臨床研究等提出・公開システム

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Combination With Topical Corticosteroids in Adult Patients With Moderate to Severe Atopic Dermatitis

I4V-MC-JAIY

Yes

Plan Description : Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement. Supporting Materials : Study Protocol, Statistical Analysis Plan(SAP),Clinical Study Report(CSR) Time Frame : Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting. Access Criteria : A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement. URL: https://vivli.org/

Eli Lilly Japan K.K.

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Eli Lilly Japan K.K.

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+81-120-023-812

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completed

Nov. 12, 2018

Interventional

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group, outpatient study evaluating the efficacy and safety of baricitinib 2-mg QD and 4-mg QD, in combination with TCS, as compared to placebo in combination with TCS, in adult patients with moderate to severe AD.

treatment purpose

3

- 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.

- 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.

Both

Atopic Dermatitis

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 for Investigational material : High or low dose of Baricitinib administered orally in combination with TCS.

control material(s)
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Placebo administered orally in combination with TCS to maintain the blind.

safety
efficacy
- Proportion of participants achieving IGA of 0 or 1 with a greater than or equal to 2 point improvement

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

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Aug. 09, 2018