A Study of Baricitinib (LY3009104) in Adults With Moderate to Severe Atopic Dermatitis

Conditions:Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Age Range:18 - Any
Start Date:November 23, 2017
End Date:August 15, 2019
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Moderate to Severe Atopic Dermatitis

The purpose of this study is to evaluate the efficacy and safety of baricitinib as
monotherapy in participants with moderate to severe atopic dermatitis.

Inclusion Criteria:

- Have been diagnosed with moderate to severe Atopic Dermatitis for at least 12 months.

- 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 randomization.

- 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 randomization 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 randomization.

- Have high blood pressure characterized by a repeated systolic blood pressure >160
millimeters of mercury (mm Hg) or diastolic blood pressure >100 mm Hg.

- 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 recurrent (≥ 2) 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, tuberculosis.

- Have specific laboratory abnormalities.

- Have received certain treatments that are contraindicated.

- Pregnant or breastfeeding.
We found this trial at
5301 Keystone Court
Rolling Meadows, Illinois 60008
Principal Investigator: Michael Bukhalo
Phone: 847-392-5440
Rolling Meadows, IL
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Charleston, South Carolina 29414
Principal Investigator: Todd Schlesinger
Phone: 843-556-8886
Charleston, SC
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Nampa, Idaho 83651
Principal Investigator: Ryan Harris
Phone: 208-377-8653
Nampa, ID
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