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
63
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243 6100 South
Murray, Utah 84107
Principal Investigator: Kristina Callis-Duffin
Phone: 801-581-6465
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Boni Elizabeth Elewski
Phone: 2055029960
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: David Rosmarin
Phone: 617-636-7462
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Joseph F. Merola
Phone: 617-264-5943
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
Principal Investigator: Nishit Patel
Phone: 813-974-4270
University of South Florida The University of South Florida is a high-impact, global research university...
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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
Principal Investigator: Craig Teller
Phone: 832-553-2318
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Beverly Hills, California 90211
Principal Investigator: Paul Wallace
Phone: 310-652-8460
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Bexley, Ohio 43209
Principal Investigator: Matthew Zirwas
Phone: 614-947-1716
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6051 North Eagle Road
Boise, Idaho 83713
Principal Investigator: Ryan Harris
Phone: 208-467-3006
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Calgary, Alberta
Principal Investigator: Kirk Allen Barber
Phone: 4032995821
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Charleston, South Carolina 29414
Principal Investigator: Todd Schlesinger
Phone: 843-556-8886
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Lara Wine Lee
Phone: 843-792-5858
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Jonathan Silverberg
Phone: 312-695-8106
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Cleveland, Ohio 44012
Principal Investigator: Neil J Korman
Phone: 216-844-3178
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Dallas, Texas 75231
Principal Investigator: Jennifer A Cather
Phone: 214-361-2008
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Danbury, Connecticut 06810
Principal Investigator: William A Notaro
Phone: 203-730-0074
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Darien, Illinois 60561
Principal Investigator: Vassilios A Dimitropoulos
Phone: 630-920-1900
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Encinitas, California 92024
Principal Investigator: Stacy R. Smith
Phone: 760-203-3839
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Exton, Pennsylvania 19341
Principal Investigator: Scott L Gottlieb
Phone: 610-594-6660
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3640 Colonel Glenn Highway
Fairborn, Ohio 45324
Principal Investigator: Jeffrey Travers
Phone: 937-775-2463
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Farmington, Connecticut 06030
Principal Investigator: Bruce E Strober
Phone: 860-679-4600
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Fort Gratiot, Michigan 48059
Principal Investigator: Fasahat Hamzavi
Phone: 810-455-1612
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Fort Smith, Arkansas 72916
Principal Investigator: Sandra Johnson
Phone: 479-649-3376
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17271 Brookhurst Street
Fountain Valley, California 92708
Principal Investigator: Vivian Laquer
Phone: 714-531-2966
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Fremont, California 94538
Principal Investigator: Sunil S Dhawan
Phone: 510-797-4111
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Indianapolis, Indiana 46256
Principal Investigator: Scott A Fretzin
Phone: 317-621-7731
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Jacksonville, Florida
Principal Investigator: Pearl Kwong
Phone: 904-619-8157
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Johnston, Rhode Island 02919
Principal Investigator: Ellen H Frankel
Phone: 401-454-3800
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2919 West Swann Avenue
Largo, Florida 33770
Principal Investigator: Matthew Zook
Phone: 813-849-5566
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Los Angeles, California 90033
Principal Investigator: Stefani Takahashi
Phone: 323-442-0084
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Louisville, Kentucky 40202
Principal Investigator: Cindy E Owen
Phone: 502-585-9059
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Macon, Georgia 31217
Principal Investigator: David J Cohen
Phone: 478-742-2180
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Mason, Ohio 45040
Principal Investigator: Rocco Serrao
Phone: 513-701-5526
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Miami, Florida 33173
Principal Investigator: Jill Waibel
Phone: 305-279-6060
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: George Han
Phone: 212-844-8800
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Norfolk, Virginia 23507
Principal Investigator: David M Pariser
Phone: 757-622-6315
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Omaha, Nebraska 68144
Principal Investigator: Joel Schlessinger
Phone: 402-697-6599
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603 North Flamingo Road
Pembroke Pines, Florida 33028
Principal Investigator: Robert Snyder
Phone: 954-435-5100
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Pflugerville, Texas 78660
Principal Investigator: Edward Lain
Phone: 512-279-2545
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Plainfield, Indiana 46168
Principal Investigator: Scott T Guenthner
Phone: 317-837-6082
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Portland, Oregon 97210
Principal Investigator: Phoebe Rich
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3303 Southwest Bond Avenue
Portland, Oregon 97239
Principal Investigator: Eric L Simpson
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Rockville, Maryland 20850
Principal Investigator: Benjamin N. Lockshin
Phone: 301-355-3183
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5301 Keystone Court
Rolling Meadows, Illinois 60008
Principal Investigator: Michael Bukhalo
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Sacramento, California 95816
Principal Investigator: Emanual Maverakis
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Saint Louis, Missouri 63117
Principal Investigator: Craig L Leonardi
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San Antonio, Texas 78218
Principal Investigator: John C. Browning
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San Diego, California 92108
Principal Investigator: Daniel Marnell
Phone: 619-521-2830
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San Diego, California 92123
Principal Investigator: Walter K Nahm
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Sandy Springs, Georgia 30328
Principal Investigator: Jamie Debra Weisman
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Santa Ana, California 92701
Principal Investigator: Jennifer Soung
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Santa Monica, California 90404
Principal Investigator: Paul S Yamauchi
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Savannah, Georgia 31406
Principal Investigator: Corinne Howington
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211 North Eddy St.
South Bend, Indiana 46617
574-234-8161
Principal Investigator: Holly Hake Harris
Phone: 574-204-6432
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Stony Brook, New York 11790
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Sugar Land, Texas 77497
Principal Investigator: Syed Ali
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314 Martin Luther King Junior Way
Tacoma, Washington 98405
(253) 403-5200
Principal Investigator: Andrew P Pace
Phone: 253-572-2842
Multicare Health System MultiCare is a not-for-profit health care organization with more than 10,000 employees...
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Tampa, Florida 33624
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Walnut Creek, California 94589
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Washington, District of Columbia 20037
Principal Investigator: Maria Sotomayor
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West Jordan, Utah 84088
Principal Investigator: Douglass W Forsha
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Winston-Salem, North Carolina 27157
Principal Investigator: Lindsay Strowd
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