Long-term Extension Study to Evaluate the Safety and Efficacy of Riliprubart (SAR445088) in Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 发起方
- Sanofi
- 入组人数
- 300
- 试验地点
- 49
- 主要终点
- Number of participants having any AEs, SAEs, adverse events leading to treatment discontinuation, AESIs, and potentially clinically significant abnormalities (PCSAs) in safety laboratory tests, ECGs, and vital signs during the study period
研究概览
简要总结
This study is a Phase 3 extension, global, multicenter open-label study. The purpose of this study is to evaluate long-term safety and efficacy of riliprubart in adult participants with chronic inflammatory demyelinating polyneuropathy (CIDP) who have completed Part B in 1 of 3 parent studies (PDY16744, EFC17236, or EFC18156) and wish to continue treatment with riliprubart. Up to approximately 300 participants will be enrolled to continue receiving treatment with riliprubart. The duration of participation for each participant will be up to approximately 4 years, including posttreatment follow-up. The treatment duration will be up to approximately 3 years. A participant who discontinues riliprubart treatment at any time during the study will be followed for safety for a minimum of 55 weeks after the last dose of riliprubart received.
详细描述
This is a single-arm study. All participants transitioning to Study LTS17261 will receive riliprubart weekly for up to 3 years, or until commercialization of riliprubart for the treatment of CIDP or termination of the riliprubart clinical development program for the treatment of CIDP, or the local availability of other options for long-term treatment with riliprubart, whichever comes first.
The total number of study visits will be 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •Participants with chronic inflammatory demyelinating polyneuropathy (CIDP) currently receiving riliprubart who completed treatment in Part B of Study PDY16744, Study EFC17236, or Study EFC
- •(Participants receiving riliprubart in Part C of PDY16744 are eligible after completing the Part C End of Treatment visit.)
- •All participants must agree to use contraception methods during and after the study as required. Contraceptive use by men and women participating in the study should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Participant must be capable of giving signed informed consent as described in Appendix 1 of the protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Pregnancy, defined as a positive result of a highly sensitive urine or serum pregnancy test, or lactation
- •Clinical diagnosis of systemic lupus erythematosus (SLE)
- •History of any hypersensitivity to riliprubart or any of its components, or severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibody
- •Any country-related specific regulation that would prevent the participant from entering the study
- •Accommodation in an institution because of regulatory or legal order; for instance, a prisoner or participant who is legally institutionalized
- •Unsuitability for participation as judged by the Investigator, whatever the reason, including: medical or clinical condition, potential risk of participant noncompliance with study procedures, or any other clinically significant change in the participants' medical condition
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
riliprubart
Participants receive subcutaneous injection with a riliprubart prefilled pen (PFP)
干预措施: Riliprubart Prefilled Pen (PFP) (Drug)
结局指标
主要结局
Number of participants having any AEs, SAEs, adverse events leading to treatment discontinuation, AESIs, and potentially clinically significant abnormalities (PCSAs) in safety laboratory tests, ECGs, and vital signs during the study period
时间窗: Up to End of Study (approx. 4 years)
adverse events: AEs, serious adverse events: SAEs, adverse events of special interest: AESIs, electrocardiograms: ECGs
次要结局
- Percentage of participants relapse-free since the first dose of riliprubart in the parent study (PDY16744, EFC17236, or EFC18156)(From first dose of riliprubart in parent study to end of treatment (up to approx. 7 years))
- Percentage of participants experiencing improvement from baseline(From Baseline to 3 years)
- Change from baseline in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score over time(From Baseline to 3 years)
- Change from baseline in Inflammatory Rasch-built Overall Disability Scale (I-RODS) over time(From Baseline to 3 years)
- Change from baseline in grip strength (kilopascals; dominant hand) over time(From Baseline to 3 years)
- Change from baseline in Medical Research Council-Sum Score (MRC-SS) for muscle strength over time(From Baseline to 3 years)