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A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis
A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis
CompletedPhase 3
Sponsor: Eli Lilly and Company
Conditions: Atopic Dermatitis
Interventions: Baricitinib, Placebo, Topical corticosteroid
Countries: Argentina, Australia, Austria, Brazil, Czechia, France, Germany, Hungary
The reason for this study is to see if the study drug called baricitinib works and is safe in children and teenage participants with atopic dermatitis.
Eligibility overview
Sex: ALL
Age: 2 Years to 17 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * At or above the 5th percentile of weight for age. * Have been diagnosed with moderate to severe atopic dermatitis for at least 12 months (if 6 years old or older) or at least 6 months (if 2 up to 6 years old). * Have had inadequate response or intolerance to existing topical (applied to the skin) medications within 6 months preceding screening. * Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period). * Agree to use emollients daily. Exclusion Criteria: * Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections. * A history of eczema herpeticum within 12 months, and/or a history of 2 or more episode of eczema herpeticum in the past. * Participants who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics. * Have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma). * Have been treated with the following therapies: * Monoclonal antibody for less than 5 half-lives prior to beginning study treatment. * Received prior treatment with any oral Janus kinase (JAK) inhibitor. * Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned initiation of study drug or are anticipated to require parenteral injection of corticosteroids during the study. * Have had an intra-articular corticosteroid injection within 2 weeks prior to study entry or within 6 weeks prior to planned initiation of study drug. * Have high blood pressure characterized by a repeated systolic or diastolic blood pressure \>95th percentile based on age, sex and height. * Have had major surgery within the past eight weeks or are planning major surgery during the study. * Have experienced any of the following within 12 weeks of screening: venous thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure. * Have a history of VTE or are considered at high risk of VTE as deemed by the investigator. * Have a history or presence of cardiovascular, respiratory, hepatic, chronic liver disease gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness. * Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster (shingles or chicken pox), tuberculosis. * Have specific laboratory abnormalities. * Have received certain treatments that are contraindicated. * Pregnant or breastfeeding.
Locations (78)
- Capital Federal, Buenos Aires, Argentina
- Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
- Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
- Buenos Aires, Argentina
- Westmead, New South Wales, Australia
- Woolloongabba, Queensland, Australia
- Melbourne, Victoria, Australia
- Vienna, State of Vienna, Austria
- Vienna, State of Vienna, Austria
- Graz, Styria, Austria
- Porto Alegre, Rio Grande do Sul, Brazil
- Santo André, São Paulo, Brazil
- Rio de Janeiro, Brazil
- Rio de Janeiro, Brazil
- São Paulo, Brazil
- Hradec Králové, Hradec Králové, Czechia
- Nový Jičín, Nový Jičín, Czechia
- Prague, Praha 5, Czechia
- Prague, Praha 8, Czechia
- Prague, Czechia
- Nice, Alpes-Maritimes, France
- Romans-sur-Isère, Drôme, France
- Brest, Finistère, France
- Lille, Hauts-de-France, France
- Montpellier, Languedoc-Roussillon, France
- Nantes, Loire-Atlantique, France
- Toulouse, Midi-Pyrénées, France
- Frankfurt am Main, Hesse, Germany
- Münster, North Rhine-Westphalia, Germany
- Dresden, Saxony, Germany
- + 48 more on CT.gov