dermatitis who have not found relief with current treatments[1][2].

Aspect Details
Drug Name Humanised IgG1 Kappa Monoclonal Antibody Against Interleukin 18 (GSK1070806)
Condition Treated Moderate to Severe Atopic Dermatitis
Trial Phases Phase 2b and Long-Term Extension
Administration Method Subcutaneous Injection
Primary Objectives Evaluate efficacy, safety, pharmacokinetics, and pharmacodynamics
Key Outcome Measures EASI score changes, IGA score improvements, adverse events
Participant Age Range 18-75 years (with country-specific variations)
Study Duration 16 weeks (initial study) to 60 months (long-term extension)
Exclusion Criteria Uncontrolled chronic diseases, significant allergies, other skin disorders
Data Sharing Anonymized individual patient-level data available to qualified researchers

FAQ

  • What is the purpose of these clinical trials? The main purpose of these clinical trials is to evaluate the efficacy and safety of GSK1070806, a Humanised IgG1 Kappa Monoclonal Antibody Against Interleukin 18, in treating moderate to severe atopic dermatitis in adults. The trials aim to determine the optimal dosing regimens and assess the drug's long-term effects.
  • Who can participate in these clinical trials? Adults aged 18-75 years (with some country-specific age requirements) who have moderate to severe atopic dermatitis can participate. Participants must meet specific criteria, including having the condition for at least one year, an IGA score ≥3, and at least 10% body surface area involvement. Some trials may include both biologic-experienced and biologic-naive patients.
  • How is the drug administered in these trials? The drug GSK1070806 is administered as a subcutaneous injection. The specific dosing regimens and frequencies are being studied as part of the clinical trials to determine the most effective treatment approach.
  • What are the main outcomes being measured in these trials? The primary outcomes include changes in the Eczema Area and Severity Index (EASI) score, incidence of adverse events, and treatment discontinuation rates. Secondary outcomes focus on improvements in IGA scores, EASI reductions, and changes in pruritus (itching) intensity.
  • How long do these clinical trials last? The duration of the trials varies. The initial phase 2b study lasts for 16 weeks, while the long-term extension study can continue for up to 60 months (5 years). This extended period allows researchers to assess the long-term safety and efficacy of the treatment.

Ongoing Clinical Trials on Humanised Igg1 Kappa Monoclonal Antibody Against Interleukin 18

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

    Not recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia France Germany Greece Italy +2

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

    Not recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia France Germany Greece Italy +2

Glossary

  • Atopic Dermatitis (AtD): A chronic inflammatory skin condition characterized by itchy, red, swollen, and cracked skin. It is a type of eczema and is often associated with allergies and asthma.
  • Monoclonal Antibody: A type of protein made in the laboratory that can bind to substances in the body, including cancer cells. In this case, it targets interleukin 18, a protein involved in inflammation.
  • Interleukin 18 (IL-18): A protein that plays a role in the immune system and inflammation processes. It is targeted by the drug being studied to potentially reduce inflammation in atopic dermatitis.
  • Eczema Area and Severity Index (EASI): A tool used to measure the extent (area) and severity of atopic eczema. It is commonly used in clinical trials to assess the effectiveness of treatments.
  • Investigator's Global Assessment (IGA): A scale used by healthcare professionals to evaluate the overall severity of a skin condition, typically ranging from 0 (clear) to 4 (severe).
  • Peak Pruritus Numerical Rating Scale (PP-NRS): A scale used to measure the intensity of itching (pruritus) experienced by patients with atopic dermatitis.
  • Body Surface Area (BSA): A measurement of the surface area of the body affected by a skin condition, expressed as a percentage of total body surface area.
  • Subcutaneous Injection: A method of administering medication by injecting it into the tissue layer between the skin and the muscle.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Serious Adverse Event (SAE): An adverse event that results in death, is life-threatening, requires hospitalization, causes persistent or significant disability, or is otherwise medically significant.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-of-gsk1070806-injection-in-adults-with-moderate-to-severe-atopic-dermatitis/
  2. http://clinicaltrials.eu/trial/study-on-long-term-safety-of-gsk1070806-for-patients-with-moderate-to-severe-atopic-dermatitis/