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



Status:Recruiting
Conditions:Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:February 20, 2018
End Date:May 25, 2021
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Email:Clinicaltrials.gov@lilly.com
Phone:1-317-615-4559

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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 in adult
participants with moderate to severe atopic dermatitis.


Inclusion Criteria:

- Have a diagnosis of atopic dermatitis (AD) at least 12 months before screening.

- Have moderate to severe AD, including all of the following:

- EASI score ≥16

- IGA score of ≥3

- ≥10% of BSA involvement

- 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 before randomization

- received prior treatment with any oral Janus kinase (JAK) inhibitor less than 4
weeks before randomization

- received any parenteral corticosteroid administered by intramuscular or
intravenous injection within 6 weeks of planned randomization or are anticipated
to require parenteral injection of corticosteroids during the study

- have had an intra-articular corticosteroid injection within 6 weeks of planned
randomization

- probenecid at the time of randomization that cannot be discontinued for the
duration of the study

- 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: myocardial
infarction (MI), unstable ischemic heart disease, stroke, or New York Heart
Association Stage III/IV heart failure.

- Have a history of venous thromboembolic event (VTE), or are considered at high risk
for VTE.

- 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.
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Los Angeles, California 90033
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1720 2nd Ave S
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800 Washington St
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4202 E Fowler Ave
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171 Ashley Avenue
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