A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE)

illy S.A.0 个研究点目标入组 300 人开始时间: 2016年4月4日最近更新: 2017年12月11日

适应症

试验速览

暂无简介。

•[1] Are at least 18 years of age.
•[2] Have a positive ANA (HEp-2 ANA titer ?1:80) and/or a positive anti-dsDNA (? 30 IU) as assessed by a central laboratory at screening.
•[3] Have a SLEDAI-2K score ?4 based on clinical symptoms (not including lab values) at randomization.
•[4] Have active arthritis and/or active rash as defined by the SLEDAI-2K at randomization.
•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 270
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•[1] Have active severe lupus nephritis
•[2] Have active severe central nervous system (CNS) lupus
•[3] 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 unaccepatable risk when taking investigational product or interfere with the interpretation of data.
•[4] Have a current or recent (<4 weeks prior to screening) clinically serious viral, bacterial, fungal, or parasitic infection.
•[5] Are currently receiving oral corticosteroids at doses >20-mg per day of prednisone (or equivalent) or have adjusted the dose of corticosteroids within 2 weeks of planned randomization.
•[6] Have started treatment with or adjusted the dose of NSAIDs (for which the NSAID use is intended for treatment of signs and symptoms of SLE) within 2 weeks of screening or within 4 weeks of planned randomization.
•[7] Have started treatment with or adjusted the dose of an antimalarial within 10 weeks of screening or within 12 weeks of planned randomization.
•[8] Have started treatment with or adjusted the dose of an immunosuppressant within 10 weeks of screening or within 12 weeks of planned randomization.
•[9] Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.

发起方

illy S.A.