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Enrolling by invitationPhase 3

Long-term safety of riliprubart for chronic inflammatory demyelinating polyneuropathy

Tests riliprubart over the long term in adults with chronic inflammatory demyelinating polyneuropathy.

Key facts

Who runs it
Sanofi
Where
Bunkyo-Ku, Higashi-Matsuyama, and Kodaira, JapanSee the 3 sitesAlso in 23 other countries, 60 sites
Trial code
Registry title
Long-term Safety and Efficacy Study of Riliprubart in Participants With CIDP
Status
Enrolling by invitation
Phase
Phase 3
People taking part
300 people, planned
Started
1 Apr 2025
Expected to end
3 Oct 2029
Type of study
Interventional
Treatments tested
  • Riliprubart Prefilled Pen (PFP)
Record updated
27 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with CIDP who are taking riliprubart and finished Part B of one of three earlier riliprubart studies. They want to keep getting the treatment.

Age
18 years or older
Sex
Men and women
Disease stage
Chronic inflammatory demyelinating polyneuropathy (CIDP)
Earlier treatment
Must be taking riliprubart now and have finished Part B of study PDY16744, EFC17236 or EFC18156. People in Part C of PDY16744 can join after the Part C End of Treatment visit.

Main reasons for not taking part

  • Pregnancy or breastfeeding
  • Diagnosis of systemic lupus erythematosus (SLE)
  • Allergy to riliprubart or severe allergic reaction to a humanized or murine monoclonal antibody
  • Living in an institution because of a regulatory or legal order
  • Judged by the investigator as unable to take part

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

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

Where in Japan

Also in 23 other countries, 60 sites

  • Bunkyo-Ku, TokyoHospital not named in the registryNo longer taking part
  • Higashi-Matsuyama, SaitamaHospital not named in the registryNo longer taking part
  • Kodaira, TokyoHospital not named in the registryNo longer taking part

About the trial

What the trial wants to find out

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.

The group in the trial

  • riliprubartTreatment being tested

    Participants receive subcutaneous injection with a riliprubart prefilled pen (PFP)

    Treatment: Riliprubart Prefilled Pen (PFP)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Long-term Extension Study to Evaluate the Safety and Efficacy of Riliprubart (SAR445088) in Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Plain-language title
Long-term safety of riliprubart for chronic inflammatory demyelinating polyneuropathyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
27 October 2026