A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab When Used in Combination With Topical Corticosteroid Treatment in Japanese Patients With Moderate-to-Severe Atopic Dermatitis - J2E-JE-KGA

Masaki Takeshi0 个研究点目标入组 280 人开始时间: 2021年3月1日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Have chronic Atopic Dermatitis (AD) that has been present for >=1 year before the screening.
•-Have moderate-to-severe AD, including all of the following:
•EASI score >=16 at the baseline
•IGA score >=3 (scale of 0 to 4) at the baseline
•AD involvement on >=10% of Body Surface Area (BSA) at the baseline
•-Have a documented history provided by a physician and/or investigator of inadequate response to existing topical medications within 6 months preceding screening as defined by at least 1 of the following:
•Inability to achieve good disease control, defined as mild disease or better (for example, IGA <=2) after use of at least a medium-potency topical corticosteroids (TCS) for at least 4 weeks, or for the maximum duration recommended by the product prescribing information (for example, 14 days for super-potent (TCS), whichever is shorter. Topical corticosteroids may be used with or without Topical Calcineurin Inhibitor (TCIs) and/or topical Janus Kinase (JAK) inhibitors.
•Participants who failed systemic therapies intended to treat AD within 6 months preceding screening, such as cyclosporine, methotrexate (MTX), azathioprine, and mycophenolate mofetil (MMF), will also be considered as surrogates for having inadequate response to topical therapy.
•-Body weight >=40 kilogram (kg)

•-Have a history of anaphylaxis
•-Have uncontrolled chronic disease that might require bursts of oral corticosteroids for example, comorbid severe uncontrolled asthma within the past 12 months requiring systemic corticosteroid treatment or hospitalization for >24 hours at baseline.
•-Have an active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitic, antiprotozoals, or antifungals within 2 weeks before the baseline or superficial skin infections within 1 week before the baseline.
•-Evidence of acute or chronic hepatitis or known liver cirrhosis.
•-Have a history of pneumocystis pneumonia (PCP) or a positive beta-D-glucan test at screening and a confirmed diagnosis of PCP.
•-Have a history of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
•-Have presence of skin comorbidities (for example, sclerosis, psoriasis, or lupus erythematosus) that may interfere with study assessments.
•-Have presence of significant uncontrolled neuropsychiatric disorder.
•-Have been exposed to a live vaccine within 12 weeks prior to the baseline visit or are expected to need/receive a live vaccine during the study or up to 125 days after the last dose of study drug.

发起方

Masaki Takeshi