Atopic dermatitis MedDRA version: 20.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
Pharmaceutical Form: Tablet
INN or Proposed INN: baricitinib
Sponsors
Lilly S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Have been diagnosed with moderate to severe Atopic Dermatitis for at least 12 months (if 6 years old or older) or at least 6 months (if 2 up to 6 years old). - Have a documented history by a physician and/or investigator of inadequate response to OR history of intolerance to topical corticosteroids (TCS) AND topical calcineurin inhibitors (TCNI). - Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period). - Agree to use emollients daily Are the trial subjects under 18? yes Number of subjects for this age range: 465 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
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 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 >95th percentile based on age, sex and height. - 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 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 (shingles or chicken pox), tuberculosis. - Have specific laboratory abnormalities. - Have received certain treatments that are contraindicated. - Pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Proportion of patients achieving IGA of 0 or 1 at week 16 Comparability of baricitinib exposure as assessed by PK parameters such as AUC, Cmax (Period 2 patients only) ;Timepoint(s) of evaluation of this end point: at week 16; Main Objective: The primary objective of the study is to demonstrate the superiority of each dose of baricitinib to placebo in the treatment of patients with moderate to severe AD. Primary Objective for PK lead-in Period is to assess whether baricitinib exposure in pediatric patients receiving baricitinib high dose once daily is comparable to the exposure in adults receiving baricitinib 4-mg once daily. ; Secondary Objective: •Compare the efficacy of baricitinib high, medium, or low dose to placebo as measured by improvement in AD symptoms •Compare the efficacy of baricitinib high, medium, or low dose to placebo as measured by patient-reported outcomes and quality of life assessments •Assess acceptability and palatability of baricitinib tablets and oral suspension •Characterize the PK profile of baricitinib in pediatric patients •Evaluate effect of baricitinib on cellular and humoral immune system •Assess safety of baricitinib during longer-term treatment •Assess growth and bone safety during longer-term treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): EASI 75 / 90 / CFB at week 16 SCORAD 75 at week 16 TCS use: mean amount used and number of days without TCS use (over first 16 weeks) Itch NRS improvement of 4+ points at weeks 1,2, 4 and 16 Mean changes in AD symptoms based on clinician and patient assessment. Mean changes in health outcomes and QoL Assessments (parent and family). Pop PK assessment based on sparse sampling of patients in the double-blind portion of the trial (Period 3 only) Acceptability/Palatability of oral tablet and suspension formulations of baricitinib (Period 2 only) Changes in pre- and postvaccination IgG titers in patients eligible for TDaP and pneumococcal vaccines. Mean changes in height, weight, growth velocity over the course of the study. IGA of 0 or 1 at 1 and 2 years and EASI75 and SCORAD75 at 1 year ;Timepoint(s) of evaluation of this end point: at week 16 and 1-2 years | — |
Countries
Argentina, Australia, Austria, Brazil, Czech Republic, France, Germany, Greece, Hungary, Israel, Mexico, Poland, Russian Federation, Spain, Switzerland, Taiwan, Ukraine, United Kingdom
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly Cork Ltd
Outcome results
None listed