Effect of Lebrikizumab on Eczema and Skin Barrier Function in Adults and Adolescents with Moderate to Severe Atopic Dermatitis

The primary objective of this study is to evaluate the efficacy of lebrikizumab in improving atopic dermatitis. The secondary objectives include:

• Assessment of skin barrier function improvement.
• Comparison of the Eczema Area and Severity Index (EASI) with other outcome measures regarding reproducibility, objectivity, onset timing, and utility in the early prediction of response.

The sponsor did not provide information regarding the total number of participants. The study population consists of patients diagnosed with atopic dermatitis. Eligible individuals include adults aged 18 to 64 years and adolescents aged 12 to less than 18 years who weigh at least 40 kg. Participants must be candidates for systemic therapy and demonstrate a history of inadequate response to topical treatment. Both male and female subjects are included in the trial.

This interventional, open-label study is designed to evaluate the effect of lebrikizumab on atopic dermatitis and skin barrier function parameters in lesional and non-lesional skin. The study includes adults and adolescents with moderate to severe disease who are candidates for systemic therapy. Following a screening visit to confirm eligibility, participants will receive lebrikizumab via subcutaneous injection. The clinical assessment focuses on the percentage of patients achieving EASI-75 at Week 24, which serves as the final study visit. Secondary endpoints include measures such as Investigator Global Assessment, Dermatology Life Quality Index, and various skin physiological outcome measures. The study duration and participant involvement are structured around these clinical milestones.

The investigational medicinal product is lebrikizumab, provided as Ebglyss. This solution for injection is administered via subcutaneous injection at a dosage of 500 mg.

The efficacy of lebrikizumab in patients with atopic dermatitis will be assessed using several parameters. The primary endpoint is the percentage of participants achieving an EASI-75, defined as a 75% or greater reduction from baseline in the Eczema Area and Severity Index score, at Week 24. Secondary clinical assessments include the Investigator's Global Assessment, Dermatology Life Quality Index, and Numeric Rating Scale for pruritus.

Additional efficacy evaluations involve the following:

• Patient-reported outcome measures including the Patient Oriented Eczema Measure, Modified Dermatology Assessment for Depression and Anxiety, and the RECAP scale.
• Skin physiological outcomes measured via Electronic Impedance Spectroscopy, evaporimetry, Epsilon, and TiVi.
• Assessment of natural moisturizing factor and skin lipid levels through tape stripping and ToF-SIMS analysis of skin biopsies.
• Vitamin D status evaluation via blood analysis and skin biopsies in the adult subgroup.