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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

NCT03952559

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