JPRN-jRCT2031210392已完成3 期
An open-label study for sutimlimab in participants with cold agglutinin disease (CAD) who have completed the CARDINAL study (BIVV009-03/EFC16215, Part B) or CADENZA study (BIVV009-04/EFC16216, Part B) in Japan
Tanaka Tomoyuki0 个研究点目标入组 7 人开始时间: 2021年10月27日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
研究概览
简要总结
All 7 participants who completed the previous studies in Japan were enrolled and received sutimlimab. All 7 participants experienced at least 1 TEAE. The most frequently reported TEAEs were back pain and pyrexia. In total, 3 TESAEs (cholangitis acute, spontaneous bacterial peritonitis, and chronic kidney disease) were reported in 1 participant who died. All of TESAEs were assessed as not related to sutimlimab. There were no other participants who had serious TEAEs. No AESIs were reported in the study.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Participant must be adults.
- •- Participants who have been enrolled in, and has completed Part B of CARDINAL or CADENZA study
- •- Participants who have ongoing diagnosis of cold agglutinin disease (CAD)
- •- Participants who continue to require treatment for CAD upon completion of participation in the previous study evidenced by return of CAD-related symptoms of anemia and/or deterioration on markers of hemolysis after the end of study visit following the 9-week safety follow up period. (9-week follow up period).
- •- Participants who have acceptable benefit/risk profile
- •- Participant who has acceptable infection risk
- •- Participants who have no available appropriate alternative therapy for CAD
- •- Body weight of >=39 kg
- •- Giving signed informed consent
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •- Clinical diagnosis of systemic lupus erythematosus (SLE) or immune complex mediated autoimmune disorders.
- •- Participants who meet recent Rituximab and/or immunosuppressive therapy.
- •- Any of the following medical conditions:
- •a) Active, serious intercurrent illness which will preclude enrolment until recovery is complete.
- •b) Pregnancy or breast-feeding.
- •- End of Study visit in CARDINAL or CADENZA took place more than 3 months before baseline visit in this study.
- •- Hypersensitivity reactions to sutimlimab or components thereof, or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
研究者
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