Status:
COMPLETED
A Study of Baricitinib (LY3009104) in Adult Participants With Moderate to Severe Atopic Dermatitis
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Incyte Corporation
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of baricitinib in adult participants with moderate to severe atopic dermatitis.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2021
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT03435081
Start Date
February 20 2018
End Date
August 16 2021
Last Update
September 9 2022
Active Locations (81)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Johnson Dermatology
Fort Smith, Arkansas, United States, 72916
3
Wallace Medical Group, Inc.
Beverly Hills, California, United States, 90211
4
California Dermatology and Clinical Research Institute
Encinitas, California, United States, 92024