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

ovartis Pharma AG0 个研究点目标入组 160 人开始时间: 2020年11月10日最近更新: 2024年9月2日

研究概览

暂无简介。

•Participants eligible for inclusion in this study must meet all of the following criteria:
•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
•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 136
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 24

•Participants meeting any of the following criteria are not eligible for inclusion in this study.
•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
•Other protocol-defined inclusion/exclusion criteria may apply

发起方