NL-OMON51920已完成2 期
A TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose levels administered subcutaneously in patients with Sjögren*s Syndrome - CCFZ533B2201E1
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Participants must have participated in the TWINSS core study, CCFZ533B2201,
- •and must have completed the entire treatment period up to Week 48 and the
- •follow-up period up to Week 60
- •2. Signed informed consent must be obtained prior to participation in the
- •extension study (i.e. before commencement of the Week 60 assessments of the
- •core study)
- •3. In the judgement of the Investigator, participants must be expected to
- •clinically benefit from continued iscalimab therapy
排除标准
- •1. Sjögren's Syndrome overlap syndromes where another autoimmune rheumatic
- •disease constitutes the principle illness, specifically:
- •Moderate-to-severe active systemic lupus erythematosus (SLE) with anti-dsDNA
- •positivity and renal involvement, or other organ involvement that impedes on
- •ability to score ESSDAI domains
- •- Active rheumatoid arthritis (RA) that impedes on the ability to score the
- •ESSDAI articular domain
- •- Systemic sclerosis
- •- Any other concurrent connective tissue disease (e.g., lupus nephritis (LN),
- •large vessel vasculitis (LVV), Sharp syndrome (mixed connective tissue disease)
- •that is active and requires immunosuppressive treatment outside the scope of
- •this trial and would impede on Sjögren's Syndrome organ domain assessments
- •2. Use of other investigational drugs other than iscalimab during the core study
- •3. Active uncontrolled viral, bacterial or other infections requiring systemic
- •treatment at the time of enrollment, or history of recurrent clinically
- •significant infection or of bacterial infections with encapsulated organisms
研究者
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