Clinical Trial Details for

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

NCT ID: NCT05559359

Last Updated: October 31, 2023

Official Title

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

Purpose

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).

The Study at a Glance

Status: RECRUITING

Phase: Phase 3

Gender: ALL

Age: 6 Months - 17 Years

Condition: Atopic Dermatitis

Study Type: Interventional

Lead Sponsor: Eli Lilly and Company

Eligibility

Ages Eligible for Study: 6 Months to 17 Years

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

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.

Additional Information, Locations & Contacts

Collaborators: Dermira, Inc.

Investigators: 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)

Please refer to this study by its clinicaltrials.gov identifier: NCT05559359
Location

Clinical Research Center of Alabama

Birmingham, Alabama, United States

Phoenix Children's Hospital

Phoenix, Arizona, United States

Arkansas Research Trials

North Little Rock, Arkansas, United States

First OC Dermatology

Fountain Valley, California, United States

Antelope Valley Clinical Trials

Lancaster, California, United States

Dermatology Research Associates

Los Angeles, California, United States

Integrative Skin Science and Research - Location 2

Sacramento, California, United States

UConn Health

Farmington, Connecticut, United States

Solutions Through Advanced Research

Jacksonville, Florida, United States

ForCare Clinical Research

Tampa, Florida, United States

Treasure Valley Medical Research

Boise, Idaho, United States

Northwestern University

Chicago, Illinois, United States

Allergy and Asthma Specialist

Owensboro, Kentucky, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Oakland Hills Dermatology

Auburn Hills, Michigan, United States

Great Lakes Research Group, Inc.

Bay City, Michigan, United States

The Derm Institute of West Michigan

Caledonia, Michigan, United States

Respiratory Medicine Research Institute of Michigan, PLC

Ypsilanti, Michigan, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Wright State Physicians

Fairborn, Ohio, United States

The Pennsylvania Centre for Dermatology, LLC

Exton, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Instituto de Neumonología Y Dermatología

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Psoriahue

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina

Fundacion Cidea

Buenos Aires, Ciudad Aut, Argentina

Fundacion Estudios Clinicos

Rosario, Santa Fe, Argentina

CONEXA Investigacion Clinica S.A.

Buenos Aires, Argentina

Fundación Respirar

Buenos Aires, Argentina

Sydney Children's Hospital

Randwick, New South Wales, Australia

The Children's Hospital at Westmead

Westmead, New South Wales, Australia

Cornerstone Dermatology

Coorparoo, Queensland, Australia

Veracity Clinical Research Pty Ltd

Woolloongabba, Queensland, Australia

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande Do Sul, Brazil

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, São Paulo, Brazil

Centro de Pesquisa Sao Lucas

Campinas, São Paulo, Brazil

Hospital de Clínicas de Ribeirão Preto

Ribeirão Preto, São Paulo, Brazil

Faculdade de Medicina do ABC

Santo Andre, São Paulo, Brazil

Pesquisare Saude

Santo André, São Paulo, Brazil

Clinica de Alergia Martti Antila

Sorocaba, São Paulo, Brazil

IBPClin - Instituto Brasil de Pesquisa Clínica

Rio de Janeiro, Brazil

Dermatology Research Institute

Calgary, Alberta, Canada

Alberta Dermasurgery Centre

Edmonton, Alberta, Canada

DermEdge Research

Mississauga, Ontario, Canada

Detska nemocnice FN Brno

Brno, Brno-město, Czechia

Fakultni nemocnice Bulovka

Prague, Praha 8, Czechia

Hôpitaux Drôme Nord - Romans

Romans-sur-Isère, Drôme, France

Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

Nantes, Loire-Atlantique, France

CHU de Toulouse - Hopital Larrey

Toulouse, Midi-Pyrénées, France

Rosenpark Research GmbH

Darmstadt, Hessen, Germany

Universitätsklinikum Frankfurt

Frankfurt, Hessen, Germany

Fachklinik Bad Bentheim

Bad Bentheim, Niedersach, Germany

Universitätsklinikum Münster

Münster, Nordrhein-Westfalen, Germany

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, Sachsen, Germany

Fujita Health University

Toyoake, Aichi, Japan

Fukuyama City Hospital

Fukuyama, Hiroshima, Japan

Asahikawa Medical College Hospital

Asahikawa, Hokkaido, Japan

National Hospital Organization Sagamihara National Hospital

Sagamihara, Kanagawa, Japan

Ina Central Hospital

Ina, Nagano, Japan

Osaka Habikino Medical Center

Habikino, Osaka, Japan

Kume Clinic

Sakai City, Osaka, Japan

Enomoto Clinic

Kumagaya, Saitama, Japan

Sugamo Sengoku Dermatology

Toshima, Tokyo, Japan

Hiroshima University Hospital

Hiroshima, Japan

University Hospital,Kyoto Prefectural University of Medicine

Kyoto, Japan

Okayama City General Medical Center Okayama City Hospital

Okayama, Japan

Hospital de Jesús Nazareno

Mexico City, Distrito Federal, Mexico

Trials in Medicine

Mexico City, Distrito Federal, Mexico

Hospital Infantil de Mexico Federico Gomez

Mexico City, Distrito Federal, Mexico

PanAmerican Clinical Research - Cuernavaca

Cuernavaca, Morelos, Mexico

Eukarya PharmaSite

Monterrey, Nuevo León, Mexico

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, Mexico

Scientia Investigacion Clinica S.C.

Chihuahua, Mexico

Arké SMO S.A de C.V

Veracruz, Mexico

Centrum Medyczne Evimed

Warsaw, Mazowieckie, Poland

Diamond Clinic

Krakow, Małopolskie, Poland

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, Pomorskie, Poland

DERMED Centrum Medyczne Sp. z o.o.

Lodz, Łódzkie, Poland

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona [Barcelona], Spain

Hospital Universitario de Gran Canaria Doctor Negrín

Las, Las Palmas, Spain

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcon, Madrid, Spain

Clinica Universidad de Navarra

Pamplona, Navarra, Spain

CHOP-Centro De Especialidades De Mollabao

Pontevedra, Pontevedra [Pontevedra], Spain

Hospital de Manises

Manises, València, Spain

Hospital Infantil Universitario Niño Jesús

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Chang Gung Memorial Hospital at Kaohsiung

Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan

Chung Shan Medical University Hospital

Taichung City, Taichung, Taiwan

Taipei Veterans General Hospital

Taipei City, Taipei, Taiwan

National Taiwan University Hospital - Hsinchu branch

Hsinchu, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Chang Gung Memorial Hospital-Taipei

Taipei, Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, Taiwan

Get the latest eczema news delivered to your inbox.