Atopic Dermatitis
Conditions
Interventions
investigational material(s)
Generic name etc : Baricitinib
INN of investigational material : Baricitinib
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration f
Sponsors
Eli Lilly Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Have been diagnosed with moderate to severe 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.
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 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 less than 4 weeks prior to randomization. * Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection 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 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 (greater than or equal to 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 |
|---|---|
| safety efficacy - Proportion of participants achieving IGA of 0 or 1 with a greater than or equal to 2 point improvement | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy - Proportion of participants achieving EASI75 - Proportion of participants achieving EASI90 - Percent change from baseline on EASI Score - Proportion of participants achieving SCORAD75 - Proportion of participants achieving a 4-Point improvement on the Itch NRS - Change from baseline in the score of item 2 of the ADSS - Change from baseline in skin pain NRS - Proportion of participants achieving EASI50 - Proportion of participants achieving IGA of 0 - Change from baseline in SCORAD - Proportion of participants achieving SCORAD90 - Change from baseline in BSA affected - Proportion of participants developing skin infections requiring antibiotic treatment - Mean gram quantity of TCS use (tube weights) - Percent change from baseline in Itch NRS - Change from baseline in the total score of the POEM - Change from baseline in the PGI-S-AD score - Change from baseline on the HADS - Change from baseline on the DLQI - Change from baseline on the WPAI-AD questionnaire - Change from Baseline on the EQ-5D-5L - Mean number of days without use of background TCS | — |
Countries
Asia except Japan, Europe, Japan, Oceania, South America
Outcome results
None listed