A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis (ADorable-1)
Atopic Dermatitis, Eczema
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility 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.
Sites / Locations
- Clinical Research Center of AlabamaRecruiting
- Arkansas Research TrialsRecruiting
- First OC DermatologyRecruiting
- Antelope Valley Clinical TrialsRecruiting
- Dermatology Research AssociatesRecruiting
- Integrative Skin Science and Research - Location 2Recruiting
- UConn HealthRecruiting
- Solutions Through Advanced ResearchRecruiting
- ForCare Clinical ResearchRecruiting
- Treasure Valley Medical ResearchRecruiting
- Northwestern UniversityRecruiting
- Allergy and Asthma SpecialistRecruiting
- Massachusetts General HospitalRecruiting
- Oakland Hills DermatologyRecruiting
- Great Lakes Research Group, Inc.Recruiting
- The Derm Institute of West MichiganRecruiting
- Respiratory Medicine Research Institute of Michigan, PLCRecruiting
- Wright State PhysiciansRecruiting
- The Pennsylvania Centre for Dermatology, LLCRecruiting
- Medical University of South CarolinaRecruiting
- The University of Texas Health Science Center at HoustonRecruiting
- Texas Dermatology and Laser SpecialistsRecruiting
- Medical College of WisconsinRecruiting
- Instituto de Neumonología Y DermatologíaRecruiting
- PsoriahueRecruiting
- Centro de Investigaciones Metabólicas (CINME)Recruiting
- Fundacion CideaRecruiting
- CONEXA Investigacion Clinica S.A.Recruiting
- Fundación RespirarRecruiting
- Sydney Children's HospitalRecruiting
- The Children's Hospital at WestmeadRecruiting
- Cornerstone DermatologyRecruiting
- Veracity Clinical Research Pty LtdRecruiting
- Hospital de Clinicas de Porto Alegre
- Fundação Pio XII - Hospital de Câncer de Barretos
- Centro de Pesquisa Sao Lucas
- Hospital de Clínicas de Ribeirão Preto
- Faculdade de Medicina do ABCRecruiting
- Pesquisare Saude
- IBPClin - Instituto Brasil de Pesquisa Clínica
- Dermatology Research InstituteRecruiting
- Alberta Dermasurgery CentreRecruiting
- DermEdge ResearchRecruiting
- Hôpitaux Drôme Nord - RomansRecruiting
- Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-DieuRecruiting
- CHU de Toulouse - Hopital LarreyRecruiting
- Rosenpark Research GmbHRecruiting
- Fachklinik Bad BentheimRecruiting
- Universitätsklinikum MünsterRecruiting
- Universitaetsklinikum Carl Gustav Carus DresdenRecruiting
- Fujita Health UniversityRecruiting
- Fukuyama City HospitalRecruiting
- Asahikawa Medical College HospitalRecruiting
- National Hospital Organization Sagamihara National HospitalRecruiting
- Ina Central HospitalRecruiting
- Osaka Habikino Medical CenterRecruiting
- Kume ClinicRecruiting
- Enomoto ClinicRecruiting
- Sugamo Sengoku DermatologyRecruiting
- Hiroshima University HospitalRecruiting
- University Hospital,Kyoto Prefectural University of MedicineRecruiting
- Okayama City General Medical Center Okayama City HospitalRecruiting
- Hospital de Jesús NazarenoRecruiting
- Trials in MedicineRecruiting
- Hospital Infantil de Mexico Federico GomezRecruiting
- PanAmerican Clinical Research - CuernavacaRecruiting
- Eukarya PharmaSiteRecruiting
- Scientia Investigacion Clinica S.C.Recruiting
- Arké SMO S.A de C.VRecruiting
- Centrum Medyczne EvimedRecruiting
- Diamond ClinicRecruiting
- Centrum Badan Klinicznych PI-House sp. z o.o.Recruiting
- DERMED Centrum Medyczne Sp. z o.o.Recruiting
- Hospital Sant Joan de DéuRecruiting
- Hospital Universitario de Gran Canaria Doctor NegrínRecruiting
- Hospital Universitario Quironsalud MadridRecruiting
- Clinica Universidad de NavarraRecruiting
- CHOP-Centro De Especialidades De MollabaoRecruiting
- Hospital de ManisesRecruiting
- Hospital Infantil Universitario Niño JesúsRecruiting
- Hospital Universitario 12 de OctubreRecruiting
- Hospital Universitario La Paz
- Chang Gung Memorial Hospital at KaohsiungRecruiting
- Chung Shan Medical University HospitalRecruiting
- Taipei Veterans General HospitalRecruiting
- National Taiwan University Hospital - Hsinchu branchRecruiting
- National Taiwan University HospitalRecruiting
- Chang Gung Memorial Hospital-TaipeiRecruiting
- Chang Gung Medical Foundation-Linkou BranchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Lebrikizumab (Cohort 1)
Lebrikizumab (Cohort 2)
Placebo
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.
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.
Participants will receive placebo matching lebrikizumab by SC injections with a TCS.