A Study of Baricitinib (LY3009104) in Participants With Moderate-to-Severe Atopic Dermatitis
NCT ID: NCT02576938
Last Updated: 2020-06-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
124 participants
INTERVENTIONAL
2016-02-29
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Baricitinib
Administered once daily in multiple oral dose cohorts for 16 weeks
(Triamcinolone 0.1% topical also permitted)
Baricitinib
Administered orally
Triamcinolone (Optional)
Administered topically
Placebo
Administered orally once daily, for 16 weeks
(Triamcinolone 0.1% topical also permitted)
Placebo
Administered orally
Triamcinolone (Optional)
Administered topically
Interventions
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Baricitinib
Administered orally
Placebo
Administered orally
Triamcinolone (Optional)
Administered topically
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Dermatology Research Associates
Los Angeles, California, United States
Forward Clinical Trials, Inc
Tampa, Florida, United States
Medical Dermatology Specialists
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Icahn School of Medicine
New York, New York, United States
Oregon Health and Science University
Portland, Oregon, United States
Menter Dermatology Research Institute
Dallas, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Center for Clinical Studies
Webster, Texas, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fukuoka, , Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sapporo, , Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Takaoka-shi, , Japan
Countries
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References
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Katoh N, Takita Y, Isaka Y, Nishikawa A, Torisu-Itakura H, Saeki H. Pooled Safety Analysis of Baricitinib in Adult Participants with Atopic Dermatitis in the Japanese Subpopulation from Six Randomized Clinical Trials. Dermatol Ther (Heidelb). 2022 Dec;12(12):2765-2779. doi: 10.1007/s13555-022-00828-5. Epub 2022 Oct 18.
King B, Maari C, Lain E, Silverberg JI, Issa M, Holzwarth K, Brinker D, Cardillo T, Nunes FP, Simpson EL. Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials. Am J Clin Dermatol. 2021 May;22(3):395-405. doi: 10.1007/s40257-021-00602-x. Epub 2021 Apr 7.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol: Protocol
Document Type: Study Protocol: Protocol Amendment (a)
Document Type: Study Protocol: Protocol Amendment (b)
Document Type: Study Protocol: Protocol Amendment (c)
Document Type: Study Protocol: Protocol Amendment (d)
Related Links
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Click here for more information about this study: A Study of Baricitinib (LY3009104) in Participants With Moderate-to-Severe Atopic Dermatitis
Other Identifiers
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I4V-MC-JAHG
Identifier Type: OTHER
Identifier Source: secondary_id
16284
Identifier Type: -
Identifier Source: org_study_id
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