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

Description

The main purpose of this study is to measure the effect, safety and how well the body absorbs lebrikizumab in pediatric participants 6 months to \<18 years of age with moderate-to-severe atopic dermatitis (AD).

Conditions

Atopic Dermatitis, Eczema

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Study Overview

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Study Details

Study overview

The main purpose of this study is to measure the effect, safety and how well the body absorbs lebrikizumab in pediatric participants 6 months to \<18 years of age with moderate-to-severe atopic dermatitis (AD).

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy, Safety and Pharmacokinetics of Lebrikizumab Compared to Placebo in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

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

Condition
Atopic Dermatitis
Intervention / Treatment

-

Contacts and Locations

Birmingham

Clinical Research Center of Alabama, Birmingham, Alabama, United States, 35209

Phoenix

Phoenix Children's Hospital, Phoenix, Arizona, United States, 85016

North Little Rock

Arkansas Research Trials, North Little Rock, Arkansas, United States, 72217

Fountain Valley

First OC Dermatology, Fountain Valley, California, United States, 92708

Lancaster

Antelope Valley Clinical Trials, Lancaster, California, United States, 93534

Los Angeles

Dermatology Research Associates, Los Angeles, California, United States, 90045

Sacramento

Integrative Skin Science and Research - Location 2, Sacramento, California, United States, 95815

Farmington

UConn Health, Farmington, Connecticut, United States, 06030-2840

Jacksonville

Solutions Through Advanced Research, Jacksonville, Florida, United States, 32256

Tampa

ForCare Clinical Research, Tampa, Florida, United States, 33613

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Have a diagnosis of AD prior to screening as stated in the criteria by the American
  • * 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.
  • * 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.

Ages Eligible for Study

6 Months to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2025-09