This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. OBJECTIVES: To evaluate the safety and tolerability of LymphoStat-B To evaluate the efficacy of LymphoStat-B STUDY DESIGN: This study is a Phase II, multicenter, placebo-controlled, parallel-design, dose-ranging 52-week study of LymphoStat-B in subjects with active systemic lupus erythematosus (SLE). The study is designed to evaluate the safety, tolerability, and efficacy of 3 different doses (1.0, 4.0, and 10.0 mg/kg) of intravenously (IV) administered LymphoStat-B in subjects with SLE. Subjects will be randomly assigned, following stratification by the screening SELENA SLEDAI score (4 to 7 vs. > 8), to one of the 4 treatment groups. A maximum of 350 SLE subjects will be enrolled, with a target of 80 subjects per treatment group. All subjects will be dosed on days 0, 14, and 28, then every 28 days for remainder of the 52 weeks. All treatments will be administered IV over a minimum 2-hr infusion period. For subjects with a history of allergies, or allergic responses to food, drugs, or insects, or a history of urticaria, it is suggested that they receive Diphenhydramine (12.5 to 50 mg based on clinical judgment) and Acetaminophen prophylactically prior to dosing. Subjects who complete the 52-week treatment period will then be given the option to continue at their current dose during a 24-week extension period. Subjects who received placebo or who received active study agent without a satisfactory response (i.e., improvement in SELENA SLEDAI or BILAG disease activity score or reduction in frequency or severity of SLE flare at week 52) may receive the highest tolerable dose of LymphoStat-B during the 24-week extension period. After 52 weeks of treatment or completion of the 24-week extension period, all subjects will complete the study, but return for an 8-wk and 24-week follow-up visit. There will be an internal Data Monitoring Committee (DMC) for this clinical trial. The DMC may include outside experts in the field of rheumatology and an external statistician. The DMC will review safety approximately 3 months after the initiation of the study or after the first 100 subjects have been enrolled, whichever comes first. The initial safety review will be performed in a blinded fashion. Data from the trial will not be unblinded unless there are safety signals arising from the review. After the initial review, the committee will review the data quarterly. When all subjects have completed 24 weeks on study, the committee will review both safety and efficacy results from the 24-week analyses in an unblinded manner. In subsequent safety reviews, held at least quarterly, the DMC will review the safety data in an unblinded fashion.
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