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
Status: Recruiting
Location: See all (84) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 17
Healthy Volunteers: f
View:
• Have a diagnosis of AD prior to screening as stated in the criteria by the American Academy of Dermatology for at least,
‣ 12 months if participants are ≥6 years of age
⁃ 6 months if participants are 2 to \<6 years of age
⁃ 3 months if participants are 6 months to \<2 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.
Locations
United States
Alabama
Clinical Research Center of Alabama
RECRUITING
Birmingham
Arkansas
Arkansas Research Trials
RECRUITING
North Little Rock
Arizona
Phoenix Children's Hospital
RECRUITING
Phoenix
California
First OC Dermatology
RECRUITING
Fountain Valley
Antelope Valley Clinical Trials
COMPLETED
Lancaster
Dermatology Research Associates
RECRUITING
Los Angeles
Integrative Skin Science and Research - Location 2
RECRUITING
Sacramento
Rady's Children Hospital San Diego - Dermatology
NOT_YET_RECRUITING
San Diego
Connecticut
UConn Health
RECRUITING
Farmington
Florida
Solutions Through Advanced Research
COMPLETED
Jacksonville
ForCare Clinical Research
COMPLETED
Tampa
Idaho
Treasure Valley Medical Research
RECRUITING
Boise
Illinois
Northwestern University
RECRUITING
Chicago
Kentucky
Allergy & Asthma Specialists, P.S.C.
RECRUITING
Owensboro
Michigan
Respiratory Medicine Research Institute of Michigan, PLC
RECRUITING
Ypsilanti
New Hampshire
Dartmouth-Hitchcock Medical Center
RECRUITING
Lebanon
New Jersey
Psoriasis Treatment Center of Central New Jersey
RECRUITING
East Windsor
Ohio
Wright State Physicians
RECRUITING
Fairborn
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Texas
Texas Dermatology and Laser Specialists
RECRUITING
San Antonio
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Other Locations
Argentina
Centro de Investigaciones Metabólicas (CINME)
RECRUITING
Buenos Aires
CONEXA Investigacion Clinica S.A.
RECRUITING
Buenos Aires
Fundación Respirar
RECRUITING
Buenos Aires
Instituto de Neumonología Y Dermatología
RECRUITING
Buenos Aires
Psoriahue
RECRUITING
Buenos Aires
Fundacion Estudios Clinicos
RECRUITING
Rosario
Australia
Cornerstone Dermatology
RECRUITING
Coorparoo
Sydney Children's Hospital
RECRUITING
Randwick
The Children's Hospital at Westmead
RECRUITING
Westmead
Veracity Clinical Research
RECRUITING
Woolloongabba
Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
RECRUITING
Barretos
Centro de Pesquisa Sao Lucas
RECRUITING
Campinas
Hospital de Clinicas de Porto Alegre
RECRUITING
Porto Alegre
Hospital de Clínicas de Ribeirão Preto
RECRUITING
Ribeirão Preto
IBPClin - Instituto Brasil de Pesquisa Clínica
RECRUITING
Rio De Janeiro
Faculdade de Medicina do ABC
RECRUITING
Santo André
Clinica de Alergia Martti Antila
RECRUITING
Sorocaba
Canada
Dermatology Research Institute
RECRUITING
Calgary
DermEdge Research
RECRUITING
Mississauga
Germany
Fachklinik Bad Bentheim
RECRUITING
Bad Bentheim
Rosenpark Research GmbH
RECRUITING
Darmstadt
Universitaetsklinikum Carl Gustav Carus Dresden
RECRUITING
Dresden
Universitätsklinikum Frankfurt
RECRUITING
Frankfurt
Universitätsklinikum Münster
RECRUITING
Münster
Japan
Asahikawa Medical University Hospital
RECRUITING
Asahikawa
Fukuyama City Hospital
RECRUITING
Fukuyama
Osaka Habikino Medical Center
RECRUITING
Habikino
Hiroshima University Hospital
RECRUITING
Hiroshima
Ina Central Hospital
RECRUITING
Ina
Enomoto Clinic
RECRUITING
Kumagaya
University Hospital,Kyoto Prefectural University of Medicine
RECRUITING
Kyoto
Okayama City General Medical Center Okayama City Hospital
RECRUITING
Okayama
National Hospital Organization Sagamihara National Hospital
RECRUITING
Sagamihara
Dermatology and Ophthalmology Kume Clinic
RECRUITING
Sakai
Sugamo Sengoku Dermatology
RECRUITING
Toshima City
Fujita Health University
RECRUITING
Toyoake
Mexico
Scientia Investigacion Clinica S.C.
RECRUITING
Chihuahua City
PanAmerican Clinical Research - Cuernavaca
COMPLETED
Cuernavaca
Hospital de Jesús Nazareno
COMPLETED
Mexico City
Hospital Infantil de Mexico Federico Gomez
RECRUITING
Mexico City
Trials in Medicine
RECRUITING
Mexico City
Eukarya PharmaSite
RECRUITING
Monterrey
Hospital Universitario Dr. Jose Eleuterio Gonzalez
RECRUITING
Monterrey
Arké SMO S.A de C.V
RECRUITING
Veracruz
Instituto Dermatologico de Jalisco
RECRUITING
Zapopan
Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
RECRUITING
Gdansk
Diamond Clinic
RECRUITING
Krakow
DERMED Centrum Medyczne Sp. z o.o.
RECRUITING
Lodz
Centrum Medyczne Evimed
RECRUITING
Warsaw
Spain
Hospital Sant Joan de Déu
RECRUITING
Esplugues De Llobregat
Hospital Universitario de Gran Canaria Doctor Negrín
RECRUITING
Las
Grupo Pedro Jaén
RECRUITING
Madrid
Hospital Infantil Universitario Niño Jesús
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Clinica Universidad de Navarra
RECRUITING
Pamplona
Taiwan
National Taiwan University Hospital - Hsinchu branch
RECRUITING
Hsinchu
Chang Gung Memorial Hospital at Kaohsiung
RECRUITING
Kaohsiung Niao Sung Dist
Chung Shan Medical University Hospital
RECRUITING
Taichung
Chang Gung Memorial Hospital-Taipei
RECRUITING
Taipei
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch
RECRUITING
Taoyuan District
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2022-10-18
Estimated Completion Date: 2026-12
Participants
Target number of participants: 360
Treatments
Experimental: Lebrikizumab (Cohort 1)
Participants who are 6 years to \<18 years of age, 12 years to \<18 years of age who weigh \<40 kilogram (kg) or 6 years to \<12 years of age (may weigh ≥40 kg) will receive a loading dose and then subsequent doses by subcutaneous (SC) injections with a topical corticosteroid (TCS).~Dosing will be based on weight.
Experimental: Lebrikizumab (Cohort 2)
Participants who are 6 months to \<6 years of age, 2 years to \<6 years of age or 6 months to \<2 years of age will receive a loading dose of lebrikizumab and then subsequent doses by SC injections with a TCS.~Dosing will be based on weight.
Placebo_comparator: Placebo
Participants will receive placebo matching lebrikizumab by SC injections with a TCS.
Related Therapeutic Areas
Sponsors
Collaborators: Dermira, Inc.
Leads: Eli Lilly and Company