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



Status:Completed
Conditions:Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:February 2016
End Date:March 2017

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A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Baricitinib in Patients With Moderate-to-Severe Atopic Dermatitis

The purpose of this study is to evaluate the safety and effectiveness of Baricitinib in
eczema.


Inclusion Criteria:

- Have moderate-to-severe Atopic Dermatitis (AD), as determined by all of the following:

1. EASI of 12 or more

2. Greater than or equal to 10% of body surface area involvement

3. Diagnosed with AD at least 2 years prior

- Have a history of inadequate clinical response to other eczema treatments

Exclusion Criteria:

- Females who are pregnant or nursing

- Participants who do not agree to use adequate contraception

- Are currently experiencing or have a history of:

- Skin conditions such as psoriasis or lupus erythematosus

- Skin disease that requires frequent hospitalizations or intravenous treatment

- Compromised immunity

- Serious illness that could interfere with study participation, or a clinically
important deviation in physical examination, vital sign measurements,
electrocardiograms, or abnormalities on laboratory tests

- Currently experiencing or have a history of:

- Active or latent Tuberculosis or specific immunity disorders and infections

- Malignancy or lymphoproliferative diseases in the last 5 years (or cervical,
basal or squamous skin cancer re-occurrence in the last 3 years)

- Human Immunodeficiency Virus (HIV)

- Hepatitis B, Hepatitis C, or chronic liver disease

- Have received certain types of vaccinations
We found this trial at
11
sites
Dallas, Texas 75246
Principal Investigator: Caitriona Ryan, MD
Phone: 214-820-9114
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Eric Simpson, MD
Phone: 503-494-4770
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
1383
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Atlanta, Georgia 30342
Principal Investigator: Jamie Weisman, MD
Phone: 404-939-9220
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Atlanta, GA
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: J Silverberg, MD
Phone: 312-695-0281
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Chicago, IL
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Fukuoka-shi,
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Houston, Texas 77030
Principal Investigator: Lauren Campbell, MD
Phone: 713-554-4688
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Houston, TX
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Houston, Texas 77030
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Houston, TX
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Los Angeles, California 90045
Principal Investigator: Howard Sofen, MD
Phone: 310-337-7171
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Los Angeles, CA
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New York, New York 10029
Principal Investigator: E Guttman-Yassky, MD
Phone: 212-241-3288
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New York, NY
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Tampa, Florida 33624
Principal Investigator: Seth Forman, MD
Phone: 813-264-2155
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Tampa, FL
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Webster, Texas 77598
Principal Investigator: P C Lee, MD
Phone: 281-333-2288
588
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Webster, TX
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