Overview

A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis

Status:
Recruiting
Trial end date:
2027-01-15
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Collaborator:
Incyte Corporation
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.