Status:
COMPLETED
A Long-term Study of Baricitinib (LY3009104) With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis That Are Not Controlled With Cyclosporine or for Those Who Cannot Take Oral Cyclosporine Because it is Not Medically Advisable
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 determine the efficacy and safety of baricitinib in combination with topical corticosteroids in participants with moderate to severe atopic dermatitis who have experien...
Eligibility Criteria
Inclusion
- Have been diagnosed with moderate to severe Atopic Eczema (Atopic Dermatitis) for at least 12 months.
- Have had inadequate response 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.
- Have a medical contraindication to cyclosporine, or had intolerance and/or unacceptable toxicity or inadequate response to cyclosporine in the past.
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 episodes of eczema herpeticum in the past.
- Participants who are currently experiencing a skin infection that requires treatment, or are 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 less than 4 weeks prior to randomization.
- Received oral corticosteroids within 4 weeks prior to randomization or 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, gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness.
- Have a current or recent and/or clinically serious viral, bacterial, fungal, or parasitic infection including but not limited to herpes zoster, tuberculosis.
- Have specific laboratory abnormalities related to thyroid, renal and liver function, or blood cells.
- Have received certain treatments that are contraindicated.
- Pregnant or breastfeeding.
Key Trial Info
Start Date :
May 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2023
Estimated Enrollment :
463 Patients enrolled
Trial Details
Trial ID
NCT03428100
Start Date
May 15 2018
End Date
April 20 2023
Last Update
May 14 2024
Active Locations (103)
Enter a location and click search to find clinical trials sorted by distance.
1
Universitätsklinikum Graz
Graz, Styria, Austria, 8036
2
Universitätsklinik Innsbruck
Innsbruck, Tyrol, Austria, 6020
3
KA Rudolfstiftung
Vienna, Austria, 1030
4
AKH
Vienna, Austria, 1090