NCT06859099Enrolling by invitationPhase 3
Long-term Safety and Efficacy Study of Riliprubart in Participants With CIDP
Long-term Extension Study to Evaluate the Safety and Efficacy of Riliprubart (SAR445088) in Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 27 Feb 2025
- Start date
- 1 Apr 2025
- Primary completion date
- 3 Oct 2029
- Lead sponsor
- Sanofi
- NCT number
- NCT06859099
- EU CT number
- 2024-517032-22-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 300
- From 1 Apr 2025 to the primary completion date, 3 Oct 2029
- 63 sites in 24 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- Pregnancy, defined as a positive result of a highly sensitive urine or serum pregnancy test, or lactation
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (63)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.