A Study of Lebrikizumab (LY3650150) With/Without Topical Corticosteroid Treatment in Participants With Moderate-to-Severe Atopic Dermatitis

Launched by ELI LILLY AND COMPANY · Feb 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called lebrikizumab to see how well it works in treating moderate-to-severe atopic dermatitis, also known as eczema. The trial will last about 62 weeks and will involve some participants using lebrikizumab alone, while others will use it alongside a topical corticosteroid, which is a type of cream used to reduce inflammation and itching. The goal is to find out how effective and safe this treatment is for people who have not had enough relief from other medications.

To be eligible for this study, participants must be at least 12 years old and have been diagnosed with chronic eczema for at least a year. They should have moderate-to-severe symptoms, and their past treatments must not have worked well for them. Participants can expect to visit the clinic regularly for assessments and to receive the study medication. It’s important to know that individuals with certain health conditions or who are currently pregnant or breastfeeding cannot participate in the trial. This study aims to provide more options for those struggling with atopic dermatitis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Have chronic AD that has been present for ≥1 year before the screening period or have chronic eczema and meet the AAD criteria.
• • Have moderate-to-severe AD, including all of the following at the baseline: EASI score ≥16, IGA score ≥3 (scale of 0 to 4), ≥10% BSA of AD involvement.
• * Have a documented history provided by a physician and/or investigator of inadequate response to existing topical medications within 6 months preceding screening as defined by at least 1 of the following:
• • 1. Inability to achieve good disease control, defined as mild disease or better after use of at least a medium-potency TCS for at least 4 weeks, or for the maximum duration recommended by the product prescribing information, whichever is shorter. TCS may be used with or without TCIs and/or topical Janus kinase (JAK) inhibitors.
• • 2. Participants who failed systemic therapies intended to treat AD within 6 months preceding screening, such as cyclosporine, MTX, azathioprine, and MMF, will also be considered as surrogates for having inadequate response to topical therapy.
• • Adolescents body weight must be ≥40 kg at baseline.
• • Males may participate in this trial and comply with specific local government study requirements. Females of childbearing potential and females not of childbearing potential may participate in this trial.
• Exclusion Criteria:
• • Have received a dose of lebrikizumab in any prior lebrikizumab clinical study.
• • Have a history of anaphylaxis or uncontrolled chronic disease that might require bursts of oral corticosteroids.
• • Have a current or recent acute, active infection. For at least 30 days before screening and up to the randomization, participants must have no symptoms or signs of confirmed or suspected infection and must have completed any appropriate anti-infective treatment.
• • Have had Serious, Opportunistic, Chronic and Recurring infection within 3 months prior to the screening or develops any of these infections before the randomization.
• • Have active tuberculosis (TB) or latent tuberculosis infection (LTBI) that has not been treated with a complete course of appropriate therapy or such treatment is underway.
• • Have a current infection with HBV, HCV, human immunodeficiency virus (HIV) infection.
• • Have presence of skin comorbidities that may interfere with study assessments.
• * Have a diagnosis or history of malignant disease within 5 years before screening, with the following exceptions:
• • 1. basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years, and
• • 2. cervical carcinoma in situ, with no evidence of recurrence within 5 years before screening visit.
• • Pregnant or breastfeeding women or women planning to become pregnant or breastfeed during the study.