An Open-label Long-term Safety Extension Trial for Subjects with Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321 (PEARL-SC)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 600
- 试验地点
- 3
- 主要终点
- -The primary objective of the study is to assess the safety of A-623 following long-term
研究概览
简要总结
This is a multi-center, open-label long-term extension study to assess the safety of A-623 in subjects with serologically active SLE who have completed studyAN-SLE3321.
The study will be conducted in approximately 90 centers worldwide. Up to 600 subjects will be eligible to enroll into the study if they complete the AN-SLE3321 study. In order to preserve the blind on study AN-SLE3321 through its completion, subjects who received A-623 in the double-blind study AN-SLE3321 will continue treatment with the same dose of A-623 (200 mg subcutaneous [SC] weekly, 100 mg SC weekly, or 200 mg SC every 4 weeks). Subjects who received placebo will now receive A-623 at a dose corresponding to the treatment arm to which they were randomized in the doubleblind study AN-SLE3321. Subjects will receive study drug starting on Day 0 and then either weekly (100 mg and 200 mg dose groups) or every 4 weeks (200 mg dose group). Safety will be monitored throughout the study, with study visits at Week 4, 8, 16, and then every 12 weeks thereafter. Subjects who discontinue study drug or withdraw from the study will be followed for an additional 8 weeks for additional clinical and safety evaluations. This is a multi-center, open-label long-term extension study to assess the safety of A-623 in subjects with serologically active SLE who have completed study AN-SLE3321.The study will be conducted in approximately 90 centers worldwide. Up to 600 subjects will be eligible to enroll into the study if they complete the AN-SLE3321 study. In order to preserve the blind on study AN-SLE3321 through its completion, subjects who received A-623 in the double-blind study AN-SLE3321 will continue treatment with the same dose of A-623 (200 mg subcutaneous [SC] weekly, 100 mg SC weekly, or 200 mg SC every 4 weeks). Subjects who received placebo will now receive A-623 at a dose corresponding to the treatment arm to which they were randomized in the doubleblind study AN-SLE3321. Subjects will receive study drug starting on Day 0 and then either weekly (100 mg and 200 mg dose groups) or every 4 weeks (200 mg dose group). Safety will be monitored throughout the study, with study visits at Week 4, 8, 16, and then every 12 weeks thereafter. Subjects who discontinue study drug or withdraw from the study will be followed for an additional 8 weeks for additional clinical and safety evaluations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Completed the treatment period specified in study AN-SLE3321.
排除标准
- •1.Developed a new medical disease or condition that has made the subject unsuitable for this study in the opinion of the Investigator, including interference with written informed consent, study evaluation, completion, and/or procedures.
- •a)This includes active significant infection, malignancy, and acutely life or organ-threatening manifestation of SLE (e.g., proliferative nephritis or unstable CNS lupus).
- •2.Females who are nursing, pregnant, or intending to become pregnant during the time of the study, or who have a positive pregnancy test at baseline (if the subject is a female of childbearing potential).
- •Males who are intending to impregnate a female.
- •All sexually-active subjects of reproductive potential are required to use a reliable method of birth control during the study and for 3 months following completion of therapy.
- •A reliable method of birth control is defined as one of the following: oral or injectable contraceptives, intrauterine device, contraceptive implants, tubal ligation, hysterectomy, or a double-barrier method (diaphragm with spermicidal foam or jelly, or a condom) or vasectomy.
- •Received cyclophosphamide, cyclosporine, anti-TNF alpha therapies, transfusion, plasmapheresis or plasma exchange, IV immunoglobulin, or live vaccines according to listed wash-out periods a)Cyclophosphamide or other alkylating agent – 3 months prior to screening b)Cyclosporine – 2 months prior to screening c)Anti-TNF alpha – 3 months prior to screening d)Transfusion, IV immunoglobulin, plasmapheresis or plasma exchange – 3 months prior to screening e)Live vaccines – 30 days prior to screening 4.Any prior administration of a B-cell modulating therapy (i.e., belimumab, TACI-Ig, epratuzumab, rituximab) other than A-
- •5.General a) Subject has known sensitivity to any of the products to be administered during dosing.
- •b) Subject will not be available for follow-up assessment.
结局指标
主要结局
-The primary objective of the study is to assess the safety of A-623 following long-term
时间窗: long-term treatment i.e 52 weeks
administration.
时间窗: long-term treatment i.e 52 weeks
次要结局
- No secondary objective in the study(None)