Long-term Safety and Efficacy Study of Riliprubart in Participants With CIDP

Más betegség

• History of any hypersensitivity to riliprubart or any of its components, or severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibody
• 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.

Laborértékek

• Pregnancy, defined as a positive result of a highly sensitive urine or serum pregnancy test, or lactation

Egyéb

• Participants are excluded from the study if any of the following criteria apply:
• Clinical diagnosis of systemic lupus erythematosus (SLE)
• 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

• 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 EFC18156. (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.