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A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Outpatient Study Evaluating the Pharmacokinetics, Efficacy, and Safety of Baricitinib in Pediatric Patients With Moderate to Severe Atopic Dermatitis
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.
2 Years to 17 Years
– 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.
– 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
– 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
– 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.
Eli Lilly and Company
Study Director: 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)
Eli Lilly and Company
Please refer to this study by its ClinicalTrials.gov identifier: NCT03952559
GBUZ Clinical dermatology and venereological dispensary
Krasnodar, Krasnodarskiy Kray 350020
Moscow Scientific and Practical Center of Dermatovenerology and Cosmetology