A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

Inclusion Criteria: - Have a diagnosis of AD prior to screening as stated in the criteria by the American Academy of Dermatology for at least: - 12 months s if participants are =6 years of age, and - 6 months if participants are 6 months to <6 years of age - Have an EASI score =16 at the screening and baseline - Have an IGA score =3 (scale of 0 to 4) at the screening and baseline - Have =10% BSA of AD involvement at the screening and baseline. Exclusion Criteria: - Are currently enrolled or have participated within the last 8 weeks in a clinical study involving an investigational intervention or any other type of medical research judged not to be scientifically or medically compatible with this study. - Treatment with the following prior to the baseline: - An investigational drug within 8 weeks or less than 5 half-lives, whichever is longer. - Dupilumab within 8 weeks. Note: The enrollment of participants with prior use of Dupilumab will be limited to <20%. - Treatment with a topical investigational drug within 2 weeks prior to the baseline. - Have received a Bacillus Calmette-Guerin vaccination or treatment within less than 4 weeks before randomization.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with an Investigator Global Assessment (IGA) score 0 or 1 and a Reduction =2 points from Baseline;Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) =75% Reduction from Baseline in EASI Score

Secondary Outcome Measures

Name	Time	Method

Related Trials

BA058 Transdermal Phase 2 Study in Women with Osteoporosis

Phase 1

Radius Health Inc.

Updated 10/31/2016

A study to assess whether different doses of KVD824 are effective in preventing attacks of Hereditary Angiodedema Type I or Type II.

Phase 1

Kalvista Pharmaceuticals Ltd

Updated 5/16/2022

A Phase 3 study of investigational drug ISIS 678354 administered under skin to patients with severely increased amount of triglycerides in blood.

Phase 1

Ionis Pharmaceuticals, Inc.

Updated 6/18/2024

A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).

Phase 1

ChemoCentryx, Inc.

Updated 2/1/2020

A Controlled Study to Investigate the Effectiveness and Safety of Daily Oral TAK-875 Compared with Placebo in Individuals Diagnosed with Type 2 Diabetes

Takeda Global Research & Development Centre (Europe) Ltd.

Updated 10/14/2013

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis

Eli Lilly and Company

Updated 1/19/2015