Effectiveness and Safety of Lebrikizumab in Adults and Adolescents with Moderate-to-Severe AD
Research type
Research Study
Full title
A Phase 3b, Open-label Study to Evaluate the Effectiveness and Safety of Lebrikizumab Treatment in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis
IRAS ID
1008291
Contact name
Marwane Payet
Contact email
Sponsor organisation
Almirall, S.A.
Research summary
Atopic dermatitis (AD), also known as eczema, is a common skin disease that can cause diverse symptoms, such as itching, skin redness, or a rash that is scaly or oozing. The symptoms can look different on different people. AD usually begins in childhood, but can occur at any age, including adolescence and adulthood. There is currently no known cure for this condition. Several medicines are available to treat people with AD. However, for some people, their symptoms may not improve using the available treatments, improvements may not last, or they may have medical problems related to these treatments. Therefore, researchers continue looking for new AD treatments. Lebrikizumab is a new experimental treatment for people with moderate-to-severe AD. Almirall (study sponsor) is performing a study to assess how well lebrikizumab works in helping to improve symptoms in adults and adolescents with moderate-to-severe AD. The secondary goal is to assess the impact of lebrikizumab on the symptoms and day-to-day life of adults and adolescents with moderate-to-severe AD. This study will be performed by doctors at multiple sites in Germany, the Netherlands, and the United Kingdom. The study will enrol about 240 people. Adults and adolescents (aged 12 to <18 years and weighing ≥ 40 kilograms) who have had moderate-to-severe AD for at least 1 year will take part in the study. All participants in this study will be treated with lebrikizumab for up to 24 weeks. Participants will visit the study site every 2 weeks for up to 4 weeks, then every 8-12 weeks. During these visits, the study doctors will examine the participants and assess their AD symptoms, collect blood samples for laboratory testing, ask about any medical problems, and participants will describe their quality of life. Between these visits, participants will keep a diary of lebrikizumab treatments, any other drugs prescribed by the study doctor or another doctor, any medical problems, and how much itching they experience.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
23/EM/0181
Date of REC Opinion
17 Oct 2023
REC opinion
Further Information Favourable Opinion