Atopic Dermatitis MedDRA version: 21.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Have been diagnosed with moderate to severe Atopic Eczema (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 and throughout the study). • Agree to use emollients daily. • Have a medical contraindication to cyclosporine A, or had intolerance and/or unacceptable toxicity or inadequate response to cyclosporine A in the past. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 475 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: • 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. - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that baricitinib 4 mg + topical corticosteroids (TCS) or baricitinib 2 mg + TCS is superior to placebo + TCS in the treatment of moderate to severe atopic dermatitis;Secondary Objective: • To test the hypothesis that baricitinib 1 mg + topical corticosteroids (TCS) is superior to placebo + TCS in the treatment of patients with moderate to severe atopic dermatitis. • To compare the efficacy of baricitinib 4 mg + TCS, baricitinib 2 mg + TCS, or baricitinib 1 mg + TCS to placebo + TCS in atopic dermatitis during the double blind placebo controlled treatment period as measured by improvement of signs and symptoms of atopic dermatitis. • To compare the efficacy of baricitinib 4 mg + TCS, baricitinib 2 mg + TCS, or baricitinib 1 mg + TCS to placebo + TCS in atopic dermatitis during the double blind placebo controlled treatment period as assessed by patient reported outcome measures. ;Primary end point(s): Proportion of patients achieving Investigator’s Global Assessment (IGA) of 0 or 1 with a = 2 point improvement ;Timepoint(s) of evaluation of this end point: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1, • Proportion of patients achieving Investigator’s Global Assessment (IGA) of 0 or 1 with a = 2 point improvement • Proportion of patients achieving EASI75 • Proportion of patients achieving EASI 90 • Mean change from baseline in EASI score • Proportion of patients achieving SCORAD75 • Mean change from baseline in Skin Pain NRS 2; • Proportion of patients achieving a 4-point improvement in Itch NRS 3; • Mean change from baseline in the score of Item 2 of the ADSS 4; • Proportion of patients achieving IGA of 0 or 1 with a =2-point improvement from baseline • Proportion of patients achieving EASI75 ;Timepoint(s) of evaluation of this end point: 1; assessed at week 16 2; assessed at 16, 4, 2, and 1 weeks 3; assessed at 16 weeks and 1 week. 4; assessed at 24 weeks | — |
Countries
Australia, Austria, Belgium, Brazil, Finland, France, Germany, Italy, Japan, Netherlands, Poland, Russian Federation, Spain, Switzerland, United Kingdom
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed