A Randomized, Double Blind, Placebo Controlled, Parallel Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus

Eli Lilly Japan K.K.0 个研究点目标入组 750 人开始时间: 2018年9月3日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Have a clinical diagnosis of SLE at least 24 weeks prior to screening.
•- Have documentation of having met at least 4 of 11 Revised Criteria for Classification of Systemic Lupus Erythematosus according to the 1997 Update of the 1982 American College of Rheumatology (ACR) criteria for classification of SLE prior to randomization.
•- Have a positive antinuclear antibody (ANA) (titer >=1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsDNA), and/or a positive anti-Smith (anti-Sm) as assessed by a central laboratory during screening.
•- Have a total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score >=6 during screening.
•- Have a clinical SLEDAI-2K score >=4 at randomization.
•- Have at least 1 British Isles Lupus Assessment Group (BILAG) A score or 2 BILAG B scores during screening.
•- Are receiving at least one of the following standard of care medications for SLE:
•- A single antimalarial at a stable dose for at least 8 weeks prior to screening
•- A single immunosuppressant at a stable dose for at least 8 weeks prior to screening
•- An oral corticosteroid, initiated at least 4 weeks prior to screening, at a stable dose <=40 milligrams/day prednisone (or equivalent) for at least 2 weeks prior to screening. If the participant is not receiving an antimalarial or immunosuppressant, the dose of corticosteroid must be >=7.5 milligrams/day prednisone (or equivalent)

•- Have severe active lupus nephritis.
•- Have active central nervous system (CNS) lupus.
•- Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data.
•- Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection.
•- Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.

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