A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Study 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).
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 6 Months - 17 Years |
Gender | All |
Inclusion 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.
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.
- - 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.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05559359 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Eli Lilly and Company |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
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) |
Principal Investigator Affiliation | Eli Lilly and Company |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Argentina, Australia, Brazil, Canada, Czechia, France, Germany, Japan, Mexico, Poland, Spain, Taiwan, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Atopic Dermatitis, Eczema |
Study Website: | View Trial Website |
Arms
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.
Interventions
Drug: - Lebrikizumab
Administered SC
Drug: - Placebo
Placebo given SC
Drug: - Topical corticosteroid
Topical corticosteroid
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Clinical Research Center of Alabama
Birmingham, Alabama, 35209
Status
Recruiting
Address
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Status
Recruiting
Address
Arkansas Research Trials
North Little Rock, Arkansas, 72217
Status
Recruiting
Address
First OC Dermatology
Fountain Valley, California, 92708
Status
Recruiting
Address
Antelope Valley Clinical Trials
Lancaster, California, 93534
Status
Recruiting
Address
Dermatology Research Associates
Los Angeles, California, 90045
Status
Recruiting
Address
Integrative Skin Science and Research - Location 2
Sacramento, California, 95815
Status
Recruiting
Address
UConn Health
Farmington, Connecticut, 06030-2840
Status
Recruiting
Address
Solutions Through Advanced Research
Jacksonville, Florida, 32256
Status
Recruiting
Address
ForCare Clinical Research
Tampa, Florida, 33613
Status
Recruiting
Address
Treasure Valley Medical Research
Boise, Idaho, 83706
Status
Recruiting
Address
Northwestern University
Chicago, Illinois, 60611
Status
Recruiting
Address
Allergy and Asthma Specialist
Owensboro, Kentucky, 42301
Status
Recruiting
Address
Massachusetts General Hospital
Boston, Massachusetts, 02114
Status
Recruiting
Address
Oakland Hills Dermatology
Auburn Hills, Michigan, 48326
Status
Recruiting
Address
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706
Status
Recruiting
Address
The Derm Institute of West Michigan
Caledonia, Michigan, 49316
Status
Recruiting
Address
Respiratory Medicine Research Institute of Michigan, PLC
Ypsilanti, Michigan, 48197
Status
Recruiting
Address
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
Status
Recruiting
Address
Wright State Physicians
Fairborn, Ohio, 45324
Status
Recruiting
Address
The Pennsylvania Centre for Dermatology, LLC
Exton, Pennsylvania, 19341
Status
Recruiting
Address
Medical University of South Carolina
Charleston, South Carolina, 29425
Status
Recruiting
Address
The University of Texas Health Science Center at Houston
Bellaire, Texas, 77401
Status
Recruiting
Address
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
International Sites
Status
Recruiting
Address
Instituto de Neumonología Y Dermatología
Ciudad Autonoma de Buenos Aire, Buenos Aires, 1425
Status
Recruiting
Address
Psoriahue
Ciudad Autonoma de Buenos Aire, Buenos Aires, C1425DKG
Status
Recruiting
Address
Fundacion Cidea
Buenos Aires, Ciudad Autónoma De Buenos Aires, C1121ABE
Status
Recruiting
Address
Fundacion Estudios Clinicos
Rosario, Santa Fe, S2000DEJ
Status
Recruiting
Address
CONEXA Investigacion Clinica S.A.
Buenos Aires, , 1012
Status
Recruiting
Address
Fundación Respirar
Buenos Aires, , C1426ABP
Status
Recruiting
Address
Sydney Children's Hospital
Randwick, New South Wales, 2031
Status
Recruiting
Address
The Children's Hospital at Westmead
Westmead, New South Wales, 2145
Status
Recruiting
Address
Cornerstone Dermatology
Coorparoo, Queensland, 4151
Status
Recruiting
Address
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, 4102
Status
Recruiting
Address
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande Do Sul, 90035-903
Status
Recruiting
Address
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, 14784400
Status
Recruiting
Address
Centro de Pesquisa Sao Lucas
Campinas, São Paulo, 13060-803
Status
Recruiting
Address
Hospital de Clínicas de Ribeirão Preto
Ribeirão Preto, São Paulo, 14051-140
Status
Recruiting
Address
Faculdade de Medicina do ABC
Santo Andre, São Paulo, 09060-870
Status
Recruiting
Address
Pesquisare Saude
Santo André, São Paulo, 09080-110
Status
Recruiting
Address
Clinica de Alergia Martti Antila
Sorocaba, São Paulo, 18040-425
Status
Recruiting
Address
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, , 20241-180
Status
Recruiting
Address
Dermatology Research Institute
Calgary, Alberta, T2J 7E1
Status
Recruiting
Address
Alberta Dermasurgery Centre
Edmonton, Alberta, T6G 1C3
Status
Recruiting
Address
DermEdge Research
Mississauga, Ontario, L4Y 4C5
Status
Recruiting
Address
Detska nemocnice FN Brno
Brno, Brno-město, 613 00
Status
Recruiting
Address
Fakultni nemocnice Bulovka
Prague, Praha 8, 180 81
Status
Recruiting
Address
Hôpitaux Drôme Nord - Romans
Romans-sur-Isère, Drôme, 26102
Status
Recruiting
Address
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, Loire-Atlantique, 44093 Cedex 1
Status
Recruiting
Address
CHU de Toulouse - Hopital Larrey
Toulouse, Midi-Pyrénées, 31400
Status
Recruiting
Address
Rosenpark Research GmbH
Darmstadt, Hessen, 64283
Status
Recruiting
Address
Universitätsklinikum Frankfurt
Frankfurt, Hessen, 60590
Status
Recruiting
Address
Fachklinik Bad Bentheim
Bad Bentheim, Niedersach, 48455
Status
Recruiting
Address
Universitätsklinikum Münster
Münster, Nordrhein-Westfalen, 48149
Status
Recruiting
Address
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, Sachsen, 01307
Status
Recruiting
Address
Fujita Health University
Toyoake, Aichi, 470-1192
Status
Recruiting
Address
Fukuyama City Hospital
Fukuyama, Hiroshima, 721-8511
Status
Recruiting
Address
Asahikawa Medical College Hospital
Asahikawa, Hokkaido, 078-8510
Status
Recruiting
Address
National Hospital Organization Sagamihara National Hospital
Sagamihara, Kanagawa, 252-0392
Status
Recruiting
Address
Ina Central Hospital
Ina, Nagano, 396-0033
Status
Recruiting
Address
Kume Clinic
Sakai City, Osaka, 593-8324
Status
Recruiting
Address
Enomoto Clinic
Kumagaya, Saitama, 360-0018
Status
Recruiting
Address
Sugamo Sengoku Dermatology
Toshima, Tokyo, 170-0002
Status
Recruiting
Address
Hiroshima University Hospital
Hiroshima, , 734-8551
Status
Recruiting
Address
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, , 602-8566
Status
Recruiting
Address
Okayama City General Medical Center Okayama City Hospital
Okayama, , 700-8557
Status
Recruiting
Address
Hospital de Jesús Nazareno
Mexico City, Distrito Federal, 06090
Status
Recruiting
Address
Trials in Medicine
Mexico City, Distrito Federal, 06700
Status
Recruiting
Address
Hospital Infantil de Mexico Federico Gomez
Mexico City, Distrito Federal, 06720
Status
Not yet recruiting
Address
Instituto Dermatologico de Jalisco
Zapopan, Jalisco, 45190
Status
Recruiting
Address
PanAmerican Clinical Research - Cuernavaca
Cuernavaca, Morelos, 62290
Status
Recruiting
Address
Eukarya PharmaSite
Monterrey, Nuevo León, 64718
Status
Recruiting
Address
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 66460
Status
Recruiting
Address
Scientia Investigacion Clinica S.C.
Chihuahua, , 31207
Status
Recruiting
Address
Arké SMO S.A de C.V
Veracruz, , 91910
Status
Recruiting
Address
Centrum Medyczne Evimed
Warsaw, Mazowieckie, 02-625
Status
Recruiting
Address
Diamond Clinic
Krakow, Małopolskie, 31-559
Status
Recruiting
Address
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomorskie, 80-546
Status
Recruiting
Address
DERMED Centrum Medyczne Sp. z o.o.
Lodz, Łódzkie, 90-265
Status
Recruiting
Address
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona [Barcelona], 08950
Status
Recruiting
Address
Hospital Universitario de Gran Canaria Doctor Negrín
Las, Las Palmas, 35010
Status
Recruiting
Address
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcon, Madrid, 28223
Status
Recruiting
Address
Clinica Universidad de Navarra
Pamplona, Navarra, 31008
Status
Recruiting
Address
CHOP-Centro De Especialidades De Mollabao
Pontevedra, Pontevedra [Pontevedra], 36001
Status
Recruiting
Address
Hospital de Manises
Manises, València, 46940
Status
Recruiting
Address
Grupo Pedro Jaén
Madrid, , 28006
Status
Recruiting
Address
Hospital Infantil Universitario Niño Jesús
Madrid, , 28009
Status
Recruiting
Address
Hospital Universitario 12 de Octubre
Madrid, , 28041
Status
Recruiting
Address
Hospital Universitario La Paz
Madrid, , 28046
Status
Recruiting
Address
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, Kaohsiung, 83301
Status
Recruiting
Address
Chung Shan Medical University Hospital
Taichung City, Taichung, 402
Status
Recruiting
Address
Taipei Veterans General Hospital
Taipei City, Taipei, 11217
Status
Recruiting
Address
National Taiwan University Hospital - Hsinchu branch
Hsinchu, , 300
Status
Recruiting
Address
National Taiwan University Hospital
Taipei, , 10002
Status
Recruiting
Address
Chang Gung Memorial Hospital-Taipei
Taipei, , 105
Status
Recruiting
Address
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, , 333