jRCT2031210119已完成不适用
[M20-186] A Phase 2, Long-Term Extension (LTE) Study With Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT)
AbbVie G.K.0 个研究点目标入组 260 人开始时间: 2021年4月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 65age old under（—）
- 性别
- All
入选标准
- •Completed Study M19-130 (i.e., the preceding study of elsubrutinib, upadacitinib, and ABBV-599 [elsubrutinib/upadacitinib] combination) and will not have developed any laboratory or clinical discontinuation criteria as defined in that study.
- •On stable background treatment for SLE throughout the study.
排除标准
- •Active, chronic, or recurrent viral, or bacterial infection.
- •Active tuberculosis (TB)
- •History of gastrointestinal (GI) perforation, diverticulitis, or a significantly increased risk for GI perforation per investigator assessment.
- •Participant require vaccination with live vaccine during study participation.
结局指标
主要结局
-
Number of Participants With Adverse Events [ Time Frame: Through Week 108 ]
次要结局
未报告次要终点
研究者
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