Atopic Dermatitis MedDRA version: 20.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Sponsors
Lilly S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -At least 18 years of age. -Have a diagnosis of AD at least 12 months prior to screening, as defined by the American Academy of Dermatology -Have moderate to severe AD, including all of the following: a. Eczema Area and Severity Index (EASI) score =16 b. IGA score of =3 c. =10% of BSA involvement -Have a documented history by a physician and/or investigator of inadequate response to existing topical medications within 6 months preceding screening, or history of intolerance to topical therapy. -Are male or nonpregnant, nonbreastfeeding female patients. Male patients, and female patients of childbearing potential, must agree to use a reliable method of birth control during the study and for at least 4 weeks following the last dose of investigational product. 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 285 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: -Have other concomitant skin conditions that would interfere with evaluations of the effect of study medication -Have had an important side effect to Topical Corticosteroids (e.g., intolerance to treatment, hypersensitivity reactions, significant skin atrophy, and systemic effects), as assessed by the investigator or treating physician that would prevent further use. -Are currently experiencing or have a history of erythrodermic,refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections that may interfere with participation in the study. -Skin infection that requires treatment with topical or systemic antibiotics. -Serious concomitant illness -Are immunocompromised and at an unacceptable risk for participating in the study. -Have a clinically serious viral, bacterial, fungal, or parasitic infection -Have been exposed to a live vaccine within 12 weeks prior to planned randomization or are expected to need/receive a live vaccine during the course of the study. -Have evidence of active TB or latent TB -Have evidence of HBV, HCV or HIV infection
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of patients achieving EASI75 2. Proportion of patients achieving EASI90 3. Percent change from baseline in EASI score 4. Proportion of patients achieving SCORAD75 5.Mean change from baseline in the score of Item 2 of the ADSS 6.Mean change from baseline in Skin Pain NRS 7.Proportions of patients achieving a 4 point improvement in Itch NRS ; Timepoint(s) of evaluation of this end point: Endpoint 1 to 6 only at week 16 Endpoint 7 at week 1, week 2, week 4 and week 16 | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that baricitinib 4 mg QD + Topical Corticosteroids or baricitinib 2 mg QD + Topical Corticosteroids is superior to placebo + Topical Corticosteroids in the treatment of patients with moderate to severe AD.;Primary end point(s): Proportion of patients achieving IGA of 0 or 1 with a =2 point improvement;Timepoint(s) of evaluation of this end point: Week 16; Secondary Objective: -To compare the efficacy of baricitinib 2 mg QD + Topical Corticosteroids or baricitinib 4 mg QD + Topical Corticosteroids to placebo + Topical Corticosteroids in AD during the 16 week double blind placebo controlled treatment period as measured by improvement in signs and symptoms of AD. -To compare the efficacy of baricitinib 2 mg QD + Topical Corticosteroids or baricitinib 4 mg QD + Topical Corticosteroids to placebo + Topical Corticosteroids in AD during the 16 week double blind placebo controlled treatment period as assessed by patient reported outcome measures. | — |
Countries
Argentina, Australia, Austria, Germany, Italy, Japan, Korea, Republic of, Poland, Spain, Taiwan
Contacts
Public ContactElena Tsiamparlis
Lilly S.A.
Outcome results
None listed