Study on Long-Term Safety of GSK1070806 for Patients 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 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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

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
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
Universita’ Campus Bio-medico Di Roma Rome Italy
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
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
Dqhztddola Aij Cnbgjhzzux Cijgow Xriptojnnmji Euzy Sofia Bulgaria
Uccfwfjiismwetorisxzc Ewqgg Ael Essen Germany
Mugwjdo Dovgknsqzcgt I Mobqwern Eebfwgonaq Lwvcpd Dcbvuw Dlhjpepmj I Mhuinm Dpuuhwwsv Snc z oboz Elblag Poland
Lmuxf Cpqceu Skxd dm Tfgnpx Kpjqljfxcsv dh Ajcdayq Kzteotbi Szczecin Poland
Awknwjhfvd Ppqyyqec Hpebarba Dz Pqrjl Paris France
Ujyipkfzoooceutttbwqr Mfenrapv Afz Munster Germany
Aubsoek Usnxt Skkifsiuu Lsbbpv Dh Bdfztiw Bologna Italy
Macujjf Cfxxig Mxofvnhdzn Pvydro Osh 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
22.08.2024
Czechia Czechia
Not recruiting
22.08.2024
France France
Not recruiting
22.08.2024
Germany Germany
Not recruiting
22.08.2024
Greece Greece
Not recruiting
22.08.2024
Italy Italy
Not recruiting
22.08.2024
Poland Poland
Not recruiting
22.08.2024
Spain Spain
Not recruiting
22.08.2024

Trial locations

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.

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 ID:
2023-508474-29-00
Protocol code:
220723
NCT ID:
NCT06447506
Trial Phase:
Therapeutic exploratory (Phase II)

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