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ACTIVE NOT RECRUITING

NCT06280716

PHASE3

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

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab with/without Topical Corticosteroid Treatment in Participants with Moderate-to-Severe Atopic Dermatitis. The study will last approximately 62 weeks.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase 3 Trial to Investigate the Efficacy and Safety of Lebrikizumab When Used With/Without Topical Corticosteroid Treatment in Participants With Moderate-To-Severe Atopic Dermatitis

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

301

Start Date

2024-04-24

Completion Date

2026-08

Last Updated

2025-10-15

Healthy Volunteers

Conditions

Atopic Dermatitis

Interventions

DRUG

Placebo

Subcutaneous injection

DRUG

Lebrikizumab

Subcutaneous injection

DRUG

Topical Corticosteroid

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.