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.
We found this trial at
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Danbury, Connecticut 06810
Principal Investigator: William A Notaro
Phone: 203-730-0074
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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Phone: 2055029960
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: David Rosmarin
Phone: 617-636-7462
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Joseph F. Merola
Phone: 617-264-5943
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
Principal Investigator: Nishit Patel
Phone: 813-974-4270
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Bay City, Michigan 48706
Principal Investigator: Brent Boyce
Phone: 989-895-9100
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6565 West Loop South Freeway
Bellaire, Texas 77401
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Beverly Hills, California 90211
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Bexley, Ohio 43209
Principal Investigator: Matthew Zirwas
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6051 North Eagle Road
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Calgary, Alberta
Principal Investigator: Kirk Allen Barber
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Charleston, South Carolina 29414
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Lara Wine Lee
Phone: 843-792-5858
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Jonathan Silverberg
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Cleveland, Ohio 44012
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Dallas, Texas 75231
Principal Investigator: Jennifer A Cather
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Exton, Pennsylvania 19341
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Farmington, Connecticut 06030
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17271 Brookhurst Street
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Indianapolis, Indiana 46256
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Johnston, Rhode Island 02919
Principal Investigator: Ellen H Frankel
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2919 West Swann Avenue
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Louisville, Kentucky 40202
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Macon, Georgia 31217
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Mason, Ohio 45040
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Miami, Florida 33173
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243 6100 South
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1428 Madison Ave
New York, New York 10029
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Omaha, Nebraska 68144
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211 North Eddy St.
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Sugar Land, Texas 77497
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314 Martin Luther King Junior Way
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Washington, District of Columbia 20037
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