A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults with Systemic Lupus Erythematosus - ISLAND-SLE

Eli Lilly & Company0 个研究点目标入组 280 人开始时间: 2020年9月10日最近更新: 2020年11月9日

适应症

试验速览

暂无简介。

•- Have received a clinical diagnosis of SLE at least 24 weeks before the screening visit (Visit 1).
•- Have documentation of having met at least 4 of the 11 Revised Criteria for Classification of Systemic Lupus Erythematosus according to the 1997 Update of the 1982 ACR (Tan et al. 1982; Hochberg 1997) before randomization.
•- Have a positive ANA (titer =1:80) and/or a positive anti-dsDNA and/or positive anti-Sm antibody test at screening (Visit 1) as assessed by the central laboratory
•- Have a SLEDAI-2K score =6 at screening (Visit 1) and clinical SLEDAI-2K score =4 at randomization (Visit 2).
•- Have active arthritis and/or active rash as defined by the SLEDAI-2K at screening and 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 280
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Are currently receiving oral corticosteroids at doses >20 mg per day of prednisone (or equivalent) or have adjusted the dosage of corticosteroids within 2 weeks before randomization (Visit 2).
•- Have received topical corticosteroids, other than stable doses of Class VI (mild, such as desonide) or Class VII (least potent, such as hydrocortisone), within 8 weeks before randomization (Visit 2).
•- Have received parenteral (that is, intravenous or intramuscular) corticosteroids within 12 weeks before randomization (Visit 2) or are expected to require parenteral corticosteroids during the study.

发起方

Eli Lilly & Company