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



Status:Enrolling by invitation
Conditions:Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:June 27, 2018
End Date:September 18, 2021

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A Multicenter, Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Moderate to Severe Atopic Dermatitis

This open-label study will evaluate the long-term efficacy and safety of baricitinib in adult
participants with moderate to severe atopic dermatitis (AD), who have completed participation
in study BREEZE-AD5/Study JAIW (NCT03435081). This 116-week outpatient study, includes a
treatment period of approximately 104-weeks and up to 11 planned study visits.


Inclusion Criteria:

- Have been discontinued from study JAIW, and completed at least 16 weeks on treatment.

Exclusion Criteria:

- Have significant uncontrolled cerebro-cardiovascular (e.g., myocardial infarction
[MI], unstable angina, unstable arterial hypertension, severe heart failure, or
cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine,
hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed
during a previous baricitinib study that, in the opinion of the investigator, pose an
unacceptable risk to the participant if investigational product continues to be
administered.

- Have a known hypersensitivity to baricitinib or any component of this investigational
product.

- Had investigational product permanently discontinued at any time during a previous
baricitinib study, except for participants who had investigational product
discontinued during originating study because of rescue with an oral systemic AD
therapy (e.g., corticosteroid, cyclosporine, methotrexate).

- Had temporary investigational product interruption continue at the final study visit
of a previous baricitinib study and, in the opinion of the investigator, this poses an
unacceptable risk for the participant's participation in the study.

- Pregnant or breastfeeding.
We found this trial at
63
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Fort Gratiot, Michigan 48059
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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
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
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
University of South Florida The University of South Florida is a high-impact, global research university...
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Bay City, Michigan 48706
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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
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Calgary, Alberta
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Charleston, South Carolina 29414
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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
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Dallas, Texas 75231
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Danbury, Connecticut 06810
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Darien, Illinois 60561
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Exton, Pennsylvania 19341
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3640 Colonel Glenn Highway
Fairborn, Ohio 45324
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Farmington, Connecticut 06030
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Fort Smith, Arkansas 72916
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17271 Brookhurst Street
Fountain Valley, California 92708
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Fremont, California 94538
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Indianapolis, Indiana 46256
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Johnston, Rhode Island 02919
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2919 West Swann Avenue
Largo, Florida 33770
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Louisville, Kentucky 40202
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Miami, Florida 33173
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243 6100 South
Murray, Utah 84107
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Norfolk, Virginia 23507
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Omaha, Nebraska 68144
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603 North Flamingo Road
Pembroke Pines, Florida 33028
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Plainfield, Indiana 46168
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Portland, Oregon 97210
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3303 Southwest Bond Avenue
Portland, Oregon 97239
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Rockville, Maryland 20850
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5301 Keystone Court
Rolling Meadows, Illinois 60008
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Sacramento, California 95816
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Saint Louis, Missouri 63117
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San Antonio, Texas 78218
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San Diego, California 92108
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San Diego, California 92123
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Sandy Springs, Georgia 30328
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Santa Ana, California 92701
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Santa Monica, California 90404
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Savannah, Georgia 31406
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211 North Eddy St.
South Bend, Indiana 46617
574-234-8161
South Bend Clinic The South Bend Clinic employs a staff of 610 at its five...
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Stony Brook, New York 11790
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Sugar Land, Texas 77497
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314 Martin Luther King Junior Way
Tacoma, Washington 98405
(253) 403-5200
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
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West Jordan, Utah 84088
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Winston-Salem, North Carolina 27157
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