Status:
COMPLETED
Study of Baricitinib (LY3009104) in Patients 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 as monotherapy in participants with moderate to severe atopic dermatitis.
Eligibility Criteria
Inclusion
- Have been diagnosed with moderate to severe Atopic Dermatitis for at least 12 months.
- 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 prior to randomization.
- Received prior treatment with any oral Janus kinase (JAK) inhibitor.
- Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study.
- Have had an intra-articular corticosteroid injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization.
- 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: venous thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
- Have a history of recurrent (≥ 2) VTE or are considered at high risk of VTE as deemed by the investigator.
- 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 :
November 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2018
Estimated Enrollment :
615 Patients enrolled
Trial Details
Trial ID
NCT03334422
Start Date
November 27 2017
End Date
December 12 2018
Last Update
January 22 2020
Active Locations (80)
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1
CENIT Centro de Neurociencias, Investigación y Tratamiento
Caba, Buenos Aires, Argentina, C1125ABD
2
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1056ABJ
3
Clinica Adventista de Belgrano
Ciudad de Buenos Aires, Buenos Aires, Argentina, C1430EGF
4
Fundacion CIDEA
Buenos Aires, Argentina, C1121ABE