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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Praglandia s.r.o. Prague Czechia
Medical Center Hera EOOD Sofia Bulgaria
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Fakultni Nemocnice Bulovka Prague Czechia
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis La Rochelle France
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
MENSINGDERMAresearch GmbH Hamburg Germany
ISA Interdisciplinary Study Association GmbH Berlin Germany
Pratia Pardubice a.s. Pardubice Czechia
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate Chieti Italy
Universita’ Campus Bio-medico Di Roma Rome Italy
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Warsaw Poland
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Universidade De Santiago De Compostela Santiago De Compostela Spain
Andreas Syngros Hospital Of Venereal And Dermatological Diseases Athens Greece
Pratia S.A. Skorzewo Poland
Centre Hospitalier Universitaire De Nice Nice France
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Vithas Hospital Nosa Senora De Fatima Vigo Spain
Dqwqhanztb Aby Cdcorqetwo Csiyvp Xzjxralreqfy Ewym Sofia Bulgaria
Unantzsgqgirhatmpdtsq Ezmjp Axa Essen Germany
Mkmwhss Dvcmokygvnlf I Morsmpci Emjtodfxjh Lfxegs Dcuiyx Ddquogmnw I Mumggo Dbytnidhl Svv z ogvr Elblag Poland
Lbdjh Czlndr Schp dd Tzioen Kkawhvrirho dv Afzeogw Kdvkyttm Szczecin Poland
Awizjpdnwc Penmmwdv Heesphbu Dx Pxncp Paris France
Uuasofiviyisbuevmhaxl Meuecfbm Asb Munster Germany
Aaxvfxp Upwjr Savgyljee Lsfmfu Db Bxefvdl Bologna Italy
Mnfjbey Cigmtx Mnaqideajw Pcloxb Ojp Pleven Bulgaria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
07.02.2024
Czechia Czechia
Not recruiting
07.02.2024
France France
Not recruiting
07.02.2024
Germany Germany
Not recruiting
07.02.2024
Greece Greece
Not recruiting
07.02.2024
Italy Italy
Not recruiting
07.02.2024
Poland Poland
Not recruiting
07.02.2024
Spain Spain
Not recruiting
07.02.2024

Trial locations

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.

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 ID:
2023-505414-15-00
Protocol code:
219538
NCT ID:
NCT05999799
Trial Phase:
Therapeutic exploratory (Phase II)

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