Long-term extension study to evaluate the safety and efficacy of riliprubart (SAR445088) in participants with chronic inflammatory demyelinating polyneuropathy (CIDP)

未提供0 个研究点目标入组 300 人开始时间: 待定

适应症

试验速览

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•Participants are eligible to be included in the study only if all of the following criteria apply:
•Participants with 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.

•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.

发起方

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