Phase IV Open-Label Study of Lebrikizumab for Moderate-to-Severe Atopic Dermatitis to Understand How the Drug Works

What this Trial Is About

Researchers are studying lebrikizumab, a drug already approved for treating moderate-to-severe atopic dermatitis AD, to see if it leads to long-term skin improvement. This phase IV, non-randomized, open-label trial collects health information, blood, and skin samples to better understand how the drug works on AD. The study is led by Johann E Gudjonsson MD PhD and involves patients with active AD affecting more than 10% of their body surface area. Participants will receive lebrikizumab starting with a 500 mg loading dose given under the skin at the beginning and at week 2, followed by 250 mg every two weeks until week 24. After week 24, those showing significant improvement continue treatment every four weeks until week 60, while others stop the treatment. Patients with sustained low disease activity after week 36 will also stop the drug. The study lasts 60 weeks and involves multiple sites in the United States and Europe. During the study, participants will attend regular visits for clinical assessments including skin evaluations using standard scales like Eczema Area and Severity Index EASI and Investigator Global Assessment IGA. Researchers will monitor skin barrier function, molecular responses, and itch severity using the Peak Pruritus Numerical Rating Scale. Blood and skin samples will be collected to analyze changes at the molecular level. The main outcome is the degree of normalization of gene and epigenetic profiles up to week 60. Safety and adherence to treatment will be tracked throughout the study period.

Lebrikizumab in Moderate-to-severe Atopic Dermatitis